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

Last updated: September 20, 2023
Sponsor: Antonio Rapacciuolo
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Diabetic Foot Ulcers

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT05994755
v1.0 22042023
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient already wearing CIEDs (Implantable Cardiac Electronic Device) with Bluetoothtechnology
  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 ableto comply with the protocol described evaluations

Exclusion

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 Design

Total Participants: 58
Study Start date:
October 30, 2023
Estimated Completion Date:
July 01, 2025

Study 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.

Connect with a study center

  • Federico II University

    Naples,
    Italy

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.