Research on the usefulness of patch-type continuous blood glucose meters in ICU

JRCT ID: jRCTs042230176

Registered date:21/03/2024

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

Hypoglycemia
Hyperglycemia

• Date of first enrollment: 21/03/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): After entering the intensive care unit, a continuous blood glucose meter will be attached to the patient, and blood sugar levels will be continuously measured until the patient leaves the intensive care unit.

Outcome(s)

• Primary Outcome: Correlation between the blood glucose level obtained by the first central blood sampling after admission to the intensive care unit and the blood glucose level measured by a continuous blood glucose meter at the time of the first central blood sampling

Secondary Outcome

Correlation between the blood glucose level measured by the first central blood sampling after admission to the intensive care unit and the blood glucose level measured by a continuous blood glucose meter at the time of the first central blood sampling in diabetic patients
Correlation between the blood glucose level measured by the first central blood sampling after admission to the intensive care unit and the blood glucose level measured by a continuous blood glucose meter at the time of the first central blood sampling in non-diabetic patients
Correlation between the blood sugar level measured by the initial arterial blood gas test using ABL-800 and the blood sugar level measured by a continuous blood glucose meter at the same time (all cases, diabetic cases, non-diabetic cases)
Correlation between the blood glucose level at the initial arterial blood gas test by EPOC and the blood glucose level at the same time using a continuous blood glucose meter (all cases, diabetic cases, non-diabetic cases)
Correlation between the initial blood glucose level measured using a simple blood glucose meter using arterial blood and the blood glucose level measured at the same time using a continuous blood glucose meter (all cases, diabetic cases, non-diabetic cases)
Comparison of blood glucose levels obtained by arterial blood gas testing using ABL-800 (routine measurement every 4 hours) and blood glucose levels obtained using a continuous blood glucose meter at the same time
Comparison of blood glucose levels obtained by EPOC arterial blood gas tests (routine measurements every 4 hours) and blood glucose levels measured using a continuous blood glucose meter at the same time.
Percentage of blood glucose outside the acceptable range (70-180 mg/dL) in arterial blood gas tests using ABL-800 (routine measurements every 4 hours, until discharge from the intensive care unit) (compared with historical control)
Percentage of blood glucose outside the acceptable range (70-180 mg/dL) in arterial blood gas tests by EPOC (routine measurements every 4 hours, until discharge from the intensive care unit) (compared with historical control)
Comparison of the blood glucose level determined by an arterial blood gas test using ABL-800 after the start of continuous insulin administration and the blood glucose level determined by a continuous blood glucose meter at the same time.
Comparison of the blood glucose level determined by EPOC arterial blood gas test after starting continuous insulin administration and the blood glucose level determined by a continuous blood glucose meter at the same time.
Rate of blood glucose outside the acceptable range (70-180 mg/dL) in arterial blood gas tests using ABL-800 (until discharge from intensive care unit) after starting continuous insulin administration (compared with historical control)
- Rate of blood glucose outside the acceptable range (70-180 mg/dL) in arterial blood gas tests by EPOC (until discharge from intensive care unit) after starting continuous insulin administration (compared with historical control)
For all of the above, analysis using blood glucose levels using a simple blood glucose meter using arterial blood instead of a continuous blood glucose meter
Construction of a model that uses machine learning to predict blood sugar levels from central blood sampling and arterial blood gas tests using EPOC or ABL-800 using blood sugar levels measured by continuous blood glucose meters and various blood sugar-related items.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients admitted to the intensive care unit who are 18 years of age or older
Patients with an arterial line inserted
Patients who understand the research content and have obtained written consent from themselves or their families

Exclude criteria

Patients under 18 years old
Patients who do not have an arterial line inserted or have difficulty collecting blood from an arterial line
Patients using other implanted medical devices such as pacemakers
Patients who are judged to be unsuitable for participation in this study by the principal investigator or co-investigator

Related Information

• Primary Sponsor: Tamura Takahiro