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

NCT04436796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-12-02

Study results available
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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

Interventions

DEVICE

interoperable Artificial Pancreas System (iAPS)

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

OTHER

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

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

Sponsors & Collaborators

  • Harvard University

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Jaeb Center for Health Research

    collaborator OTHER

  • Sansum Diabetes Research Institute

    lead OTHER

Principal Investigators

  • Eyal Dassau, PhD · Harvard University

  • Jordan Pinsker, MD · Sansum Diabetes Research Institute

  • Francis J Doyle III, PhD · Harvard University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2021-05-10
Completion
2021-05-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04436796 on ClinicalTrials.gov