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

NCT02778269 | Completed

• 1 other identifier: 14-030 MPG
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypoglycaemia; Chronic Kidney Disease

Keywords

ECG; CGM; Hypoglycaemia; Sudden Cardiac Death

Outcome Measures

Primary Outcomes (4)

• QRS duration [sec]

  Prolonged duration indicates e.g. hyperkalemia or bundle branch block.

  7 days

• QRS amplitude [mV]

  Increased amplitude indicates cardiac hypertrophy.

  7 days

• Ventricular activation time (VAT) [sec]

  Measured in increased QRS amplitude.

  7 days

• Number of power-line interference on the ECG

  Feasibility of the 12-lead ECG T-shirt: movements of the t-shirt might cause power-line interferences on the ECG.

  7 days

Secondary Outcomes (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".

  7 days

Study Arms (1)

Study Treatment

EXPERIMENTAL

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; Device: Dexcom G4-System

Interventions

12-lead ECG T-shirt DEVICE

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.

Study Treatment

Dexcom G4-System DEVICE

Continuous Glucose Monitoring

Also known as: CGM

Study Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Medizinische Klinik I

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (14)

• Causes of death. USRDS. United States Renal Data System. Am J Kidney Dis. 1997 Aug;30(2 Suppl 1):S107-17. No abstract available.

  PMID: 9259696 BACKGROUND

• Carrero JJ, de Mutsert R, Axelsson J, Dekkers OM, Jager KJ, Boeschoten EW, Krediet RT, Dekker FW; NECOSAD Study Group. Sex differences in the impact of diabetes on mortality in chronic dialysis patients. Nephrol Dial Transplant. 2011 Jan;26(1):270-6. doi: 10.1093/ndt/gfq386. Epub 2010 Jul 9.

  PMID: 20621930 BACKGROUND

• Tattersall RB. Brittle diabetes revisited: the Third Arnold Bloom Memorial Lecture. Diabet Med. 1997 Feb;14(2):99-110. doi: 10.1002/(SICI)1096-9136(199702)14:23.0.CO;2-I.

  PMID: 9047086 BACKGROUND

• Gill GV, Woodward A, Casson IF, Weston PJ. Cardiac arrhythmia and nocturnal hypoglycaemia in type 1 diabetes--the 'dead in bed' syndrome revisited. Diabetologia. 2009 Jan;52(1):42-5. doi: 10.1007/s00125-008-1177-7. Epub 2008 Oct 30.

  PMID: 18972096 BACKGROUND

• Rana OA, Byrne CD, Greaves K. Intensive glucose control and hypoglycaemia: a new cardiovascular risk factor? Heart. 2014 Jan;100(1):21-7. doi: 10.1136/heartjnl-2013-303871. Epub 2013 May 22.

  PMID: 23697655 BACKGROUND

• Shamseddin MK, Parfrey PS. Sudden cardiac death in chronic kidney disease: epidemiology and prevention. Nat Rev Nephrol. 2011 Mar;7(3):145-54. doi: 10.1038/nrneph.2010.191. Epub 2011 Feb 1.

  PMID: 21283136 BACKGROUND

• Hanefeld M, Duetting E, Bramlage P. Cardiac implications of hypoglycaemia in patients with diabetes - a systematic review. Cardiovasc Diabetol. 2013 Sep 21;12:135. doi: 10.1186/1475-2840-12-135.

  PMID: 24053606 BACKGROUND

• Giorgino F, Leonardini A, Laviola L. Cardiovascular disease and glycemic control in type 2 diabetes: now that the dust is settling from large clinical trials. Ann N Y Acad Sci. 2013 Apr;1281(1):36-50. doi: 10.1111/nyas.12044. Epub 2013 Feb 6.

  PMID: 23387439 BACKGROUND

• Schachinger H, Port J, Brody S, Linder L, Wilhelm FH, Huber PR, Cox D, Keller U. Increased high-frequency heart rate variability during insulin-induced hypoglycaemia in healthy humans. Clin Sci (Lond). 2004 Jun;106(6):583-8. doi: 10.1042/CS20030337.

  PMID: 14717655 BACKGROUND

• Landstedt-Hallin L, Englund A, Adamson U, Lins PE. Increased QT dispersion during hypoglycaemia in patients with type 2 diabetes mellitus. J Intern Med. 1999 Sep;246(3):299-307. doi: 10.1046/j.1365-2796.1999.00528.x.

  PMID: 10475998 BACKGROUND

• Koivikko ML, Karsikas M, Salmela PI, Tapanainen JS, Ruokonen A, Seppanen T, Huikuri HV, Perkiomaki JS. Effects of controlled hypoglycaemia on cardiac repolarisation in patients with type 1 diabetes. Diabetologia. 2008 Mar;51(3):426-35. doi: 10.1007/s00125-007-0902-y. Epub 2007 Dec 19.

  PMID: 18097646 BACKGROUND

• Junttila MJ, Castellanos A, Huikuri HV, Myerburg RJ. Risk markers of sudden cardiac death in standard 12-lead electrocardiograms. Ann Med. 2012 Nov;44(7):717-32. doi: 10.3109/07853890.2011.594807. Epub 2011 Jul 11.

  PMID: 21745092 BACKGROUND

• Robinson RT, Harris ND, Ireland RH, Lee S, Newman C, Heller SR. Mechanisms of abnormal cardiac repolarization during insulin-induced hypoglycemia. Diabetes. 2003 Jun;52(6):1469-74. doi: 10.2337/diabetes.52.6.1469.

  PMID: 12765959 BACKGROUND

• Koivikko ML, Tulppo MP, Kiviniemi AM, Kallio MA, Perkiomaki JS, Salmela PI, Airaksinen KE, Huikuri HV. Autonomic cardiac regulation during spontaneous nocturnal hypoglycemia in patients with type 1 diabetes. Diabetes Care. 2012 Jul;35(7):1585-90. doi: 10.2337/dc11-2120. Epub 2012 May 18.

  PMID: 22611064 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia; Renal Insufficiency, Chronic; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death

Study Officials

• Nikolaus Marx, Prof. Dr.

  Uniklinik RWTH Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 19, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 7, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)