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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hyperglycaemic Crisis in Diabetes Mellitus, Diabetic Ketoacidosis, Hyperglycaemic Hyperosmolar Nonketotic Syndrome

Intervention / Treatment
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* Drug: Insulin Glargine 300 UNT/ML [Toujeo]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: basal insulin and insulin pump<br>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. | Drug: Insulin Glargine 300 UNT/ML [Toujeo]<br>* insulin glargine sc (0.25 U/kg body weight)<br>|
| No Intervention: insulin pump<br>Patients in the control group did not receive placebo injections. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rates of rebound hyperglycemia | the rates of hyperglycemia( serum glucose >300mg/dl) after ceasing insulin infusion | the next 12 hours after ceasing insulin infusion | 
| the rates of hypoglycemia | the rates of hypoglycemia( serum glucose <70mg/dl) during insulin infusion | the next 12 hours after ceasing insulin infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin infusion time | hours of the total insulin infusion therapeutic time | 'the next 12 hours' after ceasing insulin infusion | 
| ICU length of stay | days of ICU admission | through study completion, an average of 1 year | 
| ventilator use days | days of ventilator depending time(from intubation to extubation) | through study completion, an average of 1 year | 
| ICU Mortality rate | mortality rate during ICU admission | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperglycemic crisis, DKA, HHS, insulin pump, basal insulin, critical care