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Clinical Trials/NL-OMON46042
NL-OMON46042
Completed
Phase 2

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

Medische Hulpmiddelen Industrie0 sites6 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Diabetes type 1
Sponsor
Medische Hulpmiddelen Industrie
Enrollment
6
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
Medische Hulpmiddelen Industrie

Eligibility 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

  • 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).

Outcomes

Primary Outcomes

Not specified

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