CompletedPhase 4ACTRN12612000817842

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


Sponsor

Dr Morton Burt

Enrollment

50 participants

Start Date

Aug 9, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 100 Yearss

Inclusion Criteria5

  • Prednisolone >20 mg/day for acute treatment of an inflammatory or autoimmune disease
  • 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
  • Expected to stay in hospital > 48 hours

Exclusion Criteria6

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

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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

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.


Locations(1)

SA, Australia

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ACTRN12612000817842