Skip to content

Treatment of steroid-induced diabetes in hospitalized patients

Randomized-controlled study of isophane and aspart insulin versus glargine and aspart insulin to treat prednisolone-induced hyperglycaemia in hospitalized patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000817842
Enrollment
50
Registered
2012-08-03
Start date
2012-08-09
Completion date
2016-07-15
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

The aim is to determine whether an insulin regimen specific for prednisolone-induced hyperglycaemia is safer and more efficacious than basal bolus insulin, the current regimen commonly used in many hospitals. As we have previously showm that prednisolone predominantly increases blood glucose between midday and midnight, we hypothesize that delivering the majority of insulin during this time period and less insulin between midnight and breakfast will reduce nocturnal hypoglycaemia and better treat postprandial hyperglycaemia.

Interventions

Update Isophane insulin once daily and aspart insulin 3 times a day administered subcutaneously for up to 7 days. Subjects not treated with insulin prior to enrolment will initially receive a total daily insulin dose of 0.5 U/kg. Subjects receiving insulin prior to enrolment in the study will receive 130% of their current daily dose of insulin or 0.5 U/kg/day (whichever is greater). Insulin isophane will comprise 50% of the total daily dose and insulin aspart 50% of total daily dose with 20% of

Update Isophane insulin once daily and aspart insulin 3 times a day administered subcutaneously for up to 7 days. Subjects not treated with insulin prior to enrolment will initially receive a total daily insulin dose of 0.5 U/kg. Subjects receiving insulin prior to enrolment in the study will receive 130% of their current daily dose of insulin or 0.5 U/kg/day (whichever is greater). Insulin isophane will comprise 50% of the total daily dose and insulin aspart 50% of total daily dose with 20% of this dose administered before breakfast, 40% at lunch and 40% at dinner. Insulin dose adjustment will be carried out once daily by the study team using a designated protocol based on finger prick BGLs. Appropriate insulin doses will be increased by 2 units if BGL 10-15 mmol/L, 4 units if BGL 15-20 mmol/L and 6 units if >20 mmol/L. Insulin dose will be reduced by 2 units if the BGL is 2.8-4 mmol/L and 4 units if the BGL is <2.8 mmol/L or there is symptomatic hypoglycaemia. If there is severe hypoglycaemia the study team may either reduce the insulin dose by 50% or cease insulin. Isophane doses will be adjusted if fasting glucose is not within the target range (4-10 mmol/L). If individual blood glucose concentrations before lunch, dinner or at 21.00 are outside target, then the insulin aspart dose before the previous meal will be adjusted.

Sponsors

Dr Morton Burt
Lead SponsorIndividual

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 100 Years
Healthy volunteers
No

Inclusion criteria

1. Prednisolone >20 mg/day for acute treatment of an inflammatory or autoimmune disease 2. Hyperglycaemia requiring institution of insulin therapy or higher insulin doses - one finger prick BGL >15 mmol/L - two finger prick BGLs >10 mmol/L within 24 hours 3. Expected to stay in hospital > 48 hours

Exclusion criteria

1. Type 1 diabetes mellitus 2. Patients with an acute psychiatric illness 3. Patients unable to consent 4. Patients on existing oral corticosteroids > 5mg prednisolone/day or equivalent 5. Prolonged fasting 6. Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026