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

NCT02985866 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2022-12-05

Study results available
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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.

Conditions

  • Type1 Diabetes Mellitus

Interventions

DEVICE

Artificial Pancreas

Use of CTR at home for 3 months

OTHER

Sensor Augmented Therapy

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

Sponsors & Collaborators

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

    collaborator NIH

  • Jaeb Center for Health Research

    collaborator OTHER

  • TypeZero Technologies

    collaborator INDUSTRY

  • DexCom, Inc.

    collaborator INDUSTRY

  • Roche Diagnostic Ltd.

    collaborator INDUSTRY

  • Ascensia Diabetes Care

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Boris P. Kovatchev, PhD · University of Virginia Center for Diabetes Technology

  • Stacey M. Anderson, MD · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-27
Primary Completion
2018-09-04
Completion
2018-09-04
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02985866 on ClinicalTrials.gov