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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-01-31

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).

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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).

Conditions

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Hyperglycaemic Crisis in Diabetes Mellitus Diabetic Ketoacidosis Hyperglycaemic Hyperosmolar Nonketotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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basal insulin and insulin pump

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.

Group Type EXPERIMENTAL

Insulin Glargine 300 UNT/ML [Toujeo]

Intervention Type DRUG

insulin glargine sc (0.25 U/kg body weight)

insulin pump

Patients in the control group did not receive placebo injections.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Insulin Glargine 300 UNT/ML [Toujeo]

insulin glargine sc (0.25 U/kg body weight)

Intervention Type DRUG

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)