Ear gadget could spot dangerous sugar drops after gastric bypass

NCT ID NCT07082478

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Stopped early
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Cancelled before anyone took part.

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small pilot study aims to see if a new in-ear wearable device can comfortably and reliably measure blood flow changes in the head. Researchers will compare people who have low blood sugar after bariatric surgery to those who don't. The goal is to learn if this device can help detect or understand hypoglycemia better. Only 5 participants are needed for this first phase.

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 5 people

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

Started

Jul 2025

Expected to finish

Sep 2026

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

healthy individuals without hypoglycemia or upper gastrointestinal surgery

Ages

18 to 70 years

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: * Age 18-70 years of age, inclusive at screening. * Individuals able to provide informed consent and follow all study procedures, including complete daily food, activity, and symptom diaries, and willingness to provide access to medical record review. * For healthy control group: individuals without a history of upper gastrointestinal surgery and without reported symptoms of hypoglycemia. * Individuals with access to personal iPhone running operating system 16 (iOS) or later versions (not feasible for Android platform users) and a password-protected home Wi-Fi network. Exclusion Criteria: * History of coronary artery disease or presence of 2 or more risk factors including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use. * History of myocardial infarction, unstable angina or revascularization within the past 6 months. * History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia. * Documented hypoglycemia occurring in the fasting state (\> 12 hours fast). * Concurrent administration of β-blocker therapy. * Vigorous physical activity within 24 hours prior to assessment. * Seizure disorder (other than with suspect or documented hypoglycemia). * Hematocrit \< 33% (women) or \<36% (men) within the past 6 months. * History of insulinoma. * Use of central nervous system-active medications, including: antidepressants, anxiolytics, antipsychotics, stimulants, antiepileptics, sedatives and opioids. * History of severe neurologic vascular disease (e.g. cerebrovascular disease/stroke). * History of previous diseases associated with dysautonomia (e.g. multiple system atrophy, multiple sclerosis, Parkinson's disease). * Impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase \>2x upper limit of normal range), as determined within the past 6 months. * Impaired renal function (serum creatinine \>1.5 mg/dL), as determined within the past 6 months. * Serious psychiatric or substance abuse disorders (e.g. alcohol, opioid, cocaine use disorder), as judged by the study investigator. * Non-consent or inability to comply with study procedures. * Current pregnancy and/ or lactation. * Vulnerable individuals (e.g., fetuses, children, prisoners) and those judged by the investigator to be unsuitable for the study. * Individuals wearing earrings or other jewelry in the left ear who are unable or unwilling to remove them for the duration of the study. * Unwillingness to wear study masked CGM for duration of study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Joslin Diabetes Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

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