Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Type 1 Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

This is a pilot study to assess glycemic responses to three different approaches to insulin dosing for carbohydrate ingestion, with different approaches to a closed-loop system in random order; without the meal anticipation module and without carbohydrate announcement (FCL) with the meal anticipatio...

This is a pilot study to assess glycemic responses to three different approaches to insulin dosing for carbohydrate ingestion, with different approaches to a closed-loop system in random order; without the meal anticipation module and without carbohydrate announcement (FCL) with the meal anticipation module and without carbohydrate announcement (FCL+) without the meal anticipation module and with carbohydrate announcement (HCL), This study will target completion of up to 18 adults in a randomized cross-over trial, comparing blood glucose time in range 70-180 mg/dL following meals with and without the meal anticipation module in use (FCL+ vs FCL), and comparing to a system with carb announcement instead of a meal anticipation module (HCL). The study will also assess safety when dinner is consumed later than usual and when a lunch is consumed without having been entrained in the meal anticipation module. Each participant will complete each of the 3 modules in random order.

Tracking Information

NCT #
NCT04877730
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Sue Brown, MD University of Virginia Center for Diabetes Technology