The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients
Condition: Hyperglycemia; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that includes patient weight and glucocorticoid dose can be
      used to safely initiate insulin treatment in diabetic/hyperglycemic patients who are to be
      treated with pharmacological doses of glucocorticoids.
    

Detailed description: 
      The target fasting serum glucose (FSG) and pre-meal SG was 90-140 mg/dL, and the random SG
      was less than 180 mg/dL, taking into consideration the ADA/AACE target glucose levels in
      non-ICU patients (15).

      The Glargine/Lispro Protocol included 0.2 unit/kg/day as insulin glargine once daily if the
      dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80
      units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve
      patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its
      equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg
      per day.

      The prandial dose of lispro was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG
      was between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG is >200
      mg/dL. The prandial dose of lispro was decreased by 10% if the pre-lunch, pre-dinner, or
      bedtime SG is between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was
      less than 70 mg/dL.

      The Glargine/Lispro/NPH Protocol included 0.2 unit/kg/day as insulin glargine as per G/L;
      plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve
      patients. A "coverage" dose of 0.1 unit/kg/day of Neutral Protamine Hagedorn (NPH) for each
      10 mg of prednisone or its equivalent was given twice daily with the administration of the
      glucocorticoid. The maximum starting "coverage" dose was 0.4 units/kg per day.

      The NPH dose was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between
      141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was greater than 200
      mg/dL. The NPH dose was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG was
      between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70
      mg/dL.

      In both protocols glargine dose was increased by 10% if the fasting glucose value is 141-200
      mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10%
      if the FSG was 70-89 mg/dL and by 20% if the FSG was less than 70 mg/dL.

      If the patient had an outpatient regimen which includes a total daily dose of insulin (TDI)
      that exceeded 0.4 unit/kg/day, then the same TDI was continued with 50% given as glargine
      once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40
      or more than 80 units; and 50% given as lispro divided between three meals. The patient was
      still randomly assigned to either one of the two protocols as described previously.

      If the patient were on a TDI less than 0.4 unit/kg/day in addition to oral antidiabetic
      medications as an outpatient, then all the oral antidiabetic medications were discontinued
      and the patient was started on 0.5 unit/kg/day divided as 50% glargine given once daily if
      the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80
      units; and 50% lispro divided between three meals. The patient was randomly assigned to
      either one of the two protocols based upon even and odd hospital numbers.
    

Intervention name(s): Glargine insulin; Lispro insulin; NPH Insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In both protocols glargine dose was increased by 10% if the FSG value was 141-200 mg/dL and by 20% if the FSG value was more than 200 mg/dL, and decreased by 10% if the FSG was 70-89 mg/dL and by 20% if the FSG was less than 70 mg/dL.; In both protocols lispro insulin was given to cover meals. Additional lispro insulin was Lispro insulin was administered before meals to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro Insulin Arm.; NPH insulin was given once or twice a day to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro/NPH Insulin Arm
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glucocorticoids; hyperglycemia; diabetes mellitus