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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05155917
Enrollment
70
Registered
2021-12-14
Start date
2022-03-01
Completion date
2024-01-31
Last updated
2022-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Changhua Christian Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
the rates of rebound hyperglycemiathe next 12 hours after ceasing insulin infusionthe rates of hyperglycemia( serum glucose \>300mg/dl) after ceasing insulin infusion
the rates of hypoglycemiathe next 12 hours after ceasing insulin infusionthe rates of hypoglycemia( serum glucose \<70mg/dl) during insulin infusion

Secondary

MeasureTime frameDescription
insulin infusion time'the next 12 hours' after ceasing insulin infusionhours of the total insulin infusion therapeutic time
ICU length of staythrough study completion, an average of 1 yeardays of ICU admission
ventilator use daysthrough study completion, an average of 1 yeardays of ventilator depending time(from intubation to extubation)
ICU Mortality ratethrough study completion, an average of 1 yearmortality rate during ICU admission

Countries

Taiwan

Contacts

Primary ContactYU FU LEE, college
181318@cch.org.tw886-4-7238595

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026