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International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol

NCT02844517 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-05-07

No results posted yet for this study

Summary

The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Artificial Pancreas

Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump and continuous glucose monitor. This AP system is designed to help control blood sugar in people living with type 1 diabetes.

Sponsors & Collaborators

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

    collaborator NIH

  • Jaeb Center for Health Research

    collaborator OTHER

  • TypeZero Technologies, LLC

    collaborator INDUSTRY

  • Tandem Diabetes Care, Inc.

    collaborator INDUSTRY

  • DexCom, Inc.

    collaborator INDUSTRY

  • Roche Diagnostic Ltd.

    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
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-10-31
Completion
2017-10-31
FDA Device
Yes

Countries

  • United States
  • France
  • Italy
  • Netherlands

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 NCT02844517 on ClinicalTrials.gov