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

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ClinicalTrials.gov Identifier: NCT03570138
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia Device: FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System Device: Usual self monitoring Blood Glucose device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Prevalence of each component of the primary outcome [ Time Frame: 14 days ]
  2. Prevalence of ≥ 5 minutes Atrial Fibrillation episodes [ Time Frame: 14 days ]
  3. Mean QT interval [ Time Frame: First 24 hours ]
  4. Prevalence of ventricular extrasystoles [ Time Frame: First 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570138


Contacts
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Contact: SAULNIER Pierre-Jean, Prof. +33 549444689 pierre-jean.saulnier@chu-poitiers.fr
Contact: BONNIN Marie, Project chief +33 549443317 Marie.BONNIN@chu-poitiers.fr

Locations
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France
University Hospital, Bordeaux Recruiting
Bordeaux, France, 33000
Principal Investigator: MOHAMMEDI Kamel, Prof.         
University Hospital, Limoges Recruiting
Limoges, France, 87000
Principal Investigator: TEISSIER Marie-Pierre, Prof.         
University Hospital, Nantes Recruiting
Nantes, France, 44000
Principal Investigator: CARIOU Bertrand, Prof.         
Hospital, Niort Not yet recruiting
Niort, France, 79000
Principal Investigator: TEYNIE Julie, Dr.         
Hospital, Pau Recruiting
Pau, France, 64000
Principal Investigator: TEYNIE Julie, Dr.         
University Hospital, Poitiers Recruiting
Poitiers, France, 86000
Principal Investigator: SAULNIER Pierre-Jean, Prof.         
University Hospital, Toulouse Recruiting
Toulouse, France, 31000
Principal Investigator: GOURDY Pierre, Prof.         
Sponsors and Collaborators
Poitiers University Hospital
More Information
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03570138    
Other Study ID Numbers: SPIDER-STYLE
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poitiers University Hospital:
Freestyle libre
Type 2 diabetes
Hypoglycemia-induced cardiac arrhythmias
Flash Continuous Glucose Monitoring
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Diabetes Mellitus, Type 2
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Pathologic Processes