Overnight Closed Loop Study in U.S. (OCL)
|ClinicalTrials.gov Identifier: NCT01857973|
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: Hybrid Closed Loop||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||subjects undergo treatment with the hybrid closed loop system under various experimental conditions|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||In-Clinic Feasibility Study to Observe the Overnight Closed Loop System|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||October 2016|
Experimental: Hybrid Closed Loop
In-clinic evaluation of the HCL System under various conditions.
Device: Hybrid Closed Loop
The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
- Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform) [ Time Frame: 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.
- Percentage of Time in Euglycemic Range - Exploratory A Phase [ Time Frame: 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.
- Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 days ]Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2
- Percentage of Time in Euglycemic Range - Phase 4 [ Time Frame: 12 days ]Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4
- Percentage of Time in Euglycemic Range - Phase 6 [ Time Frame: 7 days ]Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6
- Percentage of Time in Euglycemic Range - Phase 7 [ Time Frame: 7 days ]Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857973
|United States, California|
|AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201|
|Escondido, California, United States, 92026|
|United States, Colorado|
|Barbara Davis Center, 1775 Aurora Court, A140|
|Aurora, Colorado, United States, 80045|
|United States, Connecticut|
|Yale University School of Medicine, 2 Church Street South, Suite 404|
|New Haven, Connecticut, United States, 06519|
|United States, Idaho|
|Rocky Mountain Diabetes and Osteoporosis Center|
|Idaho Falls, Idaho, United States, 83404|
|United States, Virginia|
|University of Virginia, 617 West Main Street, 4th Floor|
|Charlottesville, Virginia, United States, 22903|
|United States, Washington|
|Rainier Clinical Research, 723 SW 10th Street, Suite 100|
|Renton, Washington, United States, 98057|
|Study Director:||Scott Lee, MD||Medtronic|