Clinical trial NCT03623113: The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Type1 Diabetes Mellitus
Glucose Metabolism Disorders
Keywords: Carbohydrate counting
Basic carbohydrate counting
Advanced carbohydrate counting
Carbohydrates
Diet
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2018-08-09
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline, 6 months
measure: Change in mean amplitude of glycaemic excursions (MAGE)
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 12 months
measure: Change in body weight
timeFrame: Baseline, 6 months, 12 months
measure: Change in low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline, 6 months, 12 months
measure: Change in high-density cholesterol (HDL-C)
timeFrame: Baseline, 6 months, 12 months
measure: Change in total cholesterol (TC)
timeFrame: Baseline, 6 months, 12 months
measure: Change in free fatty acids (FFA)
timeFrame: Baseline, 6 months, 12 months
measure: Change in triglycerides (TG)
timeFrame: Baseline, 6 months, 12 months
measure: Change in systolic blood pressure
timeFrame: Baseline, 6 months, 12 months
measure: Change in diastolic blood pressure
timeFrame: Baseline, 6 months, 12 months
measure: Change in waist circumference
timeFrame: Baseline, 6 months, 12 months
measure: Change in hip circumference
timeFrame: Baseline, 6 months, 12 months
measure: Change in total fat free mass
timeFrame: Baseline, 6 months
measure: Change in total fat mass
timeFrame: Baseline, 6 months
measure: Change in time in range (3.9-10.0 mmol/l)
timeFrame: Baseline, 6 months
measure: Changes in % time spent in hypoglycaemia (<3.9 mmol/l)
timeFrame: Baseline, 6 months
measure: Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l)
timeFrame: Baseline, 6 months
measure: Change in standard deviation of mean plasma glucose
timeFrame: Baseline, 6 months
measure: Change in mathematical literacy
timeFrame: Baseline, 6 months, 12 months
measure: Change in carbohydrate estimation accuracy
timeFrame: Baseline, 6 months, 12 months
measure: Change in diet-related quality of life
timeFrame: Baseline, 6 months, 12 months
measure: Change in perceived competences in diabetes
timeFrame: Baseline, 6 months, 12 months
measure: Change in degree of autonomy-supportive dietitian
timeFrame: Baseline, 6 months, 12 months
measure: Change in total energy intake
timeFrame: Baseline, 6 months
measure: Change in dietary intake of carbohydrates
timeFrame: Baseline, 6 months
measure: Change in dietary intake of total fat
timeFrame: Baseline, 6 months
measure: Change in dietary intake of saturated fatty acids (SFA)
timeFrame: Baseline, 6 months
measure: Change in dietary intake of monounsaturated fatty acids (MUFA)
timeFrame: Baseline, 6 months
measure: Change in dietary intake of polyunsaturated fatty acids (PUFA)
timeFrame: Baseline, 6 months
measure: Change in dietary intake of protein
timeFrame: Baseline, 6 months
measure: Change in dietary intake of added sugar
timeFrame: Baseline, 6 months
measure: Change in intake of dietary fibre
timeFrame: Baseline, 6 months
Other outcomes:
measure: Change in physical activity level
timeFrame: Baseline, 6 months, 12 months
measure: Change in urinary biomarkers of carbohydrate intake
timeFrame: Baseline, 6 months
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Bettina Ewers, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ewers B, Vilsboll T, Andersen HU, Bruun JM. The dietary education trial in carbohydrate counting (DIET-CARB Study): study protocol for a randomised, parallel, open-label, intervention study comparing different approaches to dietary self-management in patients with type 1 diabetes. BMJ Open. 2019 Sep 3;9(9):e029859. doi: 10.1136/bmjopen-2019-029859.