Effects of Pre-Exercise Basal Insulin Manipulation on Glucose Dynamics in Females vs. Males With Type 1 Diabetes
Summary
A randomized crossover clinical trial (NCT07550608) registered on ClinicalTrials.gov compares blood sugar dynamics during exercise in 18-45-year-old adults with Type 1 Diabetes who use insulin pumps. The study examines whether a 50% reduction in basal insulin dose 90-120 minutes before exercise reduces hypoglycemia risk differently in males versus females. Participants complete three laboratory visits including a fitness test and two 60-minute moderate-intensity treadmill sessions under different insulin conditions.
“Researchers want to understand if biological sex affects the risk of low blood sugar (hypoglycemia) during physical activity.”
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What changed
This ClinicalTrials.gov registry entry documents a new randomized crossover study investigating sex-based differences in glucose response to exercise in Type 1 Diabetes patients. The study population consists of adults aged 18-45 with T1D for at least 18 months who use insulin pumps, who will complete two 60-minute moderate-intensity treadmill sessions with either 50% basal insulin reduction or habitual insulin maintenance. The primary outcome measures include blood sugar levels every 10 minutes during exercise and hormone levels from blood samples collected before and after sessions.
For clinical investigators and diabetes researchers, this trial adds to the evidence base on exercise management in T1D and may inform future clinical guidance on pre-exercise insulin adjustments. The crossover design allows each participant to serve as their own control, strengthening the validity of sex-based comparisons. Researchers studying glycemic control, hypoglycemia prevention, or sex differences in diabetes management may find this trial relevant to their programs.
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Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Effects of Pre-Exercise Basal Insulin Manipulation on Glucose Dynamics in Females vs. Males With Type 1 Diabetes: A Cross-Over Study
N/A NCT07550608 Kind: NA Apr 24, 2026
Abstract
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.
Conditions: Type 1 Diabetes
Interventions: 50% Pre-Exercise Basal Insulin Rate Reduction (BIRR), Habitual Basal Insulin Rate Maintenance
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