Efficacy of Flash Glucose-Sensing Technology on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia

Intervention / Treatment
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* Device: FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System
* Device: Usual self monitoring Blood Glucose device


Participation Criteria
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Eligibility Criteria
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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 : 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 .

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flash continuous glucose monitoring system<br>Participants will wear the FREESTYLE LIBRE device and receive a specific therapeutic education for its use. | Device: FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System<br>* Specific therapeutic education for diabetes self management<br>|
| Active Comparator: Standard self monitoring blood glucose system<br>Participants will use their own usual self monitoring blood glucose system and receive a C They will wear a masked FREESTYLE LIBRE Pro system. | Device: Usual self monitoring Blood Glucose device<br>* Standard therapeutic education for diabetes self management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | 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 |  | First 24 hours | 
| Prevalence of ventricular extrasystoles |  | First 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Freestyle libre, Type 2 diabetes, Hypoglycemia-induced cardiac arrhythmias, Flash Continuous Glucose Monitoring