NCT03623113

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type1diabetes
• Type1 Diabetes Mellitus
• Glucose Metabolism Disorders

Interventions

Type	Name	Description
BEHAVIORAL	BCC intervention	Structured training and education i basic carbohydrate counting principles
BEHAVIORAL	ABC-ACC intervention	Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate
BEHAVIORAL	Standard dietary education	Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences

Timeline

• Start date: 2018-09-28
• Primary completion: 2022-08-17
• Completion: 2022-08-17
• First posted: 2018-08-09
• Last updated: 2024-01-05

Locations

1 site across 1 country: Denmark