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Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump

NCT03653533 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-07-10

No results posted yet for this study

Summary

This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.

Conditions

  • Type I Diabetes

Interventions

DEVICE

MiniMed™ 640G

The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin

DEVICE

Captor CGM Enlite®

The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level

DEVICE

SmartGuard®

This SmartGuard® function is used to improve the glycemia stability in real condition

Sponsors & Collaborators

  • ARAIR Assistance

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2019-10-18
Completion
2019-10-18

Countries

  • France

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 NCT03653533 on ClinicalTrials.gov