International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02844517|
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : May 7, 2018
- Study Details
- Tabular View
- Results Submitted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: Artificial Pancreas||Not Applicable|
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)|
|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|
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
- 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 ]
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, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|United States, California|
|William Sansum Diabetes Center|
|Santa Barbara, California, United States, 93105|
|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|
|Rochester, Minnesota, United States, 55902|
|United States, New York|
|New York, New York, United States, 10029|
|United States, Virginia|
|University of Virginia Center for Diabetes Technology|
|Charlottesville, Virginia, United States, 22903|
|University of Montpellier|
|University of Padova|
|Academic Medical Center|
|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|
|Other Study ID Numbers:||
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|
Closed Loop Control
Continuous Glucose Monitor (CGM)
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases