NCT04878120

Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes

Hybrid Closed-Loop Control With Prandial Insulin Dosing Informed by Insulin Sensitivity in Adolescents With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp.

Detailed description

This is a single center, double-blind, randomized, crossover trial. The study team will target enrollment of 30 adolescents (age 12 - \<18 years) with T1D who currently manage their diabetes with an insulin pump and a continuous glucose monitoring (CGM) system. Participants will be randomized 1:1 to the use of the standard HCL system (USS Virginia) vs. the HCL system with the smart bolus calculator first. The trial will be held at a local camp facility and will consist of EITHER a weeklong (6 day/5 night) camp OR two long weekends (4 day/3 night) separated by a washout period of about one week.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Standard HCL System	Standard HCL system (USS Virginia)
DEVICE	HCL System with Smart Bolus Calculator	HCL system (USS Virginia) with smart bolus calculator informed by insulin sensitivity

Timeline

• Start date: 2021-05-14
• Primary completion: 2022-06-24
• Completion: 2022-06-28
• First posted: 2021-05-07
• Last updated: 2024-05-30
• Results posted: 2024-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study