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

244 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new system called the Glucose Telemetry System (GTS) that sends blood sugar levels from a patient's bedside to a monitor at the nurse's station. It aims to help hospitalized Veterans with diabetes by preventing dangerously low blood sugar levels. The system allows nurses to keep track of patients' blood sugar without entering the room often. A new system has been developed to monitor blood sugar levels in diabetic patients.

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 data supports the effectiveness of the treatment GTS, Continuous Glucose Monitoring Devices, Glucose Telemetry System for diabetes?

Continuous glucose monitoring (CGM) is shown to help people with diabetes better control their blood sugar levels by providing frequent glucose readings, which can reduce hemoglobin A1c (a measure of average blood sugar over time) and prevent low blood sugar episodes. The use of CGM systems has been beneficial for both type 1 and type 2 diabetes patients, offering detailed glucose data that helps manage their condition more effectively. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

Continuous glucose monitoring (CGM) systems have been evaluated for safety, with some adverse events reported. In 2022, there were 281,963 adverse events related to CGMs, but specific studies have shown that systems like the Eversense CGM and Medtronic MiniMed are generally safe for use in managing diabetes, including in children and during regular activities. ^{6 7 8 9 10}

How does continuous glucose monitoring differ from other diabetes treatments?

Continuous glucose monitoring is unique because it provides real-time glucose readings from the interstitial fluid every few minutes, allowing for immediate adjustments in insulin, diet, or activity. This system helps reduce the risk of hypoglycemia (low blood sugar) and provides detailed glucose patterns, unlike traditional methods that only offer snapshot readings. ^{2 11 12 13 14}

Research Team

Ilias Spanakis, MD

Principal Investigator

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

Eligibility Criteria

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 with type 1 diabetes.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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) 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]

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 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 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]

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]

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]

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 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]

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]

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

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

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

Continuous Glucose Monitoring for the Internist. [2022]

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

Continuous glucose monitoring in type 1 diabetes. [2019]

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

Feasibility of Real-Time Continuous Glucose Monitoring Telemetry System in an Inpatient Diabetes Unit: A Pilot Study. [2022]

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

Test-retest reliability of a continuous glucose monitoring system in individuals with type 2 diabetes. [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

Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial. [2021]

9. England 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. [2022]

10. Czech Republic pubmed.ncbi.nlm.nih.gov

Occurence of adverse events due to continuous glucose monitoring. [2019]

11. Brazil pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring system: dawn period calibration does not change accuracy of the method. [2019]

12. Czech Republic pubmed.ncbi.nlm.nih.gov

[Continuous monitoring of tissue glucose]. [2010]

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

Telemetry glucose monitoring device with needle-type glucose sensor: a useful tool for blood glucose monitoring in diabetic individuals. [2019]

14. Hungary pubmed.ncbi.nlm.nih.gov

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