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Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia

NCT02657213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-10-18

No results posted yet for this study

Summary

The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1 diabetic adults with an increased risk of hypoglycemia.

The study should show:

* A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a reduction in the time spent in hypoglycemia six months in any group compared to Baseline.
* A complete prevention of severe and not severe hypoglycemia in the pump group Minimed 640G + Enlite sensor with SmartGuard activation

Conditions

  • Diabetes, Type 1

Interventions

DEVICE

Minimed 640G with smartguard activated

Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation

DEVICE

Minimed 640G with smartguard off

Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Sandrine LABLANCHE, MD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-06-30
Completion
2017-06-30

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 NCT02657213 on ClinicalTrials.gov