The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes
- Conditions
- Type1 Diabetes MellitusType1diabetesGlucose Metabolism Disorders
- Interventions
- Behavioral: BCC interventionBehavioral: Standard dietary educationBehavioral: ABC-ACC intervention
- Registration Number
- NCT03623113
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- Brief Summary
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:
1. The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention)
2. 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
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Type 1 diabetes
- Diabetes duration; >12 months
- HbA1c of 53-97 mmol/mol
- Multiple daily insulin injection therapy
- Provided voluntary written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BCC intervention BCC intervention 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 Standard dietary education Standard dietary education 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 ABC-ACC intervention ABC-ACC intervention 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
- Primary Outcome Measures
Name Time Method Change in HbA1c Baseline, 6 months mmol/mol
Change in mean amplitude of glycaemic excursions (MAGE) Baseline, 6 months mmol/l
- Secondary Outcome Measures
Name Time Method Change in diastolic blood pressure Baseline, 6 months, 12 months mm Hg
Change in carbohydrate estimation accuracy Baseline, 6 months, 12 months Total score or percent (%)
Change in diet-related quality of life Baseline, 6 months, 12 months Total score or percent (%)
Change in perceived competences in diabetes Baseline, 6 months, 12 months Total score or percent (%)
Change in degree of autonomy-supportive dietitian Baseline, 6 months, 12 months Total score or percent (%)
Change in total energy intake Baseline, 6 months kJ/day
Change in dietary intake of carbohydrates Baseline, 6 months gram/day or percent of total energy (E%)
Change in body weight Baseline, 6 months, 12 months kg
Change in free fatty acids (FFA) Baseline, 6 months, 12 months mmol/l
Change in triglycerides (TG) Baseline, 6 months, 12 months mmol/l
Change in systolic blood pressure Baseline, 6 months, 12 months mm Hg
Change in waist circumference Baseline, 6 months, 12 months cm
Change in hip circumference Baseline, 6 months, 12 months cm
Change in time in range (3.9-10.0 mmol/l) Baseline, 6 months Percent (%)
Changes in % time spent in hypoglycaemia (<3.9 mmol/l) Baseline, 6 months Percent (%)
Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l) Baseline, 6 months Percent (%)
Change in standard deviation of mean plasma glucose Baseline, 6 months mmol/l
Change in mathematical literacy Baseline, 6 months, 12 months Total score or percent (%)
Change in HbA1c 12 months mmol/mol
Change in high-density cholesterol (HDL-C) Baseline, 6 months, 12 months mmol/l
Change in total cholesterol (TC) Baseline, 6 months, 12 months mmol/l
Change in low-density lipoprotein cholesterol (LDL-C) Baseline, 6 months, 12 months mmol/l
Change in total fat free mass Baseline, 6 months gram
Change in total fat mass Baseline, 6 months gram
Change in dietary intake of total fat Baseline, 6 months gram/day or percent of total energy (E%)
Change in dietary intake of polyunsaturated fatty acids (PUFA) Baseline, 6 months gram/day or percent of total energy (E%)
Change in dietary intake of saturated fatty acids (SFA) Baseline, 6 months gram/day or percent of total energy (E%)
Change in dietary intake of monounsaturated fatty acids (MUFA) Baseline, 6 months gram/day or percent of total energy (E%)
Change in dietary intake of protein Baseline, 6 months gram/day or percent of total energy (E%)
Change in dietary intake of added sugar Baseline, 6 months gram/day or percent of total energy (E%)
Change in intake of dietary fibre Baseline, 6 months gram/day or g/MJ
Trial Locations
- Locations (1)
Steno Diabetes Center Copenhagen
š©š°Gentofte, Denmark