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

Not Applicable

• Conditions: Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia
• Interventions: Device: Usual self monitoring Blood Glucose device; Device: FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System

• Registration Number: NCT03570138
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-26
• Study Start: 2018-06-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard self monitoring blood glucose system	Usual self monitoring Blood Glucose device	Participants will use their own usual self monitoring blood glucose system and receive a C They will wear a masked FREESTYLE LIBRE Pro system.
Flash continuous glucose monitoring system	FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System	Participants will wear the FREESTYLE LIBRE device and receive a specific therapeutic education for its use.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Prevalence of each component of the primary outcome	14 days
Mean QT interval	First 24 hours
Prevalence of ≥ 5 minutes Atrial Fibrillation episodes	14 days
Prevalence of ventricular extrasystoles	First 24 hours

Trial Locations

Locations (7)

University Hospital, Bordeaux; 🇫🇷 Bordeaux, France

University Hospital, Nantes; 🇫🇷 Nantes, France

Hospital, Pau; 🇫🇷 Pau, France

University Hospital, Toulouse; 🇫🇷 Toulouse, France

University Hospital, Limoges; 🇫🇷 Limoges, France

Hospital, Niort; 🇫🇷 Niort, France

University Hospital, Poitiers; 🇫🇷 Poitiers, France