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Stochastic Targeted Glycemic Control in the Intensive Care Unit Pilot Trials

Insulin and Nutrition Dosing Using a Stochastic Targeting Model-Based System for Improved Control of Blood Glucose Levels in Intensive Care Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001261909
Enrollment
30
Registered
2011-12-08
Start date
2011-01-11
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Critically ill patients often experience stress-induced hyperglycaemia (high blood sugar levels) and insulin resistance, resulting in increased infection, cardiac events and death. The Christchurch ICU currently controls glucose levels using a system called SPRINT, a paper-based protocol that has provided world leading control and reduced mortality 25-40% in patients who stay 3 days or longer in the ICU. It has also reduced costs by over $1000 per patient treated. However, SPRINT does not allow clinicians to make changes or provide more patient-specific care, when necessary. STAR is a system that uses an algorithm and computer model to provide equivalent or tighter control of glucose levels with greater clinical flexibility and less nursing effort through reduced need for measurements or/and intervention. It also improves safety from low glucose levels (hypoglycaemia) using a statistical model to provide a guaranteed risk of hypoglycemia of 0.1%. STAR pilot trials will be supervised by medical personnel and run for as long as a patient requires glycemic control during their ICU stay. Target glycemic levels will be chosen by the clinical staff. The algorithm will determine all insulin doses and enteral nutrition given to achieve that target with guaranteed safety from hypoglycemia.

Interventions

STAR is a system that uses an algorithm and computer model to provide equivalent or tighter control of glucose levels. Target glycemic levels will be chosen by the clinical staff dependent on patient characteristics, the most common target range is 4.4-8.0 mmol/L. The algorithm will determine all insulin doses and enteral nutrition given to achieve that target with safety from hypoglycemia. STAR clinical trials will run until 30 June 2012 and will occur whenever there is an eligible patient in t

STAR is a system that uses an algorithm and computer model to provide equivalent or tighter control of glucose levels. Target glycemic levels will be chosen by the clinical staff dependent on patient characteristics, the most common target range is 4.4-8.0 mmol/L. The algorithm will determine all insulin doses and enteral nutrition given to achieve that target with safety from hypoglycemia. STAR clinical trials will run until 30 June 2012 and will occur whenever there is an eligible patient in the ICU from whom consent has been obtained.

Sponsors

Dr Geoffrey M Shaw
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1 In-patient in Intensive Care. 2 Blood glucose >8 mmol/L, same as with SPRINT. 3 In-situ arterial line.

Exclusion criteria

1 Moribund or not expected to survive >72 hours 2 No arterial line present

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026