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

Sponsor

University of Virginia (Other)

Overall Status

Completed

CT.gov ID

NCT02844517

Collaborator

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)

Enrollment

Locations

Arm

Actual Duration (Months)

4.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Device: Artificial Pancreas	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

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.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 :

Nov 1, 2016

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

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 Names: inControl Diabetes Medical Platform

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 Names:

inControl Diabetes Medical Platform

Outcome Measures

Primary Outcome Measures

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. [2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	William Sansum Diabetes Center	Santa Barbara	California	United States	93105
2	Stanford University	Stanford	California	United States	94304
3	Barbara Davis Center, University of Colorado	Aurora	Colorado	United States	80045
4	Harvard University (Joslin Diabetes Center)	Boston	Massachusetts	United States	02215
5	Mayo Clinic	Rochester	Minnesota	United States	55902
6	Mt. Sinai	New York	New York	United States	10029
7	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia	United States	22903
8	University of Montpellier	Montpellier		France
9	University of Padova	Padova		Italy
10	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