Carbohydrate Content in the Diet in Type 1 Diabetes

  • STATUS
    Recruiting
  • days left to enroll
    10
  • participants needed
    50
  • sponsor
    Vastra Gotaland Region
Updated on 25 February 2022
diabetes
hemoglobin a1c
glycosylated hemoglobin
ketoacidosis
continuous glucose monitoring

Summary

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.

Details
Condition Diabetes Mellitus, Type 1
Treatment Moderate carbohydrate diet, Higher carbohydrate diet
Clinical Study IdentifierNCT03400618
SponsorVastra Gotaland Region
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

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
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