Carbohydrate Content in the Diet in Type 1 Diabetes

Vastra Gotaland Region

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

Other: Higher carbohydrate diet

Other: Moderate carbohydrate diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03400618

Carbohydrate study

Details and patient eligibility

About

The aim of this study is to analyse the effect of 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 diabetes
Adults 18 years or older
Written Informed Consent
HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)

Exclusion criteria

Pregnancy or planned pregnancy for the study duration
Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion
Problems with compliance to the intervention diets (excluding a lot of the foods that are common in the diets like wholegrain/beans/lentils/fruit/vegetables) because of personal preferences, other diseases, stomach problems etc.
Diabetes duration < 1 year
Planned change in diabetes treatment (eg. Start with insulin pump, CGM etc.) during the study period
Other investigator-determined criteria unsuitable for patient participation