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

• ClinicalTrials.gov Identifier: NCT02985866
• Recruitment Status: Completed
• First Posted: December 7, 2016
• Results First Posted: December 5, 2022
• Last Update Posted: December 5, 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
• Information provided by (Responsible Party): University of Virginia

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.

Condition or disease	Intervention/treatment	Phase
Type1 Diabetes Mellitus	Device: Artificial Pancreas; Other: Sensor Augmented Therapy	Not Applicable

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%.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: October 27, 2017
• Actual Primary Completion Date: September 4, 2018
• Actual Study Completion Date: September 4, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Artificial Pancreas; 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; Use of CTR at home for 3 months; Other Name: Control-to-Range (CTR) closed-loop (CL)
Active Comparator: Sensor Augmented Therapy; Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.	Other: Sensor Augmented Therapy; Use of personal pump with study CGM & glucometer at home for 3 months; Other Name: SAP

Outcome Measures

Primary Outcome Measures :

1. Time Below 70 mg/dL [ Time Frame: Post randomization (final 11 weeks) ]
   CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)
2. Time Above 180 mg/dL [ Time Frame: Post randomization (final 11 weeks) ]
   CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)

Secondary Outcome Measures :

1. Time Below 54 mg/dL [ Time Frame: Post randomization (final 11 weeks) ]
   Percent time CGM readings were below 54 mg/dL
2. Time Below 60 mg/dL [ Time Frame: Post randomization (final 11 weeks) ]
   CGM-measured % time below 60 mg/dL
3. Time in Range 70-180 mg/dL [ Time Frame: Post randomization (final 11 weeks) ]
   CGM-measured % in range 70-180 mg/dL
4. Time in Range 70-140 mg/dL [ Time Frame: Post randomization (final 11 weeks) ]
   CGM-measured % time in range 70-140 mg/dL
5. Time Above 250 mg/dL [ Time Frame: Post randomization (final 11 weeks) ]
   CGM-measured % time above 250 mg/dL
6. Time Above 300 mg/dL [ Time Frame: Post randomization (final 11 weeks) ]
   CGM-measured % time above 300 mg/dL
7. Coefficient of Variation [ Time Frame: Post randomization (final 11 weeks) ]
   CGM-measured coefficient of variation (CV)

Eligibility Criteria

• Ages Eligible for Study: 14 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)
11. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
12. 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:

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

Contacts and Locations

Locations

United States, California

William Sansum Diabetes Center

Santa Barbara, California, United States, 93105

Stanford University

Stanford, California, United States, 94304

United States, Colorado

Barbara Davis Center, University of Colorado

Aurora, Colorado, United States, 80045

United States, Massachusetts

Harvard University (Joslin Diabetes Center)

Boston, Massachusetts, United States, 02215

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

United States, Virginia

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States, 22903

Sponsors and Collaborators

University of Virginia

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

Investigators

• Principal Investigator: Boris P. Kovatchev, PhD; University of Virginia Center for Diabetes Technology
• Study Chair: Stacey M. Anderson, MD; University of Virginia Center for Diabetes Technology

  Study Documents (Full-Text)

Documents provided by University of Virginia:

Study Protocol and Statistical Analysis Plan  [PDF] February 9, 2018

Informed Consent Form  [PDF] April 6, 2018

More Information

Publications of Results:

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.

Other Publications:

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.

• Responsible Party: University of Virginia
• ClinicalTrials.gov Identifier: NCT02985866
• Other Study ID Numbers: iDCL; UC4DK108483 ( U.S. NIH Grant/Contract )
• First Posted: December 7, 2016
• Results First Posted: December 5, 2022
• Last Update Posted: December 5, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by University of Virginia:

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

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pancrelipase; Gastrointestinal Agents