Overnight Closed Loop Study in U.S.

Type 1 Diabetes Clinical Trial

— OCL  

Official title:

In-Clinic Feasibility Study to Observe the Overnight Closed Loop System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857973
• Other study ID #: CEP273
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2018
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Hybrid Closed Loop
The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)	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.	12 days
Secondary	Percentage of Time in Euglycemic Range - Exploratory A Phase	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.	1 day
Secondary	Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase	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.	1 day
Secondary	Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1	Number of subject under-calibrated to introduce a persistent under-reading sensor measurement bias- Phase 1	1 day
Secondary	Percentage of Time in Euglycemic Range - Phase 2	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2	3 days
Secondary	Percentage of Time in Euglycemic Range - Phase 4	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4	12 days
Secondary	Percentage of Time in Euglycemic Range - Phase 6	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6	7 days
Secondary	Percentage of Time in Euglycemic Range - Phase 7	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7	7 days