NL-OMON47792
Completed
Phase 2
A pilot study to investigate the functionality of intra-vaginal glucose sensor in vagina.<br> - Pilot Study intra-vaginal LiGalli ring * glucose sensor device
igalli BV0 sites5 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- igalli BV
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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