Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia
NCT ID: NCT02657213
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-02-29
2017-06-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
Minimed 640G with smartguard activated
Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation
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
Minimed 640G with smartguard off
Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation
Interventions
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Minimed 640G with smartguard activated
Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation
Minimed 640G with smartguard off
Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Sandrine LABLANCHE, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Grenoble University Hospital
Grenoble, , France
Montpellier University Hospital
Montpellier, , France
Countries
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References
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Bergenstal RM, Klonoff DC, Garg SK, Bode BW, Meredith M, Slover RH, Ahmann AJ, Welsh JB, Lee SW, Kaufman FR; ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med. 2013 Jul 18;369(3):224-32. doi: 10.1056/NEJMoa1303576. Epub 2013 Jun 22.
European User Evaluation of the MiniMed® 640G system. Poster session at the American Diabetes Association (ADA) 75th Scientific Sessions on Sunday, June 7 2015. Boston Convention and Exhibition Center.
Other Identifiers
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38RC15.110
Identifier Type: -
Identifier Source: org_study_id