Overnight Closed Loop Study in U.S.
Completed · Not applicable
Conditions studied: Type 1 Diabetes
In brief
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.
Key facts
- Study ID
- NCT01857973
- Run by
- Medtronic MiniMed, Inc.
- People needed
- 78
- Starts
- 2013-06-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2019-02-28
Who can join
Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is 2-75 years of age at time of screening
- 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 that are Based on Demands of In-Clinic Study Procedures :
- 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
- Adequate venous access as assessed by investigator or appropriate staff
- Subject should have an established insulin carbohydrate and insulin sensitivity ratio.
- Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL
- 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)
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.