Continuous Glucose Monitoring by subcutaneous measurement compared to frequent point of care measurement by Accu Chek in critically ill patients; a randomized controlled trial (RESCUEII).

Continuous Glucose Monitoring by subcutaneous measurement compared to frequent point of care measurement by Accu Chek in critically ill patients; a randomized controlled trial (RESCUEII). - RESCUE II

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34507

Enrollment

178

Registered

2010-11-25

Start date

2010-12-18

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

diabetes mellitus sugar disease

Interventions

The continuous glucose measurement (CGM) device (Freestyle navigator) will be inserted in both study groups. We will only use the results of the intervention group. The results of the control group

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -ICU patients of 18 years and older -Expected length of stay longer than 24 hours -Indication for glucose regulation with insuline. (see appendix study protocol) - Availability of the Freestyle Nagivator

Exclusion criteria

Exclusion criteria: Participation in another WMO study - No informed consent - Contra indication for the use of the AccuChek: (peritoneal dialysis, Hematocrit 0,65 , paracetamol intoxication) - Abdominal abnormalities that inhibit sensor insertion - Participation of the same study in an earlier ICU admittance.

Design outcomes

Primary

Measure	Time frame
- Number of severe hypoglycemia and severe hyperglycemia Definitions: - Hypoglycemia: glucose level 25 mmol/l	—

Secondary

Measure	Time frame
- Amount of time in which the patient blood glucose levels are in the blood glucose target range ( measured with the Freestyle Navigator) - Amount of time in which the patient blood glucose levels are above or beneath the blood glucose target range. ( measured with the Freestyle Navigator) - Variability of the glucose regulation measured with the blood gas analyser. (use of arterial bloodsamples) Expressed as mean Absolute Glucose change per hour (MAG). - Length of stay on the ICU - Mortality - False positive alarms of the Freestyle Navigator - Number of unwanted low glucose every 24 hours ( glucose between 2.5 - 5.0 mmol) - Number of not detected hypoglycemia by the AccuChek. ( measured with the Freestyle Navigator) - Number of obtained bloodsamples per day per patient	—

Measure

Time frame

- Amount of time in which the patient blood glucose levels are in the blood glucose target range ( measured with the Freestyle Navigator) - Amount of time in which the patient blood glucose levels are above or beneath the blood glucose target range. ( measured with the Freestyle Navigator) - Variability of the glucose regulation measured with the blood gas analyser. (use of arterial bloodsamples) Expressed as mean Absolute Glucose change per hour (MAG). - Length of stay on the ICU - Mortality - False positive alarms of the Freestyle Navigator - Number of unwanted low glucose every 24 hours ( glucose between 2.5 - 5.0 mmol) - Number of not detected hypoglycemia by the AccuChek. ( measured with the Freestyle Navigator) - Number of obtained bloodsamples per day per patient

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)