Back to resultsCarbohydrate Content in the Diet in Type 1 Diabetes
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Moderate carbohydrate diet
Higher carbohydrate diet
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Carbohydrates, Diet, Diabetes Mellitus, Type 1
Eligibility Criteria
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
Sites / Locations
- NU Hospital Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Moderate carbohydrate diet
Higher carbohydrate diet
Arm Description
A healthy diet containing 30 E % carbohydrates
A healthy diet containing 50 E % carbohydrates
Outcomes
Primary Outcome Measures
The difference in mean glucose level
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Secondary Outcome Measures
The difference in standard deviation of glucose levels
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
Measured by continuous glucose monitoring (CGM) between week 3-4 and 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
Weight
The difference in weight between week 4 and week 12
Total cholesterol
The difference in total cholesterol between week 4 and week 12
LDL cholesterol
The difference in LDL cholesterol between week 4 and week 12
HDL cholesterol
The difference in HDL cholesterol between week 4 and week 12
Triglycerides
The difference in triglycerides between week 4 and week 12
Total insulin dose
The difference in total insulin dose between week 1-4 and week 9-12
Diabetes Treatment Satisfaction Questionnaire (DTSQc) score
The difference in DTSQc score at week 12
Diabetes Treatment Satisfaction Questionnaire (DTSQs) score
The difference in DTSQs scores between week 4 and week 12
Hypoglycemia confidence score
The difference in hypoglycaemia confidence scores between week 4 and week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03400618
Brief Title
Carbohydrate Content in the Diet in Type 1 Diabetes
Official Title
The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Carbohydrates, Diet, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate carbohydrate diet
Arm Type
Experimental
Arm Description
A healthy diet containing 30 E % carbohydrates
Arm Title
Higher carbohydrate diet
Arm Type
Experimental
Arm Description
A healthy diet containing 50 E % carbohydrates
Intervention Type
Other
Intervention Name(s)
Moderate carbohydrate diet
Intervention Description
30 E % carbohydrates included in the diet
Intervention Type
Other
Intervention Name(s)
Higher carbohydrate diet
Intervention Description
50 E % carbohydrates included in the diet
Primary Outcome Measure Information:
Title
The difference in mean glucose level
Description
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Time Frame
Week 3-4, week 11-12
Secondary Outcome Measure Information:
Title
The difference in standard deviation of glucose levels
Description
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Time Frame
Week 3-4, week 11-12
Title
The difference in the proportion of time with high glucose levels
Description
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Time Frame
Week 3-4, week 11-12
Title
The difference in the proportion of time with euglycaemic levels
Description
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Time Frame
Week 3-4, week 11-12
Title
Weight
Description
The difference in weight between week 4 and week 12
Time Frame
Week 4, week 12
Title
Total cholesterol
Description
The difference in total cholesterol between week 4 and week 12
Time Frame
Week 4, week 12
Title
LDL cholesterol
Description
The difference in LDL cholesterol between week 4 and week 12
Time Frame
Week 4, week 12
Title
HDL cholesterol
Description
The difference in HDL cholesterol between week 4 and week 12
Time Frame
Week 4, week 12
Title
Triglycerides
Description
The difference in triglycerides between week 4 and week 12
Time Frame
Week 4, week 12
Title
Total insulin dose
Description
The difference in total insulin dose between week 1-4 and week 9-12
Time Frame
Week 1-4, week 9-12
Title
Diabetes Treatment Satisfaction Questionnaire (DTSQc) score
Description
The difference in DTSQc score at week 12
Time Frame
Week 12
Title
Diabetes Treatment Satisfaction Questionnaire (DTSQs) score
Description
The difference in DTSQs scores between week 4 and week 12
Time Frame
Week 4, week 12
Title
Hypoglycemia confidence score
Description
The difference in hypoglycaemia confidence scores between week 4 and week 12
Time Frame
Week 4, week 12
Other Pre-specified Outcome Measures:
Title
The difference in Mean Amplitude of Glycemic Excursions (MAGE)
Description
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Time Frame
Week 3-4, week 11-12
Title
HbA1c
Description
The difference in HbA1c between week 4 and week 12
Time Frame
Week 4, week 12
Title
Apolipoproteins
Description
The difference in apolipoproteins between week 4 and week 12
Time Frame
Week 4, week 12
Title
The difference in the proportion of time with low glucose levels
Description
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Time Frame
Week 3-4, week 11-12
Title
Ketones
Description
The difference in ketone levels between week 1-4 and week 9-12
Time Frame
Week 1-4, week 9-12
Title
Ketoacidosis
Description
Occurence of ketoacidosis during the study period and differences between week 1-4 and week 9-12
Time Frame
Week 1-4, week 9-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Lind, PhD
Organizational Affiliation
NU Hospital Organization/University of Gothenburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
NU Hospital Organization
City
Uddevalla
ZIP/Postal Code
45180
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Carbohydrate Content in the Diet in Type 1 Diabetes
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