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Hidden sensor reveals dangerous blood sugar dips during routine eye surgery

NCT ID NCT07696910

Knowledge-focused Sponsor: Yonsei University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

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Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study uses a hidden continuous glucose monitor (CGM) to track blood sugar levels in people with diabetes during vitrectomy eye surgery. The monitor records glucose every 15 minutes but does not show readings to doctors or patients, so it does not affect care. The goal is to find out how often low blood sugar (hypoglycemia) occurs during and right after surgery, which standard fingerstick tests might miss. Results could help improve monitoring for future patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
masked continuous glucose monitor (FreeStyle Libre 2)
What this could lead to
If this study finds that hidden low blood sugar episodes are common during eye surgery, it could lead to better monitoring guidelines to protect patients with diabetes.
What could go wrong
This is a small, single-center observational study, so results may not apply to all hospitals or patients. The monitor is hidden and does not guide treatment, so it cannot prevent hypoglycemia during the study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 85 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults aged 19 years or older with diabetes mellitus scheduled for pars plana vitrectomy (TPPV) at a single tertiary center. Participants are enrolled sequentially after written informed consent, with no randomization or control group. A masked continuous glucose monitor (FreeStyle Libre 2®) is applied for observational purposes only and does not influence clinical care; all glycemic management follows the standard of care. The cohort reflects the institution's vitrectomy population with diabetes (estimated 40% of vitrectomy cases), enabling assessment of perioperative hypoglycemia incidence and glycemic variability.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged 19 years or older 2. Diagnosed with diabetes mellitus 3. Scheduled to undergo pars plana vitrectomy (TPPV) 4. Able to provide written informed consent Exclusion Criteria: 1. CGM sensor placement not feasible 2. Known allergy to the CGM sensor 3. Unable to obtain valid CGM data 4. Unable to provide voluntary informed consent

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Conditions

The condition(s) this trial relates to.

diabetes mellitus hypoglycemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus Hypoglycemia

How to take part

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  1. The official record

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