NCT06575790 Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems
| NCT ID | NCT06575790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-11-25 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06575790 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 26 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06575790 currently recruiting?
Yes, NCT06575790 is actively recruiting participants. Contact the research team at alexandra.sawyer@childrenscolorado.org for enrollment information.
Where is the NCT06575790 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06575790 clinical trial?
NCT06575790 is sponsored by University of Colorado, Denver. The trial plans to enroll 40 participants.
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