Diabetes Mellitus, Hyperglycemia
Conditions
Keywords
Diabetes Mellitus, Hospital Hyperglycemia
Brief summary
The objective of this study is to compare the therapeutic efficacy of three regimens of insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.
Detailed description
Patients will be randomly assigned to one of the three treatment regimens. Also, the use of oral antidiabetic drugs would be suspended during their stay at the hospital.
Interventions
DRUGOnce-daily Insulin
Patients will receive NPH insulin in a once-daily regimen. The starting dose is calculate according to body mass index (BMI): 0.3 U/kg for BMI \< 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the once-daily regimen will be administered subcutaneously before breakfast. Regular insulin subcutaneously wil be given in three equally divided doses before each meal.
DRUGTwice-daily Insulin
Patients receive NPH insulin in twice-daily regimen. The starting dose is calculated according to body mass index (BMI): 0.3 U/kg for BMI \< 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will de fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the twice-daily regimen will be administered subcutaneously before breakfast and before dinner. Regular insulin will be given in three equally divided doses before each meal.
DRUGTriple-daily Insulin
Patients receive NPH insulin in a triple-daily regimen. The starting dose was calculated according to body mass index (BMI): 0.3 U/kg for BMI \< 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the triple daily regimen will be administered subcutaneously before each meal. Regular insulin will be given in three equally divided doses before each meal.
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Admitted to medical services * Persistent blood glucose level \> 140 mg/dL * With an expected stay ≥ 48 hours
Exclusion criteria
* Subjects with type 1 diabetes mellitus * Parenteral nutrition * Glucose levels ≥ 400 mg/dL at screening * Diabetic ketoacidosis or non-ketosis hyperosmolar state * Clinically relevant hepatic disease * Glomerular filtration rate ≤ 30 ml/min * Pregnancy * Terminal disease * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | Within the time the patient stays at hospital (2 to 14 days) | The achievement of fasting glucose between 70-140 mg/dL and random glucose levels of \<180 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in the percentage of glucoses in the hypoglycemic range | Within the time the patient stays at hospital (2 to 14 days) | Hypoglycemia was defined as glucose levels of \< 70 mg/dL. Severe hypoglycemia was defined as glucose levels of \< 40 mg/dL or the need of assistance. |
| Total insulin dose required during follow up and at discharge to achieve glycemic control | Within the time the patient stays at hospital (2 to 14 days) | — |
| Differences in hospital stay days | Within the time the patient stays at hospital (2 to 14 days) | — |
Outcome results
None listed