Clinical trial NCT03570138: Efficacy of Flash Glucose-Sensing Technology on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia
Keywords: Freestyle libre
Type 2 diabetes
Hypoglycemia-induced cardiac arrhythmias
Flash Continuous Glucose Monitoring
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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 .

Primary outcomes:
measure: Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring
timeFrame: 14 days
Secondary outcomes:
measure: Prevalence of each component of the primary outcome
timeFrame: 14 days
measure: Prevalence of ≥ 5 minutes Atrial Fibrillation episodes
timeFrame: 14 days
measure: Mean QT interval
timeFrame: First 24 hours
measure: Prevalence of ventricular extrasystoles
timeFrame: First 24 hours
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital, Bordeaux
city: Limoges
country: France
facility: University Hospital, Limoges
city: Nantes
country: France
facility: University Hospital, Nantes
city: Niort
country: France
facility: Hospital, Niort
city: Pau
country: France
facility: Hospital, Pau
city: Poitiers
country: France
facility: University Hospital, Poitiers
city: Toulouse
country: France
facility: University Hospital, Toulouse
Study officials:
References: