External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorJoslin Diabetes Center
About this trial
This is a pilot study (small-scale study) that aims to understand more about how blood flow changes in people who have low blood sugar after bariatric surgery (post-bariatric hypoglycemia) compared to those who have had surgery without hypoglycemia, those who have hypoglycemia without surgery, or those who do not experience low blood sugar.
This study has two phases. This is the first phase, and the purpose is to test comfort and feasibility of a novel in-ear wearable device (Lumia Health) that measures blood flow changes to the head. Information from the study will help the investigators determine if the device is suitable to be used in the second phase of the study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
healthy individuals without hypoglycemia or upper gastrointestinal surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
in-ear device measuring blood flow
DeviceA small in-ear wearable device will be placed to monitor the blood flow to the head. The investigators will make sure it fits comfortably and show the participant how to use it properly. Dexcom G6 Pro: This continuous glucose monitor (CGM) will be placed under the skin of the abdomen to monitor sensor sugar levels. These sensors will be placed during visit one and will be worn together for 10 days. A followup visit (visit 2) will occur remotely at 4-6 days later. A final visit will occur after 10 days when the device will be removed.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: healthy individuals1 intervention
Trial outcomes
Primary outcomes
1
Rate of study completion
Feasibility as determined by rate of study completion
Time frame
up to 10 days2
Number of days with viable data (complete recordings)
Feasibility as determined by number of days with viable data (complete recordings)
Time frame
up to 10 days3
Participant-reported outcome scores
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.
Time frame
up to 10 days4
Correlation between external cerebral blood flow (eCBF) (arbitrary units) and corresponding sensor glucose values (mg/dL)
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
Time frame
up to 10 daysSecondary outcomes
1
Success of data transfer from ear device to study database
Success of blood flow data transfer (yes/no) from ear device to study database for each participant
Time frame
up to 10 days2
Percentage of time with successful blood flow (arbitrary units) data collection
The percentage of time with successful data collection, normalized to total wear time (hours)
Time frame
up to 10 days3
Change in eCBF over 3 hours after meal initiation
Change in eCBF over 3 hours after meal initiation, as compared with mean eCBF over 1 hour prior to meal ingestion
Time frame
up to 10 days4
Change in eCBF during physical activity, measured by integrated eCBF changes from onset of activity to completion of activity.
Change in eCBF from baseline during physical activity, measured by integrated eCBF changes from onset of activity to completion of activity
Time frame
up to 10 daysOther outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse events will be recorded and graded for severity and relatedness by study staff during course of study
Time frame
through study completion, up to 10 daysSponsors and contacts
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Source ClinicalTrials.gov