The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes

Study Overview
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Brief Summary
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The study is designed to evaluate two different dietitian-led self-management approaches in carbohydrate counting compared to routine dietary care (control) on glycaemic control in adult patients with type 1 diabetes: The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention) The advanced carbohydrate counting concept aims at improving prandial insulin dose accuracy using an automated bolus calculator (the ABC-ACC intervention) The main hypothesis is that structured training and education in either the BCC concept or the ABC-ACC concept will reduce HbA1c or the average glucose variability more than routine dietary education.

Detailed Description
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The current study is a randomized controlled trial with a parallel-group design. A total of 231 patients will be enrolled in the trial. Participants will be randomized to one of three arms: 1) Basic carbohydrate counting (BCC), 2) Advanced carbohydrate counting with an automated bolus calculator (ABC-ACC), or 3) Standard dietary care. The primary objective is to evaluate the six months effects of education in the BCC concept and the ABC-ACC concept compared to standard dietary care on glycaemic control as assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).

Official Title
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The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study): A Randomized, Parallel, Open-label, Intervention Study Comparing Different Approaches to Dietary Self-management in Patients With Type 1 Diabetes

Conditions
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Type1diabetes, Type1 Diabetes Mellitus, Glucose Metabolism Disorders

Intervention / Treatment
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* Behavioral: BCC intervention
* Behavioral: ABC-ACC intervention
* Behavioral: Standard dietary education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes Diabetes duration; >12 months HbA1c of 53-97 mmol/mol Multiple daily insulin injection therapy Provided voluntary written informed consent Exclusion Criteria: Practicing carbohydrate counting, as judged by the investigator Participated in a BCC group program within the last two years Use of insulin pump, or plans of having an insulin pump within the study period Fixed dose of rapid acting insulin therapy for meals Split-mixed insulin therapy Use of open CGM Use of Freestyle Libre Use of an automated bolus calculator Gastroparesis Pregnancy or breastfeeding, or plans of pregnancy within the study period Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator Uncontrolled medical issues, as judged by the investigator or a medical expert Concomitant participation in other clinical studies Unable to understand the informed consent and the study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCC intervention<br>The BCC program consists of three group sessions and is delivered by two trained dietitians. In addition to the BCC program, the participants receive regular medical care in the diabetes clinic | Behavioral: BCC intervention<br>* Structured training and education i basic carbohydrate counting principles<br>* Other names: Basic carbohydrate counting;|
| Experimental: ABC-ACC intervention<br>The ABC-ACC program consists of one group session and two individual follow-up sessions and is delivered by trained dietitians with supervision by a medical doctor. In addition to the ABC-ACC program, the participants receive regular medical care in the diabetes clinic | Behavioral: ABC-ACC intervention<br>* Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate<br>* Other names: Advanced carbohydrate counting with a bolus calculator;|
| Active Comparator: Standard dietary education<br>The routine outpatient dietary care consists of three individual consultations delivered by a trained dietitian. The individual guidance is based on the overall treatment goal(s), the defined personal dietary goals for behavioral change which will be in accordance with the patient's needs and preferences. In addition to the dietary counselling, the participants receive regular medical care in the diabetes clinic | Behavioral: Standard dietary education<br>* Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences<br>* Other names: Routine dietary care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | mmol/mol | Baseline, 6 months | 
| Change in mean amplitude of glycaemic excursions (MAGE) | mmol/l | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | mmol/mol | 12 months | 
| Change in body weight | kg | Baseline, 6 months, 12 months | 
| Change in low-density lipoprotein cholesterol (LDL-C) | mmol/l | Baseline, 6 months, 12 months | 
| Change in high-density cholesterol (HDL-C) | mmol/l | Baseline, 6 months, 12 months | 
| Change in total cholesterol (TC) | mmol/l | Baseline, 6 months, 12 months | 
| Change in free fatty acids (FFA) | mmol/l | Baseline, 6 months, 12 months | 
| Change in triglycerides (TG) | mmol/l | Baseline, 6 months, 12 months | 
| Change in systolic blood pressure | mm Hg | Baseline, 6 months, 12 months | 
| Change in diastolic blood pressure | mm Hg | Baseline, 6 months, 12 months | 
| Change in waist circumference | cm | Baseline, 6 months, 12 months | 
| Change in hip circumference | cm | Baseline, 6 months, 12 months | 
| Change in total fat free mass | gram | Baseline, 6 months | 
| Change in total fat mass | gram | Baseline, 6 months | 
| Change in time in range (3.9-10.0 mmol/l) | Percent (%) | Baseline, 6 months | 
| Changes in % time spent in hypoglycaemia (<3.9 mmol/l) | Percent (%) | Baseline, 6 months | 
| Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l) | Percent (%) | Baseline, 6 months | 
| Change in standard deviation of mean plasma glucose | mmol/l | Baseline, 6 months | 
| Change in mathematical literacy | Total score or percent (%) | Baseline, 6 months, 12 months | 
| Change in carbohydrate estimation accuracy | Total score or percent (%) | Baseline, 6 months, 12 months | 
| Change in diet-related quality of life | Total score or percent (%) | Baseline, 6 months, 12 months | 
| Change in perceived competences in diabetes | Total score or percent (%) | Baseline, 6 months, 12 months | 
| Change in degree of autonomy-supportive dietitian | Total score or percent (%) | Baseline, 6 months, 12 months | 
| Change in total energy intake | kJ/day | Baseline, 6 months | 
| Change in dietary intake of carbohydrates | gram/day or percent of total energy (E%) | Baseline, 6 months | 
| Change in dietary intake of total fat | gram/day or percent of total energy (E%) | Baseline, 6 months | 
| Change in dietary intake of saturated fatty acids (SFA) | gram/day or percent of total energy (E%) | Baseline, 6 months | 
| Change in dietary intake of monounsaturated fatty acids (MUFA) | gram/day or percent of total energy (E%) | Baseline, 6 months | 
| Change in dietary intake of polyunsaturated fatty acids (PUFA) | gram/day or percent of total energy (E%) | Baseline, 6 months | 
| Change in dietary intake of protein | gram/day or percent of total energy (E%) | Baseline, 6 months | 
| Change in dietary intake of added sugar | gram/day or percent of total energy (E%) | Baseline, 6 months | 
| Change in intake of dietary fibre | gram/day or g/MJ | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbohydrate counting, Basic carbohydrate counting, Advanced carbohydrate counting, Carbohydrates, Diet