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.

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. - FACT-CGM study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42920

Enrollment

Registered

2016-07-04

Start date

2016-07-18

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

diabetes Diabetes type 1

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Mean absolute (relative) difference (MAD/ MARD) of the Dexcom G5 system is calculated and compared using regular venous (YSI) and arterialized-venous (YSI) reference glucose samples.	—

Secondary

Measure	Time frame
Exploratory: Mean absolute (relative) difference (MAD/ MARD) of the Dexcom G5 system is calculated and compared using regular venous (YSI), arterialized-venous (YSI) and capillary (Contour XT) reference glucose samples. Exploratory: difference in mean glucose concentration of regular venous (Contour XT) arterialized-venous (Contour XT) and capillary (Contour XT) reference glucose samples. A separate analysis will be performed on the accuracy of the sensor and difference in glucose concentration in the hypoglycemic (defined as a blood glucose value 3.9 mmol/L) and hyperglycemic area (defined as a blood glucose value 10.0 mmol/L) for all comparisons. Additionally, a separate analysis will be performed to assess sensor performance and accuracy per day of sensor life. Data on the percentage of points in the clinically accurate A and B zone of the Clarke error grid will be analyzed. In addition, the percentage of paired sensor values within 20% of the YSI reference values at glucose concentrations *5.6 mmol/L (100 mg/dL) or within ±0.83 mmol/L (15 mg/dL) for YSI glucose concentrations	—

Measure

Time frame

Exploratory: Mean absolute (relative) difference (MAD/ MARD) of the Dexcom G5 system is calculated and compared using regular venous (YSI), arterialized-venous (YSI) and capillary (Contour XT) reference glucose samples. Exploratory: difference in mean glucose concentration of regular venous (Contour XT) arterialized-venous (Contour XT) and capillary (Contour XT) reference glucose samples. A separate analysis will be performed on the accuracy of the sensor and difference in glucose concentration in the hypoglycemic (defined as a blood glucose value *3.9 mmol/L) and hyperglycemic area (defined as a blood glucose value *10.0 mmol/L) for all comparisons. Additionally, a separate analysis will be performed to assess sensor performance and accuracy per day of sensor life. Data on the percentage of points in the clinically accurate A and B zone of the Clarke error grid will be analyzed. In addition, the percentage of paired sensor values within 20% of the YSI reference values at glucose concentrations *5.6 mmol/L (100 mg/dL) or within ±0.83 mmol/L (15 mg/dL) for YSI glucose concentrations

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Countries

Netherlands

Outcome results