Ear gadget could spot dangerous sugar drops after gastric bypass
NCT ID NCT07082478
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Joslin Diabetes Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Other studies related to the condition(s) this trial covers.
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