A pilot study to investigate the functionality of a glucose sensor device in the human eye

A pilot study to investigate the functionality of a glucose sensor device in the human eye - NSGS

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46042

Enrollment

Registered

2017-11-27

Start date

2017-12-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes type 1 insulin-dependent diabetes mellitus

Interventions

diabetes

Glucose

sensor

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this pilot study is to determine the efficiency of a glucose monitor device to measure in the tear fluid of human eye for up to 5 hours. Efficiency is measured by: • The ability to measure a repeatable stable signal in the eye; • The correlation of glucose values in the eye with those found in blood both from blood analysis and external CGM sensor.	—

Secondary

Measure	Time frame
The secondary endpoint of this pilot study is to ensure that the functional prototype device has equally good tolerability with surrounded tissues in course of continues glucose measurement as it has been confirmed when dummy devices were trailed. Therefore, basic information about ease of positioning, removal, on the measurement or data quality and compatibility of the prototype device with surrounded tissues in course of continues glucose measurement will be evaluated. Additional tolerability of the glucose sensor. This is measured as follows: • Qualitative assessment of irritation by an ophthalmologist; • Comparison of the diameters of the capillary veins on conventional photographs taken before installation and after removal of the device (possible irritation would lead to dilatation of the veins); Answers to questionnaires filled out by the subjects (information about red eyes, itching, burning feeling etc.);	—

Measure

Time frame

The secondary endpoint of this pilot study is to ensure that the functional prototype device has equally good tolerability with surrounded tissues in course of continues glucose measurement as it has been confirmed when dummy devices were trailed. Therefore, basic information about ease of positioning, removal, on the measurement or data quality and compatibility of the prototype device with surrounded tissues in course of continues glucose measurement will be evaluated. Additional tolerability of the glucose sensor. This is measured as follows: • Qualitative assessment of irritation by an ophthalmologist; • Comparison of the diameters of the capillary veins on conventional photographs taken before installation and after removal of the device (possible irritation would lead to dilatation of the veins); Answers to questionnaires filled out by the subjects (information about red eyes, itching, burning feeling etc.);

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)