Clinical Trial Details

NCT ID: NCT02844517
Date Last Changed: August 31, 2017

Overview

Research Study Summary

A clinical study for patients with Diabetes Mellitus, Type 1

Research Study Title

Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol

Purpose

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.

To Learn more

Recruitment Details

Gender
All
Age
14 to 74 Years
Overall Status
Recruiting
Lead Sponsor
University of Virginia
Duration
11 Months
Facility Type
N/A
Compensation

Eligibility

All ages 14 Years to 74 Years

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

Site Locations (10)

Country State City Zip Facility and Contact
United States California Santa Barbara 93105 William Sansum Diabetes Center
Jordan Pinsker, MD
jpinsker@sansum.org

Jordan Pinsker, MD
Principal Investigator

Mei Mei Church, NP
Sub-Investigator
United States California Stanford 94304 Stanford University
Bruce Buckingham, MD
650-723-5791
bbendo@stanford.edu

Bruce Buckingham, MD
Principal Investigator
United States Colorado Aurora 80045 Barbara Davis Center, University of Colorado
R. Paul Wadwa, MD
303-724-2323
paul.wadwa@ucdenver.edu

R. Paul Wadwa, MD
Principal Investigator
United States Massachusetts Boston 02215 Harvard University (Joslin Diabetes Center)
Lori Laffel, MD, MPH
617-732-2603
lori.laffel@joslin.harvard.edu

Francis Doyle, PhD
Principal Investigator

Lori Laffel, MD, MPH
Principal Investigator
United States Minnesota Rochester 55902 Mayo Clinic
Yogish Kudva, MBBS, M.D.
507-284-3964
kudva.yogish@mayo.edu

Yogish Kudva, MBBS, M.D.
Principal Investigator
United States New York New York 10029 Mt. Sinai
Carol Levy, MD, CDE
212-241-9089
selassie.ogyaadu@mssm.edu

Carol Levy, MD, CDE
Principal Investigator

David Lam, MD
Sub-Investigator
United States Virginia Charlottesville 22903 University of Virginia Center for Diabetes Technology
Stacey M. Anderson, MD
434-982-0945
sg4c@virginia.edu

Stacey Anderson, MD
Principal Investigator

Sue Brown, MD
Sub-Investigator
France Montpellier University of Montpellier
Eric Renard, MD, PhD
+33-04 67 33 84 24
e-renard@chu-montpellier.fr

Eric Renard, MD, PhD
Principal Investigator

Anne Farret, MD
Sub-Investigator
Italy Padova University of Padova
Claudio Cobelli, PhD
+39-049-8277803
cobelli@dei.unipd.it

Claudio Cobelli, PhD
Principal Investigator

Daniela Bruttomesso, MD
Sub-Investigator
Netherlands Amsterdam Academic Medical Center
J Hans DeVries, MD, PhD
+3120 5666525
j.h.devries@amc.uva.nl

J Hans DeVries, MD, PhD
Principal Investigator

Contact

Stacey M. Anderson, MD
434-982-0945
E-mail:

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