Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems: A Randomized Crossover Trial
University of Colorado, Denver
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
Description
This is a prospective randomized crossover trial in adolescents and adults on HCL systems at the Barbara Davis Center for Childhood Diabetes (BDC) with the objective of testing a new simple meal bolus strategy that would not require carbohydrate counting. Given the clear benefit of HCL systems on glycemic control, the ability to use an alternative meal bolus strategy may make HCL systems more accessible. This is a fixed dose of insulin given at meals for small, medium, or large meals that would eliminate the need for precise carbohydrate counting and increase access to patients with low numera…
Eligibility
- Age range
- 14–26 years
- Sex
- All
- Healthy volunteers
- No
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 diseas…
Interventions
- BehavioralSimple Meal Bolusing
Participants will enter pre-determined numbers for small, medium, or large carbohydrate meals rather than using precise carbohydrate counting
- BehavioralCarbohydrate counting
Participants will be instructed to enter accurate carbohydrate counts to the best of their ability for all meals and snacks
Location
- Barbara Davis CenterAurora, Colorado