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Effects of Pre-Exercise Basal Insulin Manipulation on Glucose Dynamics in Females vs. Males With Type 1 Diabetes
Sponsor: Naama Constantini
Summary
The Purpose of the Study The purpose of this study is to compare how blood sugar levels change during exercise in men and women with type 1 diabetes (T1D). Researchers want to understand if biological sex affects the risk of low blood sugar (hypoglycemia) during physical activity. Additionally, the study examines whether reducing the background (basal) insulin dose before exercise is effective at keeping blood sugar stable. Study Population The study includes active adults (men and women) aged 18-45 who have lived with type 1 diabetes for at least 18 months and use an insulin pump. What Happens During the Study Participants complete three laboratory visits: Visit 1: A fitness test on a treadmill to measure the participant's aerobic capacity. Visits 2 \& 3: Two 60-minute moderate-intensity exercise sessions on a treadmill. In one session, participants reduce their basal insulin by 50% starting 90-120 minutes before exercising. In the other session, they maintain their usual insulin dose. Researchers measure blood sugar every 10 minutes during exercise and collect blood samples before and after the sessions to monitor hormone levels. Study Design This is a randomized crossover study, meaning every participant performs both exercise strategies in a random order to serve as their own control.
Official title: Effects of Pre-Exercise Basal Insulin Manipulation on Glucose Dynamics in Females vs. Males With Type 1 Diabetes: A Cross-Over Study
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2023-10-20
Completion Date
2025-07-01
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
50% Pre-Exercise Basal Insulin Rate Reduction (BIRR)
Participants are instructed to reduce their habitual basal insulin infusion rate by 50% using their continuous subcutaneous insulin infusion (CSII) pump. This reduction is initiated 90 to 120 minutes prior to the start of the 60-minute moderate-intensity treadmill exercise bout. The intervention is designed to evaluate if this proactive reduction mitigates the risk of exercise-induced hypoglycemia in both male and female recreational athletes with type 1 diabetes.
Habitual Basal Insulin Rate Maintenance
Participants perform a 60-minute moderate-intensity treadmill exercise bout while maintaining their full habitual basal insulin infusion rate as programmed in their CSII pump. No adjustments, reductions, or suspensions of the basal rate are made prior to or during the exercise session. This condition serves as the active comparator to evaluate standard glucose dynamics without anticipatory insulin manipulation.
Locations (1)
Sylvan Adams Sport Institute, Tel Aviv University
Tel Aviv, Israel