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

October 19, 2020 updated by: Poitiers University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • University Hospital, Bordeaux
        • Principal Investigator:
          • MOHAMMEDI Kamel, Prof.
      • Limoges, France, 87000
        • Recruiting
        • University Hospital, Limoges
        • Principal Investigator:
          • TEISSIER Marie-Pierre, Prof.
      • Nantes, France, 44000
        • Recruiting
        • University Hospital, Nantes
        • Principal Investigator:
          • CARIOU Bertrand, Prof.
      • Niort, France, 79000
        • Not yet recruiting
        • Hospital, Niort
        • Principal Investigator:
          • TEYNIE Julie, Dr.
      • Pau, France, 64000
        • Recruiting
        • Hospital, Pau
        • Principal Investigator:
          • TEYNIE Julie, Dr.
      • Poitiers, France, 86000
        • Recruiting
        • University Hospital, Poitiers
        • Principal Investigator:
          • SAULNIER Pierre-Jean, Prof.
      • Toulouse, France, 31000
        • Recruiting
        • University Hospital, Toulouse
        • Principal Investigator:
          • GOURDY Pierre, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flash continuous glucose monitoring system
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
Specific therapeutic education for diabetes self management
Active Comparator: Standard self monitoring blood glucose system
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
Standard therapeutic education for diabetes self management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring
Time Frame: 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)
14 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2018

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

June 15, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPIDER-STYLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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