NCT04436796|CompletedResultsDMCFDA Device
The International Diabetes Closed Loop (iDCL) Trial: Protocol 4
DCLP4
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Sponsor study identifier
Secondary identifiers
NIH
interventional
35
1 country
5
Study Start
August 5, 2020
Actual (reported)Primary Completion
May 10, 2021
Actual (reported)Study Completion
May 10, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 10, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 16, 2020
Actual (reported)June 18, 2020
Actual (reported)August 5, 2020
Actual (reported)May 10, 2021
Actual (reported)May 10, 2021
Actual (reported)December 2, 2022
Actual (reported)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
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
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
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.
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.
Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.
Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
Stanford University
Stanford, California, 94304, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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.
Eyal Dassau, PhD
Harvard University
Jordan Pinsker, MD
Sansum Diabetes Research Institute
Francis J Doyle III, PhD
Harvard University
35 participants (actual enrollment reported by the registry).
First Submitted
June 16, 2020
First Posted
June 18, 2020
Study Start
August 5, 2020
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 10, 2021
Actual (reported)Study Completion
May 10, 2021
Actual (reported)Last Updated
December 2, 2022
Results First Posted
December 2, 2022
Record last verified: 2022-11
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 \& boluses, 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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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