Predicting Hypoglycaemia and Arrhythmias in the Vulnerable Patient With Diabetes and Chronic Kidney Disease

NCT02315300 | Completed

• 1 other identifier: 14-030
• Study Type: interventional
• Target: 62
• 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). Hypoglycemia is a frequent problem in insulin-treated patients, especially in those with CKD, and 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.

Conditions

Electrocardiography

Keywords

ECG, CGM, Hypoglycaemia, Sudden Cardiac Death

Outcome Measures

Primary Outcomes (10)

• heart rate

  Changes of ECG parameters during 7 days long term ECG

  not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events

• cardiac rhythm abnormalities

  Changes of ECG parameters during 7 days long term ECG

  not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events

• AV block

  Changes of ECG parameters during 7 days long term ECG

  not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events

• QT length

  Changes of ECG parameters during 7 days long term ECG

  not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events

• QT dispersion

  Changes of ECG parameters during 7 days long term ECG

  not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events

• heart-rate variability

  Changes of ECG parameters during 7 days long term ECG

  not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events

• T-wave alternans

  Changes of ECG parameters during 7 days long term ECG

  not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events

• late potentials

  Changes of ECG parameters during 7 days long term ECG

  not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events

• left or right bündle branch blocks

  Changes of ECG parameters during 7 days long term ECG

  not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events

• Glucose Levels < 65 mg/dl

  Changes of ECG parameters during 7 days long term ECG

  not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events

Secondary Outcomes (1)

• Association anf temporal coincidence of glycemic variability as assessed by changes in glucose excursion as well as mean amplitude of glycemic excursion (MAGE)

  18 months

Study Arms (1)

Study Tretament

EXPERIMENTAL

Long term ECG measurement is performed with the 12-lead ECG system medilog® DARWIN FD12 from Schillermed to detect different ECG parameter. The continuous glucose monitoring (CGM) system G4 from Dexcom use a tiny sensor inserted under the skin to check glucose levels in tissue fluid. The sensor stays in place for 7 days in parallel to the ECG measurement. A transmitter sends information about glucose levels via radio waves from the sensor to a pagerlike wireless monitor.

Device: medilog® DARWIN FD12; Device: Continuous Glucose Monitoring

Interventions

medilog® DARWIN FD12 DEVICE

Also known as: ECG

Study Tretament

Continuous Glucose Monitoring DEVICE

Also known as: CGM

Study Tretament

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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 \< 40 ml/min (determined using the MDRD formula)
• Male or female aged \> 18 years
• Written informed consent prior to study participation

You may not qualify if:

• Pregnancy or women without sufficient contraception, adapted specifically to amenorrhoic 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
• 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

MeSH Terms

Conditions

Hypoglycemia; Death, Sudden, Cardiac

Interventions

Electrocardiography; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Nikolaus Marx, Prof.

  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: December 1, 2014
• First Posted: December 11, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-05

Locations

DE (1)