FreeStyle Libre System for Type 2 Diabetes

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

350 Participants Needed

Trial Summary

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 data supports the effectiveness of the FreeStyle Libre System for Type 2 Diabetes?

Research shows that using the FreeStyle Libre system helps lower HbA1c (a measure of blood sugar control) in people with type 2 diabetes, and these benefits can last for up to 24 months. ^{1 2 3 4 5}

Is the FreeStyle Libre System safe for humans?

The FreeStyle Libre System has been evaluated for safety in people with type 1 and type 2 diabetes, and it is generally considered safe for use in monitoring glucose levels at home. ^{1 3 6 7 8}

How is the FreeStyle Libre System treatment different from other treatments for type 2 diabetes?

The FreeStyle Libre System is unique because it uses a sensor to monitor glucose levels without the need for finger-pricks, and it can be enhanced with additional readers to provide continuous glucose monitoring and alerts for abnormal glucose levels. This system, combined with a food app, helps users manage their diabetes more effectively by providing real-time data and insights into their glucose levels. ^{6 7 9 10 11}

What is the purpose of this trial?

A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.

Research Team

Shridhara A Karinka, PhD

Principal Investigator

Abbott Diabetes Care Inc

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

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]

References

1. United Arab Emirates 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 [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Reductions in HbA1c with Flash Glucose Monitoring Are Sustained for up to 24 Months: A Meta-Analysis of 75 Real-World Observational Studies. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a continuous glucose monitoring system for home-use conditions. [2019]

4. Netherlands 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. [2022]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluating a Glucose-Sensor-Based Tool to Help Clinicians and Adults With Type 1 Diabetes Improve Self-Management Skills. [2019]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Comparing Glucose Outcomes Following Face-to-Face and Remote Initiation of Flash Glucose Monitoring in People Living With Diabetes. [2023]

9. United States 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. [2021]

10. Ireland 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). [2023]