Clinical trial

Continuous Glucose Monitoring in Metabolic Surgery

Opening soon · Not applicable · 1 countries · Registry ID NCT07095972

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity (Disorder)

Full registry criteria

Inclusion criteria: (1) age 20 to 60 years; (2) body mass index (BMI) ≥35 kg/m2 Exclusion Criteria: (1) age \<20 or \>60 years; (2) confirmed type 1 diabetes; (3) pregnancy or breastfeeding; (4) history of hypersensitivity to any of the components of the subcutaneous infusions; (5) without access at home to a telephone or other factor likely to interfere with ability to participate reliably in the study; (6) history of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer; (7) patients on insulin therapy before surgery; and (8) patients receiving revisional surgery.

Treatments and study arms

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.

Primary outcomes

Differences in coefficient of variance (CV) evaluated by CGM9 months

Differences in coefficient of variance (CV) evaluated by CGM

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Pennington Biomedical Research Center🇺🇸 Baton Rouge, Louisiana, United States

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Yun Shen, MDContact

Email · Call +1 2253486652

Peter T Katzmarzyk, PhDSub Investigator

Gang Hu, MD PhD MPHSub Investigator