Status:
COMPLETED
Overnight Closed Loop Study in U.S.
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
2-75 years
Phase:
NA
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...
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. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01857973
Start Date
June 1 2013
End Date
October 1 2016
Last Update
February 28 2019
Active Locations (6)
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1
AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201
Escondido, California, United States, 92026
2
Barbara Davis Center, 1775 Aurora Court, A140
Aurora, Colorado, United States, 80045
3
Yale University School of Medicine, 2 Church Street South, Suite 404
New Haven, Connecticut, United States, 06519
4
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404