Continuous Glucose Monitoring in Metabolic Surgery

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Pennington Biomedical Research Center
Study ID
NCT07095972
Status
Not Yet Recruiting

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Conditions

  • Obesity (Disorder)

Eligibility Criteria

Sex
ALL
Age
20 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Abbot Freestyle Libre CGM — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CGM group
  • No Intervention: SMBG group

Primary Outcome Measure

Differences in coefficient of variance (CV) evaluated by CGM [ Time Frame: 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pennington Biomedical Research CenterBaton RougeLouisiana70808
Yun Shen, MD
[email protected]
+1 2253486652
Peter T Katzmarzyk, PhD (SUB_INVESTIGATOR)
Gang Hu, MD PhD MPH (SUB_INVESTIGATOR)
Zubaidah Nor Hanipah, MD (SUB_INVESTIGATOR)
Phillip R Schauer, MD (SUB_INVESTIGATOR)
Jean Domercant, MD (SUB_INVESTIGATOR)

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