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External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia

This pilot study aims to understand how blood flow to the head changes in people who experience low blood sugar (hypoglycemia) after weight-loss surgery (bariatric surgery). It also compares these changes to people who had bariatric surgery without hypoglycemia, people with hypoglycemia who haven't had surgery, and people who don't have low blood sugar. The study is testing a new in-ear device called Lumia Health, which measures blood flow. You would also wear a continuous glucose monitor (Dexcom G6 Pro) on your abdomen. The main goals are to see how many people complete the study, how much usable data is collected, and how participants feel about the device. You can join if you are between 18 and 70 years old. The study status is unclear.

Study design
This is an observational pilot study with a planned enrollment of 5 participants. It is the first phase of a larger study.
What's involved
You would have a 2-hour screening visit at Joslin Diabetes Center, which includes a medical history review, physical exam, and possibly a pregnancy test. You would also need to complete daily food, activity, and symptom diaries for up to 10 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at up to 10 days after starting the study.

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NCT07082478

External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia

Recruiting
Not specifiedAges 18–70Observational
Joslin Diabetes Center
~5 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:in-ear device measuring blood flow

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of study completion
Measured over up to 10 days
+4 more outcomes measured

Conditions

Hypoglycemia
Cerebral Blood Flow

Explore related trials

HypoglycemiaPost-Bariatric Hypoglycemia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Mary E Patti, M.D. · PRINCIPAL_INVESTIGATOR · Joslin Diabetes Center

Who to contact

Gabriela Londono, B.S.
[email protected]
6173091940
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rate of study completionup to 10 days

    Feasibility as determined by rate of study completion

  • Number of days with viable data (complete recordings)up to 10 days

    Feasibility as determined by number of days with viable data (complete recordings)

  • Participant-reported outcome scoresup to 10 days

    Scores from a qualitative survey (Patient-Reported Outcomes for In-Ear Device, adapted from the COPROD questionnaire (COnfort des PROtections auDitives/COmfort of hearing PROtection Devices) of patient acceptance of in-ear wearable device at study completion.

  • Correlation between external cerebral blood flow (eCBF) (arbitrary units) and corresponding sensor glucose values (mg/dL)up to 10 days

    Determine correlation between external cerebral blood flow (arbitrary units) and nearest sensor glucose levels (mg/dL), summed over the length of wear for each participant

  • Correlation between rate of change in eCBF (arbitrary units) and rate of change in sensor glucose (mg/dL)up to 10 days

    Determine correlation between rate of change from baseline in eCBF and rate of change in sensor glucose values, summed over the length of wear for each participant