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Factors affecting insulin dose requirements for treatment of prednisolone induced hyperglycaemia.

Determination of clinical factors that influence insulin dose requirements during treatment of hyperglycaemia while taking prednisolone

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001211257
Enrollment
50
Registered
2018-07-19
Start date
2019-06-17
Completion date
2021-07-30
Last updated
2023-03-27

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

Conditions

None listed

Brief summary

Prednisolone is an oral glucocorticoid used in the acute treatment of many inflammatory diseases. Glucocorticoid excess leads to hyperglycaemia. There is wide variability in the degree of hyperglycaemia associated with oral prednisolone use. We aim to define how clinical features and different times of day are associated with insulin requirement in hyperglycaemic hospitalised patients taking prednisolone. We will recruit 50 consecutive participants who are admitted to general medical or medical sub-specialty inpatient teams at Flinders Medical Centre or Lyell McEwin Hospital who meet eligibility criteria. This is an open interventional study. Eligible, consenting participants will receive 24 hours of intravenous insulin infusion. Flash glucose monitoring will be used to measure hourly blood glucose concentration. Use of intravenous insulin infusion will follow Flinders Medical Centre infusion protocol. We expect to be able to characterise how clinical features and time periods throughout the day predict for insulin requirements in hyperglycaemic hospitalised patients taking prednisolone.

Interventions

Administration of short-acting neutral insulin (Atrapid) via insulin infusion for total duration of 24 hours in participants who have been prescribed prednisolone and are experiencing hyperglycaemia. Insulin infusion will comprise 50 units of Actrapid insulin pre-mixed with 50ml of normal saline. Starting rate of insulin infusion will be based on participant blood glucose level and based on the Flinders Medical Centre insulin infusion protocol. Insulin infusion will be commenced if hyperglycaemi

Administration of short-acting neutral insulin (Atrapid) via insulin infusion for total duration of 24 hours in participants who have been prescribed prednisolone and are experiencing hyperglycaemia. Insulin infusion will comprise 50 units of Actrapid insulin pre-mixed with 50ml of normal saline. Starting rate of insulin infusion will be based on participant blood glucose level and based on the Flinders Medical Centre insulin infusion protocol. Insulin infusion will be commenced if hyperglycaemia is identified following prednisolone administration. Hyperglycaemia is classified as one point-of-care capillary glucose level > 15 mmol/L or two point-of-care capillary glucose levels > 10 mmol/L.

Sponsors

Flinders Medical Centre
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

1. Age greater than or equal to 18 years 2. Prescribed a morning dose of oral prednisolone greater than or equal to 20 mg/day for an acute inflammatory illness. 3. Hyperglycaemia in the prior 24 hours, defined as: A) One point-of-care blood glucose greater than or equal to 15 mmol/L. B) Two point-of-care blood glucose greater than or equal to 10 mmol/L.

Exclusion criteria

1. Nil by mouth or reduced oral intake. 2. Type 1 diabetes mellitus (T1DM). 3. Prescribed long-term oral prednisolone greater than or equal to 10 mg/day (or equivalent). 4. Psychiatric illness or another condition precluding providing informed consent. 5. Pregnancy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026