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External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia

NCT07082478 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2025-11-28

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

in-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.

Sponsors & Collaborators

  • Joslin Diabetes Center

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2026-09-15
Completion
2026-09-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07082478 on ClinicalTrials.gov