Continuous Glucose Monitoring in Metabolic Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorPennington Biomedical Research Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: CGM groupExperimental treatment 1 intervention
Group B: SMBG groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Differences in coefficient of variance (CV) evaluated by CGM

Differences in coefficient of variance (CV) evaluated by CGM

Time frame
6 months

Secondary outcomes

1

Differences in HbA1c

Time frame
6 months
2

Total number of hypoglycemia events

Time frame
6 months

Other outcomes

Sponsors and contacts

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Pennington Biomedical Research Center

Lead sponsor

LA CaTS Clinical Research Resources Core

Collaborator

This trial is not recruiting at the moment. You can still explore other options: