NCT06575790

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 14 Years – 26 Years
• Healthy volunteers: Not accepted

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

Detailed 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 numeracy or difficulty with carbohydrate counting. Although HCL systems cannot yet provide automatic meal bolus insulin, such systems can minimize hyperglycemia through basal modulation and automated correction dosing and should be able to mitigate some of the impact of non-precise carbohydrate coverage. The systems can also help prevent hypoglycemia through basal modulation and pausing insulin delivery. This study will evaluate glycemic control while using the simple meal bolus strategy as compared to traditional precise carbohydrate counting in addition to assessing feasibility, acceptability, and impact on meal-related diabetes burden of each meal bolus strategy. The proposed study will be a prospective, randomized crossover trial at a single site. Study participants will be randomized via REDCap 1:1 to Group A or Group B with plan for up to a max of 60 total participants to account for drop-out. Neither the participants nor the investigators will be blinded to group assignments due to the nature of the study. After enrollment, groups will have a 2-week run-in period of usual care. At the first study visit, patients will upload their pump/CGM data, take pre-study surveys, and review carbohydrate counting or simple meal boluses. Pump settings may be adjusted per provider discretion and typical clinical care. Both groups will be instructed to use their systems as they typically would for 4 weeks with the exception of what is entered for carbohydrates for meal boluses. Group B will enter the precise carbohydrate count to the best of their ability, while the Group A will be instructed to enter an assigned number of carbohydrates based on if the meal is small, medium, or large. Participants will have a follow-up visit (in-person, virtual, or by phone) after 4 weeks to provide pump and CGM data, adjust insulin dosing as needed, and review the new strategy. They will have 1 week of usual care as a wash-out period followed by 4 weeks using the opposite strategy. Participants will have a final study visit to upload data and take post-study surveys.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-25
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-08-28
• Last updated: 2024-12-10

Locations

1 site across 1 country: United States