Status:
COMPLETED
The Impact of Macronutrient Composition on Glucose Dynamics in Persons With Type 1 Diabetes
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Swansea University
Conditions:
type1diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A randomized, open-label, three-arm crossover study will be conducted. The aim of the study is to determine the effect of different isocaloric diet macronutrient compositions (High-carbohydrate-Low-fa...
Detailed Description
Background: In order to increase time, spend in euglycemia ranges many persons with type 1 diabetes choose to follow a low-carbohydrate diet. However, to date strong evidence on the effects of low-ca...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Type 1 diabetes ≥ 5 years
- Insulin pump use ≥ 1 year
- Use of intermittently scanned continuous glucose monitoring (isCGM) or continuous glucose monitoring (CGM) ≥ 3 months
- HbA1c ≤ 69 mmol/mol (8.5%)
- Self-reported hypoglycemia awareness
- Exercising at least 30 minutes at moderate or vigorous intensity two times per week.
Exclusion
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- Use of a hybrid closed-loop system
- Females who are pregnant, breast-feeding or intend to become pregnant during the study period
- Ischemic heart disease
- Severe asthma
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation
Key Trial Info
Start Date :
February 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05268705
Start Date
February 3 2022
End Date
November 8 2022
Last Update
January 9 2023
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730