Status:
COMPLETED
The Importance of Meal Composition on Preventing Exercise-induced Hypoglycemia in People With Type 1 Diabetes.
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Swansea University
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is a clinical, randomized, crossover study. The study investigates the effect of a low-carbohydrate-high-protein pre-exercise meal on preventing exercise-induced hypoglycemia in people with...
Detailed Description
Background: People with type 1 diabetes practicing a low-carbohydrate diet can increase the fat and/or protein content of the diet to cover their energy needs. In relation to physical activity, inges...
Eligibility Criteria
Inclusion
- Age 18-70 years.
- Type 1 diabetes ≥ 5 years.
- Insulin pump use ≥ 1 year.
- Use of flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) ≥ 3 months.
- Body mass index 18.5-30 kg/m2.
- HbA1c ≤ 64 mmol/mol (8.0%).
- Self-reported hypoglycemia awareness
- Ability to carbohydrate count for all meals.
- Familiarity with the insulin pump bolus calculator for all meals.
- Moderate to vigorous level of physical activity
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 Metronic Minimed 670G insulin pump system.
- Allergy to paracetamol or nuts
- Females who are pregnant, breast-feeding or intend to become pregnant.
- 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 :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04472962
Start Date
August 14 2020
End Date
January 30 2021
Last Update
February 15 2021
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, 2820