|

Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems

RECRUITINGN/ASponsored by University of Colorado, Denver
Actively Recruiting
PhaseN/A
SponsorUniversity of Colorado, Denver
Started2024-11-25
Est. completion2025-09-30
Eligibility
Age14 Years – 26 Years
Healthy vol.Accepted
Locations1 site

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

Age: 14 Years – 26 YearsHealthy volunteers accepted
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

Conditions2

DiabetesType 1 Diabetes

Locations1 site

Barbara Davis Center
Aurora, Colorado, 80045
Alexandra Sawyer, MD, MPH720-724-2323alexandra.sawyer@childrenscolorado.org

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.