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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Artificial Pancreas
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1 focused on measuring Artificial Pancreas, Closed Loop Control, Continuous Glucose Monitor (CGM)

Eligibility Criteria

14 Years - 74 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
  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

  1. More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
  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

Sites / Locations

  • William Sansum Diabetes Center
  • Stanford University
  • Barbara Davis Center, University of Colorado
  • Harvard University (Joslin Diabetes Center)
  • Mayo Clinic
  • Mt. Sinai
  • University of Virginia Center for Diabetes Technology
  • University of Montpellier
  • University of Padova
  • Academic Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artificial Pancreas

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2016
Last Updated
May 1, 2018
Sponsor
University of Virginia
Collaborators
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.
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1. Study Identification

Unique Protocol Identification Number
NCT02844517
Brief Title
International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
Official Title
Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
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.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Artificial Pancreas, Closed Loop Control, Continuous Glucose Monitor (CGM)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artificial Pancreas
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Artificial Pancreas
Other Intervention Name(s)
inControl Diabetes Medical Platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris P. Kovatchev, PhD
Organizational Affiliation
University of Virginia Center for Diabetes Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stacey M. Anderson, MD
Organizational Affiliation
University of Virginia Center for Diabetes Technology
Official's Role
Study Chair
Facility Information:
Facility Name
William Sansum Diabetes Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Barbara Davis Center, University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Harvard University (Joslin Diabetes Center)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Virginia Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
University of Montpellier
City
Montpellier
Country
France
Facility Name
University of Padova
City
Padova
Country
Italy
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Not yet determined

Learn more about this trial

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

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