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International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol | Clinical Trials | Clareo Health

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

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

NCT02844517•University of Virginia

View on ClinicalTrials.gov

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.

Eligibility

Age

14 - 74 years

Sex

ALL

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
+2 more criteria

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

Locations (10)

William Sansum Diabetes Center

Santa Barbara, California, United States

Stanford University

Stanford, California, United States

Barbara Davis Center, University of Colorado

Aurora, Colorado, United States

Harvard University (Joslin Diabetes Center)

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Mt. Sinai

New York, New York, United States

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

University of Montpellier

Montpellier, France

University of Padova

Padua, Italy

Academic Medical Center

Amsterdam, Netherlands

Key Dates

Start Date

November 1, 2016

Primary Completion Date

October 1, 2017

Completion Date

October 1, 2017

Last Updated

May 7, 2018

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 1

Interventions

Artificial Pancreas

DEVICE

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

NCT04786262

Diabetes Mellitus, Type 1Impaired Hypoglycemic Awareness+1 more

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RECRUITINGNA

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

NCT06748963

Diabetes Mellitus, Type 1

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

Closed Loop and Education for Hypoglycemia Awareness Restoration

A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes

Achieving Health in Emerging Adults With Diabetes (AHEAD) Program: A Clinical Trial Designed to Understand if Participation in a Clinical Program Developed Specifically to Support Emerging Adults With Type 1 Diabetes Leads to Improved Diabetes Outcomes.

Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes