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Feasibility Study of a Portable Artificial Pancreas System in Type 1 Diabetes Mellitus (T1DM) - Padova

NCT01447992 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-06-19

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 Control-To-Range

We will test the new portable Control-To-Range system in clinical research center conditions for 10 hours followed by 18 hours of Control-To-Range in a hotel.

Sponsors & Collaborators

  • University of Padova

    collaborator OTHER

  • University Hospital, Montpellier

    collaborator OTHER

  • University of California, Santa Barbara

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Angelo Avogaro, MD · University of Padova Hospital

  • Boris Kovatchev, PhD · 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
2011-09-30
Primary Completion
2012-04-30
Completion
2012-04-30

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 NCT01447992 on ClinicalTrials.gov