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

Primary Purpose

Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System
Usual self monitoring Blood Glucose device
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia focused on measuring Freestyle libre, Type 2 diabetes, Hypoglycemia-induced cardiac arrhythmias, Flash Continuous Glucose Monitoring

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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 .

Sites / Locations

  • University Hospital, BordeauxRecruiting
  • University Hospital, LimogesRecruiting
  • University Hospital, NantesRecruiting
  • Hospital, Niort
  • Hospital, PauRecruiting
  • University Hospital, PoitiersRecruiting
  • University Hospital, ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flash continuous glucose monitoring system

Standard self monitoring blood glucose system

Arm Description

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

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

Outcomes

Primary Outcome Measures

Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring
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

Prevalence of each component of the primary outcome
Prevalence of ≥ 5 minutes Atrial Fibrillation episodes
Mean QT interval
Prevalence of ventricular extrasystoles

Full Information

First Posted
June 15, 2018
Last Updated
October 19, 2020
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03570138
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 29, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia
Keywords
Freestyle libre, Type 2 diabetes, Hypoglycemia-induced cardiac arrhythmias, Flash Continuous Glucose Monitoring

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flash continuous glucose monitoring system
Arm Type
Experimental
Arm Description
Participants will wear the FREESTYLE LIBRE device and receive a specific therapeutic education for its use.
Arm Title
Standard self monitoring blood glucose system
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System
Intervention Description
Specific therapeutic education for diabetes self management
Intervention Type
Device
Intervention Name(s)
Usual self monitoring Blood Glucose device
Intervention Description
Standard therapeutic education for diabetes self management
Primary Outcome Measure Information:
Title
Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring
Description
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)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Prevalence of each component of the primary outcome
Time Frame
14 days
Title
Prevalence of ≥ 5 minutes Atrial Fibrillation episodes
Time Frame
14 days
Title
Mean QT interval
Time Frame
First 24 hours
Title
Prevalence of ventricular extrasystoles
Time Frame
First 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SAULNIER Pierre-Jean, Prof.
Phone
+33 549444689
Email
pierre-jean.saulnier@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
BONNIN Marie, Project chief
Phone
+33 549443317
Email
Marie.BONNIN@chu-poitiers.fr
Facility Information:
Facility Name
University Hospital, Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MOHAMMEDI Kamel, Prof.
Facility Name
University Hospital, Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TEISSIER Marie-Pierre, Prof.
Facility Name
University Hospital, Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CARIOU Bertrand, Prof.
Facility Name
Hospital, Niort
City
Niort
ZIP/Postal Code
79000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TEYNIE Julie, Dr.
Facility Name
Hospital, Pau
City
Pau
ZIP/Postal Code
64000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TEYNIE Julie, Dr.
Facility Name
University Hospital, Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SAULNIER Pierre-Jean, Prof.
Facility Name
University Hospital, Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GOURDY Pierre, Prof.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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