NCT01857973

Overnight Closed Loop Study in U.S.

In-Clinic Feasibility Study to Observe the Overnight Closed Loop System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.

Detailed description

Subjects that have met eligibility criteria will undergo treatment with the hybrid closed loop system under various experimental conditions.There is no statistically powered study hypothesis testing. The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American. The study is anticipated to last no more than 12 months from investigational center initiation to finalization of all data entry and monitoring procedures. Subjects are expected to participate for approximately 1- 2 months.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Hybrid Closed Loop	The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-06-01
• Completion: 2016-10-01
• First posted: 2013-05-20
• Last updated: 2019-02-28
• Results posted: 2019-02-28

Locations

6 sites across 1 country: United States