Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia Clinical Trial
Official title:
Efficacy of Flash Continuous Glucose Monitoring (FREESTYLE LIBRE) on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia in Patients With Type 2 Diabetes, High Risk of Hypoglycemia and Insulin Therapy : Open-label Randomized Controlled Trial
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | September 30, 2021 |
| Est. primary completion date | September 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years to 85 Years |
| Eligibility | 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 : - Estimated glomerular filtration rate 15-59 ml/min/1.73 m² (according to CKD-EPI formula) - Or history of stable proliferative diabetic retinopathy - Or body mass index = 30 kg/m² - Or history of severe hypoglycemia in the previous 6 months - Or history of non-severe =70mg/dL hypoglycemia in the previous 4 weeks Exclusion criteria: - Type 1 diabetes mellitus or diabetes due to other cause - History of atrial fibrillation - Pacemaker - Estimated glomerular filtration rate <15 ml/min/1.73 m² (according to CKD-EPI formula) - Currently using a flash continuous Glucose Monitoring device - In the investigator's opinion, acute or chronic medical condition considered as unsuitable for inclusion in the study . |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital, Bordeaux | Bordeaux | |
| France | University Hospital, Limoges | Limoges | |
| France | University Hospital, Nantes | Nantes | |
| France | Hospital, Niort | Niort | |
| France | Hospital, Pau | Pau | |
| France | University Hospital, Poitiers | Poitiers | |
| France | University Hospital, Toulouse | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Poitiers University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring | Cardiac arrythmic events :
Bradycardia < 45 bpm for = 10 seconds or Asystole = 3 seconds or Atrial Fibrillation = 30 seconds or Non-sustained ventricular tachycardia defined as runs of beats arising from the ventricles with duration between 3 beats and 30 s with QRS = 120ms and with RR intervall = 600 ms (>100 bpm) |
14 days | |
| Secondary | Prevalence of each component of the primary outcome | 14 days | ||
| Secondary | Prevalence of = 5 minutes Atrial Fibrillation episodes | 14 days | ||
| Secondary | Mean QT interval | First 24 hours | ||
| Secondary | Prevalence of ventricular extrasystoles | First 24 hours |