Loading clinical trials...

The International Diabetes Closed Loop (iDCL) Trial: Protocol 1 | Clinical Trials | Clareo Health

COMPLETEDNA

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

Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes

NCT02985866•University of Virginia

View on ClinicalTrials.gov

Summary

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.

Detailed Description

The protocol is a 3-month parallel group multi-center randomized trial designed to compare Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP). Approximately 126 subjects will be entered into the randomized trial at approximately seven clinical sites in the United States, such that at least 110 subjects complete the randomized trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of randomizing 126 subjects. In order to have a broad range of glycemic control among the subjects, a study goal will be to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c \< 7.5%.

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. 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)
+2 more criteria

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

Locations (7)

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

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

October 27, 2017

Primary Completion Date

September 4, 2018

Completion Date

September 4, 2018

Last Updated

December 5, 2022

Enrollment

127

ACTUAL participants

Conditions

Type1 Diabetes Mellitus

Interventions

Artificial Pancreas

DEVICE

Sensor Augmented Therapy

OTHER

Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes

NCT05777330

Type1 Diabetes Mellitus

View study

RECRUITING

China Diabetes Registry by Metabolic Management Center

NCT03811470

Type 2 Diabetes MellitusType1 Diabetes Mellitus+4 more

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: December 5, 2022Data 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes

China Diabetes Registry by Metabolic Management Center

Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus

The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes

Comparison of Real-time CGMS With Intermittently-scanned CGMS in Adolescents and Adults With Type 1 Diabetes Mellitus

Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients