A pilot study to investigate the functionality of intra-vaginal glucose sensor in vagina.<br>

Phase 2

Completed

Conditions: Diabetes
intravaginal ring
10012653

Registration Number: NL-OMON47792

Lead Sponsor: igalli BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

* Subject is > 18 years old on the date she signed the informed consent;
* Subject is taking oral contraceptive birth control (excluding vaginal contraceptive devices) and not menstruating;
* Diagnosed diabetes type 1;
* Wearing a CGM sensor;
* Signed informed consent.

Exclusion Criteria

* Subjects having any historic vaginal disease;
* Pregnant subjects;
* Subjects having their menstrual cycles;
* Not able or willing to comply to the protocol;
* Subjects with signs/ symptoms of any additional disease except diabetes (medical judgement and/or medication history).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this pilot study is to determine the efficacy of<br /><br>intravaginal device to measure glucose in vagina for up to 5 hours.<br /><br>Efficacy is measured by:<br /><br>* The ability to measure a repeatable stable signal in the vagina;<br /><br>* The correlation of glucose values measured with the glucose sensor at the<br /><br>vaginal wall with those found in blood both from finger stick glucose analysis<br /><br>and external CGM sensor will be made.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint of this pilot study is to determine the compatibility of<br /><br>the intra vaginal device with surrounding tissues in the course of continuous<br /><br>glucose measurement.<br /><br>Compatibility is measured by:<br /><br>* Qualitative assessment gynecologist;<br /><br>* Answers to questionnaires filled out by the subjects (information about<br /><br>comfort).</p><br>