Diabetes, Type 1
Conditions
Keywords
Diabetes, Type 1, Hypoglycemia, Insulin Infusion Systems
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
Interventions
DEVICEMinimed 640G with smartguard activated
Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation
DEVICEMinimed 640G with smartguard off
Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 months | Number of events of hypoglycemia (severe and non-severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Improving of overall glycemic control with SmartGuard activation in type 1 diabetic patients at risk of severe hypoglycemia | 6 months | Comprehensive metabolic evaluation data and evaluation data of severe hypoglycaemic risk |
| Assessment of the quality of life of patients with smartguard activation | 6 months | Quality of Life Questionnaire |
| Assessment of the number of adverse events | 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) |
| Study of average cost per patient for each therapeutic strategy supported from the point of view of society | 6 months | An average cost per patient will be calculated for each strategy. The horizon time is 6 months from randomization of the patient. |
Countries
France
Outcome results
None listed