Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
NCT Number: NCT00338104
The primary objective of this study is to determine the optimal dose of glargine insulin when converting from intravenous short-acting continuous insulin infusions in surgical and intensive care unit patients using a prospective, controlled, parallel group, randomized study design.
Note: Lantus insulin is the proprietary name for glargine insulin.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Chicago, Illinois, 60611, United States
Critical illness causes an impairment of insulin secretion and insulin action, resulting in hyperglycemia even in normal individuals and a worsening of the hyperglycemia in patients with diabetes. Normalization of elevated glucose levels by intensive insulin infusion therapy in these critically ill patients has been proven to dramatically improve in-hospital mortality rates. After glucose levels have been controlled with insulin infusions, the best way to convert them to subcutaneous insulin regimens has not been demonstrated conclusively but the insulin regimen best suited is a combination of a basal insulin such as glargine (Lantus) insulin with premeal insulin boluses using a short-acting insulin such as Lispro or Aspart.
Subjects will be randomized into three groups, 25 subjects in each group, the groups differing according to the starting dose of glargine insulin as follows:
The glargine insulin will then be continued as the basal insulin, adjusting doses every 24 hours based on the fasting blood glucose level. In addition, patients will receive Lispro or Aspart insulin as prandial bolus insulins with the goals premeal being 80 - 120 mg/dl, including bedtime. Glucose measurements will be obtained every 1- 4 hours while patients are on their insulin infusions, depending upon the stability of their condition and the stability of their glucose levels. Following transfer to glargine insulin, they will have glucose measured at least four times per day, premeal and bedtime as per standard protocol in the hospital for patients receiving insulin. Glucose data will be obtained from such patients and this will be compared among the various glargine regimens.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Insulin glargine given at 40% of prior stable drip rate.
Other names: Lantus is brand name for Glargine
Time frame: First 24 hours after conversion
Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL
Time frame: First 24 hours after conversion
Percentage of blood glucose values < 50 mg/dL
Time frame: First 24 hours after conversion
Percentage of blood glucose levels > 180 mg/dL
Northwestern University
Other
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