External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Joslin Diabetes Center
Study ID
NCT07082478
Status
Recruiting
Apply to this trial

Conditions

  • Cerebral Blood Flow
  • Hypoglycemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • in-ear device measuring blood flow — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 28, 2025
Status verified
Nov 2025
Primary completion
Sep 15, 2026
Completion
Sep 15, 2026

Study Design

Enrollment
5 participants (estimated)

Arms

  • Arm: healthy individuals
    individuals with no history of hypoglycemia or upper gastrointestinal surgery

Primary Outcome Measure

Rate of study completion [ Time Frame: up to 10 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Joslin Diabetes CenterBostonMassachusetts02215
Yael Sarig, B.A.
[email protected]
617-309-1940
Mary E Patti, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Joslin Diabetes Center· Boston, MA

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