Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems
Recruiting now · Not applicable
Conditions studied: Type 1 Diabetes
In brief
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 on a hybrid closed loop system. The main question it aims to answer are: What is the blood sugar time in range when using simple meal boluses versus carbohydrate counting? Participants will: Use the simple meal bolus plan for 4 weeks. Do precise carbohydrate counting for 4 weeks. Provide their continuous glucose monitor and pump data Take surveys about the experience of meal bolusing during the study
Key facts
- Study ID
- NCT06575790
- Run by
- University of Colorado, Denver
- People needed
- 40
- Starts
- 2024-11-25
- Expected to finish
- 2025-09-30
- Last updated by the study team
- 2024-12-10
Who can join
Age: 14 and older, up to 26. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Barbara Davis Center — Aurora, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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