The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:2/9/2017
Start Date:September 2010
End Date:September 2013

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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.

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.

Inclusion Criteria:

- Admission for Chronic Obstructive Pulmonary Disease (COPD) exacerbation.

- Treatment with pharmacological doses of glucocorticoids (GCs) ≥10 mg of prednisone or
its equivalent if they are not on maintenance dose of GCs in the outpatient settings.

- Treatment with pharmacological doses of GCs ≥10 mg of prednisone or its equivalent
above their maintenance dose of GCs in the outpatient settings.

- Have either a previous diagnosis of diabetes mellitus which has been treated with
diet or medications, hemoglobin A1c ≥6.5%, or confirmed inpatient hyperglycemia
defined as a fasting laboratory glucose or finger stick reading ≥126 mg/dL or random
glucose reading ≥200 mg/dL on two or more determinations.

Exclusion Criteria:

Unwilling to sign informed consent.
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