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Search / Trial NCT05994755

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

Launched by ANTONIO RAPACCIUOLO · Aug 9, 2023

Trial Information

Current as of July 25, 2025

Not yet recruiting

Keywords

Diabetes Type Ii Cardiac Arrhythmias

ClinConnect Summary

This clinical trial is looking to understand how changes in blood sugar levels (glycemic variability) and low blood sugar episodes (hypoglycemia) may be linked to heart rhythm problems (cardiac arrhythmias) in patients with Type 2 diabetes. Specifically, it will focus on patients who have a special heart device called an implantable cardiac defibrillator (ICD) and who can be monitored remotely using Bluetooth technology and continuous glucose monitoring (CGM). The researchers hope to learn more about these connections to improve care for individuals with diabetes and heart issues.

To participate in this study, you must be an adult over 18 years old, have Type 2 diabetes (but not on insulin), and already have an implantable heart device that connects via Bluetooth. It’s also important that you have a normal heart rhythm at the time you join the study. Unfortunately, if you’re pregnant, have certain types of persistent heart arrhythmias, or might be hard to contact for follow-ups, you won’t be able to take part. If you join, you’ll help researchers gather important information that could lead to better management of diabetes and heart health in the future.

Gender

ALL

Eligibility 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

About Antonio Rapacciuolo

Antonio Rapacciuolo is a dedicated clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With a strong foundation in clinical development and regulatory affairs, he leads innovative trials across various therapeutic areas, ensuring adherence to the highest ethical standards and scientific rigor. His collaborative approach fosters partnerships with research institutions and healthcare professionals, driving the successful execution of studies that aim to bring groundbreaking therapies to market. Through a focus on patient-centric methodologies, Rapacciuolo is dedicated to enhancing the efficiency and effectiveness of clinical trials, ultimately contributing to the evolution of healthcare solutions.

Locations

Naples, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported