Status:
RECRUITING
Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems
Lead Sponsor:
University of Colorado, Denver
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
14-26 years
Phase:
NA
Brief Summary
The goal of this trial is to evaluate blood sugar control in patients with type 1 diabetes when using a simple meal bolus strategy (small, medium, large meals) compared to carbohydrate counting when o...
Detailed Description
This is a prospective randomized crossover trial in adolescents and adults on HCL systems at the Barbara Davis Center for Childhood Diabetes (BDC) with the objective of testing a new simple meal bolus...
Eligibility Criteria
Inclusion
- Clinical diagnosis of T1D of at least 1 year duration
- Using a commercial HCL system
- Willingness to not start any new non-insulin glucose-lowering agent during trial
- Willingness to participate in all study procedures
- Investigator has confidence that participant can successfully operate all study devices and adhere to protocol
Exclusion
- History of \>1 severe hypoglycemic event with seizure or loss of consciousness in the last 6 months or \>1 DKA event in the last 6 months not related to illness or infusion set failure
- History of chronic renal disease or currently on hemodialysis, adrenal insufficiency, hypothyroidism that is not adequately treated, use of oral or injectable steroids within the last 8 weeks, or known ongoing adhesive intolerance
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another interventional trial at the time of enrollment
- Pregnancy
Key Trial Info
Start Date :
November 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06575790
Start Date
November 25 2024
End Date
September 30 2025
Last Update
December 10 2024
Active Locations (1)
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1
Barbara Davis Center
Aurora, Colorado, United States, 80045