• Created by Unknown User (kasperik), last modified on 6.10.2017

Louis Osarogiagbon and Kasperi Kilpi           

Introduction

Diabetes is a chronic autoimmune disease, which make the body of the sufferer unable to produced or properly use up insulin. In the United States of American, there are over 30.3 million sufferers and it is the seventh leading cause of death and number 1 leading cause of kidney failure, lower limb amputations and adult-onset of blindness. Estimated direct and indirect cost of treatment was 245 billion dollars in 2012 an average cost of between $13,700 to $7,900 for each patient (Centers for Disease Control and Prevention, 2017.) While in Europe, there are estimated 53 million adults living with diabetes and the cost of treatment -excluding the complications such as kidney failure, heart disease, amputation etc. - is estimated to cost 9 % of total health expenditure of European countries (International Diabetes Federation Europe & Primary Diabetes Care Europe, 2011.) There are currently no known cures for diabetes diseases. Therefore, proper monitoring of the level of glucose in the blood is fundamental, if the patient is to stay healthy and avoid life-threatening complications that might result from uncontrolled diabetes disease (CDC, 2017.) According to Ginsberg Barry H (2007) blood glucose monitoring is of paramount importance for four reasons: (a) it informs the patient of how much medication (self-adjust insulin) is needed; (b) it provides rough data to the patient on how much they are doing to avoid for example hypoglycemia; (c) it reminds them to change their behaviour to meet their medical need; and (d) it provides data for health care providers to make necessary adjustment of mediation regimen of the patient. The severity of the disease, its prevalence and estimated effects across the globe, highlighted our keen interest in the disease and one of the most modern tools to control the impact.

How does Dexcom 5G Mobile CGM work

Can the monitoring device Dexcom G5 Mobile Continuous Glucose Monitoring System (Dexcom G5 Mobile CGM) revolutionize glucose monitoring and set the standard in the near future? Dexcom G5 CGM is the first real-time glucose trends detecting device for adults and children 2 years and older with diabetes. The aim is to detect hyperglycemia (glucose levels too high) and hypoglycemia (glucose levels too low) in real-time with alerts and to help patients to make treatment decisions for example, administer insulin or carbohydrates. It will also facilitate long-time therapy for patients by helping them to determine the patterns in glucose levels. (United States, Food and Drug Administration, FDA 2017.) Dexcom G5 CGM needs prescription and is intended for a single patient use. It consists of a small flexible metal wire sensor (worn subcutaneously for up to 7 days), a transmitter (externally-worn) and a dedicated receiver and/or compatible mobile device. The sensor will respond to the amount of sugar by generating a small electrical signal, which the transmitter will then collect as a glucose value. The transmitter will send the collected values and trends to the receiver every 5 minutes via Bluetooth connection. Before that user must download the application from Android Market or from iTunes App Store and create Dexcom account. Then connect the receiver/mobile device with the transmitter and insert the sensor under the skin. After that user can start receive glucose information. (Dexcom 2017.)

Use and safety

It is important to know that the transmitter and sensor must be removed before MRI, CT scan or diathermy treatment and if medications with acetaminophen is in use while wearing the Dexcom G5, glucose readings may falsely raise (Dexcom 2017). For proper user safety, the equipment must always be in good condition and the system must be calibrated every 12 hours by using a fingertip blood sample. The system will start show glucose values only after 2 hours from startup. If the system does not show glucose values, user must always take fingertip blood sample and make the treatment decision according to that value. User must also never ignore high or low glucose symptoms despite that the system shows normal glucose values. The system has not been tested with pregnant women and with persons in dialysis so the glucose readings may be inaccurate. (Dexcom 2017.)

Dexcom G5 Pros and Cons

Pros

  • Dexcom G5 Mobile CGM will enable patients to see their glucose reading and trends at all times in real-time.
  • In addition to the primary smart device, glucose data can be shared with up to five people utilizing the Dexcom Follow App. This helps parents and caregivers to follow their kids or patients' blood glucose levels at all times.
  • The trend graph is simple to use and view in addition, the user can see individual glucose values by scrolling the finger over the graph.
  • The trend arrow shows when the glucose levels may be going low or going high.

Cons

  • The transmitter range for the Bluetooth connectivity is only about 3m so the receiver must be in that range to maintain the connection with the transmitter.
  • Transmitter's battery lasts only about 3 months and new one must be ordered every time through Dexcom web page. This can cause problems for the user if he/she forget to order new transmitter on time.
  • If user's phone runs out of battery power, there will be no way to receive data from the transmitter. Also, the Bluetooth connection consumes a lot of phone battery.
  • Bluetooth connection is not so reliable.
  • Still fingertip blood sample need to be taken and calibrated every 12 hours.

Future views

According to David Rodbard (2017) the use of continuous glucose monitoring devices are now reliable in reducing the hypoglycemia and hyperglycemia. Furthermore, they have improved patients quality of lives across wide range of patient population. Continuous glucose monitoring is having a remarkable success in reducing HbA1c glucose level. Real-time glucose monitoring (RT-CGM) provides diabetes management tools for patient with type 1 and type 2 diabetes by giving them valuable information to make and sustain healthy lifestyle choices. The provision of RT-CGM every 5 minutes for patient with type 2 diabetes who are generally not good at monitoring their diabetes level. This patient group using RT-CGM were able to reduce the time they spent-on hyperglycemia (23%), hypoglycemia (21%) and they have reduced level of HbA1c compare to patient using Self-monitoring blood glucose. Glycemic variability has adverse effects on: endothelial tissue function, cognitive functions, retinopathy and cardiovascular system but with Dexcom 5G constant RT-CGM, these dangers can be avoided and minimized. On the disadvantage side, Dexcom 5G requires twice daily calibrations and alarm fatigue can develop which lead to some users completely ignoring the warnings ( Fonda S., J, Salkind S., Vigersky A. R. Walker M. S. 2012.) The increase in the level of accuracy, user friendliness, reliability and the ability to share, monitor data. These highlight the future prospects RT-CGM which some health care providers see as the "artificial pancreas systems" have come to stay ( Balo Andrew K, Bhavaraju Naresh C., Hughes J., Vanslyke Stephen J., & Welsh John B. 2017.)
In conclusion, we strongly believe most of the studies given above that the Dexcom G5 Mobile CGM is a reliable device. Which is going to further improve the relationship between health care providers and patients. By providing continuous real-time raw data to health care providers the connection between patient and care provider will be strengthen. Dexcom G5 is the pacesetter in taking patients and nurses into the future in a new direction of artificial pancreas, providing real-time solution to diabetes disease.

References

About diabetes: Available at <https://www.cdc.gov/diabetes/basics/diabetes.html> accessed 29 September 2017.

Balo, A., K., Bhavaraju, N. C., Hughes J., Vanslyke, S. J., & Welsh, J. B., (2017) Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. Diabetes Technology & Therapeutics: Volume 19(3)

Dexcom wep page. Available at <https://www.dexcom.com/fi-FI> Accessed 30 September 2017.

Fonda S., J, Salkind S., Vigersky A. R. Walker M. S. (2012) Advantages and Disadvantages of Realtime Continuous Glucose Monitoring in People with Type 2 Diabetes.

National Diabetes Statistics Report, 2017 Estimates of Diabetes and Its Burden in the United States. Available at <https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf> Accessed 29 September 2017.

Product Classification. Available at <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=MDS> accessed 27 September 2017.

Rodbard, D. (2017) Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes. Diabetes Technology & Therapeutics: Volume 19(3).

The Policy Puzzle: Is Europe Making Progress. Available at <https://ec.europa.eu/health/sites/health/files/major_chronic_diseases/docs/policy_puzzle_2011.pdf>accessed> Accessed 27 September 2017.

U.S. Food & Drug Administration (FDA). Recently-Approved Medical Devices. <https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm533969.htm> Accessed 2 October 2017.

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