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Identifying the worries and concerns about hypoglycemia in adults with type 2 diabetes
Identifying the Worries and Concerns about Hypoglycemia in Adults with Type 2 Diabetes W.H. Polonsky, L. Fisher, D. Hessler, S.V. Edelman PII: DOI: Reference:
S1056-8727(15)00329-3 doi: 10.1016/j.jdiacomp.2015.08.002 JDC 6517
To appear in:
Journal of Diabetes and Its Complications
Received date: Revised date: Accepted date:
21 July 2015 1 August 2015 4 August 2015
Please cite this article as: Polonsky, W.H., Fisher, L., Hessler, D. & Edelman, S.V., Identifying the Worries and Concerns about Hypoglycemia in Adults with Type 2 Diabetes, Journal of Diabetes and Its Complications (2015), doi: 10.1016/j.jdiacomp.2015.08.002
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ACCEPTED MANUSCRIPT IDENTIFYING THE WORRIES AND CONCERNS ABOUT HYPOGLYCEMIA IN ADULTS WITH TYPE 2 DIABETES
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W.H. Polonsky1,2; L. Fisher3, D. Hessler3, S.V. Edelman4
Department of Psychiatry, University of California, San Diego, USA
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Behavioral Diabetes Institute, San Diego, USA
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Department of Family and Community Medicine, University of California, San Francisco
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Division of Endocrinology and Metabolism, University of California, San Diego, and Veterans
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Affairs Medical Center, San Diego
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Corresponding author: William H. Polonsky, PO Box 2148, Del Mar, CA, PHONE: 760-525-
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5256, FAX: 760-942-5780, [email protected]
Running Title: Worries and concerns about hypoglycemia Word count: 3116 Tables: 5 Figures: 0
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ACCEPTED MANUSCRIPT ABSTRACT AIMS. To identify the hypoglycemic concerns of adults with type 2 diabetes (T2D) and examine
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how these concerns are associated with key patient characteristics.
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METHODS: Qualitative interviews with 16 T2D adults and 11 diabetes care providers were conducted. Survey items were then developed and submitted to exploratory factor analyses
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(EFA). Construct validity was assessed by correlations with diabetes distress, anxiety and
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depressive symptoms, well-being, hypoglycemic fear, hypoglycemia history and glycemic control (A1C).
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RESULTS: An EFA with 226 insulin users and 198 non-insulin users yielded 3 factors (14 items): Hypoglycemia Anxiety, Avoidance and Confidence. For both T2D groups, higher
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Anxiety and Avoidance were significantly associated with more hypoglycemia, lower well-being,
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and greater diabetes distress, depressive symptoms and hypoglycemic fear. Similar associations, in the converse direction, were found for Confidence. Among insulin users only, Anxiety was
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independently associated with greater emotional distress and more hypoglycemia, while
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Confidence was independently linked to less emotional distress and lower A1C. Avoidance was independently associated with greater emotional distress in both groups. CONCLUSIONS: Using the new 14-item Hypoglycemic Attitudes and Behavior Scale (HABS), we found that hypoglycemic concerns are significant in T2D adults, are linked to emotional distress and A1C, and merit attention in clinical practice.
KEYWORDS: Hypoglycemia; fear; worry; avoidance; type 2 diabetes; distress
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ACCEPTED MANUSCRIPT 1. INTRODUCTION Worries and concerns about hypoglycemia among adults with diabetes often have a
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deleterious impact on glycemic control and quality of life [1, 2]. Most of the available literature,
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however, has focused primarily on type 1 diabetes (T1D) and, except for a handful of recent studies [3-7], little is known about hypoglycemic worries in type 2 diabetes (T2D). For example,
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it is unclear how common and pervasive such concerns may be among those with T2D and how,
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or if, they may influence self-management decisions and glycemic control. Given the impact of hypoglycemic worries and concerns among T1D individuals, should clinicians be equally
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attentive to similar experiences among T2D adults?
We suspect that there may be important differences in the experience of hypoglycemic
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worries and concerns between those with T1D and those with T2D, given, for example, the
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relatively limited exposure to hypoglycemia in T2Ds compared to T1Ds. Furthermore, many of the potentially unique features or concerns about hypoglycemia in T2D may not be captured by
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existing measures, such as the Hypoglycemic Fear Survey (HFS), a widely-used self-report scale
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developed by Gonder-Frederick and her colleagues several decades ago [8] and later revised as the HFS-II [9]. The HFS and HFS-II were originally validated with T1D samples and most studies since that time have focused almost exclusively on T1D [10]. Therefore, to help describe the experience of T2D adults, we developed the Hypoglycemic Attitudes and Behavior Scale (HABS) and herein describe its development and validation. More critically, we used the HABS to examine the following research questions: 1. What are the key worries and concerns that characterize T2D attitudes about hypoglycemia? 2. How prevalent are hypoglycemic worries and concerns in the T2D population?
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ACCEPTED MANUSCRIPT 3. Do such worries and concerns differ between those T2D patients who use and do not use insulin?
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4. How are T2D patient characteristics, including demographic factors as well as previous
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experience with hypoglycemia, linked to current worries and concerns?
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2. METHODS 2.1 Design, setting and sample
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With content guided by the current literature, we conducted structured interviews with 16 adults
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with type 2 diabetes (T2D), half of whom were using insulin and half of whom were not, and with 11 diabetes health care professionals (HCPs). We recorded respondents’ verbal descriptions
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of their attitudes and experiences concerning hypoglycemia, including their ability to manage diabetes and the impact of hypoglycemia on their overall health and quality of life (QOL).
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Content saturation was reached after the 16 patient ad 11 HCP interviews, such that no new
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worries or concerns were identified. Responses were reviewed for duplication and were converted into an initial set of 30 survey items. The draft scale was formatted such that
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respondents could rate each item on a 5-point scale: 1 = ”strongly disagree”, 2 = ”disagree”, 3 = ”neutral”, 4 = ”agree” and 5 = “strongly agree”. The 30 items were part of a larger, online assessment battery that included previously validated instruments to be used for documenting the construct validity of the new scale. Separate samples of insulin-using and non-insulin-using T2D adults were recruited from the Taking Control of Your Diabetes (TCOYD) Research Registry, an online platform of individuals recruited primarily from TCOYD’s one-day diabetes education events in the United States. For the current study, participants were required to be > 21 years old and diagnosed with type 2 diabetes > 1 year. Respondents were asked to complete a brief eligibility questionnaire, an
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ACCEPTED MANUSCRIPT informed consent and the survey battery online. They received a $10 electronic gift card for participation. The research protocol was approved by Ethical and Independent Review Services,
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a community-based, institutional review board.
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2.2 Measures
Three groups of measures were included. Demographic measures included age, gender,
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ethnicity (Non-Hispanic White vs. not Non-Hispanic White), education (years), type of diabetes,
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number of years since diagnosis, and body mass index (BMI, calculated from self-reported weight and height). Diabetes status included frequency of self-monitoring of blood glucose
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(SMBG), self-reported last A1C value, number of low blood glucoses (< 70 mg/dl) in the past week, symptoms of hypoglycemia in the past week, and any occurrence of severe hypoglycemia
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during the past six months (i.e., an event requiring the assistance of another person).
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Psychosocial measures included the World Health Organization-5 (WHO-5), a 5-item scale that assesses well-being (alpha = .86) [11]; the Diabetes Distress Scale (DDS), which assesses
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worries and concerns specifically related to diabetes and its management and has been shown to
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be a good marker of diabetes-related QOL (alpha = .93) [12]; the 7-item Generalized Anxiety Disorder Assessment (GAD-7), a widely used measure of global anxiety (alpha = .92) [13]; the HFS-II, including both the behavior (HFS-B) (alpha = .94) and worry subscales (HFS-W) (alpha = .85) [9]; and the Patient Health Questionnaire-8 (PHQ-8) [14], an 8-item scale that assesses symptoms linked to DSM-V criteria for Major Depressive Disorder (alpha = .89). The suicide item was omitted, which does not affect scale distribution or utility of cut-points [15]. 2.3 Data Analysis Chi-square and t tests, as appropriate, were conducted to test for differences in participant characteristics and outcome variables between insulin-using and non insulin-using T2D
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ACCEPTED MANUSCRIPT individuals. Separate exploratory factor analyses (EFA) with Promax rotation were conducted for each of the two samples to determine whether the HABS items could be reduced and grouped
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into meaningful subscales, and to explore whether differences in response patterns might point to
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the construction of separate instruments for each sample. Construct validity was examined by Pearson correlations between HABS scores and the psychosocial variables, A1C and
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hypoglycemia history. Hierarchical regression analyses examined the unique contribution of
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each of the resulting HABS subscales on key psychosocial constructs and hypoglycemia history.
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3. RESULTS 3.1 Clinical characteristics of the sample
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Four hundred thirty-seven T2D patients began the survey, with 424 (97%) completing the entire survey (insulin-using N = 226; non insulin-using N = 198) (Table 1). Among insulin-using
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participants, the majority reported using a pen for insulin administration (68.4%), while 20.4%
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used vial and syringe and 11.1% used an insulin pump. As expected, the insulin-using group reported a significantly longer duration of diabetes, higher A1C, more frequent and more severe
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hypoglycemic events, and more frequent blood glucose monitoring than the non-insulin-using group (all p < .001). In addition, insulin users reported higher diabetes distress (p = .009), poorer well-being (p < .001), greater general anxiety (p < .001), and greater hypoglycemic fear (both HFS-B and HFS-W, p < .001) than non-insulin users. 3.2 Factor analysis of the HABS An exploratory factor analysis of the 30 original HABS items yielded 4-factor solutions (eigenvalues > 1.00) for each T2D sample that accounted for 55.1% of the common item variance for the non-insulin group and 58.6% for the insulin group. A review of the scale items in each factor and the scree plot of successive eigenvalues indicated that three factors provided a
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ACCEPTED MANUSCRIPT good description of the data in each analysis. Items that were poorly loaded (< .50) on all factors or that were cross-loaded on multiple factors (i.e., > .30) were dropped, and the remaining items
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were submitted to a second EFA for each sample. Fourteen of these items were identical across
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the two samples. The final EFA yielded three coherent, meaningful factors in each sample that accounted for 55.6% of the variance in the non-insulin group and 61.3% in the insulin group
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(Table 2).
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The three subscales were labeled as follows: Hypoglycemia Anxiety centered on a profound unease concerning the potential harm that hypoglycemia might cause, e.g. “I am
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terrified that I might injure myself or someone else because of a low blood sugar episode.” (5 items, alpha = .85 for insulin user, .83 for non-insulin users); Hypoglycemia Avoidance focused
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on the use of frequent, typically unhealthy actions to avoid the possibility of hypoglycemic
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problems, e.g., “To avoid serious problems due to low blood sugar, I eat or drink a lot more often than I really need to.” (4 items, alpha = .77 insulin users, .74 non-insulin users); and
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Hypoglycemia Confidence reflected a sense of personal strength and comfort drawn from having
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the resources needed to stay safe from any hypoglycemia-related problems, e.g., “I am confident that I can catch and respond to low blood sugar before my blood sugars get to low.” (5 items, alpha = .80 insulin users, .73 for non-insulin users). Thus, analysis of the initial HABS items yielded the same three coherent, internally consistent and reliable subscales for each T2D sample. Each subscale total was calculated as the mean of the contributing items (range = 1.0 to 5.0). Inter-correlations among subscales were low to moderate (r = ± .13 to r = ± .51 insulin users; r = ± .33 to r = ± .48 non-insulin users). Mean HABS subscale scores for insulin and noninsulin users, respectively, were: Anxiety =1.93 (+ .78) and 1.65 (+ .64), Avoidance = 2.50 (+ .92) and 2.37 (+ .82), and Confidence = 3.75 (+ .75) and 3.93 (+ .70). Of note, mean scores
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ACCEPTED MANUSCRIPT for insulin users were significantly higher for Anxiety (p < .001) and lower for Confidence (p = .01) than for non-insulin users. No between-sample differences were noted for Avoidance.
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Correlations between the three HABS scores and demographics and diabetes status
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(Table 3) yielded only one significant finding for non-insulin-using respondents: greater Anxiety was significantly associated with shorter time since diagnosis (r = -.16, p = .03). Among insulin
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users, greater Confidence was linked to higher BMI (r = .14, p = .04) and longer time since
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diagnosis (r = .15, p = .03); greater Avoidance was associated with younger age (r = -.20, p = .003); and greater Anxiety was linked to younger age (r = -.20, p = .003), lower BMI (r = -.19,
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p = .005) and shorter time since diagnosis (r = -.24, p = .001). Of note, there were no significant associations between frequency of SMBG, gender or ethnicity and any of the HABS scales,
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neither for insulin users nor non-insulin users. The findings suggest greater concerns and worries
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about hypoglycemia among younger adults and those with a shorter history of T2D, especially among insulin-using patents.
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3.3 Construct Validity of the HABS
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The three HABS subscales were significantly associated with the construct validity variables for both the insulin-using and non-insulin-using samples (Table 4). Higher Anxiety and Avoidance scores were significantly associated with: lower well-being, greater diabetes distress, more symptoms of depression and anxiety, higher HFS-W and HFS-B scores, and higher incidence of hypoglycemic episodes (all p < .05). Similar significant associations in the converse direction were found for the Confidence scale. One notable difference between the insulin-using and non-insulin-using samples was the link between HABS and glycemic control: higher A1C levels were significantly associated with greater Avoidance and lower Confidence, but only for insulin users.
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ACCEPTED MANUSCRIPT 3.4 The Independent Value of the Three HABS Subscales Because fear of hypoglycemia has been the central focus of the majority of studies (most
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typically involving use of the HFS-W), we also examined the added utility of the HABS
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Avoidance and Confidence subscales, over and above the HABS Anxiety scale. In multiple regression equations, after adjusting for demographics in Step 1, Anxiety was entered in Step 2
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and Avoidance and Confidence were entered in Step 3, with psychosocial variables, glycemic
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control and hypoglycemic events as dependent variables.
Among insulin users, all three HABS subscales reached statistical significance in the
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third step of the equation for most outcomes (Table 5). Most importantly, Avoidance and Confidence accounted for significant variance over and above Anxiety. Avoidance was
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significantly associated with: lower well-being, greater diabetes distress, more symptoms of
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depression and anxiety, and more frequent hypoglycemic symptoms in the past week. HABS Confidence was significantly associated with lower A1c and lower likelihood of experiencing a
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severe episode of hypoglycemia in the past 6 months. These findings point to the independent
with T2D.
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utility of each scale, with respect to the dependent variables studied for insulin-using individuals
For non-insulin users, only Avoidance and Confidence reached statistical significance with the psychosocial and hypoglycemia dependent variables in Step 3. HABS Anxiety, which was significant in step 2, was no longer significant in step 3. Higher HABS Confidence was independently associated with greater well-being and lower anxiety, with a trend toward lower diabetes distress and fewer recent occurrences of hypoglycemic symptoms and events. Greater HABS Avoidance was independently associated with lower well-being, higher diabetes distress, and more symptoms of depression and anxiety. It is noteworthy that Confidence and Avoidance
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ACCEPTED MANUSCRIPT explained a larger portion of the variance in outcomes than Anxiety, suggesting their unique
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utility and their potentially important role for T2D adults not using insulin.
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4. DISCUSSION
The14-item Hypoglycemic Attitudes and Behavior Scale (HABS) consists of three
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clinically meaningful subscales that capture key features associated with T2D adults’ hypoglycemic experience. Two of these are oriented toward the more negative aspects of this
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experience-- Hypoglycemia Anxiety, which focuses on the major fears that individuals may
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harbor about hypoglycemia, and Hypoglycemia Avoidance, which centers on the typically unhealthy actions taken to prevent or avert the possibility of hypoglycemia. The third subscale,
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Hypoglycemia Confidence, focuses on the more positive element of the experience and highlights the individual’s sense of their ability to stay safe from hypoglycemic problems.
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Although EFAs resulted in the same HABS subscales for both T2D samples, there were
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notable between-group differences in the relationship of the HABS with demographic, diabetes status and psychosocial variables. For example, T2D insulin users report significantly more
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Anxiety and less Confidence than non-insulin users, perhaps due to the greater frequency and ongoing risk of hypoglycemia in the former group. In contrast, Avoidance is similarly common among both insulin and non-insulin users, and is independently associated with greater emotional distress in both groups. Finally, Confidence is independently linked to less emotional distress, but only among non-insulin users, and is associated with better glycemic control, but only among insulin users. Of note, concerns and worries about hypoglycemia are generally greater among younger individuals and those with a shorter history of T2D, especially among insulin-using patents. In total, these findings suggest that the hypoglycemia experience is meaningful and
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ACCEPTED MANUSCRIPT impactful for both T2D insulin users and non insulin-users, but that it is notably different for each.
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Overall, these findings indicate that major concerns about hypoglycemia are far from rare
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in T2D adults. We find that 43.8% of insulin users and 27.3% of non-insulin users report hypoglycemic symptoms within the past week. In addition, 19.5% of insulin users and 11.1% of
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non-insulin users report at least one severe event within the past 6 months. Although HABS cut-
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off points have not yet been determined statistically, if we consider the face validity of the response options, a mean score > 3.0 would indicate general agreement. Using this criterion,
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mean HABS Avoidance scores > 3.0 are observed in 35.4% of insulin users and 29.8% of noninsulin users, suggesting that unhealthy actions to avoid hypoglycemia are common. Paralleling
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this finding, Confidence appears to be relatively low, with only 16.4% of insulin users and 7.1%
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of non-insulin users achieving a mean score > 3.0. Anxiety is less prevalent, with only 12.4 % of insulin users and 5.1% of non-insulin users scoring > 3.0. In sum, these data suggest that worries
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about hypoglycemia in the T2D population may be more widespread than has been commonly
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assumed, even among those who do not use insulin. Our findings build upon those of Gonder-Frederick and her colleagues in the development of the HFS [8, 9]. The HABS items were developed to differ from the HFS in three major ways: HABS Anxiety items were created to assess unreasonable fears and worries (thus, the use of the word “terrified” in each item); HABS Avoidance items were similarly developed to highlight unhealthy actions that would not likely be construed as reasonable responses. HABS Confidence items were created to highlight an aspect of an individual’s hypoglycemic experience that has not been previously considered: not merely the absence of fear and worry, but a sense that hypoglycemia concerns can be mastered. Of note, the HABS was developed for and
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ACCEPTED MANUSCRIPT evaluated with T2D adults only, which is quite different from the T1D population that has been the major focus of HFS studies [10]. Since this study was not designed to determine whether the
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HABS is a better, or worse, tool than the HFS, we recommend the HABS as a complement to the
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HFS when exploring the ramifications of hypoglycemia among T2D individuals. These data raise important implications regarding how concerns about hypoglycemia in
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the T2D population are acknowledged and addressed. Our findings indicate that there are real
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and coherent worries about hypoglycaemia among both insulin- and non insulin-using T2D adults. Focusing attention solely on feelings of fear and anxiety, however, tells only part of the
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story. Equally, if not more importantly, is how T2D adults cope with their concerns, especially through such negative means as avoidance strategies [16], as well as their overall sense of self-
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efficacy in the face of hypoglycemia. These concerns are rarely addressed in clinical care. Of the
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three major dimensions of hypoglycemic concerns that we have identified, it is striking that only Confidence is positively linked to glycemic control, suggesting that a focus on addressing low
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levels of hypoglycemic confidence may be especially beneficial in helping T2D adults feel more
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comfortable in following management recommendations. It is because of these distinct differences in the three HABS dimensions that we have not put forward a HABS total score; each subscale provides unique information and a score that combines all three may not be meaningful. The strengths of this study are that relatively large numbers of T2D adults, both insulinusing and non-insulin-using, participated; the initial HABS items were generated directly from interviews with T2D adults and healthcare professionals; and the resulting HABS subscales indicate acceptable reliability and validity. Several limitations should be acknowledged. The samples were highly educated and mostly Non-Hispanic White, both of which may restrict
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ACCEPTED MANUSCRIPT generalizability. Given the noted prevalence of T2D among Hispanics and African Americans as well as in those with lower literacy, the scales should be re-evaluated with a more diverse sample.
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Also, height, weight and glycemic control were assessed via self-report, which may introduce
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bias. In this last case, however, it is noteworthy that the mean A1C of our study sample (7.3%) was very close to the A1C mean value derived from the NHANES study (7.2%) [17].
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Furthermore, in our previous studies with T1D adults, there was a high level of agreement
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between self-reported and laboratory assessed A1C (r= .84; see Fisher et al, in preparation). 5. CONCLUSIONS
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Our findings suggest that hypoglycemia fears and worries are pervasive among both insulin-using and non insulin-using T2D adults, and that they are significantly related to
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demographic, diabetes status and psychosocial variables in both groups. The HABS is a valid
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and reliable measure that captures key elements of hypoglycemic worries and concerns among adults with T2D. It is comprised of three subscales that can help to pinpoint an individual’s
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clinical intervention.
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specific hypoglycemic concerns, thus allowing for greater understanding and more targeted
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ACCEPTED MANUSCRIPT Conflicts of Interest No author reported a conflict of interest. William Polonsky: consultant for Sanofi Diabetes Care,
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Dexcom, Roche Diabetes Care, Abbott Diabetes Care and Johnson & Johnson; Lawrence Fisher:
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consultant for Roche Diabetes Care, Eli Lilly, Abbott Diabetes Care and Sanofi Diabetes Care; Steven Edelman: consultant for Sanofi Diabetes Care, Dexcom, Bayer Diabetes Care, Abbott
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Diabetes Care and Johnson & Johnson.
Acknowledgements
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This investigator-initiated study was supported by Sanofi.
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ACCEPTED MANUSCRIPT analysis by the Centers for Disease Control and Prevention, National Center for Chronic
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Disease Prevention and Health Promotion, Division of Diabetes Translation.
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58.1 (11.4) 273 (64.4%) 14.8 (4.0)
T2DM not using insulin (n=198) 58.1 (11.4) 129 (66.2%) 15.0 (3.9)
T2DM using insulin (n=226) 58.1 (11.5) 144 (63.7%) 14.7 (4.1)
314 (74.1%) 25 (5.9%) 21 (5.0%) 32 (7.5%) 4 (0.9%) 17 (4.0%) 11 (2.6%) 11.6 (9.2)
142 (71.7%) 15 (7.6%) 7 (3.5%) 17 (8.6%) 3 (1.5%) 8 (4.0%) 6 (3.0%) 8.8 (8.0)
172 (76.1%) 10 (4.4%) 14 (6.2%) 15 (6.6%) 1 (0.4%) 9 (4.0%) 5 (2.2%) 14.1 (9.5)
36 (9.2%) 72 (18.3%) 85 (21.6%) 65 (16.5%) 136 (34.5%)
31 (17.6%) 45 (25.4%) 41 (23.2%) 38 (21.5%) 22 (12.4%)
5 (2.3%) 27 (12.4%) 44 (20.3%) 27 (12.4%) 114 (52.5%)
302 (71.2%) 82 (19.3%) 40 (9.4%)
163 (82.3%) 28 (14.1%) 7 (3.5%)
139 (61.5%) 54 (23.9%) 33 (14.6%)
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Total sample (n=424) Age Gender (female) Education level (years) Ethnicity Non-Hispanic White (NHW) African American Hispanic Asian or Pacific Islander Native American Mixed race Other Years since diagnosis SMBG frequency Once a week or less A few times a week Once daily Twice daily More than twice daily Number of low blood glucose readings (<70), past week 0 1-2 3 or more Number of times experienced symptoms of hypoglycemia, past week 0 1-2 3 or more Severe hypoglycemic event (requiring assistance of another), past 6 months) BMI A1C % Mmol/mol Well-being (WHO-5) Diabetes Distress (DDS) PHQ GAD HFS-B HFS-W
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Table 1. Sample description by insulin use p value .94 .76 .49 .29
<.001 <.001
<.001
.002 271 (63.9%) 98 (23.1%) 55 (13.0%) 66 (15.6%)
144 (72.7%) 35 (17.7%) 19 (9.6%) 22 (11.1%)
127 (56.2%) 63 (27.9%) 36 (15.9%) 44 (19.5%)
33.4 (8.3)
32.6 (8.0)
34.1 (8.6)
7.3 (1.3) 56 (14.2) 2.9 (1.1) 2.2 (1.0) 9.4 (5.4) 4.1 (4.5) 11.1 (9.9) 16.5 (13.0)
6.8 (1.0) 51 (10.9) 3.1 (0.9) 2.1 (0.9) 8.9 (5.5) 3.2 (3.5) 7.8 (8.4) 13.2 (13.0)
7.7 (1.3) 61(14.2) 2.7 (1.1) 2.3 (1.0) 9.8 (5.3) 5.0 (5.0) 14.0 (10.2) 19.3 (12.4)
.02 .07 <.001
<.001 .009 .08 <.001 <.001 <.001
Means and standard deviations are presented for continuous variables. Comparing patients using insulin vs. not using insulin (t-test or χ2).
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ACCEPTED MANUSCRIPT Table 2. Factor analysis of Hypoglycemia Attitudes and Behaviors items by insulin use. T2DM not using insulin Anxiety
Confidence
I am terrified that I might pass out in public due to a low blood sugar episode.
.816
-.020
If I don't have plenty of emergency supplies to raise my blood sugar with me, I won't leave my house.
.681
-.023
I am terrified that I might injure myself or someone else because of a low blood sugar episode.
.711
-.083
.833
T2DM using insulin
Avoidance Anxiety Confidence Avoidance .856
-.069
-.084
.758
.013
-.209
.004
.657
-.127
.110
.026
.049
.743
.063
.262
.756
.046
.178
.804
.030
.145
-.085
.636
.115
-.213
.647
.171
.267
.821
-.166
.096
.733
-.148
-.062
.744
.107
.042
.788
-.034
-.076
.560
-.168
.054
.777
-.049
-.247
.623
.136
-.137
.704
.103
To avoid serious problems with low blood sugar, I tend to keep my blood sugars higher than I probably should.
-.160
-.067
.821
-.250
-.172
.888
Without even bothering to test, I take quick action to raise my blood sugars at the first hint of any funny feelings
.050
.165
.595
.057
.176
.661
To avoid serious problems due to low blood sugar, I eat or drink a lot more often than I really need to.
.219
-.004
.671
.054
-.035
.805
If I think my blood sugar is too low, I'll start eating and eating and I won't stop until I feel better.
.032
-.041
.716
.191
.056
.676
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I am confident that I can stay safe from serious problems with low blood sugar while driving.
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I am confident that I can stay safe from serious problems with low blood sugar while exercising.
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I am confident that I can avoid serious problems due to low blood sugar when I'm alone. I am confident that I can catch and respond to low blood sugar before my blood sugars get to low. I am confident that I can stay safe from serious problems with low blood sugar while out in public.
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To avoid serious problems due to low blood sugar, I stay close to home more than I would really like to. I spend so much time worrying about the possibility of a low blood sugar episode that it interferes with my ability to do the things I really want to do.
-.012
ACCEPTED MANUSCRIPT
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PT
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Bolded items are those that load most highly on the individual factor.
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ACCEPTED MANUSCRIPT
Confidence
-.07
-.03
.01
.03
Avoidance
-.02
.07
.16*
-.08
-.20**
-.07
-.19**
-.04
.01
.14*
-.01
.05
Avoidance
.01
-.12
.02
-.01
.04
-.10
-.24**
-.03
.08
.13
.15*
-.02
.07
-.06
-.05
.02
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*p<.05, ** p<.01
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-.20
***
.08
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Anxiety Confidence
-.10
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T2DM using insulin
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Table 3. Zero-order correlations between HABS subscales and patient demographics and diabetes status Age Gender BMI Education SMBG Years since Ethnicity level frequency diagnosis (NHW vs. non-NHW) T2DM not using insulin .11 -.13 Anxiety -.11 .01 -.07 .13 -.16*
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ACCEPTED MANUSCRIPT Table 4. Construct validity associations WHO5 Diabetes PHQ Distress
GAD
HFS- HFS-W BG < 70 Hypo Severe SelfB past symptoms hypoglycemia reported week past week in past 6 A1C monthsa
28
***
***
.28
***
-.18
***
.20
Anxiety Confidence
-.22
***
.45
Avoidance
-.30
**
.17
-.11
**
-.19
.24***
**
.21
**
.49
***
*** .24 .38
***
.30
***
-.25
***
-.34
***
.09
.15*
.10
.06
-.14*
-.15*
-.12
-03
.06
.14*
.02
.06
.35***
.33***
.49***
.06
-.01
-.02
-.05
-.14*
.26***
.35***
.32***
.15*
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-.28
Avoidance
**
.12
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Confidence
-.24
T2DM using insulin
-19
***
.44*
.37
-.14* .25***
***
-.15
***
.58
***
*** .37
.32***
.36
***
.55
***
-.30 .34
***
***
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CE
PT
ED
***
**
.24***
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.09
***
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Anxiety
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T2DM not using insulin
*p<.05, ** p<.01, *** p<.001. a
requiring assistance from another person
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ACCEPTED MANUSCRIPT Table 5. Hierarchical Regression Analyses
β
β
-.24***
.14+
.13+
.15
.08
.14*
1.61
.07
-.05 .19* -.19*
-.01 -.14+ .15*
.01 -.04 .22***
-.01 -.15* .15*
.01 -.15+ -.01
.03 -.14+ .07
1.29 .53 .74
.03 -.03 .03
.06** .06*** .18
.02+ .04* .09
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MA .01 .05** .09
.02* .04* .11
.01 .02 .07
.02+ .02 .11
.40***
.22***
.32***
.35***
.32***
3.21***
.07
-.08 .05 -.21**
.23** -.07 .27***
.11 -.11 .14*
.22** -.05 .14*
.37*** .12 .04
.26*** .08 .18**
2.07* .51* 1.55+
-.09 -.19* .15+
.04** .03* .16
.15*** .05*** .36
.05*** .02+ .14
.09*** .02+ .26
.11*** .01 .19
.10*** .03* .22
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-.21**
R2 change Step 2 R2 change Step 3 Total R2 at Step 3
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β
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T2DM USING INSULIN Step 2 Anxiety Step 3 Anxiety Confidence Avoidance
BG < Hypoglycemic Severe A1C 70 symptoms hypoglycemia past past week in past 6 week monthsa β β OR β
β
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R2 change Step 2 R2 change Step 3 Total R2 at Step 3
GAD
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T2DM NOT USING INSULIN Step 2 Anxiety Step 3 Anxiety Confidence Avoidance
PHQ
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WHO5 Diabetes Distress
.004 .002 .04
.004 .04* .11
+p<.10, *p<.05, ** p<.01, *** p<.001. a
requiring assistance from another person
Note: Hierarchical multiple regressions included the following steps: Step 1 (not pictured) age, years since diagnosis, gender, and ethnicity (NHW vs. non-NHW); Step 2 Anxiety; Step 3
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ACCEPTED MANUSCRIPT Confidence and Avoidance. Standardized beta coefficients are presented for continuous
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outcomes and odds ratios (OR) are presented for binary outcomes.
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ACCEPTED MANUSCRIPT IDENTIFYING THE WORRIES AND CONCERNS ABOUT HYPOGLYCEMIA IN ADULTS WITH TYPE 2 DIABETES
This study reports on the hypoglycemic worries and concerns of adults with type 2
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Highlights:
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diabetes (T2D) and examines how these concerns are associated with key patient characteristics.
We surveyed 226 T2D insulin users and 198 non-insulin users, leading to the
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concerns in T2D individuals.
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development of a new self-report instrument for assessing hypoglycemic worries and
The measure comprises three key subscales: Hypoglycemia Anxiety, Hypoglycemia
Among insulin users, all three subscales are independently associated with emotional
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Avoidance and Hypoglycemia Confidence.
distress, while Hypoglycemia Anxiety is linked to more frequent hypoglycemia and
Among non-insulin users, only Hypoglycemia Avoidance is independently associated
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Hypoglycemia Confidence is linked to lower A1C.
with emotional distress.
Hypoglycemic concerns are significant among T2D adults with type 2 diabetes, are linked to emotional distress and A1C, and merit attention in clinical practice. Taking time to discuss and address these issues with T2D patients could be of great value.
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S1056-8727(15)00329-3 doi: 10.1016/j.jdiacomp.2015.08.002 JDC 6517
To appear in:
Journal of Diabetes and Its Complications
Received date: Revised date: Accepted date:
21 July 2015 1 August 2015 4 August 2015
Please cite this article as: Polonsky, W.H., Fisher, L., Hessler, D. & Edelman, S.V., Identifying the Worries and Concerns about Hypoglycemia in Adults with Type 2 Diabetes, Journal of Diabetes and Its Complications (2015), doi: 10.1016/j.jdiacomp.2015.08.002
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT IDENTIFYING THE WORRIES AND CONCERNS ABOUT HYPOGLYCEMIA IN ADULTS WITH TYPE 2 DIABETES
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W.H. Polonsky1,2; L. Fisher3, D. Hessler3, S.V. Edelman4
Department of Psychiatry, University of California, San Diego, USA
2
Behavioral Diabetes Institute, San Diego, USA
3
Department of Family and Community Medicine, University of California, San Francisco
4
Division of Endocrinology and Metabolism, University of California, San Diego, and Veterans
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Affairs Medical Center, San Diego
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1
Corresponding author: William H. Polonsky, PO Box 2148, Del Mar, CA, PHONE: 760-525-
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5256, FAX: 760-942-5780, [email protected]
Running Title: Worries and concerns about hypoglycemia Word count: 3116 Tables: 5 Figures: 0
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ACCEPTED MANUSCRIPT ABSTRACT AIMS. To identify the hypoglycemic concerns of adults with type 2 diabetes (T2D) and examine
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how these concerns are associated with key patient characteristics.
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METHODS: Qualitative interviews with 16 T2D adults and 11 diabetes care providers were conducted. Survey items were then developed and submitted to exploratory factor analyses
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(EFA). Construct validity was assessed by correlations with diabetes distress, anxiety and
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depressive symptoms, well-being, hypoglycemic fear, hypoglycemia history and glycemic control (A1C).
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RESULTS: An EFA with 226 insulin users and 198 non-insulin users yielded 3 factors (14 items): Hypoglycemia Anxiety, Avoidance and Confidence. For both T2D groups, higher
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Anxiety and Avoidance were significantly associated with more hypoglycemia, lower well-being,
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and greater diabetes distress, depressive symptoms and hypoglycemic fear. Similar associations, in the converse direction, were found for Confidence. Among insulin users only, Anxiety was
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independently associated with greater emotional distress and more hypoglycemia, while
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Confidence was independently linked to less emotional distress and lower A1C. Avoidance was independently associated with greater emotional distress in both groups. CONCLUSIONS: Using the new 14-item Hypoglycemic Attitudes and Behavior Scale (HABS), we found that hypoglycemic concerns are significant in T2D adults, are linked to emotional distress and A1C, and merit attention in clinical practice.
KEYWORDS: Hypoglycemia; fear; worry; avoidance; type 2 diabetes; distress
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ACCEPTED MANUSCRIPT 1. INTRODUCTION Worries and concerns about hypoglycemia among adults with diabetes often have a
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deleterious impact on glycemic control and quality of life [1, 2]. Most of the available literature,
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however, has focused primarily on type 1 diabetes (T1D) and, except for a handful of recent studies [3-7], little is known about hypoglycemic worries in type 2 diabetes (T2D). For example,
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it is unclear how common and pervasive such concerns may be among those with T2D and how,
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or if, they may influence self-management decisions and glycemic control. Given the impact of hypoglycemic worries and concerns among T1D individuals, should clinicians be equally
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attentive to similar experiences among T2D adults?
We suspect that there may be important differences in the experience of hypoglycemic
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worries and concerns between those with T1D and those with T2D, given, for example, the
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relatively limited exposure to hypoglycemia in T2Ds compared to T1Ds. Furthermore, many of the potentially unique features or concerns about hypoglycemia in T2D may not be captured by
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existing measures, such as the Hypoglycemic Fear Survey (HFS), a widely-used self-report scale
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developed by Gonder-Frederick and her colleagues several decades ago [8] and later revised as the HFS-II [9]. The HFS and HFS-II were originally validated with T1D samples and most studies since that time have focused almost exclusively on T1D [10]. Therefore, to help describe the experience of T2D adults, we developed the Hypoglycemic Attitudes and Behavior Scale (HABS) and herein describe its development and validation. More critically, we used the HABS to examine the following research questions: 1. What are the key worries and concerns that characterize T2D attitudes about hypoglycemia? 2. How prevalent are hypoglycemic worries and concerns in the T2D population?
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ACCEPTED MANUSCRIPT 3. Do such worries and concerns differ between those T2D patients who use and do not use insulin?
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4. How are T2D patient characteristics, including demographic factors as well as previous
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experience with hypoglycemia, linked to current worries and concerns?
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2. METHODS 2.1 Design, setting and sample
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With content guided by the current literature, we conducted structured interviews with 16 adults
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with type 2 diabetes (T2D), half of whom were using insulin and half of whom were not, and with 11 diabetes health care professionals (HCPs). We recorded respondents’ verbal descriptions
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of their attitudes and experiences concerning hypoglycemia, including their ability to manage diabetes and the impact of hypoglycemia on their overall health and quality of life (QOL).
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Content saturation was reached after the 16 patient ad 11 HCP interviews, such that no new
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worries or concerns were identified. Responses were reviewed for duplication and were converted into an initial set of 30 survey items. The draft scale was formatted such that
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respondents could rate each item on a 5-point scale: 1 = ”strongly disagree”, 2 = ”disagree”, 3 = ”neutral”, 4 = ”agree” and 5 = “strongly agree”. The 30 items were part of a larger, online assessment battery that included previously validated instruments to be used for documenting the construct validity of the new scale. Separate samples of insulin-using and non-insulin-using T2D adults were recruited from the Taking Control of Your Diabetes (TCOYD) Research Registry, an online platform of individuals recruited primarily from TCOYD’s one-day diabetes education events in the United States. For the current study, participants were required to be > 21 years old and diagnosed with type 2 diabetes > 1 year. Respondents were asked to complete a brief eligibility questionnaire, an
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ACCEPTED MANUSCRIPT informed consent and the survey battery online. They received a $10 electronic gift card for participation. The research protocol was approved by Ethical and Independent Review Services,
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a community-based, institutional review board.
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2.2 Measures
Three groups of measures were included. Demographic measures included age, gender,
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ethnicity (Non-Hispanic White vs. not Non-Hispanic White), education (years), type of diabetes,
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number of years since diagnosis, and body mass index (BMI, calculated from self-reported weight and height). Diabetes status included frequency of self-monitoring of blood glucose
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(SMBG), self-reported last A1C value, number of low blood glucoses (< 70 mg/dl) in the past week, symptoms of hypoglycemia in the past week, and any occurrence of severe hypoglycemia
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during the past six months (i.e., an event requiring the assistance of another person).
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Psychosocial measures included the World Health Organization-5 (WHO-5), a 5-item scale that assesses well-being (alpha = .86) [11]; the Diabetes Distress Scale (DDS), which assesses
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worries and concerns specifically related to diabetes and its management and has been shown to
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be a good marker of diabetes-related QOL (alpha = .93) [12]; the 7-item Generalized Anxiety Disorder Assessment (GAD-7), a widely used measure of global anxiety (alpha = .92) [13]; the HFS-II, including both the behavior (HFS-B) (alpha = .94) and worry subscales (HFS-W) (alpha = .85) [9]; and the Patient Health Questionnaire-8 (PHQ-8) [14], an 8-item scale that assesses symptoms linked to DSM-V criteria for Major Depressive Disorder (alpha = .89). The suicide item was omitted, which does not affect scale distribution or utility of cut-points [15]. 2.3 Data Analysis Chi-square and t tests, as appropriate, were conducted to test for differences in participant characteristics and outcome variables between insulin-using and non insulin-using T2D
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ACCEPTED MANUSCRIPT individuals. Separate exploratory factor analyses (EFA) with Promax rotation were conducted for each of the two samples to determine whether the HABS items could be reduced and grouped
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into meaningful subscales, and to explore whether differences in response patterns might point to
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the construction of separate instruments for each sample. Construct validity was examined by Pearson correlations between HABS scores and the psychosocial variables, A1C and
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hypoglycemia history. Hierarchical regression analyses examined the unique contribution of
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each of the resulting HABS subscales on key psychosocial constructs and hypoglycemia history.
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3. RESULTS 3.1 Clinical characteristics of the sample
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Four hundred thirty-seven T2D patients began the survey, with 424 (97%) completing the entire survey (insulin-using N = 226; non insulin-using N = 198) (Table 1). Among insulin-using
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participants, the majority reported using a pen for insulin administration (68.4%), while 20.4%
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used vial and syringe and 11.1% used an insulin pump. As expected, the insulin-using group reported a significantly longer duration of diabetes, higher A1C, more frequent and more severe
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hypoglycemic events, and more frequent blood glucose monitoring than the non-insulin-using group (all p < .001). In addition, insulin users reported higher diabetes distress (p = .009), poorer well-being (p < .001), greater general anxiety (p < .001), and greater hypoglycemic fear (both HFS-B and HFS-W, p < .001) than non-insulin users. 3.2 Factor analysis of the HABS An exploratory factor analysis of the 30 original HABS items yielded 4-factor solutions (eigenvalues > 1.00) for each T2D sample that accounted for 55.1% of the common item variance for the non-insulin group and 58.6% for the insulin group. A review of the scale items in each factor and the scree plot of successive eigenvalues indicated that three factors provided a
6
ACCEPTED MANUSCRIPT good description of the data in each analysis. Items that were poorly loaded (< .50) on all factors or that were cross-loaded on multiple factors (i.e., > .30) were dropped, and the remaining items
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were submitted to a second EFA for each sample. Fourteen of these items were identical across
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the two samples. The final EFA yielded three coherent, meaningful factors in each sample that accounted for 55.6% of the variance in the non-insulin group and 61.3% in the insulin group
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(Table 2).
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The three subscales were labeled as follows: Hypoglycemia Anxiety centered on a profound unease concerning the potential harm that hypoglycemia might cause, e.g. “I am
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terrified that I might injure myself or someone else because of a low blood sugar episode.” (5 items, alpha = .85 for insulin user, .83 for non-insulin users); Hypoglycemia Avoidance focused
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on the use of frequent, typically unhealthy actions to avoid the possibility of hypoglycemic
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problems, e.g., “To avoid serious problems due to low blood sugar, I eat or drink a lot more often than I really need to.” (4 items, alpha = .77 insulin users, .74 non-insulin users); and
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Hypoglycemia Confidence reflected a sense of personal strength and comfort drawn from having
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the resources needed to stay safe from any hypoglycemia-related problems, e.g., “I am confident that I can catch and respond to low blood sugar before my blood sugars get to low.” (5 items, alpha = .80 insulin users, .73 for non-insulin users). Thus, analysis of the initial HABS items yielded the same three coherent, internally consistent and reliable subscales for each T2D sample. Each subscale total was calculated as the mean of the contributing items (range = 1.0 to 5.0). Inter-correlations among subscales were low to moderate (r = ± .13 to r = ± .51 insulin users; r = ± .33 to r = ± .48 non-insulin users). Mean HABS subscale scores for insulin and noninsulin users, respectively, were: Anxiety =1.93 (+ .78) and 1.65 (+ .64), Avoidance = 2.50 (+ .92) and 2.37 (+ .82), and Confidence = 3.75 (+ .75) and 3.93 (+ .70). Of note, mean scores
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ACCEPTED MANUSCRIPT for insulin users were significantly higher for Anxiety (p < .001) and lower for Confidence (p = .01) than for non-insulin users. No between-sample differences were noted for Avoidance.
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Correlations between the three HABS scores and demographics and diabetes status
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(Table 3) yielded only one significant finding for non-insulin-using respondents: greater Anxiety was significantly associated with shorter time since diagnosis (r = -.16, p = .03). Among insulin
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users, greater Confidence was linked to higher BMI (r = .14, p = .04) and longer time since
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diagnosis (r = .15, p = .03); greater Avoidance was associated with younger age (r = -.20, p = .003); and greater Anxiety was linked to younger age (r = -.20, p = .003), lower BMI (r = -.19,
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p = .005) and shorter time since diagnosis (r = -.24, p = .001). Of note, there were no significant associations between frequency of SMBG, gender or ethnicity and any of the HABS scales,
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neither for insulin users nor non-insulin users. The findings suggest greater concerns and worries
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about hypoglycemia among younger adults and those with a shorter history of T2D, especially among insulin-using patents.
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3.3 Construct Validity of the HABS
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The three HABS subscales were significantly associated with the construct validity variables for both the insulin-using and non-insulin-using samples (Table 4). Higher Anxiety and Avoidance scores were significantly associated with: lower well-being, greater diabetes distress, more symptoms of depression and anxiety, higher HFS-W and HFS-B scores, and higher incidence of hypoglycemic episodes (all p < .05). Similar significant associations in the converse direction were found for the Confidence scale. One notable difference between the insulin-using and non-insulin-using samples was the link between HABS and glycemic control: higher A1C levels were significantly associated with greater Avoidance and lower Confidence, but only for insulin users.
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ACCEPTED MANUSCRIPT 3.4 The Independent Value of the Three HABS Subscales Because fear of hypoglycemia has been the central focus of the majority of studies (most
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typically involving use of the HFS-W), we also examined the added utility of the HABS
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Avoidance and Confidence subscales, over and above the HABS Anxiety scale. In multiple regression equations, after adjusting for demographics in Step 1, Anxiety was entered in Step 2
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and Avoidance and Confidence were entered in Step 3, with psychosocial variables, glycemic
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control and hypoglycemic events as dependent variables.
Among insulin users, all three HABS subscales reached statistical significance in the
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third step of the equation for most outcomes (Table 5). Most importantly, Avoidance and Confidence accounted for significant variance over and above Anxiety. Avoidance was
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significantly associated with: lower well-being, greater diabetes distress, more symptoms of
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depression and anxiety, and more frequent hypoglycemic symptoms in the past week. HABS Confidence was significantly associated with lower A1c and lower likelihood of experiencing a
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severe episode of hypoglycemia in the past 6 months. These findings point to the independent
with T2D.
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utility of each scale, with respect to the dependent variables studied for insulin-using individuals
For non-insulin users, only Avoidance and Confidence reached statistical significance with the psychosocial and hypoglycemia dependent variables in Step 3. HABS Anxiety, which was significant in step 2, was no longer significant in step 3. Higher HABS Confidence was independently associated with greater well-being and lower anxiety, with a trend toward lower diabetes distress and fewer recent occurrences of hypoglycemic symptoms and events. Greater HABS Avoidance was independently associated with lower well-being, higher diabetes distress, and more symptoms of depression and anxiety. It is noteworthy that Confidence and Avoidance
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ACCEPTED MANUSCRIPT explained a larger portion of the variance in outcomes than Anxiety, suggesting their unique
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utility and their potentially important role for T2D adults not using insulin.
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4. DISCUSSION
The14-item Hypoglycemic Attitudes and Behavior Scale (HABS) consists of three
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clinically meaningful subscales that capture key features associated with T2D adults’ hypoglycemic experience. Two of these are oriented toward the more negative aspects of this
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experience-- Hypoglycemia Anxiety, which focuses on the major fears that individuals may
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harbor about hypoglycemia, and Hypoglycemia Avoidance, which centers on the typically unhealthy actions taken to prevent or avert the possibility of hypoglycemia. The third subscale,
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Hypoglycemia Confidence, focuses on the more positive element of the experience and highlights the individual’s sense of their ability to stay safe from hypoglycemic problems.
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Although EFAs resulted in the same HABS subscales for both T2D samples, there were
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notable between-group differences in the relationship of the HABS with demographic, diabetes status and psychosocial variables. For example, T2D insulin users report significantly more
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Anxiety and less Confidence than non-insulin users, perhaps due to the greater frequency and ongoing risk of hypoglycemia in the former group. In contrast, Avoidance is similarly common among both insulin and non-insulin users, and is independently associated with greater emotional distress in both groups. Finally, Confidence is independently linked to less emotional distress, but only among non-insulin users, and is associated with better glycemic control, but only among insulin users. Of note, concerns and worries about hypoglycemia are generally greater among younger individuals and those with a shorter history of T2D, especially among insulin-using patents. In total, these findings suggest that the hypoglycemia experience is meaningful and
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ACCEPTED MANUSCRIPT impactful for both T2D insulin users and non insulin-users, but that it is notably different for each.
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Overall, these findings indicate that major concerns about hypoglycemia are far from rare
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in T2D adults. We find that 43.8% of insulin users and 27.3% of non-insulin users report hypoglycemic symptoms within the past week. In addition, 19.5% of insulin users and 11.1% of
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non-insulin users report at least one severe event within the past 6 months. Although HABS cut-
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off points have not yet been determined statistically, if we consider the face validity of the response options, a mean score > 3.0 would indicate general agreement. Using this criterion,
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mean HABS Avoidance scores > 3.0 are observed in 35.4% of insulin users and 29.8% of noninsulin users, suggesting that unhealthy actions to avoid hypoglycemia are common. Paralleling
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this finding, Confidence appears to be relatively low, with only 16.4% of insulin users and 7.1%
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of non-insulin users achieving a mean score > 3.0. Anxiety is less prevalent, with only 12.4 % of insulin users and 5.1% of non-insulin users scoring > 3.0. In sum, these data suggest that worries
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about hypoglycemia in the T2D population may be more widespread than has been commonly
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assumed, even among those who do not use insulin. Our findings build upon those of Gonder-Frederick and her colleagues in the development of the HFS [8, 9]. The HABS items were developed to differ from the HFS in three major ways: HABS Anxiety items were created to assess unreasonable fears and worries (thus, the use of the word “terrified” in each item); HABS Avoidance items were similarly developed to highlight unhealthy actions that would not likely be construed as reasonable responses. HABS Confidence items were created to highlight an aspect of an individual’s hypoglycemic experience that has not been previously considered: not merely the absence of fear and worry, but a sense that hypoglycemia concerns can be mastered. Of note, the HABS was developed for and
11
ACCEPTED MANUSCRIPT evaluated with T2D adults only, which is quite different from the T1D population that has been the major focus of HFS studies [10]. Since this study was not designed to determine whether the
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HABS is a better, or worse, tool than the HFS, we recommend the HABS as a complement to the
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HFS when exploring the ramifications of hypoglycemia among T2D individuals. These data raise important implications regarding how concerns about hypoglycemia in
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the T2D population are acknowledged and addressed. Our findings indicate that there are real
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and coherent worries about hypoglycaemia among both insulin- and non insulin-using T2D adults. Focusing attention solely on feelings of fear and anxiety, however, tells only part of the
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story. Equally, if not more importantly, is how T2D adults cope with their concerns, especially through such negative means as avoidance strategies [16], as well as their overall sense of self-
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efficacy in the face of hypoglycemia. These concerns are rarely addressed in clinical care. Of the
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three major dimensions of hypoglycemic concerns that we have identified, it is striking that only Confidence is positively linked to glycemic control, suggesting that a focus on addressing low
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levels of hypoglycemic confidence may be especially beneficial in helping T2D adults feel more
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comfortable in following management recommendations. It is because of these distinct differences in the three HABS dimensions that we have not put forward a HABS total score; each subscale provides unique information and a score that combines all three may not be meaningful. The strengths of this study are that relatively large numbers of T2D adults, both insulinusing and non-insulin-using, participated; the initial HABS items were generated directly from interviews with T2D adults and healthcare professionals; and the resulting HABS subscales indicate acceptable reliability and validity. Several limitations should be acknowledged. The samples were highly educated and mostly Non-Hispanic White, both of which may restrict
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ACCEPTED MANUSCRIPT generalizability. Given the noted prevalence of T2D among Hispanics and African Americans as well as in those with lower literacy, the scales should be re-evaluated with a more diverse sample.
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Also, height, weight and glycemic control were assessed via self-report, which may introduce
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bias. In this last case, however, it is noteworthy that the mean A1C of our study sample (7.3%) was very close to the A1C mean value derived from the NHANES study (7.2%) [17].
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Furthermore, in our previous studies with T1D adults, there was a high level of agreement
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between self-reported and laboratory assessed A1C (r= .84; see Fisher et al, in preparation). 5. CONCLUSIONS
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Our findings suggest that hypoglycemia fears and worries are pervasive among both insulin-using and non insulin-using T2D adults, and that they are significantly related to
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demographic, diabetes status and psychosocial variables in both groups. The HABS is a valid
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and reliable measure that captures key elements of hypoglycemic worries and concerns among adults with T2D. It is comprised of three subscales that can help to pinpoint an individual’s
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clinical intervention.
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specific hypoglycemic concerns, thus allowing for greater understanding and more targeted
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ACCEPTED MANUSCRIPT Conflicts of Interest No author reported a conflict of interest. William Polonsky: consultant for Sanofi Diabetes Care,
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Dexcom, Roche Diabetes Care, Abbott Diabetes Care and Johnson & Johnson; Lawrence Fisher:
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consultant for Roche Diabetes Care, Eli Lilly, Abbott Diabetes Care and Sanofi Diabetes Care; Steven Edelman: consultant for Sanofi Diabetes Care, Dexcom, Bayer Diabetes Care, Abbott
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Diabetes Care and Johnson & Johnson.
Acknowledgements
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This investigator-initiated study was supported by Sanofi.
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ACCEPTED MANUSCRIPT REFERENCES
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1. Wild D, von Maltzahn R, Brohan E, Christensen T, Clauson P, Gonder-Frederick L. A
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critical review of the literature on fear of hypoglycemia in diabetes: Implications for diabetes management and patient education. Patient Educ Couns 2007; 68:10-15.
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2. Fidler C, Christensen TE, Gillard S. Hypoglycemia: An overview of fear of hypoglycemia, quality-of-life, and impact on costs. J Med Econ 2011; 14: 646-655.
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3. Gilbert R, Fulcher G. Reduction in fear of hypoglycemia in subjects with sub-optimally
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controlled diabetes using a glargine insulin-based treatment regimen. Can J Diabetes 2008; 32: 101-106.
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4. Marrett E, Stargardt T, Mavros P, Alexander CM. Patient-reported outcomes in a survey of patients treated with oral antihyperglycaemic medications: associations with
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5. Vexiau P, Mavros P, Krishnarajah G, Lyu R, Yin D. Hypoglycaemia in patients with type 2 diabetes treated with a combination of metformin and sulphonylurea therapy in France.
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Diabetes Obes Metab 2008; 10 (Suppl 1): 16–24. 6. Stargardt T, Gonder-Frederick L, Krobot KJ, Alexander CM. Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes. Health Qual Life Outcomes 2009; 7: 91. 7. Hajos TR, Polonsky WH, Pouwer F, Gonder-Frederick L, Snoek FJ. Towards defining a cut-off score for elevated fear of hypoglycemia on the Hypoglycemia Fear Survey Worry subscale in patients with type 2 diabetes. Diabetes Care 2014; 37: 102-108. 8. Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care 1987; 10: 617-21.
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ACCEPTED MANUSCRIPT 9. Irvine A, Cox D, Gonder-Frederick L. The Fear of Hypoglycaemia Scale. In: Bradley C, ed. Handbook of Psychology and Diabetes. New York: Harwood Academic Publishers,
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1994.
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10. Gonder-Frederick LA, Schmidt KM, Vajda KA, Greear ML, Singh H, Shepard JA, Cox
diabetes. Diabetes Care 2011; 34: 801-806.
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DJ. Psychometric properties of the hypoglycemia fear survey-ii for adults with type 1
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11. Hajos TR, Pouwer F, Skovlund SE, den Oudsten BL, Geelhoed-Duijvestijn PH, Tack CJ, Snoek FJ. Psychometric and screening properties of the WHO-5 well-being index in adult
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outpatients with type 1 or type 2 diabetes mellitus. Diabet Med 2013; 30: 63-69. 12. Polonsky WH, Fisher L Earles J, Dudl RJ, Lees J, Mullan JT, Jackson RA. Assesing
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Care 2005; 28: 626-631.
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psychosocial stress in diabetes: Development of the Diabetes Distress Scale. Diabetes
13. Spitzer RL, Kroenke K, Williams JB, Löwe B (2006). A brief measure for assessing
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generalized anxiety disorder: the GAD-7. Arch Intern Med 2006; 166: 1092-1097.
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14. Kroenke K, Spitzer RL, Williams JB). The PHQ-9: The validity of a brief depression severity measure. J Gen Intern Med 2001: 16: 606-613. 15. Wells TS, Horton JL, LeardMann CA, Jacobson IG, Boyko EJ. A comparison of the PRIME-MD PHQ-9 and PHQ-8 in a large military prospective study, the Millennium Cohort Study. J Affect Disord 2013; 148: 77-83. 16. Gonder-Frederick L. Fear of hypoglycemia: A review. Diabetic Hypoglycemia 2013; 5: 3-11. 17. Data Source: Centers for Disease Control and Prevention, National Center for Health Statistics, data from the National Health and Nutrition Examination Survey. Statistical
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ACCEPTED MANUSCRIPT analysis by the Centers for Disease Control and Prevention, National Center for Chronic
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Disease Prevention and Health Promotion, Division of Diabetes Translation.
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58.1 (11.4) 273 (64.4%) 14.8 (4.0)
T2DM not using insulin (n=198) 58.1 (11.4) 129 (66.2%) 15.0 (3.9)
T2DM using insulin (n=226) 58.1 (11.5) 144 (63.7%) 14.7 (4.1)
314 (74.1%) 25 (5.9%) 21 (5.0%) 32 (7.5%) 4 (0.9%) 17 (4.0%) 11 (2.6%) 11.6 (9.2)
142 (71.7%) 15 (7.6%) 7 (3.5%) 17 (8.6%) 3 (1.5%) 8 (4.0%) 6 (3.0%) 8.8 (8.0)
172 (76.1%) 10 (4.4%) 14 (6.2%) 15 (6.6%) 1 (0.4%) 9 (4.0%) 5 (2.2%) 14.1 (9.5)
36 (9.2%) 72 (18.3%) 85 (21.6%) 65 (16.5%) 136 (34.5%)
31 (17.6%) 45 (25.4%) 41 (23.2%) 38 (21.5%) 22 (12.4%)
5 (2.3%) 27 (12.4%) 44 (20.3%) 27 (12.4%) 114 (52.5%)
302 (71.2%) 82 (19.3%) 40 (9.4%)
163 (82.3%) 28 (14.1%) 7 (3.5%)
139 (61.5%) 54 (23.9%) 33 (14.6%)
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Total sample (n=424) Age Gender (female) Education level (years) Ethnicity Non-Hispanic White (NHW) African American Hispanic Asian or Pacific Islander Native American Mixed race Other Years since diagnosis SMBG frequency Once a week or less A few times a week Once daily Twice daily More than twice daily Number of low blood glucose readings (<70), past week 0 1-2 3 or more Number of times experienced symptoms of hypoglycemia, past week 0 1-2 3 or more Severe hypoglycemic event (requiring assistance of another), past 6 months) BMI A1C % Mmol/mol Well-being (WHO-5) Diabetes Distress (DDS) PHQ GAD HFS-B HFS-W
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Table 1. Sample description by insulin use p value .94 .76 .49 .29
<.001 <.001
<.001
.002 271 (63.9%) 98 (23.1%) 55 (13.0%) 66 (15.6%)
144 (72.7%) 35 (17.7%) 19 (9.6%) 22 (11.1%)
127 (56.2%) 63 (27.9%) 36 (15.9%) 44 (19.5%)
33.4 (8.3)
32.6 (8.0)
34.1 (8.6)
7.3 (1.3) 56 (14.2) 2.9 (1.1) 2.2 (1.0) 9.4 (5.4) 4.1 (4.5) 11.1 (9.9) 16.5 (13.0)
6.8 (1.0) 51 (10.9) 3.1 (0.9) 2.1 (0.9) 8.9 (5.5) 3.2 (3.5) 7.8 (8.4) 13.2 (13.0)
7.7 (1.3) 61(14.2) 2.7 (1.1) 2.3 (1.0) 9.8 (5.3) 5.0 (5.0) 14.0 (10.2) 19.3 (12.4)
.02 .07 <.001
<.001 .009 .08 <.001 <.001 <.001
Means and standard deviations are presented for continuous variables. Comparing patients using insulin vs. not using insulin (t-test or χ2).
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ACCEPTED MANUSCRIPT Table 2. Factor analysis of Hypoglycemia Attitudes and Behaviors items by insulin use. T2DM not using insulin Anxiety
Confidence
I am terrified that I might pass out in public due to a low blood sugar episode.
.816
-.020
If I don't have plenty of emergency supplies to raise my blood sugar with me, I won't leave my house.
.681
-.023
I am terrified that I might injure myself or someone else because of a low blood sugar episode.
.711
-.083
.833
T2DM using insulin
Avoidance Anxiety Confidence Avoidance .856
-.069
-.084
.758
.013
-.209
.004
.657
-.127
.110
.026
.049
.743
.063
.262
.756
.046
.178
.804
.030
.145
-.085
.636
.115
-.213
.647
.171
.267
.821
-.166
.096
.733
-.148
-.062
.744
.107
.042
.788
-.034
-.076
.560
-.168
.054
.777
-.049
-.247
.623
.136
-.137
.704
.103
To avoid serious problems with low blood sugar, I tend to keep my blood sugars higher than I probably should.
-.160
-.067
.821
-.250
-.172
.888
Without even bothering to test, I take quick action to raise my blood sugars at the first hint of any funny feelings
.050
.165
.595
.057
.176
.661
To avoid serious problems due to low blood sugar, I eat or drink a lot more often than I really need to.
.219
-.004
.671
.054
-.035
.805
If I think my blood sugar is too low, I'll start eating and eating and I won't stop until I feel better.
.032
-.041
.716
.191
.056
.676
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I am confident that I can stay safe from serious problems with low blood sugar while driving.
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I am confident that I can stay safe from serious problems with low blood sugar while exercising.
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I am confident that I can avoid serious problems due to low blood sugar when I'm alone. I am confident that I can catch and respond to low blood sugar before my blood sugars get to low. I am confident that I can stay safe from serious problems with low blood sugar while out in public.
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To avoid serious problems due to low blood sugar, I stay close to home more than I would really like to. I spend so much time worrying about the possibility of a low blood sugar episode that it interferes with my ability to do the things I really want to do.
-.012
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Bolded items are those that load most highly on the individual factor.
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Confidence
-.07
-.03
.01
.03
Avoidance
-.02
.07
.16*
-.08
-.20**
-.07
-.19**
-.04
.01
.14*
-.01
.05
Avoidance
.01
-.12
.02
-.01
.04
-.10
-.24**
-.03
.08
.13
.15*
-.02
.07
-.06
-.05
.02
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*p<.05, ** p<.01
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-.20
***
.08
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Anxiety Confidence
-.10
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T2DM using insulin
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Table 3. Zero-order correlations between HABS subscales and patient demographics and diabetes status Age Gender BMI Education SMBG Years since Ethnicity level frequency diagnosis (NHW vs. non-NHW) T2DM not using insulin .11 -.13 Anxiety -.11 .01 -.07 .13 -.16*
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ACCEPTED MANUSCRIPT Table 4. Construct validity associations WHO5 Diabetes PHQ Distress
GAD
HFS- HFS-W BG < 70 Hypo Severe SelfB past symptoms hypoglycemia reported week past week in past 6 A1C monthsa
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***
***
.28
***
-.18
***
.20
Anxiety Confidence
-.22
***
.45
Avoidance
-.30
**
.17
-.11
**
-.19
.24***
**
.21
**
.49
***
*** .24 .38
***
.30
***
-.25
***
-.34
***
.09
.15*
.10
.06
-.14*
-.15*
-.12
-03
.06
.14*
.02
.06
.35***
.33***
.49***
.06
-.01
-.02
-.05
-.14*
.26***
.35***
.32***
.15*
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-.28
Avoidance
**
.12
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Confidence
-.24
T2DM using insulin
-19
***
.44*
.37
-.14* .25***
***
-.15
***
.58
***
*** .37
.32***
.36
***
.55
***
-.30 .34
***
***
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***
**
.24***
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.09
***
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Anxiety
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T2DM not using insulin
*p<.05, ** p<.01, *** p<.001. a
requiring assistance from another person
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ACCEPTED MANUSCRIPT Table 5. Hierarchical Regression Analyses
β
β
-.24***
.14+
.13+
.15
.08
.14*
1.61
.07
-.05 .19* -.19*
-.01 -.14+ .15*
.01 -.04 .22***
-.01 -.15* .15*
.01 -.15+ -.01
.03 -.14+ .07
1.29 .53 .74
.03 -.03 .03
.06** .06*** .18
.02+ .04* .09
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.02* .04* .11
.01 .02 .07
.02+ .02 .11
.40***
.22***
.32***
.35***
.32***
3.21***
.07
-.08 .05 -.21**
.23** -.07 .27***
.11 -.11 .14*
.22** -.05 .14*
.37*** .12 .04
.26*** .08 .18**
2.07* .51* 1.55+
-.09 -.19* .15+
.04** .03* .16
.15*** .05*** .36
.05*** .02+ .14
.09*** .02+ .26
.11*** .01 .19
.10*** .03* .22
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-.21**
R2 change Step 2 R2 change Step 3 Total R2 at Step 3
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β
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T2DM USING INSULIN Step 2 Anxiety Step 3 Anxiety Confidence Avoidance
BG < Hypoglycemic Severe A1C 70 symptoms hypoglycemia past past week in past 6 week monthsa β β OR β
β
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R2 change Step 2 R2 change Step 3 Total R2 at Step 3
GAD
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T2DM NOT USING INSULIN Step 2 Anxiety Step 3 Anxiety Confidence Avoidance
PHQ
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WHO5 Diabetes Distress
.004 .002 .04
.004 .04* .11
+p<.10, *p<.05, ** p<.01, *** p<.001. a
requiring assistance from another person
Note: Hierarchical multiple regressions included the following steps: Step 1 (not pictured) age, years since diagnosis, gender, and ethnicity (NHW vs. non-NHW); Step 2 Anxiety; Step 3
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ACCEPTED MANUSCRIPT Confidence and Avoidance. Standardized beta coefficients are presented for continuous
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outcomes and odds ratios (OR) are presented for binary outcomes.
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ACCEPTED MANUSCRIPT IDENTIFYING THE WORRIES AND CONCERNS ABOUT HYPOGLYCEMIA IN ADULTS WITH TYPE 2 DIABETES
This study reports on the hypoglycemic worries and concerns of adults with type 2
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Highlights:
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diabetes (T2D) and examines how these concerns are associated with key patient characteristics.
We surveyed 226 T2D insulin users and 198 non-insulin users, leading to the
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concerns in T2D individuals.
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development of a new self-report instrument for assessing hypoglycemic worries and
The measure comprises three key subscales: Hypoglycemia Anxiety, Hypoglycemia
Among insulin users, all three subscales are independently associated with emotional
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Avoidance and Hypoglycemia Confidence.
distress, while Hypoglycemia Anxiety is linked to more frequent hypoglycemia and
Among non-insulin users, only Hypoglycemia Avoidance is independently associated
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Hypoglycemia Confidence is linked to lower A1C.
with emotional distress.
Hypoglycemic concerns are significant among T2D adults with type 2 diabetes, are linked to emotional distress and A1C, and merit attention in clinical practice. Taking time to discuss and address these issues with T2D patients could be of great value.
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