Standardized procedure for the assessment of new-to-market continuous glucose monitoring systems.

Conditions: diabetes
10018424

Registration Number: NL-OMON36537

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 4

Inclusion Criteria

aged 18 years or above
diagnosed with Type 1 diabetes mellitus 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

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
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.
Patient is actively enrolled in another clinical trial or took part in a study within 30 days

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters will include blood glucose values, sensor glucose values<br /><br>and duration of sensor life. From the sensor glucose values the Mean and Median<br /><br>Absolute Relative Difference (MARD) compared to blood glucose values will be<br /><br>determined. Blood glucose values will consist of YSI values during the CRC<br /><br>period and fingerstick values thereafter. A separate analysis will be performed<br /><br>on the accuracy of the sensor in the hypoglycaemic (defined as a blood glucose<br /><br>value 3.9 mmol/L) and hyperglycaemic area (defined as a blood glucose value<br /><br>10.0 mmol/L). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A separate analysis will be performed to assess sensor performance and accuracy<br /><br>per day of sensor life, before and after approved time of use. </p><br>