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International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol

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ClinicalTrials.gov Identifier: NCT02844517
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : May 7, 2018
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.
Roche Diagnostic Ltd.
Information provided by (Responsible Party):
Stacey Anderson, University of Virginia

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Artificial Pancreas Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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. Study subjects will wear the study insulin pump and CGM for approximately 2-4 weeks.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol
Actual Study Start Date : November 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 74 Years   (Child, Adult, Older Adult)
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

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


Locations
United States, California
William Sansum Diabetes Center
Santa Barbara, California, United States, 93105
Stanford University
Stanford, California, United States, 94304
United States, Colorado
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Harvard University (Joslin Diabetes Center)
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, New York
Mt. Sinai
New York, New York, United States, 10029
United States, Virginia
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
France
University of Montpellier
Montpellier, France
Italy
University of Padova
Padova, Italy
Netherlands
Academic Medical Center
Amsterdam, Netherlands
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

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 Posted: July 26, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
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