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

March 8, 2022 updated by: Changhua Christian Hospital

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Changhua city, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rates of rebound hyperglycemia
Time Frame: "the next 12 hours" after ceasing insulin infusion
the rates of hyperglycemia( serum glucose >300mg/dl) after ceasing insulin infusion
"the next 12 hours" after ceasing insulin infusion
the rates of hypoglycemia
Time Frame: "the next 12 hours" after ceasing insulin infusion
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
Time Frame: 'the next 12 hours' after ceasing insulin infusion
hours of the total insulin infusion therapeutic time
'the next 12 hours' after ceasing insulin infusion
ICU length of stay
Time Frame: through study completion, an average of 1 year
days of ICU admission
through study completion, an average of 1 year
ventilator use days
Time Frame: through study completion, an average of 1 year
days of ventilator depending time(from intubation to extubation)
through study completion, an average of 1 year
ICU Mortality rate
Time Frame: through study completion, an average of 1 year
mortality rate during ICU admission
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Ketoacidosis

Clinical Trials on Insulin Glargine 300 UNT/ML [Toujeo]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe