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185 Use of the hemoglobin A1c test as a screening tool for cystic fibrosis related diabetes
8. Complications of CF
Posters
S105
183 Intermittent exogenous insulin may prevent progression of dysglycemia in pre-diabetic adults
185 Use of the hemoglobin A1c test as a screening tool for cystic fibrosis related diabetes
P. Dyce1 , G.H. Jones2 , M.J. Walshaw2 , D.S. Nazareth1 , V.M. Malone2 , C.L. Sumner2 . 1 Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; 2 Liverpool Heart and Chest Hospital, Respiratory, Liverpool, United Kingdom
M. Nicolo1 , D. Dorgan2 , M. Ferrin2 , D. Holsclaw2 , S. Smith2 , D. Hadjiliadis2 . 1 Hospital of the University of Pennsylvania, Philadelphia, United States; 2 University of Pennsylvania School of Medicine, Philadelphia, United States
Objectives: In prediabetes, pancreatic beta cell function may be preserved by intermittent exogenous insulin support, potentially delaying the onset of diabetes. We assessed whether this could be employed in CF, where the development CFRD greatly increases the treatment burden, morbidity and ultimately overall mortality. Methods: We studied 5 male prediabetic (defined on the basis of an abnormal continuous glucose monitoring (CGM) result and normal 2-hour oral glucose tolerance test (OGTT)) CF patients who were in an otherwise clinically stable state. Their clinical and glycaemic parameters (based on CGM) were measured for 3 months after 14 days of Detemir treatment. Results: CGM devices were well tolerated and only one data collection point was incomplete (day 18 CGM result). Glucose profiles improved in the first few weeks after treatment, and dysglycaemia had resolved entirely in 2 patients by day 64. There was no significant change in FEV1 or HbA1c.
Objective: To determine the optimal hemoglobin A1c (HgbA1c) level to screen for Cystic Fibrosis Related Diabetes (CFRD) in a population of adults with cystic fibrosis (CF). Methods: All oral glucose tolerance test (OGTT) results completed between 2012 and 2014 and HgbA1c tests within 3 months of the OGTT were included. HgbA1c levels were categorized as 5.5%, 5.6−6.4% and 6.5%. Chi-square analysis was used to compare HgbA1c categories to the following: 1. presence of CFRD, 2. 1 hour OGTT results >199 mg/dL, and 3. 1 hour OGTT results >155 mg/dL. Results: The number of OGTT tests performed per year is described in Poster Table 1. Descriptive statistics for the sample variables are described in Poster Table 2. Statistical significance was achieved comparing HgbA1c category with 2 hour OGTT results (p = 0.002). Of the patients with an HgbA1c 5.5%, 4.8% met criteria for CFRD, as did 16.7% with a HgbA1c between 5.6−6.4% and 60% with a HgbA1c 6.5%. Hypoglycemia occurred in 28.6% of patients with a HgbA1c 5.5% having a 2 hour OGTT result <70 mg/dL (p = 0.028) compared to 10% in the group with a HgbA1c between 5.6−6.4%. Comparison of HgbA1c and 1 hour OGTT >199 mg/dL achieved statistical significance (p = 0.008). Conclusion: Based on the results of this observation, using HgbA1c levels as a screening tool may be useful in determining which patients may be appropriate for OGTT testing. Using this method may have the added benefits of decreasing the incidence of hypoglycemia in the population of patients with normal HgbA1c who are most at risk. Using the HgbA1c test may increase the likelihood of patients completing OGTT test and improve utilization of hospital costs and resources.
Screening Day 18 Day 34 Day 64 Day 94 Mean % time glucose profile raised 17% Mean FEV1 % 76%
12% 75%
7% 77%
12% 76%
9% 73%
Conclusion: This study suggests that pre-diabetic adult CF patients treated with a short (2-week) course of insulin may experience extended periods of improved glucose control. These effects seem most pronounced for the immediate few weeks after treatment is received. This raises the prospect that intermittent insulin regimes may delay the progression of dysglycaemia in this increasingly common complication of the CF condition.
184 Utility of an ultra-long acting insulin to treat cystic fibrosis related diabetes
186 Manifestation and progression of illness in young children with cystic fibrosis: A targeted literature review
P. Dyce1 , G.H. Jones2 , M.J. Walshaw1,2 . 1 Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; 2 Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, United Kingdom
A.K. O’Sullivan1 , J.S. Kahle2 , D.R. VanDevanter3 , S. Sikirica1 , P. Hodgkins1 . 1 Vertex Pharmaceuticals Incorporated, Boston, United States; 2 BPS Intl, San Diego, United States; 3 Case Western Reserve University School of Medicine, Cleveland, United States
Objectives: Insulin Degludec is a new ultra-long-acting basal insulin with a halflife of 25 hours. Its long duration of action allows for scope in the timing of administration and it is claimed to have less propensity to cause nocturnal hypoglycaemia [Wang F, et al. Diabetes Metab Syndr Obes. 2012; 5: 191–204] but its efficacy and side effect profile have not been assessed. Methods: We prescribed insulin Degludec to 9 adult CFRD patients [mean FEV1 65% predicted, mean age 27.7 years, 5 female] who had displayed erratic glucose profiles on continuous glucose monitoring (CGM). Diabetic markers (CGM, HBA1c, FEV1 and weight) and overall health were assessed pre and post therapy. Additionally, we conducted a qualitative questionnaire to survey patients’ experiences. Results: Overall glucose profile, HbA1c, and time spent within normal range improved on Degludec therapy. There was also a reduction in time spent with raised glucose levels and a marked reduction in hypoglycaemic episodes including overnight events.
Mean FEV1 Mean weight (kg) Mean HbA1C (IFCC) Nocturnal hypoglycaemic episodes Median % time with glucose in normal range [IQR] Median % time raised glucose [IQR]
Pre Degludec
On Degludec
65% 57.3 65.2 15 [2.5] 43 [20−58] 52 [37−78]
62.8% 58.2 54.5 6 [0.5] 56 [42−64] 43 [33−56]
Conclusion: Patients found the injection device user-friendly and appreciated the dosing schedule flexibility. Our experience shows that this ultra-long-acting form of insulin is well tolerated by individuals with CFRD and seems to improve their glucose profiles. The low rates of hypoglycaemia suggest that it is safe. Insulin Degludec is a useful additional tool for the treatment of CFRD.
Objectives: Review evidence of disease burden and progression, accumulating tissue damage, and impact of early treatment in children 6 y old with CF, focusing on the digestive and respiratory systems. Methods: A systematic literature search identified peer-reviewed English-language studies (published 1990–2014) of children 6 y old with CF. Results: Of 10,774 unique citations, 164 were deemed relevant. These studies reported significant structural abnormalities and dysfunction in the digestive (e.g., bowel and pancreas abnormalities, nutrient deficiencies, growth deficits) and respiratory (e.g., airway anomalies, inflammation, dysfunction, infection, exacerbations) systems prenatally, in infants, and during childhood. There was evidence of progressive worsening of function by 6 months of age in both body systems, potentially irreversible lung damage by 2 y of age, and significant respiratory structural and functional decline with each year of age. Outcomes including nutrient absorption and resulting growth, lung function, delay of chronic airway infection, and survival were significantly improved with initiation of standard-of-care treatment following diagnosis via newborn screening compared with delayed treatment initiation due to later diagnosis. Digestive and respiratory health were closely related; early treatment for one system is consistently associated with improved outcomes in the other. Conclusion: CF-related structural abnormalities and dysfunction of the digestive and respiratory systems are present at birth, and disease progresses in children 6 y old. Treatment initiated early in life improves outcomes relative to later treatment initiation.
Posters
S105
183 Intermittent exogenous insulin may prevent progression of dysglycemia in pre-diabetic adults
185 Use of the hemoglobin A1c test as a screening tool for cystic fibrosis related diabetes
P. Dyce1 , G.H. Jones2 , M.J. Walshaw2 , D.S. Nazareth1 , V.M. Malone2 , C.L. Sumner2 . 1 Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; 2 Liverpool Heart and Chest Hospital, Respiratory, Liverpool, United Kingdom
M. Nicolo1 , D. Dorgan2 , M. Ferrin2 , D. Holsclaw2 , S. Smith2 , D. Hadjiliadis2 . 1 Hospital of the University of Pennsylvania, Philadelphia, United States; 2 University of Pennsylvania School of Medicine, Philadelphia, United States
Objectives: In prediabetes, pancreatic beta cell function may be preserved by intermittent exogenous insulin support, potentially delaying the onset of diabetes. We assessed whether this could be employed in CF, where the development CFRD greatly increases the treatment burden, morbidity and ultimately overall mortality. Methods: We studied 5 male prediabetic (defined on the basis of an abnormal continuous glucose monitoring (CGM) result and normal 2-hour oral glucose tolerance test (OGTT)) CF patients who were in an otherwise clinically stable state. Their clinical and glycaemic parameters (based on CGM) were measured for 3 months after 14 days of Detemir treatment. Results: CGM devices were well tolerated and only one data collection point was incomplete (day 18 CGM result). Glucose profiles improved in the first few weeks after treatment, and dysglycaemia had resolved entirely in 2 patients by day 64. There was no significant change in FEV1 or HbA1c.
Objective: To determine the optimal hemoglobin A1c (HgbA1c) level to screen for Cystic Fibrosis Related Diabetes (CFRD) in a population of adults with cystic fibrosis (CF). Methods: All oral glucose tolerance test (OGTT) results completed between 2012 and 2014 and HgbA1c tests within 3 months of the OGTT were included. HgbA1c levels were categorized as 5.5%, 5.6−6.4% and 6.5%. Chi-square analysis was used to compare HgbA1c categories to the following: 1. presence of CFRD, 2. 1 hour OGTT results >199 mg/dL, and 3. 1 hour OGTT results >155 mg/dL. Results: The number of OGTT tests performed per year is described in Poster Table 1. Descriptive statistics for the sample variables are described in Poster Table 2. Statistical significance was achieved comparing HgbA1c category with 2 hour OGTT results (p = 0.002). Of the patients with an HgbA1c 5.5%, 4.8% met criteria for CFRD, as did 16.7% with a HgbA1c between 5.6−6.4% and 60% with a HgbA1c 6.5%. Hypoglycemia occurred in 28.6% of patients with a HgbA1c 5.5% having a 2 hour OGTT result <70 mg/dL (p = 0.028) compared to 10% in the group with a HgbA1c between 5.6−6.4%. Comparison of HgbA1c and 1 hour OGTT >199 mg/dL achieved statistical significance (p = 0.008). Conclusion: Based on the results of this observation, using HgbA1c levels as a screening tool may be useful in determining which patients may be appropriate for OGTT testing. Using this method may have the added benefits of decreasing the incidence of hypoglycemia in the population of patients with normal HgbA1c who are most at risk. Using the HgbA1c test may increase the likelihood of patients completing OGTT test and improve utilization of hospital costs and resources.
Screening Day 18 Day 34 Day 64 Day 94 Mean % time glucose profile raised 17% Mean FEV1 % 76%
12% 75%
7% 77%
12% 76%
9% 73%
Conclusion: This study suggests that pre-diabetic adult CF patients treated with a short (2-week) course of insulin may experience extended periods of improved glucose control. These effects seem most pronounced for the immediate few weeks after treatment is received. This raises the prospect that intermittent insulin regimes may delay the progression of dysglycaemia in this increasingly common complication of the CF condition.
184 Utility of an ultra-long acting insulin to treat cystic fibrosis related diabetes
186 Manifestation and progression of illness in young children with cystic fibrosis: A targeted literature review
P. Dyce1 , G.H. Jones2 , M.J. Walshaw1,2 . 1 Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; 2 Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, United Kingdom
A.K. O’Sullivan1 , J.S. Kahle2 , D.R. VanDevanter3 , S. Sikirica1 , P. Hodgkins1 . 1 Vertex Pharmaceuticals Incorporated, Boston, United States; 2 BPS Intl, San Diego, United States; 3 Case Western Reserve University School of Medicine, Cleveland, United States
Objectives: Insulin Degludec is a new ultra-long-acting basal insulin with a halflife of 25 hours. Its long duration of action allows for scope in the timing of administration and it is claimed to have less propensity to cause nocturnal hypoglycaemia [Wang F, et al. Diabetes Metab Syndr Obes. 2012; 5: 191–204] but its efficacy and side effect profile have not been assessed. Methods: We prescribed insulin Degludec to 9 adult CFRD patients [mean FEV1 65% predicted, mean age 27.7 years, 5 female] who had displayed erratic glucose profiles on continuous glucose monitoring (CGM). Diabetic markers (CGM, HBA1c, FEV1 and weight) and overall health were assessed pre and post therapy. Additionally, we conducted a qualitative questionnaire to survey patients’ experiences. Results: Overall glucose profile, HbA1c, and time spent within normal range improved on Degludec therapy. There was also a reduction in time spent with raised glucose levels and a marked reduction in hypoglycaemic episodes including overnight events.
Mean FEV1 Mean weight (kg) Mean HbA1C (IFCC) Nocturnal hypoglycaemic episodes Median % time with glucose in normal range [IQR] Median % time raised glucose [IQR]
Pre Degludec
On Degludec
65% 57.3 65.2 15 [2.5] 43 [20−58] 52 [37−78]
62.8% 58.2 54.5 6 [0.5] 56 [42−64] 43 [33−56]
Conclusion: Patients found the injection device user-friendly and appreciated the dosing schedule flexibility. Our experience shows that this ultra-long-acting form of insulin is well tolerated by individuals with CFRD and seems to improve their glucose profiles. The low rates of hypoglycaemia suggest that it is safe. Insulin Degludec is a useful additional tool for the treatment of CFRD.
Objectives: Review evidence of disease burden and progression, accumulating tissue damage, and impact of early treatment in children 6 y old with CF, focusing on the digestive and respiratory systems. Methods: A systematic literature search identified peer-reviewed English-language studies (published 1990–2014) of children 6 y old with CF. Results: Of 10,774 unique citations, 164 were deemed relevant. These studies reported significant structural abnormalities and dysfunction in the digestive (e.g., bowel and pancreas abnormalities, nutrient deficiencies, growth deficits) and respiratory (e.g., airway anomalies, inflammation, dysfunction, infection, exacerbations) systems prenatally, in infants, and during childhood. There was evidence of progressive worsening of function by 6 months of age in both body systems, potentially irreversible lung damage by 2 y of age, and significant respiratory structural and functional decline with each year of age. Outcomes including nutrient absorption and resulting growth, lung function, delay of chronic airway infection, and survival were significantly improved with initiation of standard-of-care treatment following diagnosis via newborn screening compared with delayed treatment initiation due to later diagnosis. Digestive and respiratory health were closely related; early treatment for one system is consistently associated with improved outcomes in the other. Conclusion: CF-related structural abnormalities and dysfunction of the digestive and respiratory systems are present at birth, and disease progresses in children 6 y old. Treatment initiated early in life improves outcomes relative to later treatment initiation.