Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems: A Randomized Crossover Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 26
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
Barbara Davis Center
RECRUITING
Aurora
Contact Information
Primary
Alexandra Sawyer, MD, MPH
alexandra.sawyer@childrenscolorado.org
303-724-2323
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 40
Treatments
Experimental: Simple Meal Bolusing
Participants will be instructed to enter a set number of carbohydrates before meals based on if they are having a small, medium, or large meal. The preset numbers for meals will be based on their average total daily dose (TDD) determined during the 2-week usual care observation period. The participants will have their insulin to carbohydrate ratios set based on the standard formula of 450/TDD for all meals initially (e.g. a child with a TDD of 50 u/day would have 450/50=9 so an I:C of 1:9). They enter a carbohydrate amount of 30 g for small meals, 60 g for regular meals, and 90 g for large meals.
Active_comparator: Precise Carbohydrate counting
Participants will be instructed to enter a precise carbohydrate count before meals to the best of their ability. Pump settings may be adjusted per provider discretion and typical clinical care during this time period.
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov