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

Phase 2

• Conditions: Hyperglycaemic Crisis in Diabetes Mellitus; Diabetic Ketoacidosis; Hyperglycaemic Hyperosmolar Nonketotic Syndrome
• Interventions: Drug: Insulin Glargine 300 UNT/ML [Toujeo]

• Registration Number: NCT05155917
• Lead Sponsor: Changhua Christian Hospital

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).

Study Timeline

• Study First Submitted: 2021-07-27
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-14
• Study Start: 2022-03-01
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-10
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
basal insulin and insulin pump	Insulin Glargine 300 UNT/ML [Toujeo]	Subjects in the intervention group received insulin glargine sc (0.25 U/kg body weight) within 6 h of initiation of iv insulin infusion, as close to initiation of iv insulin as possible.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Changhua city, Taiwan