Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes

NCT04011683 | Completed

• 1 other identifier: H-18034040_part2
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia (Diabetic); Hyperglycaemia (Diabetic); Arrythmia, Cardiac; Type 1 Diabetes; Blood Glucose Fluctuations

Outcome Measures

Primary Outcomes (1)

• Incidence of cardiac arrhythmias during hypoglycaemia, euglycaemia, hyperglycaemia.

  Incidence of clinically relevant arrhythmias during hypoglycaemia (plasma glucose ≤3.9 mmol/l) compared to euglycaemia and hyperglycaemia.

  Within 12 months

Secondary Outcomes (9)

• 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

• The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

  Within 12 months

• The relationship between diabetes complication status at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

  Within 12 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 Diabetes recrutted in collaboration with Hillerod hospital, Gentofte hospital and Steno Diabetes Centre.

You may qualify if:

• 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\*\*:
• Nephropathy (creatinine \>130 μmol/l and/or microalbuminuria)
• Macrovascular disease defined as coronary disease (stable angina pectoris. previous unstable angina pectoris or myocardial infarction), cerebrovascular disease (previous stroke or transitional cerebral ischaemia), and peripheral vascular disease (previous intermittent claudication or prior acute ischemia)
• Peripheral neuropathy with vibration perception threshold of \>25 volt determined by biothesiometry
• Moderate to severe retinopathy
• Well-functioning ILR during run-in period (acceptable readings judged by an arrhythmologist)

You may not qualify if:

• Arrhythmia diagnosed prior to the screening visit
• 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)

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• University of Copenhagen: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator
• Hillerod Hospital, Denmark: collaborator

Study Sites (1)

Clinical Metabolic Physiology, SDCC

Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

Hypoglycemia; Hyperglycemia; Arrhythmias, Cardiac; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tina Vilsbøll, MD, Professor

  Steno Diabetes Center Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: July 8, 2019
• Study Start: December 1, 2018
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

DK (1)