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

This study is currently recruiting participants.
Verified October 2017 by Stacey Anderson, University of Virginia
Sponsor:
ClinicalTrials.gov Identifier:
NCT02985866
First Posted: December 7, 2016
Last Update Posted: October 31, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
TypeZero Technologies, Inc.
DexCom, Inc.
Roche Diagnostic Ltd.
Ascensia Diabetes Care
Information provided by (Responsible Party):
Stacey Anderson, University of Virginia
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Stacey Anderson, University of Virginia:

Primary Outcome Measures:
  • Comparing differences between baseline and 3 months post randomization periods, the first co-primary is superiority in CGM-measured time below 70 mg/dL and the second co-primary is non-inferiority in CGM-measured time above 180 mg/dL. [ Time Frame: 3 months for both measurements ]

Estimated Enrollment: 126
Actual Study Start Date: October 27, 2017
Estimated Study Completion Date: June 1, 2018
Estimated Primary Completion Date: June 1, 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 3 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 3 months
Other Name: SAP

Detailed Description:

The protocol is a 3-month parallel group multi-center randomized trial designed to compare Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP). Approximately 126 subjects will be entered into the randomized trial at approximately seven clinical sites in the United States, such that at least 110 subjects complete the randomized trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of randomizing 126 subjects.

In order to have a broad range of glycemic control among the subjects, a study goal will be to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c < 7.5%.

  Eligibility

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.


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 not assigned to the closed-loop group, to avoid use of any closed-loop control system for the duration of the clinical trial
  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
  12. For subjects less than 18 years old, living with one or more parent/legal guardian (referred to subsequently as diabetes care partner) committed to participating in study training for emergency procedures for severe hypoglycemia and able to contact the subject in case of an emergency

Exclusion Criteria:

  1. Medical need for chronic acetaminophen
  2. Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment
  3. Hemophilia or any other bleeding disorder
  4. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk including any contraindication to the use of any of the study devices per FDA labeling
  5. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  6. Use of a closed-loop system within the last month prior to enrollment
  7. Employed by, or having immediate family members employed by TypeZero Technologies, LLC
  Contacts and Locations
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): 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 Recruiting
Santa Barbara, California, United States, 93105
Contact: Jordan Pinsker, MD         
Contact: Camille Andre    805-682-7640 ext 217    candre@sansum.org   
Principal Investigator: Jordan Pinsker, MD         
Sub-Investigator: Mei Mei Church, NP         
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Bruce Buckingham, MD    650-723-5791    bbendo@stanford.edu   
Contact: Liana Hsu    650-725-3939    ljhsu@stanford.edu   
Principal Investigator: Bruce Buckingham, MD         
United States, Colorado
Barbara Davis Center, University of Colorado 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) 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 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         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, 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 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         
Sponsors and Collaborators
Stacey Anderson
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
TypeZero Technologies, Inc.
DexCom, Inc.
Roche Diagnostic Ltd.
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 ( U.S. NIH Grant/Contract )
First Submitted: December 5, 2016
First Posted: December 7, 2016
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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. Individual patterns of demographic & insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Thus, data will 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 Stacey Anderson, University of Virginia:
Artificial Pancreas
Closed Loop Control
Continuous Glucose Monitor (CGM)
inControl Diabetes Management Platform

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