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Continuous Glucose Monitoring in Metabolic Surgery

NCT07095972 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-06

No results posted yet for this study

Summary

We will recruit 20 severely obese participants at Metamor Institute. Participants with obesity who are eligible for MBS will be randomized to either CGM group or self-monitoring of blood glucose (SMBG) group before the surgery based on a 1:1 ratio. All participants live in Baton Rouge, Louisiana. The surgeon in Metamor will introduce our study to the patients. If the patients are interested, the evaluation process includes verifying basic personal information, assessing health status and medical history, and evaluating specific eligibility criteria relevant to the study. The study coordinator will be discussing informed consent, ensuring participants understand the study's purpose, procedures, and any associated risks or benefits. Participants are encouraged to ask questions, ensuring clarity and comfort with the study. All collected data is documented and securely stored, respecting data privacy protocols. Eligible individuals are informed about the screening visit, while those not suitable are considered for future studies.

Conditions

  • Obesity (Disorder)

Interventions

DEVICE

Abbot Freestyle Libre CGM

Participants assigned to the CGM group will receive the Libre 2+ systems (Abbott Diabetes Care, Alameda, CA) upon randomization. This will include comprehensive training provided by a qualified healthcare professional. The training will cover detailed instructions on sensor placement, how to download and use the associated smartphone application, and guidance on interpreting the glucose data effectively. To ensure continuous and accurate monitoring, the CGM sensor will be routinely replaced every 14 days following randomization. Additionally, in the event of sensor detachment or loss, immediate replacement will be arranged to maintain uninterrupted glucose tracking. Regular sessions are conducted to analyze glucose trends, refine management strategies, and provide additional support or education on device usage.

Sponsors & Collaborators

  • LA CaTS Clinical Research Resources Core

    collaborator UNKNOWN

  • Pennington Biomedical Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2026-12-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07095972 on ClinicalTrials.gov