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

October 17, 2017 updated by: University Hospital, Grenoble

Study of Minimed 640G Insulin Pump With SmartGuard in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Grenoble University Hospital
      • Montpellier, France, 34000
        • Montpellier University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 or insulin-dependent diabetic patients
  • Patients treated with subcutaneous insulin pump with at least 2 episodes of severe hypoglycemia within 12 months before the study enrollment
  • Affiliation to the french social security system or equivalent
  • People who signed the consent form

Exclusion Criteria:

  • Patient who have difficulty to understand the French language
  • Patient can not be raised to the use of an insulin pump, or a glucose sensor
  • Patient visually impaired
  • Patient hard of hearing
  • Pregnant woman or woman having a project of pregnancy within 6 months
  • Persons referred to in Articles L1121-5 to L1121-8 CSP: pregnant woman, woman in labor, breastfeeding women, persons deprived of their liberty by judicial or administrative decision, person under a legal protection measure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minimed 640G with smartguard activated
Group "SmartGuard On": Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640G insulin pump with SmartGuard activation
Device: Minimed 640G with smartguard activated
Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation
Other Names:
  • Minimed 640G insulin Pump with Smartguard activation
Active Comparator: Minimed 640G with smartguard off
Group "SmartGuard Off" Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640 insulin pump without 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
Other Names:
  • Minimed 640G insulin Pump without activated Smartguard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the Minimed 640G insulin pump with Smartguard activation in preventing the number of severe and non-severe hypoglycaemia in patients with diabetes type 1 at risk of severe hypoglycemia
Time Frame: 6 months
Number of events of hypoglycemia (severe and non-severe)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Improving of overall glycemic control with SmartGuard activation in type 1 diabetic patients at risk of severe hypoglycemia
Time Frame: 6 months
Comprehensive metabolic evaluation data and evaluation data of severe hypoglycaemic risk
6 months
Assessment of the quality of life of patients with smartguard activation
Time Frame: 6 months
Quality of Life Questionnaire
6 months
Assessment of the number of adverse events
Time Frame: 6 months
Assessment of the safety of the sensor augmented pump therapy with the Mimimed 640G insulin pump coupled with a 640G Minimed Enlite sensor with Smart Guard as compare to sensor augmented pump therapy with the Mimimed 640G insulin pump coupled with a 640G Minimed Enlite sensor without Smart Guard activation (Decompensated ketoacidosis, Hospitalization related to severe hypoglycemia or frequent hypoglycemia or moderate decompensation, Materiovigilance data, Collection and monitoring of serious adverse events and non-serious)
6 months
Study of average cost per patient for each therapeutic strategy supported from the point of view of society
Time Frame: 6 months
An average cost per patient will be calculated for each strategy. The horizon time is 6 months from randomization of the patient.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Sandrine LABLANCHE, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC15.110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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