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Pilot Study 1 of Outpatient Control-to-Range - System and Monitoring Testing

NCT01470807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-11-29

No results posted yet for this study

Summary

A single arm, single treatment study is proposed to assess the feasibility of a portable artificial pancreas system outside of a hospital based clinical research center.

Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions (hotel).

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

portable artificial pancreas system with CTR algorithms

The investigators will test the new portable CTR system in CRC conditions for 10h followed by 18h of CTR in a hotel.

Sponsors & Collaborators

  • University Hospital, Montpellier

    collaborator OTHER

  • University of Padova

    collaborator OTHER

  • University of California, Santa Barbara

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Claudio Cobelli, Ph.D. · University of Padova

  • Boris Kovatchev, Ph.D. · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Italy

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 NCT01470807 on ClinicalTrials.gov