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Trial record 1 of 1 for:    NCT02844517
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International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol

This study is currently recruiting participants.
Verified August 2017 by Stacey Anderson, University of Virginia
Sponsor:
ClinicalTrials.gov Identifier:
NCT02844517
First Posted: July 26, 2016
Last Update Posted: September 1, 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, LLC
Tandem Diabetes Care, Inc.
DexCom, Inc.
Roche Diagnostic Ltd.
Information provided by (Responsible Party):
Stacey Anderson, University of Virginia
  Purpose
The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.

Condition Intervention
Diabetes Mellitus, Type 1 Device: Artificial Pancreas

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol

Resource links provided by NLM:


Further study details as provided by Stacey Anderson, University of Virginia:

Primary Outcome Measures:
  • The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff. [ Time Frame: 2 weeks ]

Estimated Enrollment: 100
Actual Study Start Date: November 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artificial Pancreas
The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff.
Device: Artificial Pancreas
Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump and continuous glucose monitor. This AP system is designed to help control blood sugar in people living with type 1 diabetes.
Other Name: inControl Diabetes Medical Platform

Detailed Description:

Participation in this study will require 5 study visits over 2-4 weeks.

  • Visit 1: screening/enrollment visit to assess study eligibility.
  • Visit 2: continuous glucose monitor (CGM) training and initiation session based upon current or prior use of a CGM; if subject doesn't currently use a CGM, subject will be trained and may be asked to wear the CGM at home for 1 week.
  • Visit 3: subjects will be taught how to use the study insulin pump.
  • Visit 4: subjects will be trained on the use of inControl and wear it at home for 14 days.
  • Visit 5: subjects will return study equipment and to complete questionnaire.
  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 to 74 Years   (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 with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
  3. Age 14.0 to <75.0 years
  4. HbA1c level <10.5% at screening
  5. For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  6. Have care partner committed to participating in all training activities, knowledgeable at all times of the participants location, and being present and available to provide assistance when the system is being used at night
  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 study CGM is in use
  9. Willingness to establish network connectivity on a daily basis either via local Wi-Fi network or via a study-provided cellular service
  10. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
  11. 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)
  12. Total daily insulin dose (TDD) less than 100 U/day

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 of loss of consciousness in the 6 months prior to enrollment
  3. Medical need for chronic acetaminophen
  4. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
  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. 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): NCT02844517


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       jpinsker@sansum.org   
Contact: Laura Lindsey    805-682-7640 ext 221    LLindsey@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, 55902
Contact: Yogish Kudva, MBBS, M.D.    507-284-3964    kudva.yogish@mayo.edu   
Contact: Shelly McCrady-Spitzer    507-255-5916    mccradyspitzer.shelly@mayo.edu   
Principal Investigator: Yogish Kudva, MBBS, M.D.         
United States, New York
Mt. 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   
Principal Investigator: Stacey Anderson, MD         
Sub-Investigator: Sue Brown, MD         
France
University of Montpellier Recruiting
Montpellier, France
Contact: Eric Renard, MD, PhD    +33-04 67 33 84 24    e-renard@chu-montpellier.fr   
Contact: Jerome Place    +33 618 261 610    jerome.place@umontpellier.fr   
Principal Investigator: Eric Renard, MD, PhD         
Sub-Investigator: Anne Farret, MD         
Italy
University of Padova Recruiting
Padova, Italy
Contact: Claudio Cobelli, PhD    +39-049-8277803    cobelli@dei.unipd.it   
Contact: Simone Del Favero, PhD    +39 049 827 7661    sdelfave@dei.unipd.it   
Principal Investigator: Claudio Cobelli, PhD         
Sub-Investigator: Daniela Bruttomesso, MD         
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands
Contact: J Hans DeVries, MD, PhD    +3120 5666525    j.h.devries@amc.uva.nl   
Contact: Nathalie Masurel, MSc    +31 205 666 473    N.masurel@amc.nl   
Principal Investigator: J Hans DeVries, MD, PhD         
Sponsors and Collaborators
University of Virginia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
TypeZero Technologies, LLC
Tandem Diabetes Care, Inc.
DexCom, Inc.
Roche Diagnostic Ltd.
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, Study Chair, University of Virginia
ClinicalTrials.gov Identifier: NCT02844517     History of Changes
Other Study ID Numbers: 19068
UC4DK108483 ( U.S. NIH Grant/Contract )
First Submitted: July 21, 2016
First Posted: July 26, 2016
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Not yet determined

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)

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