The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- The difference in mean glucose level
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The difference in mean glucose level
Time Frame: Week 3-4, week 11-12
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Secondary Outcomes
- LDL cholesterol(Week 4, week 12)
- The difference in standard deviation of glucose levels(Week 3-4, week 11-12)
- Total insulin dose(Week 1-4, week 9-12)
- Diabetes Treatment Satisfaction Questionnaire (DTSQc) score(Week 12)
- The difference in the proportion of time with euglycaemic levels(Week 3-4, week 11-12)
- HDL cholesterol(Week 4, week 12)
- Diabetes Treatment Satisfaction Questionnaire (DTSQs) score(Week 4, week 12)
- The difference in the proportion of time with high glucose levels(Week 3-4, week 11-12)
- Weight(Week 4, week 12)
- Total cholesterol(Week 4, week 12)
- Triglycerides(Week 4, week 12)
- Hypoglycemia confidence score(Week 4, week 12)