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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimed 640G with smartguard activated | Experimental | 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 off | Active Comparator | Group "SmartGuard Off" Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640 insulin pump without SmartGuard activation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimed 640G with smartguard activated | Device | Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation |
|
| 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 | Number of events of hypoglycemia (severe and non-severe) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Improving of overall glycemic control with SmartGuard activation in type 1 diabetic patients at risk of severe hypoglycemia | Comprehensive metabolic evaluation data and evaluation data of severe hypoglycaemic risk | 6 months |
| Assessment of the quality of life of patients with smartguard activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandrine LABLANCHE, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble University Hospital | Grenoble | 38000 | France | |||
| Montpellier University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23789889 | Background | 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. | |
| Background | 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. |
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|
| Minimed 640G with smartguard off | Device | Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation |
|
|
Quality of Life Questionnaire |
| 6 months |
| Assessment of the number of adverse events | 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 | An average cost per patient will be calculated for each strategy. The horizon time is 6 months from randomization of the patient. | 6 months |
| Montpellier |
| 34000 |
| France |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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