Condition or disease |
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Hypoglycemia (Diabetic) Hyperglycaemia (Diabetic) Arrythmia, Cardiac Type 1 Diabetes Blood Glucose Fluctuations |
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
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 |
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 |
Inclusion Criteria:
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)
One or more clinical relevant complications to diabetes defined as**:
(**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:
Contact: Per Hagelqvist, MD | +4531390346 | per.gustav.hagelqvist.01@regionh.dk | |
Contact: Christine Rode Andreasen, MD, PHD | christine.rode.andreasen.01@regionh.dk |
Denmark | |
Clinical Metabolic Physiology, SDCC | Recruiting |
Copenhagen, Denmark, 2900 | |
Contact: Bente Petersen +4530694005 bente.petersen.03@regionh.dk | |
Sub-Investigator: Per Hagelqvist, MD | |
Sub-Investigator: Christine Rode Andreasen, MD | |
Principal Investigator: Tina Vilsbøll, MD, DMSc |
Study Director: | Tina Vilsbøll, MD, Professor | Steno Diabetes Center Copenhagen |
Tracking Information | |||||||||
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First Submitted Date | June 17, 2019 | ||||||||
First Posted Date | July 8, 2019 | ||||||||
Last Update Posted Date | November 20, 2020 | ||||||||
Actual Study Start Date | December 1, 2018 | ||||||||
Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes | ||||||||
Official Title | Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes | ||||||||
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 |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Patients with type 1 Diabetes recrutted in collaboration with Hillerod hospital, Gentofte hospital and Steno Diabetes Centre. | ||||||||
Condition |
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Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Not Provided | ||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
30 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 1, 2021 | ||||||||
Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion 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)
(**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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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Denmark | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT04011683 | ||||||||
Other Study ID Numbers | H-18034040_part2 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Steno Diabetes Center Copenhagen | ||||||||
Study Sponsor | Steno Diabetes Center Copenhagen | ||||||||
Collaborators |
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Investigators |
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PRS Account | Steno Diabetes Center Copenhagen | ||||||||
Verification Date | November 2020 |