FreeStyle Libre System for Type 2 Diabetes

Not currently recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Diabetes Care

Must be taking: Metformin, SGLT-2 inhibitors

Must not be taking: Insulin, Sulfonylureas

Disqualifiers: Pregnancy, Skin diseases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the FreeStyle Libre Flash Glucose Monitoring System in managing type 2 diabetes, both on its own and when paired with a food logging smartphone app. The focus is on reducing the time participants with type 2 diabetes spend with blood sugar levels above 180 mg/dL. Eligible participants should have type 2 diabetes, be on specific oral diabetes medications, and be willing to make diet and lifestyle changes. The trial is ideal for those who own a smartphone and are not currently using insulin or sulfonylurea-based medications. As an unphased trial, it offers an opportunity to explore innovative diabetes management strategies.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current diabetes medications, but you must agree to not change your diabetes medications for 3 months.

What prior data suggests that the FreeStyle Libre System is safe for managing type 2 diabetes?

Research has shown that the FreeStyle Libre System is generally safe for people with diabetes. This system helps monitor blood sugar levels and has been tested for accuracy and ease of use. It comes pre-calibrated, requiring minimal adjustments, which makes it simple and reliable. However, it may occasionally give false alerts for low blood sugar.

When used with a food tracking app, the app helps track blood sugar and dietary intake. No specific safety data indicates additional risks when using the app with the FreeStyle Libre System. However, avoid using this system with automated insulin dosing devices, as it could cause safety issues.

Overall, the FreeStyle Libre System, whether used with the food app or not, is well-tolerated. The FDA has approved it for managing diabetes, indicating its safety. Users should be aware of its limitations, such as possible false alerts, and follow instructions to use it safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FreeStyle Libre System for managing Type 2 Diabetes because it offers a more convenient and continuous way to monitor glucose levels compared to traditional fingerstick methods. This flash glucose monitoring system allows users to see real-time glucose data and trends without the need for routine finger pricks, making it less invasive and more user-friendly. Additionally, the combination of the FreeStyle Libre System with a food logging app provides users with a comprehensive tool to track how their diet directly affects their glucose levels, potentially improving overall diabetes management.

What evidence suggests that the FreeStyle Libre System and the food logging app could be effective for type 2 diabetes?

Research shows that the FreeStyle Libre System, which participants in this trial may use, helps people with type 2 diabetes manage their blood sugar levels more effectively. Studies have found that using this system increases the time spent within healthy blood sugar ranges by 5%, reducing time with high blood sugar. Additionally, it has been linked to lower HbA1c levels, a measure of average blood sugar over time.

In this trial, some participants will use the FreeStyle Libre System with a food logging app. Evidence suggests that this combination is even more effective, as people using both the FreeStyle Libre System and the app have better control over their blood sugar. This combination helps users make informed choices about their diet and medication. Overall, these tools work together to improve the management of type 2 diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Shridhara A Karinka, PhD

Principal Investigator

Abbott Diabetes Care Inc

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who have high blood sugar levels despite taking certain oral medications. Participants need to own a smartphone, be willing to track their diet and lifestyle changes, and not change their diabetes medication during the study. Pregnant individuals, those on insulin or sulfonylurea drugs, or with allergies to medical adhesives/isopropyl alcohol cannot join.

Inclusion Criteria

Your HbA1c level is between 7.5% and 12%.

I am willing to change my diet and lifestyle based on health advice and glucose data.

I agree not to change my diabetes medications for 3 months.

Exclusion Criteria

I have skin conditions that could affect glucose monitoring device placement.

Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin

Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the FreeStyle Libre Flash Glucose Monitoring System, with or without a food logging app, to manage their diabetes

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FreeStyle Libre System
• FreeStyle Libre System plus food app

Trial Overview The study compares two approaches: using the FreeStyle Libre Flash Glucose Monitoring System alone versus pairing it with a food logging app. The goal is to see which method better reduces periods of high blood sugar in people whose condition isn't well-controlled by oral meds.

How Is the Trial Designed?

Group I: FreeStyle Libre Active Control 1 Intervention

Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes.

Group II: FreeStyle Libre plus food logging Active Control 1 Intervention

Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes.

Who Is Running the Clinical Trial?

Abbott Diabetes Care

Lead Sponsor

Trials

67

Recruited

25,600+

Robert B. Ford

Abbott Diabetes Care

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Dr. Mahmood Kazemi

Abbott Diabetes Care

Chief Medical Officer

Bachelor's and Master's degrees from Stanford University, MD from the University of California, San Francisco

Published Research Related to This Trial

The FreeStyle Navigator Continuous Glucose Monitoring System was found to be safe and effective for adults with type 1 or 2 diabetes, significantly reducing time spent in hypoglycemia by 55% during the unmasked period of the study.

Participants reported high satisfaction with the system, and the accuracy of glucose readings was validated, with 77.2% of results falling in the clinically acceptable Clarke error grid zone A, indicating reliable monitoring for better glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a continuous glucose monitoring system for home-use conditions. Bode, B., Silver, M., Weiss, R., et al.[2019]

The Sugar Sleuth mobile app, used alongside the FreeStyle Libre™ glucose sensor, led to a significant average reduction in A1c levels by 0.5% over 14 weeks in adults with type 1 diabetes, indicating improved glycemic control.

Participants also reported a decrease in daily carbohydrate intake by an average of 43 grams, suggesting that the app effectively supported dietary management, although no significant changes were observed in other glycemic metrics or insulin dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Glucose-Sensor-Based Tool to Help Clinicians and Adults With Type 1 Diabetes Improve Self-Management Skills. Toschi, E., Fisher, L., Wolpert, H., et al.[2019]

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 of 86 patients with type 1 diabetes using the Freestyle Libre 2 (FSL2) system for 12 weeks, significant improvements were observed in glucose metrics, including a reduction in low glucose events and an increase in time spent within the target glucose range.

Patients reported high satisfaction with the FSL2 system, indicating it provided benefits with minimal discomfort, suggesting that it is a favorable option for continuous glucose monitoring in managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Patient-reported Satisfaction and Metabolic Outcomes Following Initiation of the Second Generation of Flash Glucose Monitoring in Patients with Type 1 Diabetes Al Hayek, A., Robert, AA., Alzahrani, WM., et al.[2023]

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]

In a study of 47 patients aged 13-21 with type 1 diabetes using insulin pumps, the introduction of Freestyle Libre 2 (FSL2) significantly increased the frequency of glucose monitoring from 2.4 times per day to 8.2 times per day over 12 weeks (p < 0.001).

The use of FSL2 also led to improvements in diabetes self-management practices and a reduction in hemoglobin A1c levels from 8.3% to 7.9%, indicating better metabolic control, although this change was not statistically significant (p = 0.064).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the freestyle libre 2 flash glucose monitoring system on diabetes-self-management practices and glycemic parameters among patients with type 1 diabetes using insulin pump. Al Hayek, AA., Robert, AA., Al Dawish, MA.[2022]

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]

Citations

1. freestyleprovider.abbott freestyleprovider.abbott/us-en/outcomes.html

Adult & Pediatric Outcomes Adult patients using the Libre app† platform experienced 5% greater TIR compared with adult patients using readers‡10: Less time in hyperglycemia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11354050/

Impact of the FreeStyle Libre 2® System on Glycaemic ... Results: Eight weeks after using FSL2, compared with results from 3–4 weeks of use, there were no differences in the glucose management ...

3. 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40161060/

The Use of Freestyle Libre Glucose Monitoring System and ... Results Participants using the FreeStyle Libre glucose monitoring system experienced higher rates of medication intensification, and the use of ...

5. diabetesjournals.org diabetesjournals.org/clinical/article/43/1/139/157329/Continuous-Glucose-Monitoring-in-Individuals-With

Continuous Glucose Monitoring in Individuals With Type 2 ... The use of CGM in the population of people with type 2 diabetes has been shown to improve patients' ability to use real-time glycemic ...

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) The FreeStyle Libre 14 Day System is factory calibrated and does not require, or allow, calibration with blood glucose values, for example as ...

8. freestyle.abbott freestyle.abbott/us-en/products/freestyle-libre-2.html

FreeStyle Libre 2 System | FreeStyle Libre US Data is applicable to FreeStyle Libre 2 system ... This program is available for patients with Type 1 diabetes or Type 2 diabetes or gestational diabetes.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5867506/

Accuracy, User Acceptability, and Safety Evaluation for the ... The accuracy, safety, and user acceptability of the FreeStyle Libre System for women with diabetes during pregnancy have been demonstrated. Accuracy was ...

10. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/p150021b.pdf

PMA P150021: FDA Summary of Safety and Effectiveness Data IMPORTANT: The device may inaccurately indicate hypoglycemia. The results of the clinical study conducted for this device showed that 40% of ...