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Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (Italy)

NCT01727817 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-09-30

No results posted yet for this study

Summary

An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control to Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a hospital based clinical research center.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Diabetes Assistant (DiAs)

A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Sansum Diabetes Research Institute

    collaborator OTHER

  • University Hospital, Montpellier

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-05-31
Completion
2013-05-31

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 NCT01727817 on ClinicalTrials.gov