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Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes (Hypo-Heart-1)

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ClinicalTrials.gov Identifier: NCT04011683
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
University of Copenhagen
University Hospital, Gentofte, Copenhagen
Hillerod Hospital, Denmark
Information provided by (Responsible Party):
Steno Diabetes Center Copenhagen

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.

Condition or disease
Hypoglycemia (Diabetic) Hyperglycaemia (Diabetic) Arrythmia, Cardiac Type 1 Diabetes Blood Glucose Fluctuations

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


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Prevalence of cardiac arrhythmias [ Time Frame: Within 12 months ]
    Prevalence of clinically relevant arrhythmias

  2. Cardiac arrhythmias during LGV, HGV. [ Time Frame: Within 12 months ]
    Clinical relevant arrhythmias during low glucose variability (LGV), defined as variations in plasma glucose below or equal to 5 mmol/l within two hours preceding an arrhythmic event, compared to high glucose variability (HGV), defined as variations in plasma glucose above 5 mmol/l within two hours preceding an arrhythmic event.

  3. The relationship between cardiovascular disease at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV [ Time Frame: Within 12 months ]
    The relationship between cardiovascular disease (heart failure and ischaemic heart disease) at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

  4. The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV [ Time Frame: Within 12 months ]
    The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

  5. The relationship between diabetes complication status at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV [ Time Frame: Within 12 months ]
    The relationship between diabetes complication status (neuropathy, nephropathy, retinopathy) at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

  6. Hypoglycaemia and cardiac arrhythmia [ Time Frame: Within 12 months ]
    The correlation between prevalence and total duration of hypoglycaemia and risk of clinically relevant arrhythmias

  7. Plasma glucose variation and cardiac arrhythmias [ Time Frame: Within 12 months ]
    The correlation between plasma glucose variation (variation in plasma glucose (Δ mmol/l) within two hours of the event) and risk of clinically relevant arrhythmias

  8. CV, SD, ADRR, LBGI, HBGI, CONGA-1 and cardiac arrhythmias [ Time Frame: Within 12 months ]
    The correlation between measures of glycaemic variability (coefficient of variation (CV), standard deviation (SD), average daily risk range (ADRR), low blood glucose index (LBGI), high blood glucose index (HBGI) and continuous overlapping net glycaemic action (CONGA-1)) and risk of clinically relevant arrhythmias

  9. Mean amplitude of glycaemic excursions (MAGE) and cardiac arrhythmia. [ Time Frame: Within 12 months ]
    Difference in mean amplitude of glycaemic excursions (MAGE) two hours preceding an arrhythmic event versus MAGE during non-event



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 1 Diabetes recrutted in collaboration with Hillerod hospital, Gentofte hospital and Steno Diabetes Centre.
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*:

    1. Recurrent hypoglycaemia (defined as >1 episode/week with a plasma glucose measurement ≤3.9 mmol/l within the last 4 weeks)
    2. 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)
    3. 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**:

    1. Nephropathy (creatinine >130 μmol/l and/or microalbuminuria)
    2. 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)
    3. Peripheral neuropathy with vibration perception threshold of >25 volt determined by biothesiometry
    4. Moderate to severe retinopathy
  • Well-functioning ILR during run-in period (acceptable readings judged by an arrhythmologist)
  • Participation in the extended study

(**The aim is that all patients will fulfil criteria a or b. If the targeted sample size cannot be recruited, patients fulfilling criteria c or d will be included)

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)

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 ClinicalTrials.gov identifier (NCT number): NCT04011683


Contacts
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Contact: Per Hagelqvist, MD +4531390346 per.gustav.hagelqvist.01@regionh.dk
Contact: Christine Rode Andreasen, MD, PHD christine.rode.andreasen.01@regionh.dk

Locations
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Denmark
Clinical Metabolic Physiology, SDCC Recruiting
Copenhagen, Denmark, 2900
Contact: Bente Petersen    +4530694005    bente.petersen.03@regionh.dk   
Principal Investigator: Per Hagelqvist, MD         
Principal Investigator: Christine Rode Andreasen, MD, PHD         
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
University of Copenhagen
University Hospital, Gentofte, Copenhagen
Hillerod Hospital, Denmark
Investigators
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Study Director: Tina Vilsbøll, MD, Professor Steno Diabetes Center Copenhagen

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Responsible Party: Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT04011683     History of Changes
Other Study ID Numbers: H-18034040_part2
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Hyperglycemia
Arrhythmias, Cardiac
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Heart Diseases
Cardiovascular Diseases
Pathologic Processes