NCT05994755

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

August 9, 2023

Last Update Submit

September 20, 2023

Conditions

DiabetesArrhythmiasAtrial FibrillationHeart Failure

Keywords

diabetes type IIcardiac arrhythmias

Outcome Measures

Primary Outcomes (1)

  • association between hypoglycemia, glycemic variability and cardiac arrhythmias

    Incidence of cardiac arrhythmias (atrial fibrillation, atrial flutter, PVC...) detected through remote monitoring and correlation with hypoglycemic episodes.

    6 months

Secondary Outcomes (1)

  • association between hypoglycemia, glycemic variability and heart failure

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with Type II Diabetes already implanted with ICD and monitored remotely through Bluetooth technology and CGM (continuous glucose monitoring).

You may qualify if:

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

You may not qualify if:

  • Subject who is, or is expected to be inaccessible for follow-up
  • pregnancy
  • Patients with persistent and longstanding persistent AF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University

Naples, Italy

Location

MeSH Terms

Conditions

Diabetes MellitusArrhythmias, CardiacAtrial FibrillationHeart FailureDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Antonio Rapacciuolo, Prof.

CONTACT

081 1962 2964antonio.rapacciuolo@unina.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 16, 2023

Study Start

October 30, 2023

Primary Completion

April 1, 2025

Study Completion

July 1, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

IT(1)