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

Primary Purpose

Type1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Artificial Pancreas

Sensor Augmented Therapy

About this trial

This is an interventional other trial for Type1 Diabetes Mellitus focused on measuring Artificial Pancreas, Closed Loop Control, Continuous Glucose Monitor (CGM), inControl Diabetes Management Platform

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

William Sansum Diabetes Center
Stanford University
Barbara Davis Center, University of Colorado
Harvard University (Joslin Diabetes Center)
Mayo Clinic
Icahn School of Medicine at Mount Sinai
University of Virginia Center for Diabetes Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artificial Pancreas

Sensor Augmented Therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Time Below 70 mg/dL

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

Time Above 180 mg/dL

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

Secondary Outcome Measures

Time Below 54 mg/dL

Percent time CGM readings were below 54 mg/dL

Time Below 60 mg/dL

CGM-measured % time below 60 mg/dL

Time in Range 70-180 mg/dL

CGM-measured % in range 70-180 mg/dL

Time in Range 70-140 mg/dL

CGM-measured % time in range 70-140 mg/dL

Time Above 250 mg/dL

CGM-measured % time above 250 mg/dL

Time Above 300 mg/dL

CGM-measured % time above 300 mg/dL

Coefficient of Variation

CGM-measured coefficient of variation (CV)

Full Information

NCT ID

NCT02985866

First Posted

December 5, 2016

Last Updated

November 8, 2022

Sponsor

University of Virginia

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02985866

Brief Title

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

Acronym

iDCL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

October 27, 2017 (Actual)

Primary Completion Date

September 4, 2018 (Actual)

Study Completion Date

September 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Virginia

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes Mellitus

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

127 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Artificial Pancreas

Arm Type

Experimental

Arm Description

Arm Title

Sensor Augmented Therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Artificial Pancreas

Other Intervention Name(s)

Control-to-Range (CTR) closed-loop (CL)

Intervention Description

Use of CTR at home for 3 months

Intervention Type

Other

Intervention Name(s)

Sensor Augmented Therapy

Other Intervention Name(s)

SAP

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Below 70 mg/dL

Description

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

Time Frame

Post randomization (final 11 weeks)

Title

Time Above 180 mg/dL

Description

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

Time Frame

Post randomization (final 11 weeks)

Secondary Outcome Measure Information:

Title

Time Below 54 mg/dL

Description

Percent time CGM readings were below 54 mg/dL

Time Frame

Post randomization (final 11 weeks)

Title

Time Below 60 mg/dL

Description

CGM-measured % time below 60 mg/dL

Time Frame

Post randomization (final 11 weeks)

Title

Time in Range 70-180 mg/dL

Description

CGM-measured % in range 70-180 mg/dL

Time Frame

Post randomization (final 11 weeks)

Title

Time in Range 70-140 mg/dL

Description

CGM-measured % time in range 70-140 mg/dL

Time Frame

Post randomization (final 11 weeks)

Title

Time Above 250 mg/dL

Description

CGM-measured % time above 250 mg/dL

Time Frame

Post randomization (final 11 weeks)

Title

Time Above 300 mg/dL

Description

CGM-measured % time above 300 mg/dL

Time Frame

Post randomization (final 11 weeks)

Title

Coefficient of Variation

Description

CGM-measured coefficient of variation (CV)

Time Frame

Post randomization (final 11 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boris P. Kovatchev, PhD

Organizational Affiliation

University of Virginia Center for Diabetes Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stacey M. Anderson, MD

Organizational Affiliation

University of Virginia Center for Diabetes Technology

Official's Role

Study Chair

Facility Information:

Facility Name

William Sansum Diabetes Center

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Barbara Davis Center, University of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Harvard University (Joslin Diabetes Center)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

University of Virginia Center for Diabetes Technology

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series, meal content, boluses, & exercise will be deidentified & retrievable only by subject ID number. Individual patterns of demographic & insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Thus, data will be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes & not to identify participants; (2) a commitment to securing the data using appropriate computer technology; & (3) a commitment to destroying or returning the data after analyses are completed.

Citations:

PubMed Identifier

32245747

Citation

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.

Results Reference

background

PubMed Identifier

31937608

Citation

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. Erratum In: Diabetes Care. 2020 Jun;43(6):1366.

Results Reference

result

Learn more about this trial

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

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