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Glycaemia and cardiac rhythm disturbances in survivors of critical illness with pre-existing diabetes

Glycaemia and cardiac rhythm disturbances in survivors of critical illness with pre-existing diabetes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000099527
Enrollment
30
Registered
2015-02-04
Start date
2016-03-15
Completion date
2019-01-21
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To continuously evaluate glucose concentrations and electrocardiogram changes in patients with pre-existing diabetes who are discharged from the Intensive Care Unit (ICU), so as to evaluate whether a relationship exists between asymptomatic hypoglycaemia and cardiac arrhythmias in this cohort.

Interventions

Thirty patients with diabetes diagnosed previously or on this admission (HbA1c > 6.5%) who were admitted to ICU with at least 24 h of organ failure and require either insulin or sulponylureas following discharge from ICU and who are anticipated to remain an inpatient for at least 48 h after ICU discharge will be eligible. All patients enrolled into the study must be able to provide informed consent. All patients will have simultaneous 12-lead Holter and continuous interstitial glucose (IG) moni

Thirty patients with diabetes diagnosed previously or on this admission (HbA1c > 6.5%) who were admitted to ICU with at least 24 h of organ failure and require either insulin or sulponylureas following discharge from ICU and who are anticipated to remain an inpatient for at least 48 h after ICU discharge will be eligible. All patients enrolled into the study must be able to provide informed consent. All patients will have simultaneous 12-lead Holter and continuous interstitial glucose (IG) monitoring (CGM) from enrolment until discharge or for a maximum of 5 days. There will be no change in treatment instituted, e.g. patients will carry on with their usual activities and diabetes treatments. Twelve-lead ambulatory ECGs (Lifecard 12; Spacelabs Healthcare, Hertford, U.K.) will be recorded at a sampling rate of 128 Hz with electrodes in a Mason-Likar configuration. Patients will also have a time-synchronized CGM attached (FreeStyle Navigator Continuous Glucose Monitoring System; Abbott Diabetes Care, Maidenhead, U.K.). Calibrations will ideally be performed daily (but no less frequent than 48 hourly) according to the manufacturer’s instructions. Studies will occur in ‘blinded mode’ which means that alarms do not sound and patients and health care practitioners cannot view CGM glucose values. Patients/health care practitioners will be also asked to keep a record of any symptomatic hypoglycaemia. An episode of IG < 3.5 mmol/L on CGM without simultaneous self-report of symptoms is regarded as asymptomatic.

Sponsors

Assoc Prof Adam Deane
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

Patients: diabetic patients admitted to the ICU with at least 24 hours of organ failure and require either insulin or sulphonyureas. Included patients must all be anticipated to remain an inpatient for at least 48 hours. All enrolled patients must provide informed consent.

Exclusion criteria

Palliative care Permanent atrial fibrillation Pacemaker in situ Post-cardiac surgery (within previous 6 months) Acute myocardial infarction (within previous 6 months) On drugs which prolong QT interval

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026