International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
NCT ID: NCT02844517
Last Updated: 2018-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2016-11-30
2017-10-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
14 Years
74 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Jaeb Center for Health Research
OTHER
TypeZero Technologies, LLC
INDUSTRY
Tandem Diabetes Care, Inc.
INDUSTRY
DexCom, Inc.
INDUSTRY
Roche Diagnostic Ltd.
INDUSTRY
University of Virginia
OTHER
Responsible Party
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Stacey Anderson
Study Chair
Principal Investigators
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Boris P. Kovatchev, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Center for Diabetes Technology
Stacey M. Anderson, MD
Role: STUDY_CHAIR
University of Virginia Center for Diabetes Technology
Locations
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William Sansum Diabetes Center
Santa Barbara, California, United States
Stanford University
Stanford, California, United States
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States
Harvard University (Joslin Diabetes Center)
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Mt. Sinai
New York, New York, United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
University of Montpellier
Montpellier, , France
University of Padova
Padua, , Italy
Academic Medical Center
Amsterdam, , Netherlands
Countries
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Other Identifiers
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19068
Identifier Type: -
Identifier Source: org_study_id
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