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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid Closed Loop
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Type 1 Diabetes focused on measuring HCL, Type 1 Diabetes, Sensor

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201
  • Barbara Davis Center, 1775 Aurora Court, A140
  • Yale University School of Medicine, 2 Church Street South, Suite 404
  • Rocky Mountain Diabetes and Osteoporosis Center
  • University of Virginia, 617 West Main Street, 4th Floor
  • Rainier Clinical Research, 723 SW 10th Street, Suite 100

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hybrid Closed Loop

Arm Description

In-clinic evaluation of the HCL System under various conditions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
Percentage of Time in Euglycemic Range - Phase 2
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2
Percentage of Time in Euglycemic Range - Phase 4
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4
Percentage of Time in Euglycemic Range - Phase 6
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6
Percentage of Time in Euglycemic Range - Phase 7
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7

Full Information

First Posted
May 15, 2013
Last Updated
October 19, 2018
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT01857973
Brief Title
Overnight Closed Loop Study in U.S.
Acronym
OCL
Official Title
In-Clinic Feasibility Study to Observe the Overnight Closed Loop System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
HCL, Type 1 Diabetes, Sensor

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
subjects undergo treatment with the hybrid closed loop system under various experimental conditions
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Closed Loop
Arm Type
Experimental
Arm Description
In-clinic evaluation of the HCL System under various conditions.
Intervention Type
Device
Intervention Name(s)
Hybrid Closed Loop
Intervention Description
The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Primary Outcome Measure Information:
Title
Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)
Description
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.
Time Frame
12 days
Secondary Outcome Measure Information:
Title
Percentage of Time in Euglycemic Range - Exploratory A Phase
Description
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.
Time Frame
1 day
Title
Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase
Description
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.
Time Frame
1 day
Title
Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1
Description
Number of subject under-calibrated to introduce a persistent under-reading sensor measurement bias- Phase 1
Time Frame
1 day
Title
Percentage of Time in Euglycemic Range - Phase 2
Description
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2
Time Frame
3 days
Title
Percentage of Time in Euglycemic Range - Phase 4
Description
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4
Time Frame
12 days
Title
Percentage of Time in Euglycemic Range - Phase 6
Description
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6
Time Frame
7 days
Title
Percentage of Time in Euglycemic Range - Phase 7
Description
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Lee, MD
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201
City
Escondido
State/Province
California
ZIP/Postal Code
92026
Country
United States
Facility Name
Barbara Davis Center, 1775 Aurora Court, A140
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine, 2 Church Street South, Suite 404
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
University of Virginia, 617 West Main Street, 4th Floor
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Rainier Clinical Research, 723 SW 10th Street, Suite 100
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Overnight Closed Loop Study in U.S.

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