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

Completed

• Conditions: diabetes; 10018424

• Registration Number: NL-OMON36957
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

* aged 18 years or above
* diagnosed with Type 1 diabes mellitus at least 6 months according to the WHO definition
* Body Mass Index (BMI) <35 kg/m²
* HbA1c <10%

Exclusion Criteria

Pregnancy
use of medication which could influence glucometabolism
use of paracetamol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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