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

September 20, 2023 updated by: Antonio Rapacciuolo

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

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).

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

58

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 Locations

  • Italy
      • Naples, Italy
        • Federico II University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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).

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

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

Sponsor

Antonio Rapacciuolo

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 (Estimated)

October 30, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • v1.0 22042023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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