The safety and efficacy of basal insulin during intravenous insulin infusion for hyperglycemic crisis patients under critical care is still unknown. We assumed that concurrent basal insulin subcutaneous injection and intravenous insulin infusion for critically ill DKA and HHS patients would shorten the time of hyperglycemic crisis correction and achieved better glycemic control(decrease hypoglycemia and rebound hyperglycemia).
Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are hyperglycemic crises sharing similar clinical features including hyperglycemia, dehydration and electrolytes abnormalities. Hyperglycemia results from relative deficient circulating insulin and oversecretion of glucagon, catecholamines, cortisol, and growth hormone. Glycosuria induced osmotic diuresis leads to dehydration and electrolyte abnormalities. Diabetic ketoacidosis is also characterized by increased gluconeogenesis, lipolysis, ketogenesis, and decreased glycolysis.\[1\] In critically ill and mentally obtunded patients with DKA or hyperosmolar hyperglycemia, continuous intravenous insulin is the standard of care.\[2\] Administration of subcutaneous insulin glargine during intravenous insulin infusion shortened the time of DKA correction and significantly decreased hyperglycemia after discontinuation of the intravenous insulin. \[3, 4\]The differences in rebound hyperglycemia rates were highly significant for at least 12 hours after transition to subcutaneous insulin regimens in the DKA and non-DKA patients as well as in organ transplant patients receiving steroids. \[4\] However, the previous studies only enrolled small numbers of patients(without Asian population) and excluded newly diagnosed hyperglycemia or critical illness and pregnant women. The safety and efficacy of basal insulin during intravenous insulin infusion for hyperglycemic crisis patients under critical care is still unknown. The investigators assumed that concurrent basal insulin subcutaneous injection and intravenous insulin infusion for critically ill DKA and HHS patients would shorten the time of hyperglycemic crisis correction and achieved better glycemic control(decrease hypoglycemia and rebound hyperglycemia).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
insulin glargine sc (0.25 U/kg body weight)
Changhua Christian Hospital
Changhua, Taiwan
RECRUITINGthe rates of rebound hyperglycemia
the rates of hyperglycemia( serum glucose \>300mg/dl) after ceasing insulin infusion
Time frame: "the next 12 hours" after ceasing insulin infusion
the rates of hypoglycemia
the rates of hypoglycemia( serum glucose \<70mg/dl) during insulin infusion
Time frame: "the next 12 hours" after ceasing insulin infusion
insulin infusion time
hours of the total insulin infusion therapeutic time
Time frame: 'the next 12 hours' after ceasing insulin infusion
ICU length of stay
days of ICU admission
Time frame: through study completion, an average of 1 year
ventilator use days
days of ventilator depending time(from intubation to extubation)
Time frame: through study completion, an average of 1 year
ICU Mortality rate
mortality rate during ICU admission
Time frame: through study completion, an average of 1 year
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