Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

Simple Meal Bolusing

Participants will enter pre-determined numbers for small, medium, or large carbohydrate meals rather than using precise carbohydrate counting

BEHAVIORAL

Carbohydrate counting

Participants will be instructed to enter accurate carbohydrate counts to the best of their ability for all meals and snacks

Locations (1)

Barbara Davis Center
Aurora, Colorado, United States