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

NCT03563313 | Completed Results DMC FDA Device

• 2 other identifiers: DCLP3UC4DK108483
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial Pancreas (AP); Type 1 Diabetes Mellitus; Insulin Pump; Continuous Glucose Monitor (CGM); Closed Loop Control (CLC); Sensor-Augmented Pump (SAP)

Outcome Measures

Primary Outcomes (1)

• Time in Target Range

  The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.

  26 weeks

Secondary Outcomes (32)

• CGM Time Above 180

  26 weeks

• CGM Mean Glucose

  26 weeks

• HbA1c at 26 Weeks

  26 weeks

• CGM Time Below 70

  26 weeks

• CGM Time Below 54

  26 weeks

Other Outcomes (16)

• Number of Participants With Severe Hypoglycemia (Per Protocol)

  26 weeks

• Number of Participants With Diabetic Ketoacidosis (Per Protocol)

  26 weeks

• Ketone Events Defined as Day With Ketone Level >1.0 mmol/L

  26 weeks

Study Arms (2)

Closed Loop Control (CLC)

EXPERIMENTAL

Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months.

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

Sensor-Augmented Pump (SAP)

ACTIVE COMPARATOR

Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months.

Device: Sensor-augmented pump (SAP)

Interventions

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

Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.

Closed Loop Control (CLC)

Sensor-augmented pump (SAP) DEVICE

Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.

Sensor-Augmented Pump (SAP)

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.
• Familiarity and use of a carbohydrate ratio for meal boluses.
• Age ≥14.0 years old.
• 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.
• 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.
• Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use.
• 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
• Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
• 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.
• Total daily insulin dose (TDD) at least 10 U/day.
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.

You may not qualify if:

• Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
• 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.
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
• 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.

Sponsors & Collaborators

• University of Virginia: lead
• Jaeb Center for Health Research: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Tandem Diabetes Care, Inc.: collaborator
• DexCom, Inc.: collaborator
• Roche Diagnostics GmbH: collaborator

Study Sites (7)

Sansum Diabetes Research Institute

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, 55902, 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 (7)

• Beck RW, Kanapka LG, Breton MD, Brown SA, Wadwa RP, Buckingham BA, Kollman C, Kovatchev B. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023 May;25(5):329-342. doi: 10.1089/dia.2022.0558. Epub 2023 Apr 12.

  PMID: 37067353 DERIVED

• Kanapka LG, Lum JW, Beck RW. Insulin Pump Infusion Set Failures Associated with Prolonged Hyperglycemia: Frequency and Relationship to Age and Type of Infusion Set During 22,741 Infusion Set Wears. Diabetes Technol Ther. 2022 Jun;24(6):396-402. doi: 10.1089/dia.2021.0548. Epub 2022 Feb 23.

  PMID: 35104166 DERIVED

• Ekhlaspour L, Town M, Raghinaru D, Lum JW, Brown SA, Buckingham BA. Glycemic Outcomes in Baseline Hemoglobin A1C Subgroups in the International Diabetes Closed-Loop Trial. Diabetes Technol Ther. 2022 Aug;24(8):588-591. doi: 10.1089/dia.2021.0524. Epub 2022 Feb 8.

  PMID: 35020488 DERIVED

• Kudva YC, Laffel LM, Brown SA, Raghinaru D, Pinsker JE, Ekhlaspour L, Levy CJ, Messer LH, Kovatchev BP, Lum JW, Beck RW, Gonder-Frederick L; iDCL Trial Research Group. Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial. Diabetes Technol Ther. 2021 Oct;23(10):673-683. doi: 10.1089/dia.2021.0089.

  PMID: 34115959 DERIVED

• Isganaitis E, Raghinaru D, Ambler-Osborn L, Pinsker JE, Buckingham BA, Wadwa RP, Ekhlaspour L, Kudva YC, Levy CJ, Forlenza GP, Beck RW, Kollman C, Lum JW, Brown SA, Laffel LM; iDCL Trial Research Group. Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop Trial. Diabetes Technol Ther. 2021 May;23(5):342-349. doi: 10.1089/dia.2020.0572. Epub 2021 Jan 21.

  PMID: 33216667 DERIVED

• O'Malley G, Messer LH, Levy CJ, Pinsker JE, Forlenza GP, Isganaitis E, Kudva YC, Ekhlaspour L, Raghinaru D, Lum J, Brown SA; iDCL Trial Research Group. Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial. Diabetes Technol Ther. 2021 Apr;23(4):245-252. doi: 10.1089/dia.2020.0472.

  PMID: 33155824 DERIVED

• Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.

  PMID: 31618560 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Sue Brown, MD
• Organization: University of Virginia

sab2f@virginia.edu

434-962-0602

Study Officials

• Sue A. Brown, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized controlled trial of 6 month at home closed loop system vs. sensor-augmented pump.

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 20, 2018
• Study Start: June 28, 2018
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: April 28, 2020
• Results First Posted: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Generally, data will be made available after the primary publications of each study.
• Access Criteria: The Data Sharing Agreements will be formulated by the Steering Committee in collaboration with the NIH Project Scientist Program Official. In addition, under special arrangements, complete data sets will be provided to industry partners who would use the data for regulatory clearance (PMA - pre-market approval) of the tested artificial pancreas system. This will be done in response to the specific requirements of RFA-DK-14-024 for this project to "…generate data able to satisfy safety and efficacy requirements by regulatory agencies regarding the clinical testing of artificial pancreas device systems" in the target population of people with type 1 diabetes.

Locations

US (7)