Last updated on December 2018

Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home

Brief description of study

The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)

Detailed Study Description

This is a 6 month, multi-center, randomized, parallel, adaptive study in type 1 diabetes with a 6 month continuation period. The study will have three periods:

  1. Run-in Period: The run-in period can be up to 60 days during which time a blinded CGM sensor will be worn for two weeks.
  2. Study Period: There will be a 6 month randomized study period with two arms: The HCL system and Control.
  3. Continuation Period: There will be a 6 month continuation period during which time all subjects will use the HCL system with Auto Mode.

Up to 1500 subjects will be enrolled in order to have 1120 subjects complete the study. Up to 70 investigational Centers in the US, Europe and Canada will be enrolled.

Clinical Study Identifier: NCT02748018

Contact Investigators or Research Sites near you

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Kevin Kaiserman, MD

SoCal Diabetes
Torrance, CA United States
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Mark Christiansen, MD

Diablo Clinical Research
Walnut Creek, CA United States
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Robert Slover, MD

Barbara Davis Center
Aurora, CO United States
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Bruce Bode, MD

Atlanta Diabetes Associates
Atlanta, GA United States
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John Reed, MD

Endocrine Research Solutions
Roswell, GA United States
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Rodica Pop-Busui, MD

University of Michigan
Ann Arbor, MI United States
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George Grunberger, MD

Grunberger Diabetes Institute
Bloomfield Hills, MI United States
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Luis Casaubon, MD

Texas Diabetes & Endocrinology
Austin, TX United States
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Ronald Brazg, MD

Rainier Clinical Research
Renton, WA United States
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Irl Hirsch, MD

University of Washington
Seattle, WA United States
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Amy Criego, MD

Initernational Diabetes Center
Minneapolis, MN United States
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Anders Carlson, MD

International Diabetes Center
Minneapolis, MN United States
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Yogish Kudva, MD

Mayo Clinic
Rochester, MN United States
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Athena Philis-Tsimikas, MD

Scripps Health System
La Jolla, CA United States
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David Liljenquist, MD

Rocky Mountain Diabetes
Idaho Falls, ID United States
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Anuj Bhargava, MD

Des Moines, IA United States
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Maria Redondo, MD

Texas Children's Hospital / Baylor University
Houston, TX United States
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Bruce Buckingham, MD

Stanford University
Palo Alto, CA United States
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Janet McGill, MD

Washington University St. Louis
Saint Louis, MO United States
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Ruth Weinstock, MD

SUNY Upstate Medical University
Syracuse, NY United States
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Kurt Griffin, MD

Sanford Health
Sioux Falls, SD United States
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Angela Girelli, MD

A.S.S.T. Spedali Civili
Brescia, Italy
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Johan Jendle, MD

Dept Internal Medicine, rebro University Hospital
Örebro, Sweden
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Recruitment Status: Open

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