Clinical trial NCT02657213: Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Type 1
Keywords: Diabetes, Type 1
Hypoglycemia
Insulin Infusion Systems
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of Improving of overall glycemic control with SmartGuard activation in type 1 diabetic patients at risk of severe hypoglycemia
timeFrame: 6 months
measure: Assessment of the quality of life of patients with smartguard activation
timeFrame: 6 months
measure: Assessment of the number of adverse events
timeFrame: 6 months
measure: Study of average cost per patient for each therapeutic strategy supported from the point of view of society
timeFrame: 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Sandrine LABLANCHE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.