Continuous Glucose Monitoring in Metabolic Surgery

Sponsored by Pennington Biomedical Research Center

About this trial

Last updated 2 months ago

Study ID

2025-021-PBRC

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 65 Years

All Sexes

Trial Timing

Started 2 months ago

What is this trial 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.

What are the Participation Requirements?

Inclusion criteria: (1) age 18 to 65 years; (2) body mass index (BMI) ≥35 kg/m2 Exclusion Criteria: (1) age <18 or >65 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.