Efficacy of Flash Glucose-Sensing Technology on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia
NCT ID: NCT03570138
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-06-29
2021-09-30
Brief Summary
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This is a open, multicenter, controlled, randomized study in parallel group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Flash continuous glucose monitoring system
Participants will wear the FREESTYLE LIBRE device and receive a specific therapeutic education for its use.
FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System
Specific therapeutic education for diabetes self management
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.
Usual self monitoring Blood Glucose device
Standard therapeutic education for diabetes self management
Interventions
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FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System
Specific therapeutic education for diabetes self management
Usual self monitoring Blood Glucose device
Standard therapeutic education for diabetes self management
Eligibility Criteria
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Inclusion 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
* 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 .
45 Years
85 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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University Hospital, Bordeaux
Bordeaux, , France
University Hospital, Limoges
Limoges, , France
University Hospital, Nantes
Nantes, , France
Hospital, Niort
Niort, , France
Hospital, Pau
Pau, , France
University Hospital, Poitiers
Poitiers, , France
University Hospital, Toulouse
Toulouse, , France
Countries
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Central Contacts
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Other Identifiers
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SPIDER-STYLE
Identifier Type: -
Identifier Source: org_study_id
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