Factors in Accuracy Studies Influencing Measured Continuous Glucose Monitoring system (CGM) Performance: a comparison of measured continuous glucose monitor performance using venous, arterialized-venous and capillary reference glucose samples.

Completed

• Conditions: diabetes; Diabetes type 1; 10018424

• Registration Number: NL-OMON42920
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

* aged 18 years or above
* diagnosed with type 1 DM at least 6 months according to the WHO definition
* Body Mass Index (BMI) <35 kg/m²
* willing and able to wear a CGM device for the duration of the study and undergo all study procedures
* HbA1c <10%
* signed informed consent form prior to study entry

Exclusion Criteria

* patient is pregnant, or breast feeding during the period of the study.
* patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration.
* patient requires regular use of acetaminophen (paracetamol) while participating in the study due to known negative impact on CGM performance.
* patient is actively enrolled in another clinical trial or took part in a study within 30 days.
* known adrenal gland problem, panhypopitutarism, gastroparesis, migraine, epilepsy or ischemic heart disease or other cardiovascular event in the year previous to study participation .
* inability of the patient to comply with all study procedures.
* inability of the patient to understand the patient information.
* patient donated blood in the last 3 months.
* has severe medical or psychological condition(s) or chronic conditions/ infections that in the opinion of the investigator would compromise the patient*s safety or successful participation in the study.
* is assessed by the investigators to have difficult intravenous (IV) access.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean absolute (relative) difference (MAD/ MARD) of the Dexcom G5 system is<br /><br>calculated and compared using regular venous (YSI) and arterialized-venous<br /><br>(YSI) reference glucose samples.</p><br>