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The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas | Clinical Trials | Clareo Health

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The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas

A Pivotal Study of t:Slim X2 With Control-IQ Technology

NCT03563313•University of Virginia

View on ClinicalTrials.gov

Summary

The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.

Detailed Description

After consent is signed, eligibility will be assessed. Eligible participants not currently using an insulin pump and Dexcom CGM with minimum data requirements will initiate a run-in phase of 2 to 8 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ Technology vs. SAP for 6 months.

Eligibility

Age

14 - No limit 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. Familiarity and use of a carbohydrate ratio for meal boluses.
•3. Age ≥14.0 years old.
•4. 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 females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
•5. For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
•6. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use.
•7. Willingness to use a regular insulin pump during the study with no automatic insulin adjustment based on glucose level when assigned to participate in an SAP group
•8. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
•9. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
•10. Total daily insulin dose (TDD) at least 10 U/day.
+1 more criteria

Exclusion Criteria

•1. Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
•2. Hemophilia or any other bleeding disorder.
•3. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
•4. Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
•5. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc. or TypeZero Technologies, LLC, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.

Locations (7)

Sansum Diabetes Research Institute

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

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Key Dates

Start Date

June 28, 2018

Primary Completion Date

April 8, 2019

Completion Date

April 8, 2019

Last Updated

April 28, 2020

Enrollment

168

ACTUAL participants

Conditions

Type 1 Diabetes Mellitus

Interventions

t:slim X2 with Control-IQ Technology & Dexcom G6 CGM

DEVICE

Sensor-augmented pump (SAP)

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Implementing the Spotlight AQ Platform in Adolescent/ Young Adult (16-25 Years Old) Type 1 Diabetics (T1D)

NCT06390371

Type 1 Diabetes Mellitus

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RECRUITING

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: April 28, 2020Data 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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The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas

Inclusion Criteria

Exclusion Criteria

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