Continuous Glucose Monitoring for Type 2 Diabetes

(FREE CGM Trial)

Overseen By Laura Anne Dapkus Humphries, NCPT

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Steroids

Disqualifiers: Mental illness, Renal disease, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether young people with Type 2 diabetes will use a continuous glucose monitor (CGM) and if it improves their diabetes management. The CGM, called FreeStyle Libre, enables users to track their blood sugar levels in real-time. In this trial, some participants will use the CGM and access their data, while others will not view their data. The trial seeks participants aged 8 to 20 who have had Type 2 diabetes for at least four weeks and have not used a CGM in the last three months. As an unphased trial, this study provides a unique opportunity for young participants to contribute to understanding how CGMs can enhance diabetes management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your medication regimen is stable, meaning no changes in medication or insulin dose in the two weeks before joining the study.

What prior data suggests that the FreeStyle Libre Continuous Glucose Monitor System is safe for youth with Type 2 Diabetes?

Research shows that the FreeStyle Libre Continuous Glucose Monitor System is generally easy for users to handle. Studies have found that the device is safe and does not require adjustment with blood glucose readings. Most people find wearing the sensor comfortable and do not experience major issues.

Some users might experience mild skin irritation where the sensor is placed, but this is uncommon and usually not serious. The FDA has approved the device for monitoring glucose levels, indicating that its safety is well-understood.

Overall, the FreeStyle Libre system appears to be a safe choice for continuous glucose monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FreeStyle Libre Continuous Glucose Monitor (CGM) System because it offers a fresh approach to managing Type 2 diabetes. Unlike traditional methods that rely on periodic finger-pricking to check blood sugar levels, this system continuously monitors glucose in real-time through a sensor worn on the skin. This means people can make more informed decisions about their diet, exercise, and medication in the moment, potentially improving their overall diabetes management. The ease of use and the ability to track glucose trends without constant finger sticks make it a game-changer for enhancing the quality of life for those with Type 2 diabetes.

What evidence suggests that the FreeStyle Libre Continuous Glucose Monitor System is effective for managing Type 2 Diabetes?

Research shows that the FreeStyle Libre Continuous Glucose Monitor (CGM) System can help people with diabetes better control their blood sugar. In this trial, participants in the intervention arm will wear the CGM sensor and access the data. Studies have found this can lower A1C levels by about 0.9% in just 3 to 6 months, helping to stabilize blood sugar levels. The system also aids in more effective diabetes management, leading to better overall health. Additionally, using the FreeStyle Libre system is linked to spending less time with low blood sugar and fewer hospital visits. Overall, these findings suggest that the FreeStyle Libre CGM System could be helpful for managing Type 2 Diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Shylaja Srinivasan, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for young people aged 8-20 with Type 2 Diabetes, who have had the condition for at least a month and are on a stable medication regimen. They must be new to using CGM devices, willing to follow study procedures, and able to give informed consent. Those with certain autoimmune markers, pregnant or breastfeeding individuals, patients undergoing cancer treatment or steroid therapy, and those with significant mental illness or plans for bariatric surgery cannot participate.

Inclusion Criteria

I am between 8 and 20 years old.

I, and if under 18, my parent/guardian, agree to attend all study sessions and follow instructions.

My medications, including insulin, have been stable for the last 2 weeks.

Exclusion Criteria

I am currently receiving cancer treatment or taking steroids.

I am planning to have weight loss surgery during the study.

I have tested positive for pancreatic autoantibodies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Blinding Period

Participants wear a blinded CGM sensor for baseline data collection

2 weeks

1 visit (in-person)

Treatment

Participants are randomized into intervention or control groups; intervention group uses CGM with app access, control group continues standard care

6 months

Monthly phone check-ins, clinic visits at 3 and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Focus Group

Participants invited to discuss their experience with the technology in an online focus group

What Are the Treatments Tested in This Trial?

Interventions

• FreeStyle Libre Continuous Glucose Monitor System

Trial Overview The study tests if youth with Type 2 Diabetes will use the FreeStyle Libre Continuous Glucose Monitor System regularly over six months. It aims to see if this influences their behavior and diabetes management decisions. The trial has two groups: one of twenty participants using the CGM system (treatment arm) and a control group of ten without it.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants will wear the CGM sensor and have access to the data during the main part of the study.

Group II: Control Active Control 1 Intervention

Participants will not have access to view the data from the CGM sensor during the screening period, nor during the main part of the study.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

The FreeStyle Libre system demonstrated a mean absolute relative difference (MARD) of 13.2% in glucose readings compared to traditional blood glucose measurements, indicating a reliable level of accuracy for monitoring blood glucose in adults with type 1 diabetes over a 10-14 day period.

Patient satisfaction with the FreeStyle Libre system was high, with ratings averaging between 8.22 and 9.8 on a visual analog scale, suggesting that users found the system effective and user-friendly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clinical Trial of the Accuracy and Treatment Experience of the Flash Glucose Monitor FreeStyle Libre in Adults with Type 1 Diabetes. Ólafsdóttir, AF., Attvall, S., Sandgren, U., et al.[2022]

In a study involving 10 patients with diabetes, the FreeStyle Libre Pro (FSL-Pro) and iPro2 glucose monitoring systems showed good overall agreement, but the FSL-Pro reported lower glucose values compared to the iPro2, particularly during hypoglycemic episodes.

The FSL-Pro had a median absolute relative difference of 8.1% from self-monitoring blood glucose, while the iPro2 had a lower difference of 5.0%, indicating that while both systems are clinically acceptable, the iPro2 may provide more accurate readings, especially in hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of glucose monitoring between Freestyle Libre Pro and iPro2 in patients with diabetes mellitus. Kumagai, R., Muramatsu, A., Fujii, M., et al.[2023]

The FreeStyle Libre flash glucose monitoring system (FGMS) was found to be easy to use and well tolerated by diabetic dogs, with only mild skin irritation observed in some cases.

The FGMS demonstrated high accuracy in measuring interstitial glucose levels, correlating well with plasma glucose concentrations, achieving 93% to 99% accuracy across different blood glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a Flash Glucose Monitoring System in Diabetic Dogs. Corradini, S., Pilosio, B., Dondi, F., et al.[2022]

The FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system showed that 85.5% of its readings from the arm fell within the clinically acceptable range when compared to a standard blood glucose measurement, indicating good efficacy for monitoring glucose levels in patients with diabetes.

However, the FSL-CGM system tended to underestimate glucose levels at lower ranges and overestimate them at higher ranges, particularly after meals, suggesting that users should be cautious and follow optimized instructions for accurate daily management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. Fokkert, MJ., van Dijk, PR., Edens, MA., et al.[2022]

The FreeStyle Libre® flash glucose monitoring system effectively measures glucose levels and trends, helping individuals with diabetes prevent dangerous highs and lows in blood sugar.

Proper use of the device can significantly enhance glycemic control and improve the quality of life for users, making it essential to understand how to interpret glucose data and trends effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Approach to Flash Glucose Monitoring: An Expert Recommendation. Chico, A., Aguilera, E., Ampudia-Blasco, FJ., et al.[2021]

In a study involving 148 insulin-treated type 2 diabetes patients, the use of the FreeStyle Libre Pro™ glucose monitoring system significantly reduced HbA1c levels by 4.9 mmol/mol (0.44%) without increasing the risk of hypoglycemia.

Patients using the Libre Pro system reported higher treatment satisfaction compared to those who only self-monitored blood glucose, indicating that this monitoring system can enhance the overall management experience for diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial. Ajjan, RA., Jackson, N., Thomson, SA.[2022]

The use of additional readers with the FreeStyle Libre flash glucose monitoring system significantly reduced self-reported glycated hemoglobin levels and episodes of hypoglycemia among 132 patients with diabetes, indicating improved metabolic control.

Patients reported enhanced quality of life due to fewer limitations in daily activities and social interactions, suggesting that the combination of flash glucose monitoring and additional readers effectively supports diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Using Additional Readers for Flash Glucose Monitoring System on Metabolic Control, Safety, and the Incidence of Complications in Patients With Diabetes Mellitus. Kublin, O., Stępień, M.[2021]

The FreeStyle Libre™ Flash Glucose Monitoring System (Flash GM) led to a significant reduction in HbA1c levels by an average of 0.41% in individuals with type 1 diabetes over a follow-up period of 2 to 24 months, based on a meta-analysis of 34 studies involving 5,466 participants.

This reduction in HbA1c was consistent even when excluding data from controlled trials, indicating that Flash GM can effectively lower blood sugar levels in diverse populations, although the variability in study designs suggests that results may differ in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of average change in laboratory-measured HbA1c among people with type 1 diabetes mellitus using the 14 day Flash Glucose Monitoring System. Gordon, I., Rutherford, C., Makarounas-Kirchmann, K., et al.[2022]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8586127/

Cost-Effectiveness of the FreeStyle Libre® System Versus ... A meta-analysis assessing clinical trials and real-world studies has shown improvement in glycaemic levels with the use of flash glucose monitoring in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S187140212100285X

Effectiveness of the freestyle libre 2 flash glucose ... Using Freestyle Libre 2 (FSL 2) was found to raise the patients' Diabetes Self-Management levels. Using FSL 2 was improved the metabolic control such as ...

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

summary of safety and effectiveness data (ssed) System performance was primarily evaluated in terms of point and rate accuracy of the FreeStyle Libre 14 Day Flash Glucose Monitoring. System ...

6. freestyle.abbott freestyle.abbott/

FreeStyle Libre Continuous Glucose Monitoring | FreeStyle ... The FreeStyle Libre 3 Plus sensor lets you see your glucose levels in real time so you can make more confident choices 1 and lower your A1C.

7. 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 ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482068/

FreeStyle Libre Flash Glucose Self-Monitoring System - NCBI Main findings from these trials are that FreeStyle Libre may slightly improve treatment satisfaction, time spent with glucose in range 3.9 to 10 mmol/L, number ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/P160030b.pdf

summary of safety and effectiveness data (ssed) The FreeStyle Libre System is factory calibrated and does not require, or allow, calibration with blood glucose values, for example as obtained ...