Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
Last updated on July 2021Recruitment
- 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