Comparing simple meal boluses to carbohydrate counting for blood sugar control in adolescents with type 1 diabetes
Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems: A Randomized Crossover Trial
This study tests whether a simpler way of calculating insulin doses for meals can help teenagers with type 1 diabetes manage their blood sugar better than the traditional method of counting carbohydrates.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 14 Years to 26 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06575790 on ClinicalTrials.gov |
What this trial studies
This trial evaluates blood sugar control in adolescents and adults with type 1 diabetes using a simplified meal bolus strategy versus traditional carbohydrate counting while on hybrid closed loop systems. Participants will follow a simple meal bolus plan for four weeks and then switch to precise carbohydrate counting for another four weeks. The study aims to assess glycemic control, feasibility, and the impact on the burden of diabetes management. By simplifying meal bolusing, the study seeks to make diabetes management more accessible for individuals with low numeracy skills.
Who should consider this trial
Good fit: Ideal candidates are adolescents and adults diagnosed with type 1 diabetes for at least one year who are using a commercial hybrid closed loop system.
Not a fit: Patients with a history of severe hypoglycemic events or other significant health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify diabetes management and improve blood sugar control for patients using hybrid closed loop systems.
How similar studies have performed: While the approach of simplifying meal bolusing is innovative, similar studies have shown that hybrid closed loop systems can improve glycemic control, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- Barbara Davis Center — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Alexandra Sawyer, MD, MPH
- Email: alexandra.sawyer@childrenscolorado.org
- Phone: 303-724-2323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.