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

NCT02985866 | Completed Results DMC FDA Device

• 2 other identifiers: iDCLUC4DK108483
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Type1 Diabetes Mellitus

Keywords

Artificial Pancreas; Closed Loop Control; Continuous Glucose Monitor (CGM); inControl Diabetes Management Platform

Outcome Measures

Primary Outcomes (2)

• Time Below 70 mg/dL

  CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)

  Post randomization (final 11 weeks)

• Time Above 180 mg/dL

  CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)

  Post randomization (final 11 weeks)

Secondary Outcomes (7)

• Time Below 54 mg/dL

  Post randomization (final 11 weeks)

• Time Below 60 mg/dL

  Post randomization (final 11 weeks)

• Time in Range 70-180 mg/dL

  Post randomization (final 11 weeks)

• Time in Range 70-140 mg/dL

  Post randomization (final 11 weeks)

• Time Above 250 mg/dL

  Post randomization (final 11 weeks)

Study Arms (2)

Artificial Pancreas

EXPERIMENTAL

Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.

Device: Artificial Pancreas

Sensor Augmented Therapy

ACTIVE COMPARATOR

Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.

Other: Sensor Augmented Therapy

Interventions

Artificial Pancreas DEVICE

Use of CTR at home for 3 months

Also known as: Control-to-Range (CTR) closed-loop (CL)

Artificial Pancreas

Sensor Augmented Therapy OTHER

Use of personal pump with study CGM \& glucometer at home for 3 months

Also known as: SAP

Sensor Augmented Therapy

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
• Use of an insulin pump for at least 6 months
• Age ≥14 years old
• HbA1c level \<10.5% at screening
• For females, not currently known to be pregnant
• Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study
• 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
• Willingness to suspend use of any personal CGM for the duration of the clinical trial once the unblinded study CGM is in use
• Willingness to establish network connectivity on at least a weekly basis either via local Wifi network or via a study-provided cellular service
• 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)
• Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
• 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

You may not qualify if:

• Medical need for chronic acetaminophen
• Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment
• Hemophilia or any other bleeding disorder
• 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
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study
• Use of a closed-loop system within the last month prior to enrollment
• Employed by, or having immediate family members employed by TypeZero Technologies, LLC

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Jaeb Center for Health Research: collaborator
• TypeZero Technologies: collaborator
• DexCom, Inc.: collaborator
• Roche Diagnostic Ltd.: collaborator
• Ascensia Diabetes Care: collaborator

Study Sites (7)

William Sansum Diabetes Center

Santa Barbara, California, 93105, United States

Location

Stanford University

Stanford, California, 94304, United States

Location

Barbara Davis Center, University of Colorado

Aurora, Colorado, 80045, United States

Location

Harvard University (Joslin Diabetes Center)

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (2)

• Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615. Diabetes Care. 2020 Jun;43(6):1366. doi: 10.2337/dc20-er06. Epub 2020 Apr 3. No abstract available.

  PMID: 32245747 BACKGROUND

• Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care. 2020 Mar;43(3):607-615. doi: 10.2337/dc19-1310. Epub 2020 Jan 14.

  PMID: 31937608 RESULT

MeSH Terms

Interventions

Pancreas, Artificial

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Boris Kovatchev, PhD
• Organization: University of Virginia Center for Diabetes Technology

mc7m@virginia.edu

434-982-0602

Study Officials

• Boris P. Kovatchev, PhD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

• Stacey M. Anderson, MD

  University of Virginia Center for Diabetes Technology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: October 27, 2017
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: December 5, 2022
• Results First Posted: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (7)