Carbohydrate Content in the Diet in Type 1 Diabetes

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Other: Moderate carbohydrate diet; Other: Higher carbohydrate diet

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uddevalla, Sweden, 45180
    • NU Hospital Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate carbohydrate diet; A healthy diet containing 30 E % carbohydrates	Other: Moderate carbohydrate diet; 30 E % carbohydrates included in the diet
Experimental: Higher carbohydrate diet; A healthy diet containing 50 E % carbohydrates	Other: Higher carbohydrate diet; 50 E % carbohydrates included in the diet

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in Mean Amplitude of Glycemic Excursions (MAGE)	Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12	Week 3-4, week 11-12
HbA1c	The difference in HbA1c between week 4 and week 12	Week 4, week 12
Apolipoproteins	The difference in apolipoproteins between week 4 and week 12	Week 4, week 12
The difference in the proportion of time with low glucose levels	Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12	Week 3-4, week 11-12
Ketones	The difference in ketone levels between week 1-4 and week 9-12	Week 1-4, week 9-12
Ketoacidosis	Occurence of ketoacidosis during the study period and differences between week 1-4 and week 9-12	Week 1-4, week 9-12

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Marcus Lind, PhD, NU Hospital Organization/University of Gothenburg

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Diet; Carbohydrates; Diabetes Mellitus, Type 1
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Carbohydrate study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No