Lifestyle Intervention for Type 2 Diabetes

(LIBERATE Trial)

Overseen By Daniel Henke, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Severe mental illness, Pregnancy, CVD, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a lifestyle program can help people better manage Type 2 diabetes. Participants will use wearable technology, such as FitBit and glucose sensors like the FreeStyle Libre Flash Glucose Monitoring System (also known as LIBERATE), to track exercise and blood sugar. The program includes classes on diet and exercise, with personal coaching available. It suits those with Type 2 diabetes who have high blood sugar levels and are new to using glucose monitors. Participants should have a smartphone, internet access, and medical clearance to exercise. As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage diabetes with cutting-edge technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this lifestyle intervention is safe for managing Type 2 Diabetes?

Research has shown that the FreeStyle Libre system, used in the LIBERATE study, is generally safe for people with diabetes. Studies have found this device, which continuously checks blood sugar levels, to be accurate, providing reliable readings. This accuracy is crucial for effective blood sugar management.

Most people find the device easy to use and encounter no problems. However, some might experience skin irritation where the sensor is placed, and it might not function well with MRI scans. These issues are rare but noteworthy.

Overall, the FreeStyle Libre is approved for managing diabetes, indicating it has passed strict safety tests. Participants in the study will also use a Fitbit to track activity, which is widely used and considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LIBERATE intervention for type 2 diabetes because it focuses on lifestyle changes, which can empower individuals to take control of their health in a sustainable way. Unlike standard treatments like medications and insulin therapy, LIBERATE emphasizes personalized diet and exercise plans tailored to each participant's needs. This approach not only targets blood sugar control but also aims to improve overall well-being and reduce the risk of diabetes-related complications. By potentially reducing reliance on medications, it offers a holistic alternative that addresses the root causes of type 2 diabetes.

What evidence suggests that this lifestyle intervention is effective for Type 2 Diabetes?

Research shows that the FreeStyle Libre 2 system, used in this trial as part of the LIBERATE Intervention, can help manage Type 2 Diabetes. Studies have found it controls blood sugar levels more effectively. Users of this system have experienced a drop in their HbA1c levels, an important measure of long-term blood sugar control. Additionally, the FreeStyle Libre 2 encourages better self-management of diabetes, empowering patients to take charge of their health. Its ability to reduce time spent with high blood sugar levels makes it a promising tool for managing Type 2 Diabetes. ^{4 5 6 7 8}

Who Is on the Research Team?

Sonja M Reichert, MD

Principal Investigator

Western University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 2 diabetes who have internet access, an email address, a compatible smartphone, and are new to using Flash glucose monitors. They must be cleared by a physician to exercise and have an HbA1c level of at least 8.0%. Pregnant individuals or those unable to safely exercise or fully participate in the program are excluded.

Inclusion Criteria

Physician cleared to participate in exercise

I have never used a Flash glucose monitor but want to try it.

Your average blood sugar level (HbA1c) is higher than 8.0%. If you haven't had this test recently, we will ask you to complete a new one.

Exclusion Criteria

I do not have any health conditions that would make exercising unsafe for me.

I do not have any severe mental, cognitive, or language issues that would prevent me from participating in a group.

Lack of access/knowledge of technology that would prevent virtual participation (Self-reported)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 phone call

Orientation

Participants attend an orientation session to learn about the study and set up wearable technology

1 session

1 visit (in-person or virtual)

Baseline Data Collection

Two weeks of baseline data collection including glucose values and step counts

2 weeks

Intervention Week 1-12

Biweekly virtual coaching sessions focusing on behavioral, nutrition, and exercise coaching

12 weeks

6 virtual sessions

Intervention Week 12-24

Monthly virtual coaching sessions focusing on creating lasting behavior change

12 weeks

3 virtual sessions

Follow-up

Participants are monitored for changes in fitness, diabetes status, and other health metrics

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LIBERATE

Trial Overview The LIBERATE intervention includes fitness testing, wearable technology (FitBit Inspire 2™ and FreeStyle® Libre sensors) for monitoring glucose levels and activity, bi-weekly then monthly virtual group classes on nutrition and exercise, with optional individualized training prescriptions. The goal is to reduce A1c levels through lifestyle changes.

How Is the Trial Designed?

Group I: LIBERATE Intervention Experimental Treatment 1 Intervention

LIBERATE is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as FreeStyle Libre for:

• Type 1 diabetes
• Type 2 diabetes

Approved in United States as FreeStyle Libre for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Canada as FreeStyle Libre for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Japan as FreeStyle Libre for:

• Type 1 diabetes
• Type 2 diabetes

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Abbott Diabetes Care

Industry 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 Libre flash glucose monitor, available since November 2017, significantly reduces the need for painful finger-stick tests and is associated with lower rates of hypoglycemia and improved HbA1c levels in diabetes management, based on randomized and observational studies.

User satisfaction is high, and the device's accuracy is comparable to other continuous glucose monitors, while being more cost-effective; however, further education for users and healthcare professionals is necessary to maximize its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flash forward: a review of flash glucose monitoring. Leelarathna, L., Wilmot, EG.[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 FreeStyle Libre (FSL) glucose-monitoring device significantly improved glycemic control in 10,370 users, with an average reduction in HbA1c from 67.5 to 62.3 mmol/mol (8.3% to 7.8%) over approximately 7.5 months, particularly benefiting those with higher initial HbA1c levels.

FSL use also enhanced hypoglycemia awareness and reduced diabetes-related distress, leading to fewer hospital admissions and paramedic callouts related to hypoglycemia and hyperglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Deshmukh, H., Wilmot, EG., Gregory, R., et al.[2022]

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 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]

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 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]

In a study of 307 patients with type 1 and type 2 diabetes on insulin, the FreeStyle Libre™ glucose monitoring system led to a significant reduction in HbA1c levels after 3 months, with decreases of -0.75% for type 1 diabetes and -0.54% for type 2 diabetes (both p < 0.001).

The reduction in HbA1c was maintained over 12 months, particularly benefiting patients with higher baseline HbA1c levels (above 7.5%), indicating that the FreeStyle Libre system is effective for improving glycemic control in insulin-treated diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving HbA1c Control in Type 1 or Type 2 Diabetes Using Flash Glucose Monitoring: A Retrospective Observational Analysis in Two German Centres. Rose, L., Klausmann, G., Seibold, A.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34488057/

Effectiveness of the freestyle libre 2 flash glucose ... Using FSL2 was found to raise the patients' DSM levels and improved metabolic control.

2. 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 ...

3. 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.

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. mdpi.com mdpi.com/1424-8220/24/17/5769

Analytical Performance of the FreeStyle Libre 2 Glucose ... In one study, the performance of the Freestyle Libre 2 sensor was assessed against plasma venous blood glucose in 144 adults with diabetes over ...

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. abbott.com abbott.com/freestyle-libre-2-continuous-glucose-monitor-cgm.html

FreeStyle Libre 2 Continuous Glucose Monitor It's the longest-lasting integrated continuous glucose monitoring (iCGM) system on the market, giving you glucose readings every minute.

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

Accuracy, User Acceptability, and Safety Evaluation for the ... The study results demonstrated good agreement between the sensor glucose values and capillary blood glucose values, as illustrated through the different ...