Overnight Closed Loop Study in U.S. (OCL)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Hybrid Closed Loop

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States, 92026
      • AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center, 1775 Aurora Court, A140
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University School of Medicine, 2 Church Street South, Suite 404
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes and Osteoporosis Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia, 617 West Main Street, 4th Floor
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research, 723 SW 10th Street, Suite 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Percentage of Time in Euglycemic Range - Phase 2	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2	3 days
Percentage of Time in Euglycemic Range - Phase 4	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4	12 days
Percentage of Time in Euglycemic Range - Phase 6	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6	7 days
Percentage of Time in Euglycemic Range - Phase 7	Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7	7 days

Collaborators and Investigators

• Sponsor: Medtronic Diabetes
• Investigators: Study Director: Scott Lee, MD, Medtronic

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (Estimate): May 20, 2013

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Sensor; HCL
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CEP273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO