Clinical Trial – Carbohydrate Content in the Diet – Type 1 Diabetes

Vastra Gotaland Region aims to study a diet with a moderate amount of carbohydrates and compare it with a traditional diabetic diet with a higher content of carbohydrates on mean glucose level, high and low glucose levels, and the risk of ketoacidosis in patients with type 1 diabetes. The glucose levels will be measured by blinded continuous glucose monitoring (CGM).

The trial has a cross-over design and 12 weeks in duration, where patients will be randomized to; 1) a diet with moderate carbohydrate content for 4 weeks and 2) a traditional diabetes diet for 4 weeks and with a wash-out period between for 4 weeks. The two diets will both be healthy and planned by a dietitian. There will be 50 subjects included in the study.

Study Type  : Interventional  (Clinical Trial)
Estimated Enrollment  : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes
Anticipated Study Start Date  : January 2018
Estimated Primary Completion Date  : January 2021
Estimated Study Completion Date  : January 2021


Contacts

Sofia Isaksson, MSc            00460104350000     sofia.isaksson.2@gu.se

Marcus Lind,     PhD           00460104350000     lind.marcus@telia.com

Locations

Sweden
NU Hospital Organization  Recruiting

Uddevalla, Sweden, 45180

ClinicalTrials.gov Identifier:  NCT03400618

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