- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02844517
International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
May 1, 2018 updated by: Stacey Anderson, University of Virginia
Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montpellier, France
- University of Montpellier
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Padova, Italy
- University of Padova
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Amsterdam, Netherlands
- Academic Medical Center
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California
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Santa Barbara, California, United States, 93105
- William Sansum Diabetes Center
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Stanford, California, United States, 94304
- Stanford University
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Colorado
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Aurora, Colorado, United States, 80045
- Barbara Davis Center, University of Colorado
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Harvard University (Joslin Diabetes Center)
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Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic
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New York
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New York, New York, United States, 10029
- Mt. Sinai
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia Center for Diabetes Technology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 74 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
- 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.
- Age 14.0 to <75.0 years
- HbA1c level <10.5% at screening
- 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.
- 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
- Willingness, if using the closed-loop system, to stop closed-loop when taking acetaminophen and avoid closed-loop for at least 4 hours afterward
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- Willingness to establish network connectivity on a daily basis either via local Wi-Fi network or via a study-provided cellular service
- Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
- 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)
- Total daily insulin dose (TDD) less than 100 U/day
Exclusion Criteria
- More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
- More than one episode of severe hypoglycemia involving seizure of loss of consciousness in the 6 months prior to enrollment
- Medical need for chronic acetaminophen
- Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
- Hemophilia or any other bleeding disorder
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Employed by, or having immediate family members employed by TypeZero Technologies, LLC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
July 21, 2016
First Submitted That Met QC Criteria
July 21, 2016
First Posted (Estimate)
July 26, 2016
Study Record Updates
Last Update Posted (Actual)
May 7, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19068
- UC4DK108483 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Not yet determined
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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