Clinical trial NCT01857973: Overnight Closed Loop Study in U.S.
Official title: In-Clinic Feasibility Study to Observe the Overnight Closed Loop System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: HCL
Type 1 Diabetes
Sensor
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 78
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: subjects undergo treatment with the hybrid closed loop system under various experimental conditions
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: Inclusion Criteria:

1. Subject is 2-75 years of age at time of screening
2. 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 :
3. 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
4. Adequate venous access as assessed by investigator or appropriate staff
5. Subject should have an established insulin carbohydrate and insulin sensitivity ratio.
6. Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL
7. 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)

Primary outcomes:
measure: Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)
timeFrame: 12 days
Secondary outcomes:
measure: Percentage of Time in Euglycemic Range - Exploratory A Phase
timeFrame: 1 day
measure: Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase
timeFrame: 1 day
measure: Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1
timeFrame: 1 day
measure: Percentage of Time in Euglycemic Range - Phase 2
timeFrame: 3 days
measure: Percentage of Time in Euglycemic Range - Phase 4
timeFrame: 12 days
measure: Percentage of Time in Euglycemic Range - Phase 6
timeFrame: 7 days
measure: Percentage of Time in Euglycemic Range - Phase 7
timeFrame: 7 days
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201
state: California
city: Aurora
country: United States
facility: Barbara Davis Center, 1775 Aurora Court, A140
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine, 2 Church Street South, Suite 404
state: Connecticut
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Charlottesville
country: United States
facility: University of Virginia, 617 West Main Street, 4th Floor
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research, 723 SW 10th Street, Suite 100
state: Washington
Study officials:
affiliation: Medtronic
name: Scott Lee, MD
role: STUDY_DIRECTOR
References: