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Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with type 2 diabetes (T2D). The study hypothesize is that the hypoglycemia reduction, achieved with the FREESTYLE LIBRE device, a Glucose Continuous Monitoring system, may decrease cardiac arrythmias associated with hypoglycemia. So the main objective is to evaluate the efficacy of the FREESTYLE LIBRE system, associated with a specific therapeutic education on the cardiac arrythmias reduction, compared to a capillary ASG system with standard therapeutic education, in patient with T2D with high risk of hypoglycemia.
This is a open, multicenter, controlled, randomized study in parallel group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flash continuous glucose monitoring system | Experimental | Participants will wear the FREESTYLE LIBRE device and receive a specific therapeutic education for its use. |
|
| Standard self monitoring blood glucose system | Active Comparator | Participants will use their own usual self monitoring blood glucose system and receive a C They will wear a masked FREESTYLE LIBRE Pro system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System | Device | Specific therapeutic education for diabetes self management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring | Cardiac arrythmic events :
| 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of each component of the primary outcome | 14 days | |
| Prevalence of ≥ 5 minutes Atrial Fibrillation episodes | 14 days | |
| Mean QT interval |
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Inclusion criteria:
Type 2 diabetes (diagnosis based on the World Health Organization criteria)
Treatment with insulin therapy (continuous subcutaneous insulin Infusion or more than 1 daily injection)
Resting heart beat ≥ 60bpm
High risk of hypoglycemia defined as :
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SAULNIER Pierre-Jean, Prof. | Contact | +33 549444689 | pierre-jean.saulnier@chu-poitiers.fr | |
| BONNIN Marie, Project chief | Contact | +33 549443317 | Marie.BONNIN@chu-poitiers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Bordeaux | Recruiting | Bordeaux | 33000 | France |
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| Usual self monitoring Blood Glucose device | Device | Standard therapeutic education for diabetes self management |
|
| First 24 hours |
| Prevalence of ventricular extrasystoles | First 24 hours |
| University Hospital, Limoges | Recruiting | Limoges | 87000 | France |
|
| University Hospital, Nantes | Recruiting | Nantes | 44000 | France |
|
| Hospital, Niort | Not yet recruiting | Niort | 79000 | France |
|
| Hospital, Pau | Recruiting | Pau | 64000 | France |
|
| University Hospital, Poitiers | Recruiting | Poitiers | 86000 | France |
|
| University Hospital, Toulouse | Recruiting | Toulouse | 31000 | France |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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