Not Yet RecruitingPhase 4ACTRN12610000574044

Proof-of-Concept Study of Insulin Glargine as Basal Insulin Support for Recovering Critically Ill Patients

Proof-of-Concept Study of Insulin Glargine as Basal Insulin Support for patients with stress diabetes in the Intensive Care and the High Dependency Units and Validation of an Insulin Glargine Pharmacokinetics Model


Sponsor

Canterbury District Health Board/Christchurch Hospital

Enrollment

60 participants

Start Date

Aug 23, 2010

Study Type

Interventional

Conditions

Summary

Intravenous insulin is commonly used to maintain normoglycaemic in the Christchurch Hospital Intensive Care Unit (ICU). The current standard protocol, SPRINT, uses intravenous insulin injections every 1-2 hours and controls the blood glucose levels very effectively. However, once patients leave the ICU, the standard protocols in the general wards are to use subcutaneous insulin, often due to the lack of intravenous lines and nursing resource. Currently, the guidelines for switching patients from intravenous to subcutaneous insulin are unclear, resulting in inconsistent levels of care. Therefore ward patients do not continue to benefit from tight blood glucose control. There is a need for a system, which can maintain good blood glucose control outside of ICU that can follow patients from ICU to less acute wards, while keeping nursing effort to a minimum. This study will first validate the Glargine pharmacokinetics model developed by the investigator’s group and test the effectiveness of Glargine as basal insulin support in the ICU populations. These steps are necessary before expending glycaemic control to less acute wards.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study tests whether insulin glargine (a long-acting insulin) can safely replace intravenous insulin in critically ill patients who are recovering in the intensive care unit. It is for patients who have stable, low insulin needs and are being fed through a tube, with improving organ function.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Recovering critically ill patients who meets the study inclusion criteria will be given insulin glargine once a day. The dose will be determined by a titration algorithm. Blood samples will be taken f

Recovering critically ill patients who meets the study inclusion criteria will be given insulin glargine once a day. The dose will be determined by a titration algorithm. Blood samples will be taken for assays of plasma insulin and C-peptide 3 times a day for the first two days a patient is receiving glargine. The samples will be taken before glargine injection, 6 hours from time of injection, and 14 hours from time of injection. The patient will continue to receive glargine for blood glucose control unless the dose become less than 10U. When the patient begins to consume meals (as oppose to naso-gastric feed), blood samples will be taken 8 times a day for the first two days. These samples will be taken before glargine injection and breakfast, before lunch, before dinner, 30 mins from start of dinner, 1 hr from start of dinner, 1.5 hrs from start of dinner, 2 hrs from start of dinner, and 4 hrs from start of dinner. Photos will be taken of the meal before and after mealtime to determine nutrition intake.


Locations(1)

New Zealand

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ACTRN12610000574044