International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
|ClinicalTrials.gov Identifier: NCT02844517|
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : May 7, 2018
|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 ]
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|