NCT06575790Recruiting
Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems
Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems: A Randomized Crossover Trial
Source: ClinicalTrials.gov · Last updated 10 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 23 Aug 2024
- Start date
- 25 Nov 2024
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Type 1 diabetes
- NCT number
- NCT06575790
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 25 Nov 2024 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
Other
- Participation in another interventional trial at the time of enrollment
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 14 years to 26 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barbara Davis Center Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
Related publications
- A Simple Meal Bolus Strategy is Effective in Adolescents and Young Adults with Type 1 Diabetes on Multiple Automated Insulin Delivery Systems.Diabetes Technol Ther · 2026 · PMID 42458783
This page is information, not medical advice. Discuss any trial with your doctor.