Continuous Glucose Monitoring for Diabetes

Overseen By Michael Goldstein

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: Insulin

Must not be taking: Systemic corticosteroids

Disqualifiers: Home insulin, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two methods of checking blood sugar levels can assist people with diabetes who are new to insulin. Participants will use either a continuous glucose monitor (CGM), which tracks sugar levels continuously, or a traditional blood glucose monitor (BGM), which requires several daily finger pricks. The trial aims to determine which method better manages blood sugar after hospital discharge. It suits individuals with type 1 or type 2 diabetes who have recently begun insulin treatment following a hospital stay. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance diabetes management for many.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants will be new to insulin therapy, so if you are already on insulin, you may not be eligible.

What prior data suggests that continuous glucose monitoring is safe for diabetes patients?

Research has shown that continuous glucose monitors (CGMs) are generally well-tolerated by people with diabetes. These devices continuously track blood sugar levels and help improve health without major safety concerns. One study found the Dexcom G4 PLATINUM CGM effective in monitoring blood sugar trends and patterns. Users of CGMs have reported better diabetes management, with no significant negative effects.

The FDA has approved these monitors for tracking blood sugar, supporting their safety. While minor skin irritation might occur where the device is attached, serious side effects are rare. Overall, CGMs provide a safe option for managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring (CGM) for diabetes because it offers real-time blood sugar tracking, unlike traditional fingerstick glucose monitoring (BGM), which requires multiple daily pricks. CGM devices provide continuous data, allowing for better management of blood sugar levels by alerting users to highs and lows as they happen. This approach not only alleviates the discomfort of frequent fingersticks but also empowers users with more comprehensive insights into their glucose trends, potentially leading to improved diabetes management and quality of life.

What evidence suggests that this trial's treatments could be effective for diabetes?

Research has shown that using a Continuous Glucose Monitor (CGM), one of the treatments studied in this trial, can help people better control their blood sugar levels. One study found that people using a CGM reduced their HbA1c, a measure of long-term blood sugar, by about 0.32%. Another study demonstrated that CGMs help people with diabetes manage their blood sugar more effectively, reducing the risk of both low and high blood sugar episodes. People using CGMs often feel more satisfied with their diabetes management. Overall, CGMs are linked to better health outcomes for those managing diabetes. Meanwhile, this trial will also evaluate the effectiveness of Blood Glucose Monitoring (BGM) as a comparator. ^{1 6 7 8 9}

Who Is on the Research Team?

Michael Goldstein

Principal Investigator

NYU Langone Hospital - Long Island

Are You a Good Fit for This Trial?

This trial is for adults aged 18-100 with type 1 or type 2 diabetes who are starting insulin treatment at NYU Langone Hospital - Long Island between Sep. 2022 and Aug. 2023. It's not for those who used insulin before admission, are on steroids, or pregnant women.

Inclusion Criteria

I have been diagnosed with diabetes.

Admitted to NYU Langone Hospital - Long Island between September 1st, 2022 and August 31st, 2023

I am starting insulin therapy as I leave the hospital.

Exclusion Criteria

I am currently taking corticosteroids.

I use insulin at home before joining the trial.

I am not currently pregnant and understand I will be withdrawn from the study if I become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are assigned to either continuous glucose monitoring (CGM) or blood glucose monitoring (BGM) for 2 weeks

2 weeks

1 visit (in-person) at hospital discharge

Follow-up

Participants have a follow-up visit at 2 weeks for insulin dose adjustment and another at 3 months for HbA1c measurement

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Blood Glucose Monitor
• Continuous Glucose Monitor

Trial Overview The study compares two methods of monitoring blood sugar in new-to-insulin patients after hospital discharge: wearing a continuous glucose monitor (CGM) for two weeks versus using a traditional blood glucose monitor (BGM). Insulin doses will be adjusted based on the results.

How Is the Trial Designed?

Group I: Continuous Glucose Monitoring (CGM) Experimental Treatment 1 Intervention

Patients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration.

Group II: Blood Glucose Monitoring (BGM) Active Control 1 Intervention

Patients in the BGM group will be instructed to check their blood glucose utilizing fingerstick glucose monitoring multiple times daily depending on their insulin regimen for 2 weeks duration.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Abbott Diabetes Care Inc

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

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]

The new continuous glucose monitoring (CGM) system demonstrated strong accuracy over a 10-day period, with a mean absolute relative difference of 9.6%, indicating reliable glucose readings for users.

With 99.6% of measurements categorized as 'no' or 'slight' risk for discrepancies compared to self-monitored blood glucose values, this CGM system supports its use in diabetes management without the need for adjunctive testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. Hughes, J., Welsh, JB., Bhavaraju, NC., et al.[2019]

Continuous glucose monitoring systems provide real-time glucose readings from interstitial fluid, significantly improving diabetes management for both type 1 and type 2 diabetes patients.

These systems help patients and healthcare providers analyze glucose patterns, leading to better glycemic control, reduced hemoglobin A1c levels, and fewer instances of hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring for the Internist. Lee, GS., Lupsa, BC.[2022]

Continuous glucose monitoring (CGM) was analyzed in 53 diabetic patients, primarily those with type 1 diabetes (90.5%), and was found to be effective in detecting asymptomatic hypoglycemic events and guiding therapy changes in 64.5% of cases.

The method provided additional information that improved glycemic control and potentially life expectancy in type 1 diabetes patients, but it was noted to be less effective for type 2 diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. Bagosi, Z., Oroszlán, T., Bujtor, Z., et al.[2022]

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]

Continuous glucose monitoring (CGM) significantly improves diabetes management for insulin-requiring patients, particularly in type 1 diabetes, by providing real-time insights into glycemic fluctuations and allowing for better lifestyle and medication adjustments.

The review highlights that CGM can lead to improved hemoglobin A1c (A1C) levels, reduced hypoglycemia, and enhanced quality of life, suggesting its potential benefits for broader patient populations with proper education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: A review of the technology and clinical use. Klonoff, DC., Ahn, D., Drincic, A.[2022]

Continuous glucose monitoring (CGM) technology allows for real-time tracking of glucose levels, helping users manage their blood sugar more effectively without increasing the risk of hypoglycemia.

Key challenges for CGM include ensuring sensor accuracy, reliability, and comfort, which are essential for advancing towards artificial pancreas systems that automate blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. DeSalvo, D., Buckingham, B.[2022]

The novel noninvasive Aprise sensor demonstrated a mean relative absolute difference (RAD) of 19.9% in tracking glucose levels in 62 subjects with diabetes, indicating its potential effectiveness in monitoring glucose excursions.

The sensor showed a high percentage of readings (66.5%) within the clinically acceptable ranges (A and B) on the Clarke error grid, suggesting it could enhance patient compliance and diabetes management compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive continuous glucose monitoring using photoacoustic technology-results from the first 62 subjects. Weiss, R., Yegorchikov, Y., Shusterman, A., et al.[2016]

Continuous glucose monitoring (CGM) devices are now widely available in the U.S. for both consumer purchase and research, providing a new tool for diabetes management.

CGM technology allows for real-time monitoring of glucose levels, which can help individuals manage their diabetes more effectively, as well as enabling retrospective analysis of glucose data for better long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical overview of continuous glucose monitoring. Buckingham, B.[2021]

Continuous Glucose Monitoring (CGM) devices, including real-time (rtCGM) and intermittently scanned (isCGM), significantly improve glucose control and reduce hypoglycemia in insulin-treated individuals with diabetes, based on recent clinical evidence.

An updated algorithm was developed to help healthcare providers choose the most suitable CGM device for different clinical scenarios, such as type 1 and type 2 diabetes, pregnancy, and frailty, ensuring a personalized approach to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. Maiorino, MI., Buzzetti, R., Irace, C., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460137/

The Effectiveness of Continuous Glucose Monitoring ... The results of our study demonstrated that the adoption of CGM device leads to significant improvements in glycemic control, as evidenced by a ...

2. 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%.

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

Continuous Glucose Monitoring (CGM) With a CGM, one can see in real time if they're trending high or low and take preventative measures against hypoglycemia (low blood glucose) and hyperglycemia ( ...

4. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.24255

Initiating continuous glucose monitoring is associated with ... This study showed that CGM use in patients with diabetes was associated with clinically meaningful improvements in A1c and reduced health care resource ...

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8861781/

Demonstrating the Clinical Impact of Continuous Glucose ... Data from this study demonstrated that a CGM device improved patient health, decreased utilization, and reduced PMPM cost in a cohort of patients with diabetes.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/P120005S018b.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4014941/

Continuous glucose monitoring system: Is it really accurate ... It was true for adults with type 1 diabetes as well as type 2 diabetes. No significant effect was noted in children and adolescents. There was no significant ...

9. 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.