The International Diabetes Closed Loop (iDCL) Trial: Protocol 1

Description

The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.

Study Start Date

October, 27 2017

Estimated Completion Date

June 2018

Interventions

  • Other: Sensor Augmented Therapy
  • Device: Artificial Pancreas

Study ID

University of Virginia -- iDCL

Status

Recruiting

Trial ID

NCT02985866

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

126

Sponsor

University of Virginia

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 3. Age ?14 years old 4. HbA1c level <10.5% at screening 5. For females, not currently known to be pregnant 6. Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study 7. Willingness, if not assigned to the closed-loop group, to avoid use of any closed-loop control system for the duration of the clinical trial 8. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the unblinded study CGM is in use 9. Willingness to establish network connectivity on at least a weekly basis either via local Wifi network or via a study-provided cellular service 10. 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) 11. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol 12. For subjects less than 18 years old, living with one or more parent/legal guardian (referred to subsequently as diabetes care partner) committed to participating in study training for emergency procedures for severe hypoglycemia and able to contact the subject in case of an emergency

Exclusion Criteria

    1. Medical need for chronic acetaminophen 2. Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment 3. Hemophilia or any other bleeding disorder 4. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk including any contraindication to the use of any of the study devices per FDA labeling 5. Participation in another pharmaceutical or device trial at the time of enrollment or during the study 6. Use of a closed-loop system within the last month prior to enrollment 7. Employed by, or having immediate family members employed by TypeZero Technologies, LLC

Gender

All

Ages

14 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (42)

Study Location Distance Name Phone Email
Harvard University Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Lori Laffel MD MPH 617-732-2603 lori.laffel@joslin.harvard.edu
Harvard University Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Lori Laffel MD MPH 617-732-2603 lori.laffel@joslin.harvard.edu
Harvard University Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Lori Laffel MD MPH 617-732-2603 lori.laffel@joslin.harvard.edu
Harvard University Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Lori Laffel MD MPH 617-732-2603 lori.laffel@joslin.harvard.edu
Harvard University Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Lori Laffel MD MPH 617-732-2603 lori.laffel@joslin.harvard.edu
Harvard University Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Lori Laffel MD MPH 617-732-2603 lori.laffel@joslin.harvard.edu
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Carol Levy MD CDE 212-241-9089 selassie.ogyaadu@mssm.edu
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Carol Levy MD CDE 212-241-9089 selassie.ogyaadu@mssm.edu
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Carol Levy MD CDE 212-241-9089 selassie.ogyaadu@mssm.edu
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Carol Levy MD CDE 212-241-9089 selassie.ogyaadu@mssm.edu
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Carol Levy MD CDE 212-241-9089 selassie.ogyaadu@mssm.edu
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Carol Levy MD CDE 212-241-9089 selassie.ogyaadu@mssm.edu
University of Virginia Center for Diabetes Technology - Charlottesville, Virginia 493.5 miles Stacey M Anderson MD 434-982-0945 sg4c@virginia.edu
University of Virginia Center for Diabetes Technology - Charlottesville, Virginia 493.5 miles Stacey M Anderson MD 434-982-0945 sg4c@virginia.edu
University of Virginia Center for Diabetes Technology - Charlottesville, Virginia 493.5 miles Stacey M Anderson MD 434-982-0945 sg4c@virginia.edu
University of Virginia Center for Diabetes Technology - Charlottesville, Virginia 493.5 miles Stacey M Anderson MD 434-982-0945 sg4c@virginia.edu
University of Virginia Center for Diabetes Technology - Charlottesville, Virginia 493.5 miles Stacey M Anderson MD 434-982-0945 sg4c@virginia.edu
University of Virginia Center for Diabetes Technology - Charlottesville, Virginia 493.5 miles Stacey M Anderson MD 434-982-0945 sg4c@virginia.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Shelly McCradySpitzer 507-255-5916 McCradySpitzer.Shelly@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Shelly McCradySpitzer 507-255-5916 McCradySpitzer.Shelly@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Shelly McCradySpitzer 507-255-5916 McCradySpitzer.Shelly@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Shelly McCradySpitzer 507-255-5916 McCradySpitzer.Shelly@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Shelly McCradySpitzer 507-255-5916 McCradySpitzer.Shelly@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Shelly McCradySpitzer 507-255-5916 McCradySpitzer.Shelly@mayo.edu
Barbara Davis Center University of Colorado - Aurora, Colorado 1,759.8 miles R Paul Wadwa MD 303-724-2323 paul.wadwa@ucdenver.edu
Barbara Davis Center University of Colorado - Aurora, Colorado 1,759.8 miles R Paul Wadwa MD 303-724-2323 paul.wadwa@ucdenver.edu
Barbara Davis Center University of Colorado - Aurora, Colorado 1,759.8 miles R Paul Wadwa MD 303-724-2323 paul.wadwa@ucdenver.edu
Barbara Davis Center University of Colorado - Aurora, Colorado 1,759.8 miles R Paul Wadwa MD 303-724-2323 paul.wadwa@ucdenver.edu
Barbara Davis Center University of Colorado - Aurora, Colorado 1,759.8 miles R Paul Wadwa MD 303-724-2323 paul.wadwa@ucdenver.edu
Barbara Davis Center University of Colorado - Aurora, Colorado 1,759.8 miles R Paul Wadwa MD 303-724-2323 paul.wadwa@ucdenver.edu
William Sansum Diabetes Center - Santa Barbara, California 2,659.5 miles Jordan Pinsker MD None None
William Sansum Diabetes Center - Santa Barbara, California 2,659.5 miles Jordan Pinsker MD None None
William Sansum Diabetes Center - Santa Barbara, California 2,659.5 miles Jordan Pinsker MD None None
William Sansum Diabetes Center - Santa Barbara, California 2,659.5 miles Jordan Pinsker MD None None
William Sansum Diabetes Center - Santa Barbara, California 2,659.5 miles Jordan Pinsker MD None None
William Sansum Diabetes Center - Santa Barbara, California 2,659.5 miles Jordan Pinsker MD None None
Stanford University - Stanford, California 2,694.6 miles Bruce Buckingham MD 650-723-5791 bbendo@stanford.edu
Stanford University - Stanford, California 2,694.6 miles Bruce Buckingham MD 650-723-5791 bbendo@stanford.edu
Stanford University - Stanford, California 2,694.6 miles Bruce Buckingham MD 650-723-5791 bbendo@stanford.edu
Stanford University - Stanford, California 2,694.6 miles Bruce Buckingham MD 650-723-5791 bbendo@stanford.edu
Stanford University - Stanford, California 2,694.6 miles Bruce Buckingham MD 650-723-5791 bbendo@stanford.edu
Stanford University - Stanford, California 2,694.6 miles Bruce Buckingham MD 650-723-5791 bbendo@stanford.edu

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