Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia
ALPPHY
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
1 other identifier
interventional
20
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2016
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedOctober 18, 2017
October 1, 2017
1.3 years
January 6, 2016
October 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Number of events of hypoglycemia (severe and non-severe)
6 months
Secondary Outcomes (4)
Assessment of Improving of overall glycemic control with SmartGuard activation in type 1 diabetic patients at risk of severe hypoglycemia
6 months
Assessment of the quality of life of patients with smartguard activation
6 months
Assessment of the number of adverse events
6 months
Study of average cost per patient for each therapeutic strategy supported from the point of view of society
6 months
Study Arms (2)
Minimed 640G with smartguard activated
EXPERIMENTALGroup "SmartGuard On": Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640G insulin pump with SmartGuard activation
Minimed 640G with smartguard off
ACTIVE COMPARATORGroup "SmartGuard Off" Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640 insulin pump without SmartGuard activation
Interventions
Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation
Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Grenoble University Hospital
Grenoble, 38000, France
Montpellier University Hospital
Montpellier, 34000, France
Related Publications (2)
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.
PMID: 23789889BACKGROUNDEuropean 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandrine LABLANCHE, MD
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2016
First Posted
January 15, 2016
Study Start
February 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
October 18, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share