Carbohydrate Content in the Diet in Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Other: Moderate carbohydrate diet
* Other: Higher carbohydrate diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate carbohydrate diet<br>A healthy diet containing 30 E % carbohydrates | Other: Moderate carbohydrate diet<br>* 30 E % carbohydrates included in the diet<br>|
| Experimental: Higher carbohydrate diet<br>A healthy diet containing 50 E % carbohydrates | Other: Higher carbohydrate diet<br>* 50 E % carbohydrates included in the diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in mean glucose level | Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12 | Week 3-4, week 11-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in standard deviation of glucose levels | Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12 | Week 3-4, week 11-12 | 
| The difference in the proportion of time with high glucose levels | Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12 | Week 3-4, week 11-12 | 
| The difference in the proportion of time with euglycaemic levels | Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12 | Week 3-4, week 11-12 | 
| Weight | The difference in weight between week 4 and week 12 | Week 4, week 12 | 
| Total cholesterol | The difference in total cholesterol between week 4 and week 12 | Week 4, week 12 | 
| LDL cholesterol | The difference in LDL cholesterol between week 4 and week 12 | Week 4, week 12 | 
| HDL cholesterol | The difference in HDL cholesterol between week 4 and week 12 | Week 4, week 12 | 
| Triglycerides | The difference in triglycerides between week 4 and week 12 | Week 4, week 12 | 
| Total insulin dose | The difference in total insulin dose between week 1-4 and week 9-12 | Week 1-4, week 9-12 | 
| Diabetes Treatment Satisfaction Questionnaire (DTSQc) score | The difference in DTSQc score at week 12 | Week 12 | 
| Diabetes Treatment Satisfaction Questionnaire (DTSQs) score | The difference in DTSQs scores between week 4 and week 12 | Week 4, week 12 | 
| Hypoglycemia confidence score | The difference in hypoglycaemia confidence scores between week 4 and week 12 | Week 4, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Carbohydrates, Diabetes Mellitus, Type 1