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Trial record 1 of 1 for:    NCT02985866
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The International Diabetes Closed Loop (iDCL) Trial: Main Protocol (iDCL Main)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2017 by University of Virginia
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
TypeZero Technologies, LLC
Tandem Diabetes Care, Inc.
DexCom, Inc.
Ascensia Diabetes Care
Information provided by (Responsible Party):
Stacey Anderson, University of Virginia
ClinicalTrials.gov Identifier:
NCT02985866
First received: December 5, 2016
Last updated: February 16, 2017
Last verified: February 2017
  Purpose
The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.

Condition Intervention
Type1 Diabetes Mellitus
Device: Artificial Pancreas
Other: Sensor Augmented Therapy
Device: continuous glucose monitor (CGM)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • The co-primary outcomes are differences in CGM-measured metrics between baseline and 6-month post-336 randomization period: - superiority in CGM-measured time below 70 mg/dL, and 338 - non-inferiority in CGM-measured time above 180 mg/dL [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Among subjects with HbA1c ≥7.5%, difference in HbA1c improvement between SAP and CTR at 6 months [ Time Frame: 6 months ]
  • Among subjects with HbA1c <7.5%, difference in CGM-measured time below 70 mg/dL between baseline and 6-month post-randomization period [ Time Frame: 6 months ]

Estimated Enrollment: 120
Anticipated Study Start Date: March 15, 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artificial Pancreas
Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.
Device: Artificial Pancreas
Use of CTR at home for 6 months
Other Name: Control-to-Range (CTR) closed-loop (CL)
Active Comparator: Sensor Augmented Therapy
Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.
Other: Sensor Augmented Therapy
Use of personal pump with study CGM & glucometer at home for 6 months
Other Name: SAP
Device: continuous glucose monitor (CGM)

Detailed Description:
The protocol is a 6-month parallel group multi-center randomized trial designed to compare Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP). Approximately 240 subjects will be entered into the randomized trial at approximately ten clinical sites in the United States and Europe, such that at least 207 subjects complete the randomized trial. The goal will be to randomize approximately 115 subjects with HbA1c ≥7.5% and 125 subjects with HbA1c < 7.5%, with the minimum being 92 subjects with HbA1c <7.5% and 86 with HbA1c >7.5%.
  Eligibility

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
  2. Use of an insulin pump for at least 6 months
  3. Age ≥14 years old
  4. HbA1c level <10.5% at screening
  5. For females, not currently known to be pregnant
  6. Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study
  7. Willingness, if using the closed-loop system, to stop closed-loop when taking acetaminophen and avoid closed-loop for at least 4 hours afterward
  8. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the unblinded study CGM is in use
  9. Willingness to establish network connectivity on at least a weekly basis either via local Wifi network or via a study-provided cellular service
  10. Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra)
  11. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol

Exclusion Criteria:

  1. More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
  2. More than one episode of severe hypoglycemia involving seizure or loss of consciousness in the 6 months prior to enrollment
  3. Medical need for chronic acetaminophen
  4. Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment
  5. Hemophilia or any other bleeding disorder
  6. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
  7. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  8. Use of a closed-loop system within the last month prior to enrollment
  9. Employed by, or having immediate family members employed by TypeZero Technologies, LLC
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02985866

Contacts
Contact: Stacey M. Anderson, MD 434-982-0945 sg4c@virginia.edu
Contact: Emma Emory, RN 434-243-3992 ee9m@virginia.edu

Locations
United States, California
William Sansum Diabetes Center Not yet recruiting
Santa Barbara, California, United States, 93105
Contact: Jordan Pinsker, MD         
Contact: Mei Mei Church, NP    805-682-7640 ext 265    mchurch@sansum.org   
Principal Investigator: Jordan Pinsker, MD         
Sub-Investigator: Mei Mei Church, NP         
Stanford University Not yet recruiting
Stanford, California, United States, 94304
Contact: Bruce Buckingham, MD    650-723-5791    bbendo@stanford.edu   
Contact: Eliana Frank    650-736-6642    elianaf@stanford.edu   
Principal Investigator: Bruce Buckingham, MD         
United States, Colorado
Barbara Davis Center, University of Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: R. Paul Wadwa, MD    303-724-2323    paul.wadwa@ucdenver.edu   
Contact: Emily Jost, MPH RD CDE    (303) 724-7313    emily.jost@ucdenver.edu   
Principal Investigator: R. Paul Wadwa, MD         
United States, Massachusetts
Harvard University (Joslin Diabetes Center) Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Lori Laffel, MD, MPH    617-732-2603    lori.laffel@joslin.harvard.edu   
Contact: Louise Ambler-Osborn, CPNP    617-732-2603    louise.ambler-osborn@joslin.harvard.edu   
Principal Investigator: Francis Doyle, PhD         
Principal Investigator: Lori Laffel, MD, MPH         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Shelly McCrady-Spitzer    507-255-5916    McCradySpitzer.Shelly@mayo.edu   
Contact: Yogish C. Kudva, MBBS, MD       kudva.yogish@mayo.edu   
Principal Investigator: Yogish Kudva, MBBS, MD         
Sub-Investigator: Ananda Basu, MD, FRCP         
United States, New York
Icahn School of Medicine at Mount Sinai Not yet recruiting
New York City, New York, United States, 10029
Contact: Carol Levy, MD, CDE    212-241-9089    selassie.ogyaadu@mssm.edu   
Contact: Camilla Levister, ANP-C, MS    212-241-5177    Camilla.Levister@mssm.edu   
Principal Investigator: Carol Levy, MD, CDE         
Sub-Investigator: David Lam, MD         
United States, Virginia
University of Virginia Center for Diabetes Technology Not yet recruiting
Charlottesville, Virginia, United States, 22903
Contact: Stacey M. Anderson, MD    434-982-0945    sg4c@virginia.edu   
Contact: Emma Emory, RN    434-243-3992    ee9m@virginia.edu   
Sub-Investigator: Sue A. Brown, MD         
Sub-Investigator: Linda Gonder-Fredrick, PhD         
France
University of Montpellier
Montpellier, France
Italy
University of Padova
Padova, Italy
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Stacey Anderson
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
TypeZero Technologies, LLC
Tandem Diabetes Care, Inc.
DexCom, Inc.
Ascensia Diabetes Care
Investigators
Principal Investigator: Boris P. Kovatchev, PhD University of Virginia Center for Diabetes Technology
Study Chair: Stacey M. Anderson, MD University of Virginia Center for Diabetes Technology
  More Information

Responsible Party: Stacey Anderson, CDT Medical Director, University of Virginia
ClinicalTrials.gov Identifier: NCT02985866     History of Changes
Other Study ID Numbers: iDCL
UC4DK108483 ( US NIH Grant/Contract Award Number )
Study First Received: December 5, 2016
Last Updated: February 16, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series, meal content, boluses, & exercise will be deidentified & retrievable only by subject ID number. The data's real value lies in their precise time stamps - each reading is coded by date & time which makes possible the data to be related to the subjects' daily routine. Individual patterns of demographic & insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Data can be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes & not to identify participants; (2) a commitment to securing the data using appropriate computer technology; & (3) a commitment to destroying or returning the data after analyses are completed.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of Virginia:
Artificial Pancreas
Closed Loop Control
Continuous Glucose Monitor (CGM)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2017