Continuous Glucose Monitoring for Diabetes

No longer recruiting at 29 trial locations

Overseen By Carla Demeterco-Berggren, M.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Diabetes

Must not be taking: Dexamethasone, Hydroxyurea, Pramlintide, others

Disqualifiers: Seizure disorder, Pregnancy, Cardiovascular events, 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: Unknown

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new continuous glucose monitor for individuals with diabetes. Participants will wear the device for 7-14 days to assess its accuracy in tracking blood sugar levels. The trial seeks individuals who have had type 1 or type 2 diabetes for at least six months and are comfortable with fingerstick blood tests. As an unphased trial, this study provides participants the chance to contribute to advancements in diabetes management technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have type 1 diabetes and are using pramlintide, DPP-4 inhibitors, GLP-1 receptor agonists, metformin, or SGLT2 inhibitors, you cannot participate. Also, if you are using hydroxyurea, you cannot join the study.

What prior data suggests that this continuous glucose monitoring system is safe for people with diabetes?

Research has shown that continuous glucose monitors (CGMs) are generally safe for people with diabetes. The FDA has approved CGMs for managing diabetes, confirming they meet safety standards. Studies indicate that CGMs help people with diabetes control their blood sugar levels more effectively, leading to greater satisfaction with their diabetes management. Importantly, these studies have not reported any major safety issues, suggesting that CGMs are well-tolerated. Many users find CGMs helpful in preventing low blood sugar episodes, a common concern for those with diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring for diabetes because it offers real-time insights into blood sugar levels without the need for frequent finger-pricking, which is a standard method used in managing diabetes. Unlike traditional blood glucose meters, continuous glucose monitors like the DS5 provide ongoing data, allowing for more precise and personalized management of diabetes. This approach can lead to improved blood sugar control, potentially reducing the risk of long-term complications and enhancing the quality of life for individuals with diabetes.

What evidence suggests that this continuous glucose monitoring system is effective for diabetes?

Research shows that continuous glucose monitoring (CGM) can help people with diabetes maintain stable blood sugar levels. Studies have found that CGM can reduce HbA1c levels, a key measure of blood sugar control, by about 0.32%, leading to better overall diabetes management. Many CGM users report greater satisfaction with their condition management. Various trials and studies have demonstrated significant health benefits from CGM, making it a promising option for those with diabetes. Participants in this trial will use the DS5 device for 7-14 days to evaluate its effectiveness. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people aged 11-80 with either type 1 or type 2 diabetes. It's designed to test a new continuous glucose monitor over a period of 7-14 days.

Inclusion Criteria

Subject or parent(s)/guardian(s) is/are literate and able to read the language offered in the study materials

Subject and/or legally authorized representative is willing to provide informed consent for participation

Is willing to perform fingerstick blood glucose measurements as needed

Exclusion Criteria

Has had a hypoglycemic seizure within the past 6 months prior to screening visit

Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment

Has a history of allergy to dexamethasone or has been told by health care provider they may not take any products containing dexamethasone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear the continuous glucose monitor for 7-14 days to test its performance

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitoring

Trial Overview Participants will use the next generation sensors (NGS) and algorithm that are part of a new continuous glucose monitoring system, which helps track blood sugar levels in real-time.

How Is the Trial Designed?

Group I: Subjects with diabetes wearing DS5 Experimental Treatment 1 Intervention

Subjects wearing DS5 over 7-14 days and participating in FSTs

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

Approved in United States as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in European Union as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes
• Gestational diabetes

Approved in Canada as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Japan as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Who Is Running the Clinical Trial?

Medtronic Diabetes

Lead Sponsor

Trials

73

Recruited

11,800+

Geoff Martha

Medtronic Diabetes

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kweli Thompson

Medtronic Diabetes

Chief Medical Officer since 2022

MD from Harvard Medical School

Published Research Related to This Trial

The user-calibrated real-time continuous glucose monitoring (rt-CGM) system demonstrated superior accuracy compared to the factory-calibrated flash glucose monitoring (FGM) system, with a mean absolute relative difference of 9.7% for rt-CGM versus 17.5% for FGM, indicating better performance in tracking blood glucose levels.

Despite the higher accuracy of rt-CGM, both systems were generally perceived as easy to use and helpful for managing diabetes, although cost concerns limited the willingness of participants to adopt either device for continuous monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A head-to-head comparison between Guardian Connect and FreeStyle Libre systems and an evaluation of user acceptability of sensors in patients with type 1 diabetes. Yeoh, E., Png, D., Khoo, J., 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 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]

Flash continuous glucose monitoring (CGM) provides real-time glucose level information, helping individuals with diabetes prevent hypoglycemia and hyperglycemia, which is crucial for effective glycemic control.

Recent real-world studies have shown that flash CGM not only improves clinical outcomes for patients with type 1 and type 2 diabetes but also enhances healthcare resource utilization, indicating its practical benefits beyond controlled trial settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flash Continuous Glucose Monitoring: A Summary Review of Recent Real-World Evidence. Bailey, CJ., Gavin, JR.[2022]

The new continuous glucose monitoring system (CGMS) was well tolerated by 20 children with type 1 diabetes over 7 days, with 90% of sensors still in use at the end of the study, indicating good patient acceptance and safety.

The study found that the CGMS could effectively function beyond the typical 72-hour limit, with 78% of sensors still operational after 7 days, suggesting that the device can provide extended monitoring without significant loss of accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended use of a new continuous glucose monitoring system with wireless data transmission in children with type 1 diabetes mellitus. Wong, LJ., Buckingham, BA., Kunselman, B., et al.[2009]

Flash continuous glucose monitoring (CGM) offers an affordable and user-friendly option for patients, allowing them to scan a sensor for real-time glucose data, which can help in adjusting therapy and understanding glucose patterns.

Increased scanning frequency with flash CGM is linked to better glycemic control, showing more time spent in the target glucose range and less time in hyperglycemia and hypoglycemia, highlighting its potential benefits for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flash Continuous Glucose Monitoring: Implications for Use of Continuous Data in Daily Diabetes Management. Hirsch, IB., Nardacci, E., Verderese, CA.[2020]

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

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]

New 'flash' continuous glucose monitoring (CGM) technology is emerging as a more affordable and user-friendly option for diabetes management, potentially increasing its accessibility for patients.

This novel CGM approach aims to provide continuous data that can be used more routinely in primary care settings, enhancing daily diabetes management for a larger number of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Flash Continuous Glucose Monitoring in Primary Practice. Hirsch, IB., Wright, EE.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37987208/

Effectiveness of Continuous Glucose Monitoring on Metrics ... Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%.

2. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) CGMs continually monitor your blood glucose (blood sugar), giving you real-time updates through a device that is attached to your body.

3. e-enm.org e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ... Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.

4. diabetesjournals.org diabetesjournals.org/clinical/article/43/3/399/158023/Impact-of-Continuous-Glucose-Monitoring-Sourcing

Impact of Continuous Glucose Monitoring Sourcing on Real ... Numerous randomized trials and real-world retrospective studies have demonstrated significant clinical benefits of continuous glucose monitoring ...

5. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.10-b.s30

Using continuous glucose monitoring to measure and ... The Glucose Management Indicator can be used as a measure of glucose control. This article discusses the benefits of value-based care, the importance of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12007415/

Transformative Advances in Continuous Glucose ... Continuous glucose monitoring (CGM) has significantly advanced diabetes management, evolving from early glucose testing methods to modern, FDA‐approved systems.

7. diabetesjournals.org diabetesjournals.org/care/article/47/1/169/154009/Efficacy-and-Safety-of-Continuous-Glucose

Efficacy and Safety of Continuous Glucose Monitoring and ... Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

8. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-101/pros-cons-of-cgm

CGM l Pros and Cons of Continuous Glucose Monitors ... It enhances hypoglycemia prevention, improves glycemic control, and allows for proactive treatment decisions. 2. Is CGM useful for people with Type 2 Diabetes ...