Working... Menu

The International Diabetes Closed Loop (iDCL) Trial: Protocol 1 (iDCL)

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. Identifier: NCT02985866
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : October 31, 2017
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

Brief Summary:
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 or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Device: Artificial Pancreas Other: Sensor Augmented Therapy Not Applicable

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%.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
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
Actual Study Start Date : October 27, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

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.

Layout table for eligibility information
Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02985866

Layout table for location contacts
Contact: Stacey M. Anderson, MD 434-982-0945
Contact: Emma Emory, RN 434-243-3992

Layout table for location information
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   
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   
Contact: Liana Hsu    650-725-3939   
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   
Contact: Emily Jost, MPH RD CDE    (303) 724-7313   
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   
Contact: Louise Ambler-Osborn, CPNP    617-732-2603   
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   
Contact: Yogish C. Kudva, MBBS, MD   
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   
Contact: Camilla Levister, ANP-C, MS    212-241-5177   
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   
Contact: Emma Emory, RN    434-243-3992   
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
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Stacey Anderson, CDT Medical Director, University of Virginia Identifier: NCT02985866     History of Changes
Other Study ID Numbers: iDCL
UC4DK108483 ( U.S. NIH Grant/Contract )
First Posted: December 7, 2016    Key Record Dates
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.

Layout table for additional information
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:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Gastrointestinal Agents