Overnight Closed Loop Study in U.S.

NCT ID: NCT01857973

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-10-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Hybrid Closed Loop

In-clinic evaluation of the HCL System under various conditions.

Group Type: EXPERIMENTAL

Hybrid Closed Loop

Intervention Type: DEVICE

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

Interventions

Hybrid Closed Loop

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is 2-75 years of age at time of screening

2. A clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis

Exclusion Criteria

3. Pump therapy for greater than 6 months with use of real time CGM for any period of time (ie. one day) 3 months prior to screening

4. Adequate venous access as assessed by investigator or appropriate staff

5. Subject should have an established insulin carbohydrate and insulin sensitivity ratio.

6. Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL

7. Subject reports at the time of screening that their average total daily insulin dose is 15 units - 110 units. (Insulin pump memory for this information may be used)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Lee, MD

Role: STUDY_DIRECTOR

Medtronic

Locations

AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201

Escondido, California, United States

Barbara Davis Center, 1775 Aurora Court, A140

Aurora, Colorado, United States

Yale University School of Medicine, 2 Church Street South, Suite 404

New Haven, Connecticut, United States

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, United States

University of Virginia, 617 West Main Street, 4th Floor

Charlottesville, Virginia, United States

Rainier Clinical Research, 723 SW 10th Street, Suite 100

Renton, Washington, United States

Countries

United States

Other Identifiers

CEP273

Identifier Type: -

Identifier Source: org_study_id