Continuous Glucose Monitoring for Diabetes

Overseen By Ilias Spanakis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Insulin

Must not be taking: Glucocorticosteroids

Disqualifiers: Type 1 DM, Pregnant, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called the Glucose Telemetry System (GTS) to help manage diabetes in hospitalized patients. The goal is to reduce the risk of hypoglycemia, a dangerous drop in blood sugar that can cause seizures or other serious issues. The trial compares the GTS, which sends blood sugar readings directly to nurses, with standard finger-stick testing. Veterans with type 2 diabetes who use insulin and are at risk for low blood sugar may be a good fit for this study. As an unphased trial, this study offers participants the opportunity to contribute to innovative diabetes management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it includes Veterans with type 2 diabetes managed with insulin, so you may continue insulin treatment.

What prior data suggests that the Glucose Telemetry System is safe for continuous glucose monitoring in hospitalized patients?

In a previous study, the Glucose Telemetry System (GTS) showed promise in helping people with type 2 diabetes manage their blood sugar levels in hospitals. Research shows that real-time continuous glucose monitoring (CGM) systems like GTS can reduce episodes of low blood sugar, which are linked to serious health issues.

Studies have found that CGM devices are generally safe and easy to use. For example, one study found that these devices accurately measure blood sugar levels, reliably tracking glucose without causing major problems.

While CGM systems have been available for some time, they are now being tested in various settings, such as hospitals, to improve patient care. This ongoing research helps ensure these devices are safe for wider use. So far, evidence suggests they are effective and safe for monitoring blood sugar in hospital patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of the Glucose Telemetry System (GTS) for continuous glucose monitoring in hospitalized patients with Type 2 Diabetes (DM2). Unlike standard care, which typically relies on periodic finger-stick blood glucose checks, GTS offers real-time monitoring and alerts for low glucose levels. This continuous approach may help prevent hypoglycemia more effectively by allowing for timely interventions. By comparing GTS with traditional point-of-care methods, researchers hope to find out if continuous monitoring can improve patient safety and outcomes.

What evidence suggests that the Glucose Telemetry System is effective for reducing hypoglycemia in hospitalized diabetics?

Research has shown that using a Continuous Glucose Monitoring (CGM) system can greatly reduce the risk of dangerously low blood sugar in people with Type 2 Diabetes. One study found that patients using CGM spent 21% less time with low blood sugar compared to those using traditional methods. Another study demonstrated that CGM users experienced far fewer low blood sugar incidents than those using standard testing methods. In this trial, the Glucose Telemetry System (GTS), a type of CGM system, is tested in the intervention group. These findings suggest that CGM systems, like the GTS being tested, could effectively lower the risk of low blood sugar in hospitalized patients with diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Ilias Spanakis, MD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

This trial is for Veterans with type 2 diabetes managed with insulin, admitted to the Baltimore VA Medical Center, and have at least one risk factor for low blood sugar. It's not for those staying in the hospital less than 3 days, pregnant women, diet-managed diabetics, type 1 diabetics or those on high-dose steroids.

Inclusion Criteria

I am a veteran with type 2 diabetes managed with insulin, at risk of low blood sugar.

Exclusion Criteria

I am a veteran taking steroids equivalent to 20 mg of hydrocortisone daily.

I am a veteran with type 1 diabetes.

Veterans that are expected to require a hospital stay <3 days will also be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are monitored with the Glucose Telemetry System (GTS) and Point of Care (POC) finger-stick blood glucose levels with application of hypoglycemia prevention protocol

4-6 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GTS

Trial Overview

The study tests a new Glucose Telemetry System (GTS) that wirelessly sends glucose levels from a patient's bedside to a monitor at the nursing station. The aim is to reduce low blood sugar incidents and improve outcomes in hospitalized diabetic patients.

How Is the Trial Designed?

Group I: Intervention group (Continuous Glucose Monitroring and POC) Active Control 2 Interventions

Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS) and Point of Care (POC) finger-stick blood glucose levels with application of hypoglycemia prevention protocol (activated based the GTS lower glucose alarms)

Group II: Control group (Point of Care-POC) Placebo Group 1 Intervention

Hospitalized patients with DM2 will be monitored with POC blood glucose levels and application of hypoglycemia prevention protocol (activated based the POC values)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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 telemetry glucose monitoring system developed for diabetic patients showed significantly lower noise levels in glucose readings compared to traditional wired systems, enhancing the accuracy of glucose monitoring.

Continuous monitoring over 77 hours in five diabetic subjects demonstrated a strong correlation between subcutaneous tissue glucose and plasma glucose levels, indicating the system's effectiveness for maintaining strict glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemetry glucose monitoring device with needle-type glucose sensor: a useful tool for blood glucose monitoring in diabetic individuals. Shichiri, M., Asakawa, N., Yamasaki, Y., et al.[2019]

The Eversense continuous glucose monitoring (CGM) system, which features a fully implantable sensor with a lifespan of up to 180 days, has shown a mean absolute relative difference (MARD) of 8.5% to 9.4%, indicating good accuracy in glucose monitoring.

Clinical trials reported no serious device-related adverse events, with minor issues such as site irritation (0.66%) and infection (0.96%), suggesting that the Eversense system is safe for long-term use in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy. Irace, C., Cutruzzolà, A., Tweden, K., et al.[2022]

The continuous glucose monitoring system (CGMS) demonstrated high test-retest reliability in measuring glucose levels in individuals with type 2 diabetes, with relative reliability scores ranging from 0.77 to 0.95 for various glycemic measures.

Specific measures of glycemic variability, such as standard deviation (SD(w)) and mean amplitude of glycemic excursions (MAGE), showed significant reliability, indicating that CGMS can be effectively used in clinical trials for monitoring glucose levels over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-retest reliability of a continuous glucose monitoring system in individuals with type 2 diabetes. Terada, T., Loehr, S., Guigard, E., et al.[2022]

In a study analyzing 34 continuous glucose monitoring data sets over 112 nights, it was found that adding calibration during the dawn period (1:00 to 5:00 AM) did not improve the accuracy of glucose readings.

The analysis included 289 paired readings, and the results indicated that the relative absolute difference in glucose measurements remained consistent regardless of whether dawn calibration was used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring system: dawn period calibration does not change accuracy of the method. Augusto, GA., Sousa, AG., Perazo, MN., et al.[2019]

Continuous glucose monitoring (CGM) is becoming a standard tool for managing type 1 diabetes, with advancements that may lead to its integration into closed-loop artificial beta-cell systems.

The review highlights the accuracy and performance of the two currently approved CGM devices, discussing their clinical trial results, limitations, and best practices for use in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in type 1 diabetes. Weinzimer, SA., Tamborlane, WV., Chase, HP., et al.[2019]

In a pilot study involving 53 insulin-requiring diabetes patients, the use of a continuous glucose monitoring (CGM) system significantly improved the time in range (TIR) for patients with type 2 diabetes and those hospitalized for acute complications, indicating better glucose control during hospitalization.

The CGM system was well accepted by patients and caregivers, with 94% finding it useful, suggesting that it could enhance both metabolic control and therapeutic education in diabetes care units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Real-Time Continuous Glucose Monitoring Telemetry System in an Inpatient Diabetes Unit: A Pilot Study. Dillmann, C., Amoura, L., Fall Mostaine, F., 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]

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]

In a study involving 22 healthy volunteers, the Medtronic continuous glucose monitoring sensor was inserted for 9 days, revealing only minor local adverse events such as itching and redness, with no serious complications leading to sensor withdrawal.

The findings suggest that the current FDA-approved 3-day insertion period for the sensor may be unnecessarily short, as the sensor function remained stable beyond this period, indicating a potential for extended use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurence of adverse events due to continuous glucose monitoring. Jadviscokova, T., Fajkusova, Z., Pallayova, M., et al.[2019]

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]

In a study involving 72 insulin-treated patients with type 2 diabetes, the use of real-time continuous glucose monitoring (RT-CGM) significantly reduced the number of hypoglycemic events compared to traditional point-of-care testing, with fewer patients experiencing low blood sugar levels.

The RT-CGM group not only had fewer overall hypoglycemic events but also experienced less time spent in dangerously low glucose ranges, demonstrating its potential as a safer monitoring method for high-risk patients in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial. Singh, LG., Satyarengga, M., Marcano, I., et al.[2021]

Continuous glucose monitoring (CGM) is a groundbreaking technology for diabetes management, providing real-time blood glucose levels and helping to reduce the risk of hypoglycemia.

CGM not only allows for immediate adjustments in insulin, diet, or exercise but also aids in identifying undetectable hypoglycemic events, particularly during sleep, which can significantly enhance long-term diabetes treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Continuous monitoring of tissue glucose]. Bendzala, M., Ocadlík, I., Krahulec, B.[2010]

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]

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When compared with control subjects, the CGM group spent 21% less time in hypoglycemia (<55 mg/dL), 23% less time in hyperglycemia (≥240 mg/dL), and 26% more ...

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diabetesjournals.org

diabetesjournals.org/care/article/48/1/118/157491/Results-From-a-Randomized-Trial-of-Intensive

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A comparison of continuous glucose monitors (CGMs) in ...

Herein, is an evaluation of currently available CGMs with an examination of their reported effectiveness for better monitoring and controlling of DM. Advocacy ...

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Compared with point-of-care monitoring, patients receiving CGM had significantly fewer hypoglycemic events (blood glucose, <70 mg/dL; ≈1 fewer ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04269655

Scripps Digital Diabetes: Cloud-Based Continuous ...

Aim 2: To evaluate the effectiveness of CB CGM versus UC in decreasing % time in hypoglycemia (<70 mg/dL) and severe hyperglycemia (>300 mg/dL).

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clinicaltrials.gov

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The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and ...

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diabetesjournals.org

diabetesjournals.org/care/article/43/11/2736/35755/Reducing-Inpatient-Hypoglycemia-in-the-General

The Glucose Telemetry System, a Randomized Clinical Trial

RT-CGM/GTS can decrease hypoglycemia among hospitalized high-risk insulin-treated patients with type 2 diabetes.

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In one single-center observational study performed during hospital admission, they reported good accuracy with MARD of 12.7% after x-ray and computed tomography ...

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thelancet.com/journals/lanwpc/article/PIIS2666-6065(24)00061-0/fulltext

Real-time continuous glucose monitoring-guided ...

In patients with diabetes who received short-term CSII during hospitalization, the rtCGM program resulted in better glucose control than the POC ...