External Carotid Blood Flow Dynamics in Individuals With Post-Bariatric Hypoglycemia (PBH): Pilot Study
Joslin Diabetes Center
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.
Description
Visit 1 (Screening) This visit will last about 2 hours. Participants will be asked to come to Joslin Diabetes Center. During the screening visit, a study team member will go over the informed consent form with participants and will explain why this study is being done and the study procedures involved. Participants will have to sign the consent form before any study related procedures take place. After participants sign the consent, the following procedures will be done to ensure eligibility and that it is safe to be part of the study. * Review medical history by the study doctor. * Particip…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
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. Ex…
Interventions
- Devicein-ear device measuring blood flow
A 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.
Location
- Joslin Diabetes CenterBoston, Massachusetts