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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment FreeStyle Libre Continuous Glucose Monitor System for Type 2 Diabetes?

Research shows that the FreeStyle Libre system can help people with diabetes better control their blood sugar levels and improve their quality of life by preventing extreme highs and lows in blood sugar. It has been effective in both Type 1 and Type 2 diabetes, helping users manage their condition more effectively. ^{1 2 3 4 5}

Is the FreeStyle Libre Continuous Glucose Monitoring System safe for humans?

The FreeStyle Libre system, used for monitoring glucose levels, has been widely used and studied in people with diabetes, showing it is generally safe for human use. It helps manage blood sugar levels and improve quality of life without significant safety concerns reported in the studies. ^{2 5 6 7 8}

How does continuous glucose monitoring differ from other treatments for type 2 diabetes?

Continuous glucose monitoring (CGM) systems like the FreeStyle Libre provide real-time glucose readings and alerts for abnormal levels, unlike traditional methods that require manual blood sugar checks. This allows for better management of glucose levels and prevention of complications by automatically tracking changes and trends. ^{2 3 5 7 8}

What is the purpose of this trial?

The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. 20 in the treatment arm and 10 in the control. The length of study participation will be 6 months for each participant.

Research Team

Shylaja Srinivasan, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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]

References

1. 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]

2. 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]

3. Japan pubmed.ncbi.nlm.nih.gov

Comparison of glucose monitoring between Freestyle Libre Pro and iPro2 in patients with diabetes mellitus. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. [2022]

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

Clinical Approach to Flash Glucose Monitoring: An Expert Recommendation. [2021]

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

Accuracy of a Flash Glucose Monitoring System in Diabetic Dogs. [2022]

7. 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]

8. 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]