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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857973
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Hybrid Closed Loop Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857973


Locations
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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
Sponsors and Collaborators
Medtronic Diabetes
Investigators
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Study Director: Scott Lee, MD Medtronic
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01857973    
Other Study ID Numbers: CEP273
First Posted: May 20, 2013    Key Record Dates
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medtronic Diabetes:
HCL
Type 1 Diabetes
Sensor
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases