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

Steno Diabetes Centers

Status: Completed

Conditions: Glucose Metabolism Disorders; Type1 Diabetes Mellitus; Type1diabetes

Treatments: Behavioral: BCC intervention; Behavioral: Standard dietary education; Behavioral: ABC-ACC intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03623113

H-18014897

Details and patient eligibility

About

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.

Full 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).

Enrollment: 63 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

BCC intervention

Experimental group

Description:

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

Treatment:

Behavioral: BCC intervention

ABC-ACC intervention

Experimental group

Description:

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

Treatment:

Behavioral: ABC-ACC intervention

Standard dietary education

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard dietary education