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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    University of Virginia
Updated on 27 November 2021
diabetes
insulin
metformin

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.

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. Participants will then attend a 6 day/5 night diabetes camp. Crossover to the other treatment group will occur midweek. Participants and study personnel actively involved in the study will be blinded to the treatment groups.

Details
Condition Diabetes Mellitus, Insulin dependent diabetes mellitus, Autoimmune disease, type 1 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus
Treatment Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI, Standard Hybrid Closed Loop Control (USS Virginia)
Clinical Study IdentifierNCT04878120
SponsorUniversity of Virginia
Last Modified on27 November 2021

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