Continuous Glucose Monitoring in Metabolic Surgery

NCT07095972 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-021-PBRC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Severe Obesity; Metabolic Surgery; Continuous Glucose Monitoring; Post-Bariatric Hypoglycemia; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Differences in coefficient of variance (CV) evaluated by CGM

  Differences in coefficient of variance (CV) evaluated by CGM

  9 months

Secondary Outcomes (2)

• Differences in HbA1c

  9 months

• Total number of hypoglycemia events

  9 months

Study Arms (2)

CGM group

EXPERIMENTAL

Device: Abbot Freestyle Libre CGM

SMBG group

NO INTERVENTION

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.

CGM group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• (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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• LA CaTS Clinical Research Resources Core: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (4)

• Hanipah ZN, Schauer PR. Bariatric Surgery as a Long-Term Treatment for Type 2 Diabetes/Metabolic Syndrome. Annu Rev Med. 2020 Jan 27;71:1-15. doi: 10.1146/annurev-med-053117-123246.

  PMID: 31986081 BACKGROUND

• Battelino T, Alexander CM, Amiel SA, Arreaza-Rubin G, Beck RW, Bergenstal RM, Buckingham BA, Carroll J, Ceriello A, Chow E, Choudhary P, Close K, Danne T, Dutta S, Gabbay R, Garg S, Heverly J, Hirsch IB, Kader T, Kenney J, Kovatchev B, Laffel L, Maahs D, Mathieu C, Mauricio D, Nimri R, Nishimura R, Scharf M, Del Prato S, Renard E, Rosenstock J, Saboo B, Ueki K, Umpierrez GE, Weinzimer SA, Phillip M. Continuous glucose monitoring and metrics for clinical trials: an international consensus statement. Lancet Diabetes Endocrinol. 2023 Jan;11(1):42-57. doi: 10.1016/S2213-8587(22)00319-9. Epub 2022 Dec 6.

  PMID: 36493795 BACKGROUND

• Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.

  PMID: 22449319 BACKGROUND

• GBD 2021 US Burden of Disease and Forecasting Collaborators. Burden of disease scenarios by state in the USA, 2022-50: a forecasting analysis for the Global Burden of Disease Study 2021. Lancet. 2024 Dec 7;404(10469):2341-2370. doi: 10.1016/S0140-6736(24)02246-3.

  PMID: 39645377 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yun Shen, MD

CONTACT

+1 2253486652; yun.shen@pbrc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be available following the publication of the primary study results. Data will be available for up to 5 years post-publication.
• Access Criteria: Access to IPD requires a formal, scientifically valid request detailing the intended analyses and ethical justification. Requests will be reviewed by the original research team to ensure compliance with ethical standards and data protection regulations.

Locations

US (1)