liberalized diet in patients with type 1 diabetes

loirrrial of Interrial Medicine 1995: 2 3 7 : 591-597

Liberalized diet in patients with type 1 diabetes

I. MUHLHAUSER, U. BOTT, H. OVERMANN, W. WAGENER, R. BENDER, V. JORGENS & M . B E R G E R Frorri the Departrnerit of Nutrition and Metabolic Diseases ( WHO-Collaborating Centre for Diabetes), Heinrich-Heine Universitu. Diisseldorf, Gcrrtiarig

Abstract. Muhlhauser I, Bott U, Overmann H, Wagener W, Bender R, Jorgens V, Berger M (Department of Nutrition and Metabolic Diseases (WHO Collaborating Centre for Diabetes), Heinrich- Heine University, Dusseldorf, Germany). Liberalized diet in patients with type 1 diabetes. 7 Intern Med 1995; 237: 591-7.

Objective. To document that strict dietary regimen are not necessary in the context of intensified insulin therapy. Design. German multicentre, prospective cohort study: 6 years follow-up. Setting. Ambulatory examination using a mobile ambulance. Subjects. A total of 636 type 1 diabetic patients (age 3 3 f 7 years, diabetes duration 1 5 f 7 years ; mean f SD), who had participated in a structured, 5-day, in-patient, group treatment and teaching programme for intensification of insulin therapy and liberalization of the diabetes diet 6 years prior to follow-up. Main outcome measures. Relations between the extent to which patients practise a liberalized diet, the degree of metabolic control (HbAlc, severe hypoglycaemia, body mass index, cholesterol), and the patients' perceived burden through dietary treatment.

Results. In the total patient group, HbAlc was 7.9+1.6%, and the incidence of severe hypoglycaemia was 0.17 cases per patient during the preceding year: 31% patients injected insulin < 3 times per day, 58% 4-7 times per day, and 11% used insulin pump therapy. Only 11 % patients reported following a meal plan, whereas 89% continually changed timing and amount of carbohydrate intake ; only 5% had the same number of meals every day, whereas as many as 20% varied the number of meals per day by four or more; 53% skipped main meals; 8 5% habitually consumed sugar or sugar containing foods. Patients with a higher degree of diet liberalization injected insulin or used an insulin pump therapy more frequently, and perceived their dietary treatment to be less burdensome. No clinically significant associations were found between the extent of diet liberalization and metabolic control. Conclusions. Under the conditions where type 1 diabetic patients have the opportunity to participate in an intensified insulin treatment and teaching programme, liberalization of the diabetes diet is not associated with adverse effects on glycaemic control, but is associated with less perceived burden through dietary treatment.

Keywords : diabetes, diet, education, hypoglycaemia, insulin therapy, quality of life.

Introduction Traditionally, diet is considered a cornerstone of insulin therapy [ l , 21. Poor diabetes control is frequently attributed to either inadequate dietary advice [3] or poor adherence to dietary prescriptions [4]. Dietary recommendations for insulin-treated patients include regimens of caloric, carbohydrate, fat, protein, fibre, sodium and alcohol intake, the ban of sugar and sugar-containing foods such as biscuits

and confectionery and, finally, to maintain a constant daily pattern of food intake with main meals and snacks [1, 21. Until recently, the American Diabetes Association (ADA) additionally proposed a complex and rigid system of food exchange lists [ l ] - poten- tially useful for the compulsive, motivated, and well educated patient [ 51. A scientific justification for its use was lacking [5]. This also holds true for the general nutritional recommendations for individuals with diabetes [ l , 21. Even the recommendations

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592 I. MUHLHAUSER et al.

concerning the carbohydrate content of the diabetes diet are still controversial [6]. It is not surprising that Kelly West entitled his famous review on diabetes diet, An analysis of failure [7].

Persons with diabetes regard diet as one of the biggest problems of their disease [8]. especially when they have to reject food offers and their daily routines are disrupted as they have to eat regularly [9]. However, type 1 diabetic patients on intensified insulin therapy can be released from complex and rigid dietary rules without adverse effects on metabolic control [ 10-161. Liberalization of the diabetes diet is associated with better quality of life and enhanced treatment satisfaction [9]. Nevertheless, diet liberalization is still withheld from most diabetic patients. It is argued that it is feasible only under research conditions and in selected patients.

In this study we investigated in a large cohort of type 1 diabetic patients, the relations between the extent to which patients practise a liberalized diabetes diet, the degree of metabolic control and the patients perceived burden through dietary treatment.

Patients and methods The study is based on a 6-year follow-up of 636 type 1 diabetic patients (81% of the original cohort) who had taken part in a German multicentre study, which documented the feasibility of translating an intensified insulin treatment and teaching programme (TTP) from a specialized university diabetes centre to general internal medicine departments. As the outcomes were comparable between the specialized centre and the nine participating general hospitals, for the purpose of the present study the combined group of 636 patients was analysed. Detailed descriptions of the study population, the TTP, translation of the TTP, medical care of the patients after discharge, evaluation protocols, drop- outs and results for up to 3 years of follow-up have been published [17, 181. In short, 784 consecutively referred type 1 diabetic patients, aged 1 5 4 0 years and free of advanced diabetic, late complications (serum creatinine > 177 pmol L- ; blindness] had taken part in the same, 5-day, inpatient TTP for intensified insulin therapy in one of the 10 participating hospitals and were re-examined after 1, 2, 3 , and 6 years. Patients already treated with continuous subcutaneous insulin infusion (CSII) on admission were not considered eligible, although change to CSII

after participation in the TTP was possible. A history of repeated severe hypoglycaemia was not an exclu- sion criteria.

The objectives of the TTP were to enable patients to improve glycaemic control without increasing the risk of severe hypoglycaemia and to liberalize the diet. Patients were advised to measure blood glucose before main meals and at bedtime and to inject NPH insulin in the morning and at bedtime and regular insulin before meals. Day-to-day adaptation of insulin dosages by the patients themselves was considered a prerequisite for achieving the treatment goals. The teaching was delivered by a nurse and a dietitjan in a structured, Monday to Friday inpatient course for groups of up to 10 patients. Dietary training was restricted to the estimation of the carbohydrate content of meals and the calculation of insulin needs for varying carbohydrate intakes. There were no regulations of daily energy intake, except for obese patients, and weight control was self-regulated. Sugar consumption was not prohibited, although its prudent use was recommended [12]. Patients were provided with lists with the carbohydrate contents of sugar containing foods such as cakes, biscuits and confectionery. There were no prescriptions with respect to fat, protein and fibre intake. No meal plan was provided. The TTP aimed to empower patients to choose the most appropriate insulin treatment and dietary regimen for themselves and to carry this out safely and effectively. Thus, the more liberalized the diet becomes, the more frequent measurements of blood glucose, injections of regular insulin, and adaptations of insulin dosages by the patients are necessary, whereas a more conservative treatment regimen with only two daily insulin injections requires meal planning with respect to timing and amount of carbohydrate intake. After discharge, patients were followed-up by their family physicians, although the consultation of a specialized diabetes outpatient clinic was possible on referral [17]. According to the German health care system, all materials for insulin therapy, metabolic self-monitoring and consultations were free of charge for all patients.

The 6-year follow-up examination was performed by two investigators, who had not been involved in the careof the patients, using a mobile ambulance as described elsewhere [19]. At the 6-year follow-up, a standardized interview about eating habits relevant to the study question was included in the evaluation

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LIBERALIZED DIET IN DIABETES 593

protocol [17, 181 in order to rate the degree of diet liberalization for the individual patient. The following eating habits were considered indicative of diet liberalization. 1 No meal planning with respect to timing and amount of carbohydrate intake: 2 day-to-day variation of the number of meals (defined as consumption of any food except for the treatment of hypoglycaemia) by two or more ; 3 skipping of main meals at least once per week: 4 habitual consumption of sugar or sugar-containing foods.

Based upon these four items, a score system was construed ranging from 0, in case none of these four characteristics was applicable (no diet liberalization at all), to 4, in case all four characteristics were applicable (highest degree of diet liberalization).

The perceived burden through dietary treatment was assessed by patients degree of agreement to four statements using a four-point rating scale. The items were adapted from a questionnaire on diabetes- related stress [20] : 1 I have to give up good tasting food: 2 I often cant eat as much as I want to; 3 I have to eat even if I am not hungry; 4 I eat as if I didnt have diabetes). Because the four items did not constitute a homo- genous subscale, single item scores were analysed.

Haemoglobin Alc was measured by the Diamat@ (Biorad, Munich, Germany) HPLC method (reference range 4.3%-6.1%), and serum cholesterol by the Reflotronm (Boehringer-Mannheim, Mannheim, Germany) method as described [19]. Body weight was measured with patients wearing normal, every- day clothes, but without shoes, coats and jackets. Severe hypoglycaemia was defined as a hypoglycaemia treated by intravenous glucose or glu- cagon injection.

For statistical analysis of the association between the liberalized diet score (LDS) and the demographic variables, gender, age, and diabetes duration, and logistic regression analysis (proportional odds model) [21] was performed with LDS as the dependent ordinal variable. Relations between LDS and relevant response variables were analysed using regression models with LDS and essential covariables as in- dependent variables. For binary response (hypoglycaemia, blood glucose self monitoring, items 1 to 4 on dietary burden [dichotomised item scores]) logistic regression analysis, and for ordinal response

(insulin treatment) the proportional odds model [2 13, and for continuous response (log cholesterol, body mass index, HbAlc) linear multiple regression were used. The covariables in all models were gender, age and diabetes duration supplemented by HbAlc and body mass index for the model with log cholesterol, and HbAlc and insulin dose for the model with body mass index as the dependent variable. The LDS scores were included in the regressions by using four dummy variables with level 4 as the reference category. Results are given as meansfSD or as frequencies. For computations, the SAS procedures LOGISTIC [22] and REG [23] were used.

Results Vital status was available for all 784 patients except nine, who could not be traced. Thirteen patients had died (suicide two : motor-cycle accidents two : cancer two : hypoglycaemia one : cardiovascular three : schizophrenia, undefined on autopsy one : pneu- monia one: alcoholism, undefined on autopsy one). A total of 135 patients either declined to participate (n = 57) or had moved away too far [17] to be re- examined. Compared to the 63 6 re-examined patients, the 135 drop outs had higher HbAlc levels before the TTP [8.8f1.9% vs. 8 .3f1.8%; P = 0.01, Students t-test] and a lower incidence of severe hypoglycaemia during the year before the TTP (0.1 5 vs. 0.28 cases per patient: P < 0.05, Mann-Whitney U-test). Selected clinical variables of the 636 patients (48% women) at the time of the present study are shown in Table 1.

The incidence of severe hypoglycaemia was 0.1 7 cases per patient during the preceding year: 26% of the patients had consulted a physician specialized in diabetes during the preceding year.

As to eating habits, only 11% of patients reported following a meal plan, whereas 89% continually changed timing and amount of carbohydrate intake.

The average number of meals per day was two to three for 20% of patients, four to five for 57%, and more than five for 23%, respcctively. Only 5% reported to have the same number of meals every day, whereas 18% varied the number of meals by one, 57% by two or three, and 20% by four or even more. When asked how often per week they skipped a main meal 17% answered three times or more often, 26% once or twice, and 57% never skipped a main meal.

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594 I. M U H L H A U S E R et a/.

Table 1 Selected variables in relation to liberalized diet score groups

Liberalized diet score groups'

0 1 2 3 4 Total group

Patients (no.) Age (years) Diabetes duration (years) Body mass index (kg/m2) Haemoglobin A l c (%) Patients with SH (%) Cholesterol (mmol L-l) lnsulin dose (U kg-l day-') lnsulin treatment. % patients with

< 3 insulin injections per day 4-7 insulin injections per day CSII

Patients with BGSM 2 3 times

Items on perceived dietary burden, per day (%)

patients who agree (%) with: 1 ' I have to give up good tasting

2 ' I often can't eat as much as

3 ' I have to eat even if I am not

4 ' I eat as if I didn't have

food'

I want to '

hungry *

diabetes'

22 35+8 17&9

23.953.0 7.9 5 1.2

6.1 + 1.7 0.6650.20

9

71 29 0

55

10

5

48

21

74 3 4 + 7 1 5 k 8

24.7k3.6 7.8 k 1.4

5.4* 1.2 0.64 f 0.1 5

8

36 61

3 70

4

6

16

19

174 34+7 15+7

24.6k3.2 7.8k1.5 14

5.5k1.3 0.65 k0.20

36 58

6 69

6

6

13

23

202 3 3 k 7 1 6 k 7

24.6 k 3.6 8.0f1.6 10

5.5k1.2 0.61 kO.19

157 3 1 k 6 14f 7

24.5k3.2 7.9k1.6 14

5.5k1.2 0.63 k0 .17

629t 33+7 1 5 + 7

24.6+ 3.4 7.9k1.6 12

5.5k1.2 0.63k0.19

29 18 31 57 63 58 14 18 11 70 77 71

4 7 6

3 7 5

7 11 12

34 35 29

Values are means f SD or as indicated. SH. severe hypoglycaemia during preceding year: CSII. continuous subcutaneous insulin infusion: BGSM. blood glucose self monitoring. * O = no diet liberalization at all; 4 = highest degree of diet liberalization. TTotal number of patients adds up to 629 rather than to 636 due to missing values.

Table 2 Logistic regression analysis (proportional odds model) of the liberalized diet score*

Logistic Standardized Odds ratio (95% CI) Variable coefficient (SE) P coefficient

Age -0.032 (0.01) < 0.005 -0.121 0.97 (0.95-0.99) Gender? -0.229 (0.14) NS -0.063 0.80 (0.60-1.06) Diabetes duration -0,000 (0.01) NS -0.001 7 .OO (0.98-1.02)

'Order of response variable: LDS 4 = highest degree of diet liberalization: LDS 0 = no diet liberalization. 7 0 = female; 1 = male. Score test for the proportional odds assumption: P = 0.43.

Only 15% of patients avoided sugar consumption completely (except for the treatment of hypoglycaemia), 30% consumed sugar or sugar containing foods daily or several times per week, and 5 5% less frequently.

The distribution of patients and selected variables according to LDS are summarized in Table 1. Older patients had a tendency to lower scores (Tables 1 , 2 ) . Patients with higher LDS injected insulin or used

CSII more frequently (Tables 1 , 3 ) , and they perceived less burden through dietary treatment as reflected by significant associations between LDS and items 3 and 4 (Tables 1 , 4). Compared to patients with the highest LDS, patients with no diet liberalization at all had higher cholesterol levels (P < 0.05), and the proportion of patients measuring blood glucose 3 times per day was lower (P < 0.05 : Table 1). Because of multiple testing these findings should not be

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LIBERALIZED DtET I N DIABETES 595

Table 3 Logistic regression analysis (proportional odds model) of insulin treatment*

Logistic Standardized Variable coefficient (SE) P coefficient Odds ratio (95% CI)

LDs=o -2.440 (0.52) < 0,0001 -0.246 0.09 (0.03-0.24) LDS=l - 1.077 (0.29) < 0.0002 -0.190 0.34 (0.19-0.61) LDs=2 -0.915 (0.23) < 0.0001 -0.225 0.40 (0.25-0.63) LDs=3 -0.529 (0.22) < 0.02 -0.137 0.59 (0.38-0.91) Age -0.018 (0.01) NS -0.068 0.98 (0.96-1.01) Gender f -0.535 (0.17) < 0.002 -0.147 0.59 (0.42-0.81) Diabetes duration 0.029 (0.01) < 0.02 0.120 1.03 (1.01-1.05)

LDS. liberalized diet score (0 = no diet liberalization: 4 = highest degree of diet liberalization). *Order of response variable: continuous subcutaneous insulin infusion : highest, 4-7 insulin injections per day: < 3 insulin injections per day: lowest: LDS score 4 as reference variable. t 0 = female: 1 = male. Score test for the proportional odds assumption: P = 0.44.

Table 4 Logistic regression analysis of dietary burden items*

' I have to eat even if I am not hungry' ' I eat as if I had no diabetes' -

Odds ratio Odds ratio Variable P (95% CI) P (95% CI)

ms=o < 0.0001 8.35 (2.97-23.4) NS 0.42 (0.13-1.36) LDS = 1 NS 1.54 (0.67-3.56) < 0.02 0.41 (0.20-0.82) LDs=2 NS 1.21 (0.60-2.46) < 0.02 0.53 (0.32-0.87) LDs=3 NS 0.68 (0.32-1.45) NS 0.90 (0.57-1.41) Age NS 1.02 (0.98-1.06) NS 1.30 (0.90-1.88)

Diabetes duration < 0.05 0.96 (0.93-0.99) < 0.1 1.02 (1.00-1.05) Gender? NS 0.79 (0.47-1.32) NS 1.00 (0.97-1.0%)

LDS = liberalized diet score (0 = no diet liberalization: 4 = highest degree of diet liberalization). 'Order of response variable: 1 = agreement, 0 = disagreement: LDS score 4 as reference variable. t o = female: 1 = male. Homer-Lemeshow goodness-of-fit test: P = 0.58.

overinterpreted. No significant associations were following a more traditional dietary regimen, found between LDS and gender, diabetes duration, indicating that, according to the goals of the treat- HbAlc levels, severe hypoglycaemia, insulin dosage, ment and teaching programme, patients were able to body mass index, and items 1 and 2 (Tables 1. 2). find an appropriate balance between eating habits Also, at baseline, metabolic parameters, such as and insulin therapy. HbAlc levels, severe hypoglycaemia and body mass The eating habits of the patients do not conform to index did not differ between LDS groups. any of the official guidelines for dietary treatment of

type 1 diabetes [1, 21. However, diet liberalization

Discussion The present study shows that almost all patients with type 1 diabetes who had the opportunity to participate in an intensified insulin treatment and teaching programme, of which an essential part is to offer patients a liberalization of the diet, practise a liberalized diabetes diet, although to a variable extent. As expected, patients with higher degrees of diet liberalization injected insulin or used an insulin pump therapy more frequently than did patients

had no adverse effects on metabolic control as assessed in this study. There were no clinically relevant associations between the extent of diet liberalization and HbAlc, severe hypoglycaemia, body mass index or serum cholesterol. Patients were fairly well controlled, as reflected by their HbAlc levels and the incidence of severe hypoglycaemia. Considering the different study conditions and patient inclusion criteria, results compare favourably with those of the intensively treated patient group of the Diabetes Control and Complications Trial (DCCT)

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596 I. MUHLHAUSER et al.

[24, 251, in which an ADA diet was recommended [l]. In the present study, HbAlc values were about 0.5% higher than respective values in the DCCT, but the frequency of severe hypoglycaemia was lower [17, 18, 24, 251. In addition, in the present study, neither serum cholesterol levels nor body weight were higher than respective age-adjusted values of the general German population [26-281.

Based on the present study, it cannot be excluded that individual patients who are overweight or who have unsatisfactory glycaemic control might profit from following a more regulated dietary regimen. On the other hand, liberalization of diabetes diet is a major motivation for our patients to opt for intensified insulin therapy. In fact, in this study, patients with the highest degree of diet liberalization perceived less burden through their diet than patients with lower degrees of diet liberalization. Nevertheless, diet re- mains a problem for type 1 diabetic patients. Even amongst the patients with the most liberalized diet, only 35% felt that they ate as if they had no diabetes.

Only limited systematic information is available on the eating habits of the patients before participation in the intensified insulin treatment and teaching programme. In general, patients were treated traditionally following the rather strict dietary recommendations of the German Diabetes Association which are comparable to international recommendations [ l , 21. This is in accordance with the conventional insulin therapy these patients practised before participation in the programme, i.e. 86% injected insulin twice daily or less frequently, only 10% measured blood glucose three times or more often per day [17, 181, and 73% reported to have six or more meals per day (data not shown). However, it is probable that patients did not adhere completely to the rigid dietary recommendations.

The present study was not intended to perform a detailed and comprehensive assessment of the nutritional behaviour and the actual composition of nutrients consumed by type 1 diabetic patients. Only aspects considered to be relevant indicators of liberalization of the diabetes diet were evaluated. To this end, a simple scoring system was construed, because to date, no specific methodology is available for the quantification of liberalized diabetes diet. The close association between the liberalized diet score system and the patients perception of restrictions through dietary treatment, shows that the scoring system is useful and valid.

There was no control group in the present study, i.e. patients performing intensified insulin therapy but following a strict dietary regimen. Such a study, especially addressing the possible effects of sugar consumption, has been performed previously in selected patients with pump treatment [12], in which sugar consumption had no adverse metabolic effects. In addition, several randomized controlled studies with observation periods of up to 2 years have demonstrated the efficacy and safety of the whole package of the intervention programme, consisting of intensified insulin therapy, comprehensive patient training and liberalization of the diet [14, 151.

In conclusion, the present study shows that a majority of patients with type 1 diabetes practise a liberalized diet 6 years after participation in an intensified insulin treatment and teaching programme. Under the condition of frequent blood glucose self-monitoring and frequent insulin injections, including self-adaptation of insulin dosages, liberalization of the diabetes diet was not associated with adverse effects on glycaemic control, but was associated with less perceived burden through dietary treatment.

Acknowledgements This study was supported by Boehringer-Mannheim, Mannheim, Germany, and by the P. Klockner Stif- tung, Duisburg, Germany (grants to Professor M. Berger).

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Received 19 September 1994: accepted 9 February 1994.

Correspondence: Dr Ingrid Muhlhauser. Medizinische Klinik der Universitat Dusseldorf, Abteilung Stoffwcchsel und Ernahrung, MoorenstraBe 5. D-40225 Dusseldorf. Germany.


liberalized diet in patients with type 1 diabetes

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