A pilot study to investigate the functionality of a glucose sensor device in the human eye
Phase 2
Completed
- Conditions
- Diabetes type 1insulin-dependent diabetes mellitus10012653
- Registration Number
- NL-OMON46042
- Lead Sponsor
- Medische Hulpmiddelen Industrie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
• Subject is > 18 years old on the date he/she signed the informed consent;
• Diagnosed diabetes type 1;
• Insulin dependent;
• Wearing a CGM device;
• Signed informed consent.
Exclusion Criteria
• Subjects having any eye surgery in the past;
• Subjects having any historic disease of the eye (e.g. conjunctivitis, keratitis, dry eye, diabetic retinopthy with lasercoagulation);
• Subjects that wear contact lenses;
• 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 efficiency of a<br /><br>glucose monitor device to measure in the tear fluid of human eye for up to 5<br /><br>hours.<br /><br>Efficiency is measured by:<br /><br>• The ability to measure a repeatable stable signal in the eye;<br /><br>• The correlation of glucose values in the eye with those found in blood both<br /><br>from blood analysis and external CGM sensor.</p><br>
- Secondary Outcome Measures
Name Time Method