The International Diabetes Closed Loop (iDCL) Trial: Protocol 1
NCT ID: NCT02985866
Last Updated: 2022-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
127 participants
INTERVENTIONAL
2017-10-27
2018-09-04
Brief Summary
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Detailed Description
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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%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
Artificial Pancreas
Use of CTR at home for 3 months
Sensor Augmented Therapy
Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.
Sensor Augmented Therapy
Use of personal pump with study CGM \& glucometer at home for 3 months
Interventions
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Artificial Pancreas
Use of CTR at home for 3 months
Sensor Augmented Therapy
Use of personal pump with study CGM \& glucometer at home for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
14 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Jaeb Center for Health Research
OTHER
TypeZero Technologies
INDUSTRY
DexCom, Inc.
INDUSTRY
Roche Diagnostic Ltd.
INDUSTRY
Ascensia Diabetes Care
INDUSTRY
University of Virginia
OTHER
Responsible Party
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Principal Investigators
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Boris P. Kovatchev, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Center for Diabetes Technology
Stacey M. Anderson, MD
Role: STUDY_CHAIR
University of Virginia Center for Diabetes Technology
Locations
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William Sansum Diabetes Center
Santa Barbara, California, United States
Stanford University
Stanford, California, United States
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States
Harvard University (Joslin Diabetes Center)
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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iDCL
Identifier Type: -
Identifier Source: org_study_id
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