Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia
Conditions
Keywords
Freestyle libre, Type 2 diabetes, Hypoglycemia-induced cardiac arrhythmias, Flash Continuous Glucose Monitoring
Brief summary
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.
Interventions
DEVICEFREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System
Specific therapeutic education for diabetes self management
DEVICEUsual self monitoring Blood Glucose device
Standard therapeutic education for diabetes self management
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring | 14 days | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence of each component of the primary outcome | 14 days |
| Prevalence of ≥ 5 minutes Atrial Fibrillation episodes | 14 days |
| Mean QT interval | First 24 hours |
| Prevalence of ventricular extrasystoles | First 24 hours |
Countries
France
Contacts
Primary ContactSAULNIER Pierre-Jean, Prof.
Backup ContactBONNIN Marie, Project chief
Outcome results
None listed