Sensor for Measuring the blood glucose level as input for the ARtificial pancreas: a sensor validation Trial.

Completed

Conditions: Diabetes type 1
10018424

Registration Number: NL-OMON49011

Lead Sponsor: Inreda Diabetic B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

* Diagnosed with diabetes mellitus type 1;
* Age between 18 and 75 years;
* Willing and able to sign informed consent.

Exclusion Criteria

* BMI > 35 kg/m2;
* Skin condition prohibiting needle insertion;
* Known or suspected problem related to enzyme based glucose sensor usage;
* Use of acetaminophen during the study period;
* Patients who go swimming or visit a sauna during the study period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main parameter to express glucose accuracy is the MARD value (mean absolute<br /><br>relative difference between self-monitoring of blood glucose (SMBG)<br /><br>measurements and Guardian Sensor 3 measurements). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary accuracy parameters are:<br /><br>* Overall percentage of measured glucose values that fall within ± 0.83 mmol/l<br /><br>of a SMBG measurement at a glucose level of < 5.55 mmol/l.<br /><br>* Overall percentage of measured glucose values that fall within 15% of a SMBG<br /><br>measurement at a glucose level of >5.55 mmol/l.<br /><br>* Overall percentage of measured glucose values that fall in zone A and B of<br /><br>the Clarke Error Grid.<br /><br>* PARD value of the Guardian Sensor 3 in combination with the Enlite Sensor.<br /><br><br /><br>AP-related outcome parameters are:<br /><br>* Life-time of the sensors;<br /><br>* Percentage of time that the sensors are available as input for the algorithm.<br /><br><br /><br>Other study parameters are demographic characteristics, weight, length, HbA1c<br /><br>and amount of administered insulin during usual diabetes treatment. </p><br>