Last updated on February 2018

Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes

Brief description of study

This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm that is built into the 670G insulin pump is safe as part of the overall system.

Detailed Study Description

The study will proceed as follows:

Run-in Period - General:

A total of up to 200 subjects (age 2-13) will be enrolled at up to 15 investigational centers (14 in the US, 1 EMEA) in order to reach 120 subjects who will complete the HCL study.

Study Period - At Home:

Following the two week run-in period using the Study Pump (670G), all subjects (age 2-13) will participate in a 3-month study period.

Study Period - Hotel Study Subjects (age 7-13) will participate in a Hotel study (6 days, 5 nights), with the remainder of the study period to be spent at home. Subjects 2-6 years of age are not required to participate in a hotel study. Instead, they will participate in an out-of-home study for 5 consecutive days, 4-6 hours per day.

Continued Access Program Subjects will be given the opportunity to extend use of their study devices for a period of 2 years. If subjects choose to participate in the continuation period, they will retain the study devices at the end of study period visit or receive them back in the event they have been returned to study staff already.

Clinical Study Identifier: NCT02660827

Contact Investigators or Research Sites near you

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Thomas Troub

AMCR Institute
Escondido, CA United States
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Bruce Buckingham, MD

Stanford Hospital and Clinics
Palo Alto, CA United States
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Thomas Troub

SoCal Diabetes
Torrance, CA United States
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Greg Forlenza, MD

Barbara Davis Center
Aurora, CO United States
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Dorothy Shulman, MD

University of South Florida - USF Health
Tampa, FL United States
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Thomas Troub

Atlanta Diabetes Associates
Atlanta, GA United States
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Thomas Troub

Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, ID United States
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Michael Wood, MD

University of Michigan
Ann Arbor, MI United States
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Thomas Troub

Sheba Medical Center
Tel Aviv, Israel
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Larry Fox, MD

Nemours Children's Clinic
Jacksonville, FL United States
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Linda DiMeglio, MD

Indiana University
Indianapolis, IN United States
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