None listed
Conditions
Brief summary
An open label, cluster randomised controlled trial to determine the comparative efficacy of 2 different insulin regimens for management for dexamethasone induced hyperglycaemia amongst diabetes patients with COVID-19. Patients with COVID-19, with hyperglycaemia when treated with dexamethasone will be eligible. The 2 regimens being compared are morning isophane insulin combined with standard basal bolus insulin therapy versus basal bolus insulin therapy alone. The hypothesis is that the addition of morning isophane insulin will result in superior glucose control, compared to basal bolus insulin therapy alone. The primary outcome is the mean of pre and post meal glucose levels following commencement of the protocol.
Interventions
Regimen of morning subcutaneous administration of Isophane insulin with basal bolus insulin (BBI). Isophane will be added to a BBI regimen at 20% of the calculated total daily dose (TDD) if the highest blood glucose (BG) is 12-16 mmol/L or 30% of TDD if highest BG is >16 mmol/L. The TDD will be determined on the basis of pre-existing insulin therapy. Participants not on pre-existing insulin (BBI or premixed) will receive BBI at a TDD of 0.5 units/kg or 0.3 units/kg if BG 12-16 mmol/L, age greate
Regimen of morning subcutaneous administration of Isophane insulin with basal bolus insulin (BBI). Isophane will be added to a BBI regimen at 20% of the calculated total daily dose (TDD) if the highest blood glucose (BG) is 12-16 mmol/L or 30% of TDD if highest BG is >16 mmol/L. The TDD will be determined on the basis of pre-existing insulin therapy. Participants not on pre-existing insulin (BBI or premixed) will receive BBI at a TDD of 0.5 units/kg or 0.3 units/kg if BG 12-16 mmol/L, age greater than or equal to 70, or chronic kidney disease stage 3. The intervention will commence from the time of recognition of hyperglycaemia following commencement of dexamethasone therapy, until one of the following occurs: cessation of dexamethasone, change to a different diabetes medication regimen (based on clinical decision), discharge from hospital, transfer to the intensive care unit, decision for palliation. Insulin administration will be recorded for the purpose of monitoring adherence to the protocol and insulin usage as a result of the protocol.
Sponsors
Prof NW Cheung
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1) have a confirmed diagnosis of COVID-19 2) are in a non-ICU ward, and are not imminently to be admitted to ICU or discharged 3) have known diabetes or newly diagnosed diabetes (diagnosed on an HbA1c >=6.5 mmol/L) 4) have had at least one fingerprick glucose level >=12 mmol/L since the commencement of dexamethasone.
Exclusion criteria
1) pregnant 2) type 1 diabetes 3) eGFR <30
Outcome results
None listed