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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| University Hospital, Gentofte, Copenhagen | OTHER |
| Hillerod Hospital, Denmark | OTHER |
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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.
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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of cardiac arrhythmias | Prevalence of clinically relevant arrhythmias | Within 12 months |
| Cardiac arrhythmias during LGV, HGV. | 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. |
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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*:
(*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**:
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:
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Patients with type 1 Diabetes recrutted in collaboration with Hillerod hospital, Gentofte hospital and Steno Diabetes Centre.
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| Name | Affiliation | Role |
|---|---|---|
| Tina Vilsbøll, MD, Professor | Steno Diabetes Center Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Metabolic Physiology, SDCC | Copenhagen | 2900 | Denmark |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| D001145 | Arrhythmias, Cardiac |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006331 | Heart Diseases |
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| Within 12 months |
| The relationship between cardiovascular disease at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV | The relationship between cardiovascular disease (heart failure and ischaemic heart 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 | 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 | The relationship between diabetes complication status (neuropathy, nephropathy, retinopathy) at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV | Within 12 months |
| Hypoglycaemia and cardiac arrhythmia | The correlation between prevalence and total duration of hypoglycaemia and risk of clinically relevant arrhythmias | Within 12 months |
| Plasma glucose variation and cardiac arrhythmias | 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 | Within 12 months |
| CV, SD, ADRR, LBGI, HBGI, CONGA-1 and cardiac arrhythmias | 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 | Within 12 months |
| Mean amplitude of glycaemic excursions (MAGE) and cardiac arrhythmia. | Difference in mean amplitude of glycaemic excursions (MAGE) two hours preceding an arrhythmic event versus MAGE during non-event | Within 12 months |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |