Obesity (Disorder)NCT07095972
Continuous Glucose Monitoring in Metabolic Surgery
A study testing Abbot Freestyle Libre CGM in people with Obesity (Disorder), run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity (Disorder)
- What is being tested?
- Abbot Freestyle Libre CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Yun Shen, MD, +1 2253486652, yun.shen@pbrc.edu
Peter T Katzmarzyk, PhD
About this study
Official title: Optimizing Glycemic Control in Metabolic Surgery With Continuous Glucose Monitoring
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.
Read the detailed description
Obesity is listed as the most important risk factor associated with organ dysfunctions. More than 42% of US are classified as obese and 9.4% have severe obesity. About 30% of patients with T2D have severe obesity. The combination of severe obesity and T2D significantly increases the risk of CVD, non-alcoholic fatty liver disease, and other comorbidities, which contribute to higher mortality rates. To tackle this heavy burden, there's a need for coordinated efforts that encompass prevention, early diagnosis, effective treatment, and patient education. The management of obesity faces several persistent challenges, including achieving sustainable weight loss and maintaining long-term glycemic control. While lifestyle interventions and pharmacotherapy often lead to initial improvements, weight regain remains a significant issue, undermining long-term success. In this context, metabolic bariatric surgery (MBS), including procedures such as Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG), has emerged as one of the most effective interventions for significant weight loss. Its metabolic benefits extend beyond weight reduction, directly improving insulin sensitivity and glycemic control. Therefore, integrating metabolic surgery into treatment guidelines and expanding access to eligible patients are critical steps toward addressing the limitations of conventional approaches. CGM is now emerging as a more precise tool for assessing glucose patterns after metabolic surgery. However, available data on CGM outcomes in patients receiving MBS remain limited, highlighting the need for further research. CGM holds significant potential for improving the assessment and management of obese patients with T2D undergoing metabolic surgery. Unlike traditional measures such as HbA1c, CGM provides real-time, continuous data on glucose levels, offering a detailed picture of glucose variability, postprandial spikes, and hypoglycemic events. This granular insight enables better tracking of short-term metabolic changes immediately after surgery and facilitates early detection of glycemic patterns that may be influenced by the changes in GI tract and dietary patterns after surgery. In addition, post-bariatric hypoglycemia (PBH) is an increasingly recognized complication that can arise following metabolic and bariatric procedures. CGM will enable a better understanding of hypoglycemia unawareness, where patients fail to perceive symptoms despite critically low glucose levels. CGM may have the potential to revolutionize the management of PBH. Despite its promise, research on CGM among patients receiving metabolic surgery remains limited. Several studies have demonstrated the advantages of CGM in identifying post-bariatric hypoglycemia. However, limitations of prior studies include their cross-sectional or retrospective design, small sample sizes, a lack of pre-surgery CGM data, and a short GDM monitoring period (most <10 days) with only one GDM measurement taken after surgery. As a result, there is a growing need for more robust studies, such as RCTs, to validate the effectiveness of this approach and optimize its integration into clinical practice.
Objectives Aim 1: To identify the glycemic patterns by using CGM in patients with severe obesity receiving bariatric surgeries before and after the procedures. Hypothesis: CGM will reveal distinct glycemic patterns in obese patients undergoing metabolic surgery, with significant improvements in mean glucose control but not glycemic variability compared to baseline measures.
Aim 2: To investigate if the metrics that are derived from CGM data before and after the surgery can predict post bariatric hypoglycemia. Hypothesis: Metrics derived from CGM data, such as time in range, glycemic variability, and mean glucose levels, can reliably predict the likelihood of post bariatric hypoglycemia, with specific thresholds or patterns serving as robust predictors of long-term glycemic control.
Aim 3: To investigate the effect of CGM use on the prevention of post bariatric hypoglycemia, as well as the influence of dietary content, formulation, and patterns on glycemic responses. Hypothesis: Dietary content, formulation, and patterns significantly influence glycemic responses in patients with obesity, with higher fiber and protein intake, balanced macronutrient formulation, and consistent meal patterns associated with improved glycemic control and reduced risk of post bariatric hypoglycemia as measured by CGM after the surgeries.
- Conditions
- Obesity (Disorder)
- Being tested
- Abbot Freestyle Libre CGM
- Keywords
- Severe Obesity, Metabolic Surgery, Continuous Glucose Monitoring, Post-Bariatric Hypoglycemia, Randomized Controlled Trial
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbot Freestyle Libre CGMDevice
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 group | Role | What they receive |
|---|---|---|
| CGM group | Experimental | Not described Receives: Device: Abbot Freestyle Libre CGM |
| SMBG group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in coefficient of variance (CV) evaluated by CGM
Differences in coefficient of variance (CV) evaluated by CGM
Measured: 6 months
Secondary outcomes (2)
Differences in HbA1c
Measured: 6 months
Total number of hypoglycemia events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start20 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- LA CaTS Clinical Research Resources Core
- Responsible party
- Principal investigator, Yun Shen, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095972
- Sponsor's protocol ID
- 2025-021-PBRC
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Specific IPD to be shared: The following individual participant data will be shared upon reasonable request and approval: Demographic Information: Age, sex, race/ethnicity, BMI. Clinical Data: Baseline and follow-up clinical parameters, including diabetes diagnosis, diabetes duration, HbA1c levels, blood glucose measures, medication use, and relevant comorbidities. Surgical Information: Type of metabolic surgery performed, date of surgery, and perioperative outcomes. Continuous Glucose Monitoring (CGM) Data: Raw and analyzed CGM data including glucose variability, time in range, episodes of hypoglycemia, and hyperglycemia. Outcomes Data: Weight loss, diabetes remission status, insulin sensitivity measures, and occurrence of post-bariatric hypoglycemia (PBH). Safety Data: Adverse events related to metabolic surgery or CGM device use
Publications
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.
PubMed 31986081Battelino 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.
PubMed 36493795Schauer 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.
PubMed 22449319GBD 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.
PubMed 39645377
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Glycemic Control in Metabolic Surgery With Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT07095972
- Acronym / sponsor ID
- 2025-021-PBRC
- Conditions
- Obesity (Disorder)
- Keywords
- Severe Obesity, Metabolic Surgery, Continuous Glucose Monitoring, Post-Bariatric Hypoglycemia, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- LA CaTS Clinical Research Resources Core
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is listed as the most important risk factor associated with organ dysfunctions. More than 42% of US are classified as obese and 9.4% have severe obesity. About 30% of patients with T2D have severe obesity. The combination of severe obesity and T2D significantly increases the risk of CVD, non-alcoholic fatty liver disease, and other comorbidities, which contribute to higher mortality rates. To tackle this heavy burden, there's a need for coordinated efforts that encompass prevention, early diagnosis, effective treatment, and patient education. The management of obesity faces several persistent challenges, including achieving sustainable weight loss and maintaining long-term glycemic control. While lifestyle interventions and pharmacotherapy often lead to initial improvements, weight regain remains a significant issue, undermining long-term success. In this context, metabolic bariatric surgery (MBS), including procedures such as Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG), has emerged as one of the most effective interventions for significant weight loss. Its metabolic benefits extend beyond weight reduction, directly improving insulin sensitivity and glycemic control. Therefore, integrating metabolic surgery into treatment guidelines and expanding access to eligible patients are critical steps toward addressing the limitations of conventional approaches. CGM is now emerging as a more precise tool for assessing glucose patterns after metabolic surgery. However, available data on CGM outcomes in patients receiving MBS remain limited, highlighting the need for further research. CGM holds significant potential for improving the assessment and management of obese patients with T2D undergoing metabolic surgery. Unlike traditional measures such as HbA1c, CGM provides real-time, continuous data on glucose levels, offering a detailed picture of glucose variability, postprandial spikes, and hypoglycemic events. This granular insight enables better tracking of short-term metabolic changes immediately after surgery and facilitates early detection of glycemic patterns that may be influenced by the changes in GI tract and dietary patterns after surgery. In addition, post-bariatric hypoglycemia (PBH) is an increasingly recognized complication that can arise following metabolic and bariatric procedures. CGM will enable a better understanding of hypoglycemia unawareness, where patients fail to perceive symptoms despite critically low glucose levels. CGM may have the potential to revolutionize the management of PBH. Despite its promise, research on CGM among patients receiving metabolic surgery remains limited. Several studies have demonstrated the advantages of CGM in identifying post-bariatric hypoglycemia. However, limitations of prior studies include their cross-sectional or retrospective design, small sample sizes, a lack of pre-surgery CGM data, and a short GDM monitoring period (most <10 days) with only one GDM measurement taken after surgery. As a result, there is a growing need for more robust studies, such as RCTs, to validate the effectiveness of this approach and optimize its integration into clinical practice.
Objectives Aim 1: To identify the glycemic patterns by using CGM in patients with severe obesity receiving bariatric surgeries before and after the procedures. Hypothesis: CGM will reveal distinct glycemic patterns in obese patients undergoing metabolic surgery, with significant improvements in mean glucose control but not glycemic variability compared to baseline measures.
Aim 2: To investigate if the metrics that are derived from CGM data before and after the surgery can predict post bariatric hypoglycemia. Hypothesis: Metrics derived from CGM data, such as time in range, glycemic variability, and mean glucose levels, can reliably predict the likelihood of post bariatric hypoglycemia, with specific thresholds or patterns serving as robust predictors of long-term glycemic control.
Aim 3: To investigate the effect of CGM use on the prevention of post bariatric hypoglycemia, as well as the influence of dietary content, formulation, and patterns on glycemic responses. Hypothesis: Dietary content, formulation, and patterns significantly influence glycemic responses in patients with obesity, with higher fiber and protein intake, balanced macronutrient formulation, and consistent meal patterns associated with improved glycemic control and reduced risk of post bariatric hypoglycemia as measured by CGM after the surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM group | Experimental | Device: Abbot Freestyle Libre CGM |
| SMBG group | No intervention | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbot Freestyle Libre CGMParticipants 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. | Device | CGM group |
Primary outcome
Differences in coefficient of variance (CV) evaluated by CGM
Time frame: 6 months
Differences in coefficient of variance (CV) evaluated by CGM
2 secondary outcomes
Differences in HbA1c
Time frame: 6 months
Total number of hypoglycemia events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 31986081Hanipah 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.
- Background: PubMed 36493795Battelino 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.
- Background: PubMed 22449319Schauer 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.
- Background: PubMed 39645377GBD 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.
- Individual participant dataSharing planned: Yes. Specific IPD to be shared: The following individual participant data will be shared upon reasonable request and approval: Demographic Information: Age, sex, race/ethnicity, BMI. Clinical Data: Baseline and follow-up clinical parameters, including diabetes diagnosis, diabetes duration, HbA1c levels, blood glucose measures, medication use, and relevant comorbidities. Surgical Information: Type of metabolic surgery performed, date of surgery, and perioperative outcomes. Continuous Glucose Monitoring (CGM) Data: Raw and analyzed CGM data including glucose variability, time in range, episodes of hypoglycemia, and hyperglycemia. Outcomes Data: Weight loss, diabetes remission status, insulin sensitivity measures, and occurrence of post-bariatric hypoglycemia (PBH). Safety Data: Adverse events related to metabolic surgery or CGM device use
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbot Freestyle Libre CGM in people with Obesity (Disorder), run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Shen, MD (+1 2253486652, yun.shen@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in coefficient of variance (CV) evaluated by CGM (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07095972, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.