The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients (GIH)

Baylor College of Medicine

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia; Diabetes Mellitus

Treatments: Drug: Lispro insulin; Drug: Glargine insulin; Drug: NPH Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01810952

H-27172

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Glargine/Lispro Insulin Arm

Experimental group

Description:

Drug: Glargine insulin was administered per above. Drug: Lispro insulin 0.2 unit/kg/day was administered per above. 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. Drug: prednisone or equivalent dose was determined by severity of exacerbation and clinician's judgement.

Treatment:

Drug: Lispro insulin

Drug: Glargine insulin

Glargine/Lispro/NPH Insulin Arm

Experimental group

Description:

Drugs Glargine and Lispro insulin included similar starting doses of glargine and lispro. Drug: A "coverage" dose of NPH insulin 0.1 unit/kg/day for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. Maximum starting "coverage" dose was 0.4 units/kg per day. 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. It 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. Drug: the dose of prednisone or equivalent glucocorticoid was determined by severity of exacerbation and clinician's judgement.

Treatment:

Drug: NPH Insulin

Drug: Lispro insulin

Drug: Glargine insulin