The International Diabetes Closed Loop (iDCL) Trial: Protocol 4

NCT04436796 | Completed Results DMC FDA Device

• 2 other identifiers: G200047UC4DK108483
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

Brief Summary

The investigators aim to compare the efficacy and safety of an AID system using an adaptive MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in people with type 1 diabetes.

Conditions

Type 1 Diabetes

Keywords

Artificial Pancreas; Automated Insulin Delivery; Closed Loop Control; Continuous Glucose Monitor (CGM); interoperable Artificial Pancreas System (iAPS)

Outcome Measures

Primary Outcomes (2)

• Percent CGM Time in Range 70-180 mg/dL

  This results shown is mean percent time in range 70-180 mg/dL.

  13 weeks

• Non-inferiority for CGM Time <54 mg/dL

  Superiority for time in range 70-180 mg/dL and non-inferiority for time \<54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure

  13 weeks

Secondary Outcomes (22)

• CGM Mean Glucose

  13 weeks

• CGM Time > 180

  13 weeks

• CGM Time > 250

  13 weeks

• CGM Time < 70

  13 weeks

• CGM Time < 54 (Superiority)

  13 weeks

Other Outcomes (16)

• CGM Metrics by Time of Day

  13 weeks

• Number of Participants With Severe Hypoglycemia (Per Protocol)

  13 weeks

• Number of Participants With Diabetic Ketoacidosis (Per Protocol)

  13 weeks

Study Arms (2)

Artificial Pancreas

EXPERIMENTAL

Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.

Device: interoperable Artificial Pancreas System (iAPS)

Sensor Augmented Pump/Predictive Low Glucose Suspend

ACTIVE COMPARATOR

Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.

Other: Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)

Interventions

interoperable Artificial Pancreas System (iAPS) DEVICE

Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.

Artificial Pancreas

Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) OTHER

Use of personal pump with study CGM \& glucometer at home for 13 weeks.

Sensor Augmented Pump/Predictive Low Glucose Suspend

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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
• Using an insulin pump for at least 3 months (which may include use of automated features)
• Familiarity and use of a carbohydrate ratio for meal boluses
• Age ≥18.0 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.
• If using a personal CGM, willingness to use a Dexcom G6 CGM and discontinue personal CGM use during the study
• Willing not to begin use of, or not to continue use of if currently using, a personal AID (closed loop control) system during the study; note if the system offers an open-loop mode or can be switched to a PLGS mode that is compatible with the Dexcom G6, the system may be used during the study in these modes only
• 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
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial, and not to use Afrezza during the trial
• Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol

You may not qualify if:

• Use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) unless participant is willing to discontinue during the trial.
• Two or more episodes of DKA requiring an emergency room visit or hospitalization in the past 6 months
• Two or more episodes of severe hypoglycemia with seizure or loss of consciousness in the last 6 months
• Hemophilia or any other bleeding disorder
• A medical or other condition that in the opinion of the investigator could create a safety concern for the participant or put the study at risk. History of frequent severe hypoglycemia or history of frequent severe hyperglycemia and/or ketosis, without emergency room visit or hospitalization, due to poor diabetes self-management may be disqualifying per investigator judgment
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Harvard University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Jaeb Center for Health Research: collaborator

Study Sites (5)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Stanford University

Stanford, California, 94304, United States

Location

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

Related Publications (1)

• Pinsker JE, Dassau E, Deshpande S, Raghinaru D, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Church MM, Desrochers H, Ekhlaspour L, Kaur RJ, Levister C, Shi D, Lum JW, Kollman C, Doyle FJ; iDCL Trial Research Group. Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4. Diabetes Technol Ther. 2022 Sep;24(9):635-642. doi: 10.1089/dia.2022.0084. Epub 2022 Jun 2.

  PMID: 35549708 RESULT

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: Jordan Pinsker
• Organization: Sansum Diabetes Research Institute

jpinsker@sansum.org

805-682-7640

Study Officials

• Eyal Dassau, PhD

  Harvard University

  STUDY CHAIR

• Jordan Pinsker, MD

  Sansum Diabetes Research Institute

  STUDY CHAIR

• Francis J Doyle III, PhD

  Harvard University

  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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: August 5, 2020
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The dataset from each iDCL protocol will be made public after publication of all manuscripts written by the study group using the dataset and any regulatory submission/completion of review by the regulatory agency, but no later than 3 years after the completion of the protocol even if additional manuscripts or regulatory submissions are planned.

Locations

US (5)