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Association Between Cardiac ARRHYTHMIAs and Glycemic Variability in Patient With Type 2 Diabetes Monitored Through FREEstyle Libre and Bluetooth Technology. (ARRHYTHMIAFREE)

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ClinicalTrials.gov Identifier: NCT05994755
Recruitment Status : Not yet recruiting
First Posted : August 16, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Antonio Rapacciuolo, Federico II University

Study Description
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Brief Summary:
The aim of this study is to investigate the association between hypoglycemia, glycemic variability and cardiac arrhythmias in patients with diabetes Type II (T2D) already implanted with implantable cardiac defibrillator (ICD) and monitored remotely through Bluetooth technology and CGM (continuous glucose monitoring).

Condition or disease
Diabetes Arrhythmias Atrial Fibrillation Heart Failure

Detailed Description:

Studies have shown that, when diabetes is present, there is a 35% to 60% greater risk of developing atrial fibrillation (AF). Diabetic patients with AF had a 61% increase in total mortality, a 77% increase in cardiovascular death and a 68% increase in heart failure. The greatest risk with the combination of AF and Type 2 Diabetes Mellitus (T2D) is a 79% increase in thromboembolic risk, particularly stroke.Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with T2D.

However, these conclusions need to be tempered by the limitations of all studies available to date, making it difficult to determine the onset and burden of AF, especially when it is not a monitored end-point.Since prospective randomized trials would be unethical, future research should focus on establishing whether such a link exists by employing an observational design and taking advantage of modern tools for long-term, real-life monitoring.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Association Between Cardiac ARRHYTHMIAs and Glycemic Variability in Patient With Type 2 Diabetes Monitored Through FREEstyle Libre and Bluetooth Technology. (ARRHYTHMIA FREE)
Estimated Study Start Date : October 30, 2023
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. association between hypoglycemia, glycemic variability and cardiac arrhythmias [ Time Frame: 6 months ]
    Incidence of cardiac arrhythmias (atrial fibrillation, atrial flutter, PVC...) detected through remote monitoring and correlation with hypoglycemic episodes.


Secondary Outcome Measures :
  1. association between hypoglycemia, glycemic variability and heart failure [ Time Frame: 6 months ]
    The relationship between cardiovascular disease (heart failure and ischemic heart disease) at baseline and clinically relevant cardiovascular disease in relation to TBR and TAR.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
patients with Type II Diabetes already implanted with ICD and monitored remotely through Bluetooth technology and CGM (continuous glucose monitoring).
Criteria

Inclusion Criteria:

  1. Patient already wearing CIEDs (Implantable Cardiac Electronic Device) with Bluetooth technology
  2. Diabetes Type II, no insulin-treated
  3. Over 18 years of age
  4. Patient in Sinus Rhythm at the time of the enrollment
  5. Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

Exclusion Criteria:

  1. Subject who is, or is expected to be inaccessible for follow-up
  2. pregnancy
  3. Patients with persistent and longstanding persistent AF
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): NCT05994755


Contacts
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Contact: Antonio Rapacciuolo, Prof. 081 1962 2964 antonio.rapacciuolo@unina.it

Locations
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Italy
Federico II University
Naples, Italy
Sponsors and Collaborators
Antonio Rapacciuolo
More Information
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Responsible Party: Antonio Rapacciuolo, Principal Investigator, Federico II University
ClinicalTrials.gov Identifier: NCT05994755    
Other Study ID Numbers: v1.0 22042023
First Posted: August 16, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Antonio Rapacciuolo, Federico II University:
diabetes type II
cardiac arrhythmias
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Pathologic Processes