Lifestyle Intervention for Type 2 Diabetes

(LIBERATE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Sonja M Reichert, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Western University, Canada

Disqualifiers: Severe mental illness, Pregnancy, CVD, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses fitness trackers and glucose monitors to help people with diabetes manage their blood sugar levels. Participants will learn about healthy eating and exercise through online classes. Real-time data from the devices will be used to create personalized health plans.

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 data supports the effectiveness of the treatment FreeStyle Libre Flash Glucose Monitoring System for Type 2 Diabetes?

Research shows that using the FreeStyle Libre system can help people with Type 2 Diabetes improve their blood sugar control (HbA1c levels) and reduce low blood sugar episodes (hypoglycemia). It is also less painful than traditional finger-stick tests and is popular among users. ^{1 2 3 4 5}

Is the FreeStyle Libre system safe for use in humans?

The FreeStyle Libre system, used for monitoring glucose levels, is generally safe for humans with low reports of adverse events. It is well-received by users and has been shown to reduce low blood sugar episodes in diabetes patients. ^{1 2 3 4 6}

How is the FreeStyle Libre Flash Glucose Monitoring System different from other treatments for type 2 diabetes?

The FreeStyle Libre Flash Glucose Monitoring System is unique because it allows people with type 2 diabetes to monitor their blood sugar levels without the need for frequent finger-stick tests. It uses a small sensor worn on the arm for up to 14 days, providing continuous glucose data that can help improve blood sugar control and reduce the risk of low blood sugar episodes. ^{1 3 4 7 8}

Research Team

Sonja M Reichert, MD

Principal Investigator

Western University

Eligibility Criteria

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)

Trial Timeline

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)

Treatment Details

Interventions

• LIBERATE (Behavioral Intervention)

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.

Participant Groups

Group I: LIBERATE Intervention Experimental Treatment 1 Intervention

LIBERATE is already approved in Canada, Japan for the following indications:

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+

Dr. Robin Farias-Eisner

Western University, Canada

Chief Executive Officer since 2022

PhD in Molecular Biology from UCLA, MD from the Royal College of Surgeons in Dublin, MBA from Pepperdine University

James Tweedy

Western University, Canada

Chief Medical Officer since 2020

MBA from Trinity Western University

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

Findings from Research

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]

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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Flash forward: a review of flash glucose monitoring. [2022]

2. United States 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. [2022]

3. 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]

4. 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]

5. United States 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. [2021]

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

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

7. 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]

8. 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]