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Hybrid Artificial Pancreas in Home Setting

NCT02153190 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-11-06

No results posted yet for this study

Summary

The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients

Conditions

  • Type 1 Diabetes Mellitus
  • Treatement by Insulin Pump

Interventions

DEVICE

HYBRID

During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.

DEVICE

OPEN

During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Eric ER RENARD, MD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • 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 NCT02153190 on ClinicalTrials.gov