Diabetes intravaginal ring
Conditions
Interventions
Sponsors
Ligalli BV
Eligibility
Age
18 Years to 64 Years
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this pilot study is to determine the efficacy of intravaginal device to measure glucose in vagina for up to 5 hours. Efficacy is measured by: * The ability to measure a repeatable stable signal in the vagina; * The correlation of glucose values measured with the glucose sensor at the vaginal wall with those found in blood both from finger stick glucose analysis and external CGM sensor will be made. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint of this pilot study is to determine the compatibility of the intra vaginal device with surrounding tissues in the course of continuous glucose measurement. Compatibility is measured by: * Qualitative assessment gynecologist; * Answers to questionnaires filled out by the subjects (information about comfort). | — |
Countries
The Netherlands
Outcome results
None listed