External Carotid Blood Flow Dynamics in Individuals With Post-Bariatric Hypoglycemia (PBH): Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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.

Locations
United States
Massachusetts
Joslin Diabetes Center
RECRUITING
Boston
Contact Information
Primary
Gabriela Londono, B.S.
glondono@joslin.harvard.edu
6173091940
Backup
Lily Swaine-Moore, B.S.
lswainem@joslin.harvard.edu
6173094468
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2025-10-15
Participants
Target number of participants: 5
Treatments
healthy individuals
individuals with no history of hypoglycemia or upper gastrointestinal surgery
Related Therapeutic Areas
Sponsors
Leads: Joslin Diabetes Center

This content was sourced from clinicaltrials.gov