Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01523665

Enrollment

508

Registered

2012-02-01

Start date

2011-10-31

Completion date

2013-07-31

Last updated

2013-11-27

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

Conditions

Intensive Care Patients

Brief summary

Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Several barriers to the implementation of glycemic control have been identified. Most importantly, there is concern about increased frequency of severe hypoglycemic episodes. To overcome these problems Space GlucoseControl was developed as a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l). The objective of this non-interventional study is to gain additional information on the performance of the Space GlucoseControl system for glycaemic control in ICU patients when used in routine clinical practice.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Inclusion: * Intensive care patients who require blood glucose control by intravenous application of insulin Exclusion: * All contraindication of intravenous insulin therapy

Design outcomes

Primary

Measure	Time frame
Blood glucose values: Percentage of time within the chosen glucose target range of 4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l	From start of treatment to the last glucose measurement under treatment, typically up to 14 days.

Secondary

Measure	Time frame
Frequency of hypoglycaemic episodes	From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Adherence to the advice of the Space GlucoseControl system	From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Blood glucose measurement interval	From start of treatment to the last glucose measurement under treatment, typically up to 14 days.

Countries

Czechia, Denmark, Estonia, Germany, Italy, Poland, Spain, Sweden, United Kingdom

Outcome results