Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoglycemia (Diabetic)
- Sponsor
- Steno Diabetes Center Copenhagen
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Incidence of cardiac arrhythmias during hypoglycaemia, euglycaemia, hyperglycaemia.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The investigators hypothesise that patients with type 1 diabetes have clinically relevant, but often unrecognised, episodes of arrhythmias linked to episodes of hypoglycaemia and/or clinically significant fluctuations in plasma glucose.
Detailed Description
30 patients with type 1 diabetes will be recruited for a one-year observational study employing CGM (Continuous glucose monitor) and ILR (Implantable loop recorder). Patients will be scheduled for a three-week run-in period to ensure that the implanted ILR provides reliable data. Patient visits are planned for 0, 3, 6, 9, and 12 months and will include clinical examination, blood and urine samples, echocardiography (only first and last visit) and implant/explant of CGM. After 12 months, the participants will continue with an extended observation period of 2 years employing ILR and clinical examination. Device: Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA) Implantation of a loop-recorder Device: Continuous glucose monitoring (Eversense XL, Senseonics, USA) Monitoring with a continuous glucose monitor
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed and written consent
- •Type 1 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
- •Age 18-80 years
- •Fulfilling at least one of the below criteria\*:
- •Recurrent hypoglycaemia (defined as \>1 episode/week with a plasma glucose measurement ≤3.9 mmol/l within the last 4 weeks)
- •An episode of severe hypoglycaemia within the last year (according to the ADA definition, an event requiring assistance of another person to actively administer carbohydrates and/or glucagon, or take other corrective actions)
- •Hypoglycaemic symptom unawareness (history of impaired autonomic response during hypoglycaemia)
- •(\*The aim is that all patients will fulfil criteria a or b. If the targeted sample size cannot be recruited, patients fulfilling criteria c will be included)
- •Insulin treatment
- •One or more clinical relevant complications to diabetes defined as\*\*:
Exclusion Criteria
- •Arrhythmia diagnosed prior to the screening visit
- •ICD or pacemaker at the time of inclusion
- •Severe heart failure (left ventricular ejection fraction \<25%)
- •Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
- •Thyroid dysfunction (except for well-regulated eltroxine substituted myxoedema)
Outcomes
Primary Outcomes
Incidence of cardiac arrhythmias during hypoglycaemia, euglycaemia, hyperglycaemia.
Time Frame: Within 12 months
Incidence of clinically relevant arrhythmias during hypoglycaemia (plasma glucose ≤3.9 mmol/l) compared to euglycaemia and hyperglycaemia.
Secondary Outcomes
- The relationship between diabetes complication status at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV(Within 12 months)
- The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV(Within 12 months)
- Hypoglycaemia and cardiac arrhythmia(Within 12 months)
- Plasma glucose variation and cardiac arrhythmias(Within 12 months)
- CV, SD, ADRR, LBGI, HBGI, CONGA-1 and cardiac arrhythmias(Within 12 months)
- Mean amplitude of glycaemic excursions (MAGE) and cardiac arrhythmia.(Within 12 months)
- Prevalence of cardiac arrhythmias(Within 12 months)
- Cardiac arrhythmias during LGV, HGV.(Within 12 months)
- The relationship between cardiovascular disease at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV(Within 12 months)