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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Continuous Glucose Monitoring for Diabetes?

Continuous glucose monitoring (CGM) helps people with diabetes better manage their blood sugar levels by providing continuous information about glucose levels, which can lead to improved control without increasing the risk of low blood sugar. Studies show that CGM can reduce hemoglobin A1c (a measure of average blood sugar over time) and help prevent hypoglycemia (low blood sugar) in patients with type 1 and type 2 diabetes. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

Continuous glucose monitors (CGMs) have been used safely in people with diabetes, including children, allowing them to participate in normal activities like sports. However, there were 281,963 adverse events reported in 2022, indicating that while generally safe, some users may experience issues. ^{3 6 7 8 9}

How is continuous glucose monitoring different from other diabetes treatments?

Continuous glucose monitoring (CGM) is unique because it provides real-time, continuous tracking of glucose levels, offering a more complete picture of glucose fluctuations compared to traditional methods. It includes features like alarms for high or low glucose levels and helps improve glucose control without increasing the risk of low blood sugar. ^{1 3 5 10 11}

What is the purpose of this trial?

The proposed study will be a randomized, prospective, non-blinded study of 120 participants with type 1 or type 2 diabetes that are new-to-insulin on hospital discharge. On hospital discharge, participants will be assigned to either the intervention of wearing a continuous glucose monitor (CGM) for 2 weeks or blood glucose monitoring (BGM) for 2 weeks. They will have a 2-week follow up visit, during which insulin doses will be adjusted as needed, and a 3-month follow-up visit, at which point HbA1c will be measured.

Research Team

Stanislaw Klek

Principal Investigator

NYU Langone Hospital - Long Island

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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 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 (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]

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]

References

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

Continuous Glucose Monitoring for the Internist. [2022]

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

Noninvasive continuous glucose monitoring using photoacoustic technology-results from the first 62 subjects. [2016]

3. Ireland pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: A review of the technology and clinical use. [2022]

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

Accuracy of the modified Continuous Glucose Monitoring System (CGMS) sensor in an outpatient setting: results from a diabetes research in children network (DirecNet) study. [2018]

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

Continuous glucose monitoring: current use and future directions. [2022]

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

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

7. United States 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. [2009]

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

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. [2019]

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

Clinical overview of continuous glucose monitoring. [2021]

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

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]

11. Hungary pubmed.ncbi.nlm.nih.gov

[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. [2022]