Hypoglycemia (Diabetic)Hypo-Heart-1NCT04011683
Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes
An observational study of Hypoglycemia (Diabetic) and Hyperglycaemia (Diabetic), run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoglycemia (Diabetic), Hyperglycaemia (Diabetic), Arrythmia, Cardiac
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2018to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 1 Diabetes recrutted in collaboration with Hillerod hospital, Gentofte hospital and Steno Diabetes Centre.
Who may be able to join
- 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)
Show all 17Show fewer
- 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)
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Hypoglycemia (Diabetic), Hyperglycaemia (Diabetic), Arrythmia, Cardiac, Type 1 Diabetes, Blood Glucose Fluctuations
- Medical subject headings
- Hypoglycemia, Hyperglycemia, Arrhythmias, Cardiac, Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months
Secondary outcomes (9)
Prevalence of cardiac arrhythmias
Prevalence of clinically relevant arrhythmias
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Within 12 months
Hypoglycaemia and cardiac arrhythmia
The correlation between prevalence and total duration of hypoglycaemia and risk of clinically relevant arrhythmias
Measured: 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
Measured: 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
Measured: 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
Measured: Within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Dec 2018
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoglycemia (Diabetic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University Hospital, Gentofte, Copenhagen, Hillerod Hospital, Denmark
- Responsible party
- Sponsor
- Investigators
- Tina Vilsbøll, MD, Professor, Study director, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011683
- Sponsor's protocol ID
- H-18034040_part2
- Acronym
- Hypo-Heart-1
- Status last verified
- Jan 2022
- First submitted
- 17 Jun 2019
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04011683
- Acronym / sponsor ID
- Hypo-Heart-1 / H-18034040_part2
- Conditions
- Hypoglycemia (Diabetic), Hyperglycaemia (Diabetic), Arrythmia, Cardiac, Type 1 Diabetes, Blood Glucose Fluctuations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen, University Hospital, Gentofte, Copenhagen, Hillerod Hospital, Denmark
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 1 Diabetes recrutted in collaboration with Hillerod hospital, Gentofte hospital and Steno Diabetes Centre.
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Prevalence of cardiac arrhythmias
Time frame: Within 12 months
Cardiac arrhythmias during LGV, HGV.
Time frame: Within 12 months
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 pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
Time frame: Within 12 months
The relationship between diabetes complication status at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
Time frame: Within 12 months
Hypoglycaemia and cardiac arrhythmia
Time frame: Within 12 months
Plasma glucose variation and cardiac arrhythmias
Time frame: Within 12 months
CV, SD, ADRR, LBGI, HBGI, CONGA-1 and cardiac arrhythmias
Time frame: Within 12 months
Mean amplitude of glycaemic excursions (MAGE) and cardiac arrhythmia.
Time frame: Within 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Hypoglycemia (Diabetic)
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Not yet recruiting
Comparing Glycemic Outcomes of Carbohydrate Counting vs. Fixed Mealtime Insulin Dosing in Hospitalized Patients With Hyperglycemia
Diabetes Type 2 on Insulin, Hypoglycemia (Diabetic)
Enrolling by invitationEarly Phase 1
An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002) for the Treatment of Diabetic Patients With Hypoglycemia Unawareness or Severe Hypoglycemic Events
T1DM - Type 1 Diabetes Mellitus, Pancreatogenic Diabetes Mellitus
Not yet recruiting
The BRIGHT Study (Device Name: HALO System)
Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Vilsbøll, MD, Professor study director
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia (Diabetic) and Hyperglycaemia (Diabetic), run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiac arrhythmias during hypoglycaemia, euglycaemia, hyperglycaemia. (time frame: Within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.