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Predicting Hypoglycaemia and Arrhythmias in the Patient With Diabetes and CKD - Validation Study (HypoArrhythmia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02778269
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : April 7, 2017
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. QRS duration [sec] [ Time Frame: 7 days ]
    Prolonged duration indicates e.g. hyperkalemia or bundle branch block.

  2. QRS amplitude [mV] [ Time Frame: 7 days ]
    Increased amplitude indicates cardiac hypertrophy.

  3. Ventricular activation time (VAT) [sec] [ Time Frame: 7 days ]
    Measured in increased QRS amplitude.

  4. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Insulin-treated diabetes mellitus (type 1 or 2)
  2. CKD with eGFR < 45 ml/min, determined using the Modification of Diet in Renal Disease (MDRD) formula
  3. Stable anti-diabetic and cardiac medication prior to inclusion
  4. Male aged ≥ 18 years
  5. Written informed consent prior to study participation
  6. Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel.

Exclusion Criteria:

  1. Pregnancy or women without sufficient contraception, adapted specifically to amenorrhoeic hemodialysis patients
  2. Life expectancy below 6 months
  3. Participation in another clinical trial within the previous 2 months
  4. History of any other illness, which, in the opinion of the investigator, might pose an unacceptable risk when administering study medication
  5. Any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study
  6. Alcohol or drug abuse
  7. Patient has been committed to an institution by legal or regulatory order
  8. Patients with any kind of pacemakers
  9. Expected non-compliance
  10. Patients unwilling or unable to give informed consent, or with limited ability to comply with instructions for this study
  11. Participation in a parallel interventional clinical trial

Information from the National Library of Medicine

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 identifier (NCT number): NCT02778269

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Medizinische Klinik I
Aachen, North Rhine Westphalia, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
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Principal Investigator: Nikolaus Marx, Prof. Dr. Uniklinik RWTH Aachen


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Responsible Party: RWTH Aachen University Identifier: NCT02778269     History of Changes
Other Study ID Numbers: 14-030 MPG
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by RWTH Aachen University:
Sudden Cardiac Death
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency