NCT05155917

Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Changhua Christian Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hyperglycaemic Crisis in Diabetes Mellitus
• Diabetic Ketoacidosis
• Hyperglycaemic Hyperosmolar Nonketotic Syndrome

Interventions

Type	Name	Description
DRUG	Insulin Glargine 300 UNT/ML [Toujeo]	insulin glargine sc (0.25 U/kg body weight)

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2021-12-14
• Last updated: 2022-03-10

Locations

1 site across 1 country: Taiwan