Diabetes Mellitus, Type 1
Conditions
Keywords
Carbohydrates, Diet, Diabetes Mellitus, Type 1
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.
Interventions
30 E % carbohydrates included in the diet
OTHERHigher carbohydrate diet
50 E % carbohydrates included in the diet
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in mean glucose level | Week 3-4, week 11-12 | Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Week 4, week 12 | The difference in weight between week 4 and week 12 |
| HDL cholesterol | Week 4, week 12 | The difference in HDL cholesterol between week 4 and week 12 |
| Triglycerides | Week 4, week 12 | The difference in triglycerides between week 4 and week 12 |
| Total insulin dose | Week 1-4, week 9-12 | The difference in total insulin dose between week 1-4 and week 9-12 |
| Diabetes Treatment Satisfaction Questionnaire (DTSQc) score | Week 12 | The difference in DTSQc score at week 12 |
| Diabetes Treatment Satisfaction Questionnaire (DTSQs) score | Week 4, week 12 | The difference in DTSQs scores between week 4 and week 12 |
| Hypoglycemia confidence score | Week 4, week 12 | The difference in hypoglycaemia confidence scores between week 4 and week 12 |
| The difference in standard deviation of glucose levels | Week 3-4, week 11-12 | Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12 |
| The difference in the proportion of time with high glucose levels | Week 3-4, week 11-12 | Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12 |
| The difference in the proportion of time with euglycaemic levels | Week 3-4, week 11-12 | Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12 |
| Total cholesterol | Week 4, week 12 | The difference in total cholesterol between week 4 and week 12 |
| LDL cholesterol | Week 4, week 12 | The difference in LDL cholesterol between week 4 and week 12 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Apolipoproteins | Week 4, week 12 | The difference in apolipoproteins between week 4 and week 12 |
| The difference in the proportion of time with low glucose levels | Week 3-4, week 11-12 | Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12 |
| Ketones | Week 1-4, week 9-12 | The difference in ketone levels between week 1-4 and week 9-12 |
| Ketoacidosis | Week 1-4, week 9-12 | Occurence of ketoacidosis during the study period and differences between week 1-4 and week 9-12 |
| HbA1c | Week 4, week 12 | The difference in HbA1c between week 4 and week 12 |
| The difference in Mean Amplitude of Glycemic Excursions (MAGE) | Week 3-4, week 11-12 | Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12 |
Countries
Sweden
Outcome results
None listed