Predicting Hypoglycaemia and Arrhythmias in the Patient With Diabetes and CKD - Validation Study (HypoArrhythmia)
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|ClinicalTrials.gov Identifier: NCT02778269|
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : April 7, 2017
Patients with insulin-dependent diabetes mellitus (DM) and chronic kidney disease (CKD) exhibit an excessive risk for cardiac arrhythmias, in particular sudden cardiac death (SCD). Various studies have shown that hypoglycemic episodes are strong predictors of cardiovascular mortality in both type 1 and type 2 diabetic patients. Experimental data and small clinical studies link hypoglycemia with ECG changes and SCD, but little is known about the direct association of hypoglycemic events and/or rapid swings in blood glucose with arrhythmias in this high risk population. Ideally, an algorithm should help to identify patients at risk for hypoglycemia-associated arrhythmias and SCD, but hitherto systematic analyses of blood glucose values and 12-channel ECGs are lacking in these patients.
In this validation study a 12-lead ECG T-shirt consisting of textile electrodes and a data logging device wich can record long-term 12-lead ECG data will be tested. The purpose of the T-shirt is to improve the patient's comfort for long-term recordings and to prevent adverse effects of regular ECG electrodes. Current systems are limited by the use of ECG electrodes involving disadvantages like severe direct side effects on the skin such as rash and bullous lesions as well as slipping electrodes. By the means of the proposed ECG T-shirt those drawbacks will be avoided.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Hypoglycaemia Chronic Kidney Disease||Device: 12-lead ECG T-shirt Device: Dexcom G4-System||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Predicting Hypoglycaemia and Arrhythmias in the Vulnerable Patient With Diabetes and Chronic Kidney Disease - Validation Study|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Experimental: Study Treatment
The patients wear a 12-lead ECG T-shirt for 7 days. During this time period ECG data are measured continuously. In addition the continous glucose monitoring system (CGM) records glucose levels via Dexcom G4-System.
Device: 12-lead ECG T-shirt
The 12-lead ECG T-shirt system consists of three parts: the recording device, amplifier boards and the T-shirt.The T-shirt has 10 textile ECG electrode patches. The patches should be in contact with the patient's skin to record the electrical activity of the heart. The electrodes are made of electrically conductive textile. They are sewn into the inside of the T-shirt and are padded with foam. The cables to the device can be attached to snap fasteners on the outer side of the T-shirt on the ECG electrode patches.
Device: Dexcom G4-System
Continuous Glucose Monitoring
Other Name: CGM
- QRS duration [sec] [ Time Frame: 7 days ]Prolonged duration indicates e.g. hyperkalemia or bundle branch block.
- QRS amplitude [mV] [ Time Frame: 7 days ]Increased amplitude indicates cardiac hypertrophy.
- Ventricular activation time (VAT) [sec] [ Time Frame: 7 days ]Measured in increased QRS amplitude.
- Number of power-line interference on the ECG [ Time Frame: 7 days ]Feasibility of the 12-lead ECG T-shirt: movements of the t-shirt might cause power-line interferences on the ECG.
- Number of congruences concerning identified arrhythmias of this validation study and the previous study "Predicting Hypoglycaemia and Arrhythmias in the vulnerable Patient with Diabetes and Chronic Kidney Disease". [ Time Frame: 7 days ]The number of congruences of this validation study and the previous study will validate the developed mathematic risk assessment model.
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): NCT02778269
|Medizinische Klinik I|
|Aachen, North Rhine Westphalia, Germany, 52074|
|Principal Investigator:||Nikolaus Marx, Prof. Dr.||Uniklinik RWTH Aachen|