Nutrition interventions for intensive therapy in the diabetes control and complications trial

DIABETES CONTROL AND COMPLICATIONS TRIAL

Nutrition interventions for intensive therapy inthe Diabetes Control and Complications Trial THEDCCTRESEARCH GROUP

ABSTRACT:

As part of an intensive treatment regimen that had as its goal achieving and maintaining blood glucose levels in the normal range in individuals with insulin-dependent diabetes mellitus, dietitians in the Diabetes Control and Complications Trial implemented varying nutrition intervention strategies to counsel patients to attain normoglycemia. Dietary management encompassed recommendations on altering insulin dosages for varying food intake. Nutrition intervention was tailored to best meet a participant's life-style, motivation, ability to grasp information, diet history, and specific intensive insulin therapy. Dietitians were integral participants in the team management of individuals in the intensive treatment group. Selected nutrition interventions-Healthy Food Choices, exchange systems, carbohydrate counting, and total available glucose-and behavior management approaches were coupled with intensive insulin therapy. Case presentations illustrate each nutrition intervention in the attainment of normoglycemia. JAm DietAssoc. 1993; 93:768-772.

Preparedforthe DCCT by: Ellen J Anderson, MS, RD; Maryanne Richardson,RD; Gay Castle, RD; Susan Cercone, MS, RD; Linda Delahanty, MS, RD; Rachel Lyon, MS, RD; Dru Mueller, MS, RD; Linda Snetselaar, PhD,RD E J Anderson (corresponding author) is with the DiabetesResearch Center and L. Delahanty is with the Department ofDietetics, Diabetes Controland Complications Trial (DCCT), Massachusetts General Hospital, Boston, MA 02114; M Richardson is with the DCCT, The New York Hospital, Cornell UniversityMedical College, New York, NY 10021; G. Castle is with the DCCT, InternationalDiabetes Center Minneapolis, MN 55416; S. Cercone is with the DCCT,University of Texas, Southwestern Medical Center at Dallas,Department of InternalMedicine, Dallas, TX 75235;R. Lyon is with the DCCT, ClinicalResearchFacility, University of CaliforniaSan Diego, La Jolla, CA 92093; and D Mueller and L. Snetselaarare with the DCCT, The University of Iowa, GeneralHospital, Department of InternalMedicine, Iowa City, IA 52242. Address reprint requests to: DCCTResearch Group, Box NDIC/DCCT,Bethesda, MD 20892. 768 / JULY 1993 VOLUME 93 NUMBER 7

atient adherence to therapeutic diets is a critical compo nent for the effective control of blood glucose levels in diabetes. Dietary modifications coupled with daily insulin schedules, glucose monitoring, safety measures, and exercise routines constitute a diabetic regimen that is "complex, of life-long duration, and requires many behavior changes on the part of the patient" (1, p 594). Meichenbaum and Turk (2) state that compliance decreases with the complexity of the regimen; thus, one of the greatest challenges faced by health professionals who treat individuals with diabetes is to simplify and streamline nutrition intervention priorities. This need, coupled with the goal of normoglycemia in the Diabetes Control and Complications Trial (DCCT) experimental group (3), has provided DCCT dietitians with a unique opportunity to use a variety of nutrition interventions as well as behavioral manage ment approaches. This article describes how selected nutrition interventionsHealthy Food Choices, exchange systems, carbohydrate counting, and total available glucose (TAG)-were coupled with intensive insulin therapy (4-6) to attain normoglycemia in subjects in the DCCT. Detailed descriptions of the nutrition interventions can be found elsewhere (7,8). Dietary guidelines for the DCCT are listed in Figure 1 (9). Dietitian counseling using these meal-planning approaches helps individuals learn how to adjust insulin and food intake to achieve target blood glucose levels. Lower hemoglobin Al, (HbAc) levels in subjects in the DCCT experimental treatment group have been associated with three specific dietary behaviors: compliance with the meal plan, adjustment of insulin dose on the basis of expected food intake, and appropriate treatment of hypoglycemia (10). Nutrition intervention for each DCCT participant is determined according to initial diet history and food records, type and method of insulin delivery, life-style, motivation, and ability to grasp information. Each clinical center was encouraged to implement the strategy with which they were most familiar and comfortable. Some centers used a single nutrition intervention uniformly whereas other centers varied the choice of interven tions for different patients. NUTRITION INTERVENTIONS Healthy Food Choices In the DCCT, Healthy Food Choices is used as the primary nutrition intervention at 2 of the 29 clinics 50% to 70% of the time. An additional 11 clinics use this approach 20% to 40% of the time whereas 9 clinics use Healthy Food Choices less than 10% of the time. Because Healthy Food Choices was designed

for a 6th- to 7th-grade reading level and has a low to moderate degree of complexity, simplification of a meal plan can facilitate learning and, therefore, increase consistency in food intake. Insulin adjustment The use of Healthy Food Choices may make adjustment of premeal insulin boluses less precise; however, it is accurate enough to devise insulin algorithms that provide adequate insulin coverage for food eaten so that normoglycemia is achieved. Furthermore, it is a simple way to teach patients to adjust insulin in response to occasional dietary deviations. Considerations Dietitians within the DCCT have found that Healthy Food Choices is a useful tool with individuals for whom simplification of the diabetes regimen is necessary. These individuals may find alternative approaches too complex and the amount of information overwhelming. In addition, the effect on blood glucose of various food items and portion sizes can be identified so that the meal plan can be refined on the basis of individual preferences. Case scenario E.D.F is a 39-year-old man who has had type I diabetes for 12 years. He was randomized to the DCCT experimental treatment group with a baseline HbA 1 c of 8.0%. He had previously been instructed on how to use an exchange diet, but had difficulty understanding his diet. E.D.F was hospitalized for 1 week to initiate insulin pump therapy. The nutrition education component was kept very basic. On the first day, the importance of the diet in achieving normoglycemia was discussed. The subject's meal plan was developed on the basis of food records and diet history. Healthy Food Choices was explained, and E.D.F. was asked to complete a worksheet that asked for examples and appropriate amounts of foods to equal one serving of each of the six food groups. On the second day, favorite foods and portion sizes were added to the Healthy Food Choices. E.D.F planned a 3-day sample menu using the Healthy Food Choices. On the third day, his previous food records were reviewed and appropriate changes were made so that foods and portions matched the new meal plan. A few fast-food menus were planned. E.D.F. memorized his meal plan and serving sizes at discharge. He was instructed to translate his meal plan into day-to-day food choices and was asked to keep records of foods eaten, blood glucose levels (11), insulin dosages, and exercise after discharge. For 2 months after discharge, E.D.F. was seen weekly by the clinical nurse specialist and dietitian, then biweekly He kept daily food records initially for several months and then periodically thereafter. Education about fiber, the step 1 (National Cholesterol Education Program) diet, sweeteners, label reading, and adjustment of insulin for varying meals was gradually introduced over many months. Other dietary topics were also covered as questions arose. One year later, E.D.E's HbA,. was 6.3%. During the year, he did not experience severe hypoglycemia and his weight had remained at 100% of ideal. He reported that Healthy Food Choices is simple and flexible enough to follow in most situations and still achieve nearly normal blood glucose control. Exchange System DCCT dietitians use the exchange system for meal planning (12,13) to provide a variety of food choices while maintaining the consistency in meal content necessary to achieve glycemic control and a well-balanced intake. The exchange system was used more often than Healthy Food Choices. Nine DCCT clinics used exchanges 10% to 40% of the time, 11 centers 50% to 70%, and 6 centers used the exchanges 80% or more.

FIG 1. Dietary guidelinesfor the Diabetes Control and Complications Trial (9). aThe study protocol was amended July 1988 consistent with the National CholesterolEducation Programstep guidelines, ie, intake of cholesterol <300mg/day, totalfat <30% oj' total energy, saturatedfatty acids <10% of total energy, polyunsaturatedfattyacids up to 10% of total energy, monounsaturatedfattyacids 10% to 15% of total energy.

The DCCT participant and dietitian work together to formulate an exchange system meal plan according to energy needs, life-style and schedule, insulin type and regimen, and food preferences. Once blood glucose goals are met, the DCCT participant may experiment with more flexibility in the meal plan. Because carbohydrate affects blood glucose levels more than protein or fat, the starch/bread, fruit, and milk groups are emphasized. Because the carbohydrate content of one starch, fruit, or milk exchange is similar, these foods can be substituted for one another, although attention to the macronutrient composition should be considered. This provides more flexibility but continues to promote a consistent carbohydrate intake and a predictable blood glucose response. Insulin adjustment Food intake can be increased or decreased and corresponding adjustments made in insulin dose. Some dietitians use as a rule of thumb one unit of Regular insulin to cover 10 to 15 g carbohydrate (or one starch, fruit, or milk exchange) as a starting point and then individualize the supplement on the basis of food intake and blood glucose records. For example, if an individual planned to eat a pasta dinner with garlic bread containing two additional starch exchanges, two to three units of Regular insulin would be added to the usual dose of insulin taken at dinner, Conversely, if an individual wished to omit one fruit exchange from a meal without substituting another carbohydrate-containing food, one unit of Regular insulin would be subtracted from the usual JOURNAL OF THE AMERICAN DIETETIC ASSOCIATION / 769

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the knowledge she had. She also increased her activity level, and slowly lost weight without compromising glycemic control.

meal dose. After insulin adjustments are made, it is important to look at postprandial blood glucose values to assess how well the adjustment appeared to work. Written notes on how much Regular insulin was required to cover favorite or frequently consumed meals are encouraged as reference for future use.

Carbohydrate Counting Carbohydrate counting is a meal-planning approach focusing on the amount of carbohydrate eaten. It follows the assumption that carbohydrate is the major factor influencing postprandial glucose excursions. The amount of carbohydrate in a meal affects insulin requirements more than the amount of protein or fat (14). Carbohydrate counting is the primary dietary strategy used in the United Kingdom (15). This regimen is used by five DCCT clinics as the nutrition intervention approach for 70% or more of their subjects. Consistent carbohydrate intake facilitates insulin adjustment and minimizes blood glucose variability secondary to variable food intake. Carbohydrate counting provides greater precision in estimating carbohydrate intake than either Healthy Food Choices or the exchanges.

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FIG 2. Carbohydratecounting planforsubject X YZ

Considerations The exchange system can be an effective meal-planning method to achieve normoglycemia while providing life-style flexibility as well as structure to promote consistent intake of carbohydrate, protein, fat, and energy.A consistent energy intake is beneficial in helping to minimize the weight gain sometimes observed in intensive therapy The structure provided by the protein and fat exchange lists also helps meet the goals for reducing intake of dietary cholesterol and saturated fat to reduce the risk of cardiovascular disease in individuals with diabetes. However, individuals applying this method need to be aware of the carbohydrate variability of food items within an exchange group and the effect that such differences may have on glycemic control. Adjustments may need to be made in insulin dose or food intake on the basis of these observed effects. Case scenario A.B.C. is a 34-year-old woman who has had type I diabetes for 6 years. When A.B.C. entered the DCCT, her insulin regimen consisted of one injection of insulin per day, and her only dietary practice was to avoid sweets. Her weight was 116% of ideal and her HbAIC was 10.2%. After randomization into the experimental treatment group, A.B.C. was hospitalized for initiation of intensive insulin therapy and diabetes education. Nutrition assessment revealed that A.B.C. was a very structured person who was determined to meet the treatment goals of the experimental treatment group. The dietitian and A.B.C. worked out an initial meal plan using the exchange lists, according to A.B.C.'s life-style, likes and dislikes, and desire for weight control. The meal plan consisted of 1,600 kcal/day with 45% energy intake from carbohydrate, 20% from protein, and 35% from fat. A.B.C. began an insulin regimen consisting of NPH and Regular insulin in the morning, Regular at dinner, and NPH at bedtime. By the time A.B.C. was discharged from the hospital, she was able to choose foods from a menu according to her meal plan, and was able to write out sample menus using the exchange lists. A.B.C. was seen monthly by the dietitian and consistently reported that she was having no problems with the meal plan. Her readiness to learn allowed her to become adept at using the exchange lists with her own recipes and when she ate out. At the end of 1 year, her HbA, level was 6.1%, but her weight had climbed to 130% of ideal. During the following months, glycemic control remained steady, and A.B.C. decided that she was ready to lose weight. She followed a meal plan of 1,000 kcal/day, continued to use the exchange system, and paid close attention to accurate portion control. Further education in the exchange system was minimal at this point; A.B.C. simply decided to apply 770 / JULY 1993 VOLUME 93 NUMBER 7

Insulin adjustment Participants in the DCCT experimental treatment group who use carbohydrate counting are taught how to adjust insulin dose on the basis of a ratio of Regular insulin to gram carbohydrate intake. The ratio of Regular insulin to gram carbohydrate intake is individualized and determined by blood glucose results and may vary from meal to meal. For example, an individual may need one unit for each 10 g carbohydrate at breakfast, but may need one unit for each 15 g carbohydrate at dinner. For each 15 g carbohydrate added or subtracted from each meal or snack, an adjustment of 1 to 2 units of Regular is typically suggested (16-19). However, be cause insulin requirements can vary dramatically with body weight and activity, each person's requirement must be individualized. Where one person needs one unit per 10 g carbohydrate, another may need 4 units. Multiple factors, such as insulin type(s), weight gain or loss, and activity level, will affect these ratios. The amount of protein and fat may also affect this ratio but to a lesser degree than carbohydrate. If the patient is being closely followed and blood glucose values are evaluated with ongoing discussions about food intake, this effect will be noted. For example, an atypical increase or decrease in the amount of protein in a meal may increase or decrease insulin requirements. An individual who doubles his or her protein intake may be able to note an increased insulin requirement. Considerations Carbohydrate counting attempts to reduce regimen complexity while focusing on the major contributor to blood glucose levels. Simplifying the regimen allows the individual to focus on some of the other changes in behavior mandated by the DCCT experimental treatment regimen. For individuals who have been discouraged or frustrated by previous dietary methods, carbohydrate counting may provide renewed interest and motivation. Diabetes self management is encouraged by allowing the patient to observe the relationship between quantities of carbohydrate consumed and insulin dose in relation to blood glucose levels. Although carbohydrate count ing ignores variations in glycemic effect of different carbohy drate sources, the significance of the glycemic index in a mixed meal may be minimal (20). Attention must also be given to the percentage of energy from protein and fat. Persons using carbohydrate counting have been shown to have a higher contribution of energy from fat (51%) and a lower percentage of energy from carbohydrate (34%) (16). Because carbohydrate counting is not the traditional ap proach for nutrition management of diabetes, physicians and health care team members have challenged and questioned the

reliability of this approach. DCCT dietitians have demonstrated that the carbohydrate counting approach can facilitate the attainment of blood glucose goals. Case scenario X.YZ. was randomized into the experimental treatment group at the age of 20 with a baseline HbAlc of 9.8%. He was 5 feet 8 inches tall and at his desired weight of 142 lb. X.Y.Z. had had diabetes for 18 months and before the DCCT had FIG 3. Total availableglucose (TAG) system using the not received nutrition intervention. At randomization, he atExchange Listsfor Meal Planning(11). tended school and worked evenings. He lived with his mother, who prepared traditional ethnic meals that included many foods the patient could not identify in English. In addition to Total Available Glucose home-cooked meals, food was consumed at diners or a friend's The total available glucose (TAG) (21) meal-planning strategy home or was purchased at convenience stores and fast-food defines foods in terms of the amount of glucose derived from outlets. The number and frequency of meals and snacks was foods consumed. TAG is based on research on the glubased on appetite. During his hospitalization after randomiza- coneogenic properties of certain proteins (22). The TAG tion, X.YZ. was taught blood glucose monitoring, insulin approach assumes that 100% of carbohydrate, 58% of animal kinetics with appropriate meal and snack timing, signs and protein, and 10% of fat will be available as glucose for cellular appropriate treatment of hypoglycemia, use of glucagon, and use. By giving each meal and snack a total TAG allotment, sick-day management. He was begun on 3 to 4 daily insulin individuals can vary intake without going over the recominjections-NPH/Regular at breakfast and dinner; Regular at mended grams of TAG. TAG can be applied to the exchange system (Figure 3). lunch and evening snack as necessary. TAG, in combination with an exchange system, can result in In addition, he received an overview of the effect of nutrients on blood glucose levels, emphasizing the difference among blood glucose control in compliant individuals who desire carbohydrate, protein, and fat. In light of all the new behaviors specific knowledge of the glucose contribution of carbohydrate, X.Y.Z. had to integrate into his life-style, the carbohydrate protein, and fat. For most DCCT participants, the nutrition counting approach was selected for its simplicity. This ap- education received before the DCCT was based on the exproach was preferred as X.YZ. consumed many foods that were change system. The rationale for using both systems was the difficult to identify because of the ethnic nature of his diet, as hope that starting with the familiar and relating it to a newer well as his lack of familiarity with food preparation. For X.Y.Z, a regimen would help to ensure success with new concepts. TAG meal plan was devised based on 30 kcal/kg (1,900 kcal) with was used by two centers as the primary nutrition intervention. 50% of total energy distributed as carbohydrate. To simplify In other centers, TAG was used in selective patient situations carbohydrate counting, each meal and snack portion was that might include the use of TAG for individuals with evening rounded off (Table 2). X.Y.Z. was instructed to focus on his snacks consisting of animal protein. carbohydrate portions, and to continue consuming protein and fat in his usual portion sizes. He was provided with a list of Insulin adjustment Several guidelines help cover TAG intake carbohydrate-containing foods in 15-g carbohydrate portions, with insulin. As a general rule, one unit of Regular insulin covers grouped as breads, cereals, crackers, grains, starchy vegetables, approximately 10 to 15 g TAG; however, in practice, as with and fruit. X.Y.Z. was asked to keep written records of blood carbohydrate counting, this algorithm is unique to the individglucose, insulin, food intake in grams of carbohydrate, and ual. For each subject, the ratio of TAG to insulin depends on the activity At the time of discharge, he verbalized anxiety about time of day and activity. The ratio may be different at breakfast incorporating the many new behaviors into his life-style. than at lunch or supper, and the timing of peak actions of Two weeks after hospitalization, X.YZ. had complete and intermediate insulins must be considered. thorough documentation of food intake, insulin, and blood When introducing TAG to a patient, the determination of this glucose data. He asked questions that demonstrated consider- ratio requires frequent interaction between the individual and able analysis of his blood glucose fluctuations. The major dietitian using food records and blood glucose results to find the problem at this time was his difficulty in including all three right match of insulin for TAG to achieve target blood glucose snacks consistently After a review of the rationale for snacks, he levels. For example, in a given patient with a preprandial blood chose to continue trying to incorporate them until his next glucose of 3.9 to 6.7 rrmmol/L x, three units of Regular insulin may follow-up visit in 2 weeks. X.YZ. demonstrated considerable be given to cover 45 g TAG at breakfast, equivalent to one unit of ability to grasp this simplified approach to food intake. insulin for every 15 g TAG. If this patient planned to increase X.YZ. continued to follow his gram carbohydrate meal plan food intake at this meal to 60 g TAG or an increase of 15 g over although planned monthly follow-up visits with the dietitian the recommended TAG, one additional unit of Regular insulin were overshadowed by a medical crisis. At the patient's visit 12 would be needed. Alternatively, only 2 units would be needed for months after randomization, his HbA, was 6.6% and his weight a smaller breakfast containing 30 g TAG. had increased by 4 lb. Nutrition assessment documented that X.Y.Z. was following the prescribed grams carbohydrate, and Considerations As a consequence of the flexibility associated was continuing to consume appropriate amounts of protein and with using TAG, several areas require additional monitoring. fat. Foods causing exaggerated or unexpected blood glucose Unlike the exchange system, the TAG system does not take into excursions were identified and discussed in detail. For X.YZ., a consideration the fat or vegetable protein calories contributed ratio of 1 unit Regular insulin to 20 g carbohydrate was observed for lunch and dinner; with a ratio of 1 unit to 15 g carbohydrate at breakfast. Over the next year, monthly HbA, levels were between 5.8)/o 'To convert mmol/L glucose to mg/dL, multiply mmol/L by 18.0. To and 6.6% and the patient remained at approximately 100% ideal convert mg/dL glucose to mmol/L, multiply mg/dL by 0.555. Glucose of body weight. 6.0 mmol/L = 108 mg/dL. 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by the diet. Patients may be consuming a high-caloric diet but have normal blood glucose levels. Many individuals may misuse the idea that fat contributes little to blood glucose elevation. If fat is "free," individuals may think that fat may be added to meals when a TAG limitation is exhausted in the meal plan. In addition, TAG can achieve optimal blood glucose results without adequate nutrient intake. The combination of TAG with the exchange system ensures more adequate nutrient intake. The TAG system is a precise way of calculating the available glucose in foods. It allows for the most precise adjustment of premeal insulin boluses of any of the methods discussed previously. Although it is similar to the carbohydrate counting system, the TAG system has the added advantage of including the available glucose coming from animal protein. Experience with this system has shown that patients can control their blood glucose levels effectively.

technicalassistance has been provided by the National Institute of Neurologic and Communicative Disordersand Stroke; the NationalHeart, Lung,andBlood Institute;,the NationalEye Institute, and the Division ofResearch Resources, National Institutes ofHealth. David M Nathan, MD, is Chairman f the DCCTEditorial Board. A complete listing of the DCCTResearchGroup is availableas NTIS document PB-882339108, DCCT Research Group, 1988.

Case scenario C.P.D. is a 30-year-old man who has had diabetes for 12 years and who had a HbA,1 of 7.2% at randomization. His HbA1, was 5.9% after he had been using the TAG regimen and insulin pump therapy for 1 year. A dietitian, along with the team, saw him once a month with calls from a nurse 1 to 3 times a week. Recommended meal and snack patterns were constructed for his daily nutrient intake. C.P.D.'s blood glucose levels were near normal but fat intake was causing weight gain and elevation of lipids. His diet was checked very carefully to determine where caloric intake was contributing to weight gain. The patient was doing everything requested in terms of following TAG; but the breakfast contained 127 kcal more than the recommended meal plan and a saturated fat intake of 14.4 g. After in-depth nutrition education on the fat and saturated fat content of breakfast food selections, C.P.D. was able to alter breakfast intake to reduce saturated fat and energy levels. Calculated TAG for the low-fat breakfast is approximately 5.4 TAG less than his high-fat breakfast. With the decrease in TAG, Regular insulin for his breakfast meal might be reduced to avoid hypoglycemia after breakfast. An alternative suggestion might be to add 4.6 g TAG, such as one third fruit exchange. For C.PD., decreasing Regular insulin was recommended because weight gain was a concern and to be consistent in the nutrition message of controlling blood glucose with less TAG and, therefore, less energy. With C.PD.'s adherence to the low-fat breakfast pattern and emphasis on the fat content of frequently eaten foods his weight has come down. He is able to maintain a low HbA, while avoiding hypoglycemia when altering his food selections. The TAG system works well in keeping blood glucose levels in control, but an emphasis on fat intake is also essential.

tions Trial (DCCT): design and methodologic considerations for the fea

SUMMARY Following a consistent meal plan and the ability to adjust insulin dose with planned food variations seems to be critical in maintaining normoglycemia. Dietary variation may be influenced by premeal/presnack blood glucose and/or planned/ spontaneous exercise. The different nutrition interventions have distinctive and varying characteristics of structure and complexity. The choice of nutrition intervention depends on both the dietitian's experience with the different strategies and on which approach best meets the individual needs of the DCCT participant. · The DCCT is supported by the Division of Diabetes, Endocrinology and Metabolic Disease of the National Institute of Diabetesand Digestive and Kidney Diseases, NationalInstitutes of Health, through cooperative agreements and a researchcontract.Additional support or 772 / JULY 1993 VOLUME 93 NUMBER 7

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