Overnight Closed Loop Study in U.S.

Not Applicable

Completed

Conditions: Type 1 Diabetes

Interventions: Device: Hybrid Closed Loop

Registration Number: NCT01857973

Lead Sponsor: Medtronic Diabetes

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 78

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 Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hybrid Closed Loop	Hybrid Closed Loop	In-clinic evaluation of the HCL System under various conditions.

Primary Outcome Measures

Name	Time	Method
Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)	12 days	time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions.

Secondary Outcome Measures

Name	Time	Method
Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase	1 day	The purpose of exploratory B study was to evaluate the efficacy and safety of the insulin upper-limit, Umax. The Umax is a patient-specific parameter which is calculated based on historical data from the pump that includes SG tracings, insulin delivery information, and the carbohydrate inputs from the user. The main objective of Umax is to prevent the user from being severely hypoglycemic (less than 50 mg/dL) by restricting the controller from over-delivery of insulin.
Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1	1 day	Number of subject under-calibrated to introduce a persistent under-reading sensor measurement bias- Phase 1
Percentage of Time in Euglycemic Range - Phase 2	3 days	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2
Percentage of Time in Euglycemic Range - Phase 4	12 days	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4
Percentage of Time in Euglycemic Range - Phase 6	7 days	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6
Percentage of Time in Euglycemic Range - Phase 7	7 days	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7
Percentage of Time in Euglycemic Range - Exploratory A Phase	1 day	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Exploratory A phase. An overnight closed-loop experiment was performed using the Android Development Platform, software version 2.0 A system's closed-loop algorithm without implementing the upper-limit for insulin delivery.

Trial Locations

Locations (6): AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201
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Escondido, California, United States
Barbara Davis Center, 1775 Aurora Court, A140
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Aurora, Colorado, United States
Rocky Mountain Diabetes and Osteoporosis Center
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Idaho Falls, Idaho, United States
University of Virginia, 617 West Main Street, 4th Floor
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Charlottesville, Virginia, United States
Rainier Clinical Research, 723 SW 10th Street, Suite 100
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Renton, Washington, United States
Yale University School of Medicine, 2 Church Street South, Suite 404
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New Haven, Connecticut, United States