Diabetic Ketoacidosis, Hyperglycaemic Crisis in Diabetes Mellitus, Hyperglycaemic Hyperosmolar Nonketotic Syndrome
Conditions
Keywords
hyperglycemic crisis, DKA, HHS, insulin pump, basal insulin, critical care
Brief summary
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).
Detailed description
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).
Interventions
insulin glargine sc (0.25 U/kg body weight)
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with hyperglycemic crisis(DKA, HHS or mixing type) receiving iv insulin infusion * Patients admitted to the Changhua Christian Hospital Medical Intensive Care Unit(MICU)
Exclusion criteria
* pregnancy * age under 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rates of rebound hyperglycemia | the next 12 hours after ceasing insulin infusion | the rates of hyperglycemia( serum glucose \>300mg/dl) after ceasing insulin infusion |
| the rates of hypoglycemia | the next 12 hours after ceasing insulin infusion | the rates of hypoglycemia( serum glucose \<70mg/dl) during insulin infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insulin infusion time | 'the next 12 hours' after ceasing insulin infusion | hours of the total insulin infusion therapeutic time |
| ICU length of stay | through study completion, an average of 1 year | days of ICU admission |
| ventilator use days | through study completion, an average of 1 year | days of ventilator depending time(from intubation to extubation) |
| ICU Mortality rate | through study completion, an average of 1 year | mortality rate during ICU admission |
Countries
Taiwan