Continuous Glucose Monitoring for Diabetes

Overseen By Yun Shen, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Insulin

Disqualifiers: Type 1 diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how continuous glucose monitoring (CGM) can enhance diabetes care after metabolic surgery, such as gastric bypass or sleeve gastrectomy. CGM devices, like the Abbot Freestyle Libre CGM, provide real-time insights into blood sugar patterns, aiding in tracking changes and identifying complications post-surgery. Participants include adults with type 2 diabetes who struggle to control their condition with medication and have a BMI of 35 or higher. The trial compares those using CGM to those using standard blood sugar self-checks to determine which method yields better results. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve diabetes management after surgery.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on insulin therapy before surgery, you are not eligible to participate.

What prior data suggests that continuous glucose monitoring is safe for diabetes patients?

Research shows that the Abbott Freestyle Libre Continuous Glucose Monitoring (CGM) system is generally safe for use. Safety data indicate very few side effects. Reports also show that most people do not experience issues when applying or removing the sensor.

Additionally, the FDA has approved the Abbott Freestyle Libre system for managing diabetes, supporting its safety. This approval means the device underwent thorough testing to ensure safety for people with diabetes. However, discussing any safety concerns or questions with a doctor before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Abbot Freestyle Libre CGM because it offers a new way for people with diabetes to monitor their blood sugar levels continuously without the need for constant finger pricks. Unlike traditional self-monitoring blood glucose (SMBG) methods, which require multiple daily tests, the Freestyle Libre CGM provides real-time glucose readings through a sensor worn on the skin. This innovative approach not only improves convenience and comfort for users but also provides more comprehensive data to help manage diabetes more effectively.

What evidence suggests that continuous glucose monitoring is effective for diabetes?

Research has shown that the Abbott Freestyle Libre Continuous Glucose Monitoring (CGM) system can help people manage diabetes more effectively. On average, users experience a 0.9% reduction in HbA1c levels within 3 to 6 months, indicating improved blood sugar control. This technology also correlates with a 78% decrease in hospital visits for heart problems among people with diabetes. Participants in this trial may join the CGM group to use this system, which provides real-time glucose level information, aiding in safer and more effective blood sugar management. These benefits make it a promising tool for improving diabetes control. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with obesity and type 2 diabetes who may benefit from metabolic surgery. It aims to assess the effectiveness of continuous glucose monitoring (CGM) post-surgery. Specific eligibility criteria are not provided, but typically participants would need a diagnosis of obesity and type 2 diabetes.

Inclusion Criteria

Body mass index (BMI) ≥35 kg/m2

Diabetes duration ≤ 10 years

I am between 20 and 60 years old.

Exclusion Criteria

I have been diagnosed with type 1 diabetes.

I am undergoing a corrective surgical procedure.

I am either younger than 20 or older than 60.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Monitoring

Participants undergo continuous glucose monitoring (CGM) to establish baseline glycemic patterns before metabolic surgery

2 weeks

Surgery and Immediate Post-Surgery Monitoring

Participants undergo metabolic surgery (Roux-en-Y gastric bypass or vertical sleeve gastrectomy) and are monitored using CGM for immediate post-surgery glycemic changes

4 weeks

Long-term Follow-up

Participants are monitored for long-term glycemic control and post-bariatric hypoglycemia using CGM

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Abbot Freestyle Libre CGM

Trial Overview

The study tests the use of Abbott Freestyle Libre CGM in patients undergoing metabolic surgery like Roux-en-Y gastric bypass or vertical sleeve gastrectomy. The goal is to monitor real-time blood sugar levels and improve long-term outcomes after surgery.

How Is the Trial Designed?

Group I: CGM group Experimental Treatment 1 Intervention

Group II: SMBG group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

LA CaTS Clinical Research Resources Core

Collaborator

Trials

1

Recruited

40+

Citations

1.

freestyleprovider.abbott

freestyleprovider.abbott/us-en/outcomes.html

Adult & Pediatric Outcomes

FreeStyle Libre CGM systems make it easy to support better outcomes by enabling greater glucose control* · 0.9% A1C reduction within 3 to 6 months among patients ...

2.

abbott.mediaroom.com

abbott.mediaroom.com/2025-05-15-Abbotts-Libre-R-Technology-is-First-Continuous-Glucose-Monitor-Associated-with-Reduced-Hospitalizations-for-Heart-Complications-in-People-with-Diabetes

Abbott's Libre® Technology is First Continuous Glucose ...

New data reveal a 78% reduction in cardiovascular disease-related hospitalizations for people living with Type 1 diabetes with prior severe low ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8875038/

Analysis of “Accuracy of a 14-Day Factory Calibrated ...

1. Abbott MediaRoom. New Real-World Data Show that Abbott's FreeStyle Libre System Delivers Positive Health Outcomes for People with Type 1 and Type 2 Diabetes.

4.

payer.freestyle.abbott

payer.freestyle.abbott/us-en/ClinicalEvidence.html

FreeStyle Libre Clinical Evidence

The FreeStyle Libre portfolio helped reduce HbA1c*†1-13, hypoglycemia*†14-15, work absenteeism*†16-17, and resource utilization*†18-21, among patients with ...

5.

abbott.com

abbott.com/corpnewsroom/diabetes-care/diabetes-and-heart-risk-two-battles-one-device.html

Diabetes and Heart Risk: Two Battles, One Device

Libre technology is linked with reduced cardiovascular disease-related hospitalization for people with diabetes.

6.

freestyle.abbott

freestyle.abbott/us-en/safety-information.html

Safety Information | The FreeStyle Libre System

Read safety information regarding your FreeStyle Libre 14 day system, including MRI contraindications, insulin contraindications, and sensor removal ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf16/P160030S017B.pdf

summary of safety and effectiveness data (ssed)

Safety data for the FreeStyle Libre 14 Day System were also collected and characterized by incidence, severity and relatedness. Device ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10658671/

Safety and Functional Integrity of Continuous Glucose ...

The CGM Pro and CGM 3 sensors store 14 days of data, whereas the CGM 1 and CGM 2 sensors store eight hours of data, after which the continuous data logging ...