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

Poitiers University Hospital

Status: Unknown

Conditions: Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia

Treatments: Device: FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System; Device: Usual self monitoring Blood Glucose device

Study type: Interventional

Funder types: Other

Identifiers

NCT03570138

SPIDER-STYLE

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Flash continuous glucose monitoring system

Experimental group

Description:

Participants will wear the FREESTYLE LIBRE device and receive a specific therapeutic education for its use.

Treatment:

Device: FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System

Standard self monitoring blood glucose system

Active Comparator group

Description:

Participants will use their own usual self monitoring blood glucose system and receive a C They will wear a masked FREESTYLE LIBRE Pro system.

Treatment:

Device: Usual self monitoring Blood Glucose device