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For this paper you will be researching and discussing an innovation in digital health that has achieved positive results in improving patient care delivery, outcomes and patient, family and provider satisfaction.
Your paper will consist of the following criteria:
1. Introduction of product including
a. Manufacturer
b. Length of time on the market
c. Targeted patient population
d. Functionality
e. Cost – is it covered by insurers, Medicare/Medicaid?
f. Is it grant funded?
g. Device approval obtained through which regulatory or governmental entity.
2. Literature review and synthesis (3-5 peer-reviewed journals). Per the literature:
a. Discuss research studies completed on device
b. What social determinants of health care are addressed by the technology?
c. Discuss patient outcomes
3. Pros and Cons of the Technology including competition from other manufacturers
4. Plans for expanded use. Provide rationale to support expansion or non-expansion
5. Summary
2 plus 3 peer review articles less than 5 years old. Plagiarism report%
Ng, Y., Alexander, S., Frith, K. (2018). Integration of mobile health applications in health information technology initiatives: Expanding opportunities for nurse participation in population health. Computers, Informatics, Nursing, 36(5), 209-213.
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Rubeis, G., Schochow, M., & Steger, F. (2017). Patient autonomy and quality of care in telehealth care. Science and Engineering Ethics, 24, 93-107. doi.org/10.1007/s11948-017-9885-3
Freestyle Libre Flash Glucose Monitoring System
- Introduction of Product
- Manufacturer
The Freestyle Libre 14 Day Flash Glucose Monitoring System is a system for monitoring the level of glucose in adult persons to decide effectively about its management without getting a blood sample. The system is manufactured by Abbott Diabetes Care Inc, which is also the organization that applied for PMA.
- Length of Time on the Market
The FDA approved the system on July 23, 2018, which means that it has been in the market since them. The approval means that the product is safe and effective and can be marketed for consumption.
- Targeted Patient Population
The target population for the product are diabetic adults (18 years and older), who require it to monitor their glucose level without necessarily having to draw a blood sample from their fingertips.
- Functionality
The product has a glucose sensor, won externally that continuously monitors the level of glucose and displays the value for the person to see. The information is displayed following an action (scan) initiated by the user.
- Cost
Following approval, the product is available through prescription at approved pharmacies, but it is yet to be covered by insurers. Each 10-day sensor costs a minimum of $35.99.
- Funding
The product is commercial, manufactured by Abbott Diabetes Care Inc. for availability in the market.
- Device Approval
The Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) approved the system for marketing and safe usage.
- Literature Review and Synthesis
- Discussion of Research Studies
Paris et al. (2018) reveal an increase in the popularity of FSL among patients with type 1 diabetes and its association with minimal hypoglycaemic events. Garg and Akturk (2017) suggest that the new system is more accurate and costs less than previous CGM systems to provide better glucose level monitoring. Mancini et al. (2020) concluded that FGM is significant and has a vast potential in type 1 diabetes management since it helps in metabolic control and prevents more severe and chronic complications.
- Social Determinants of Health Care
The technology addresses various social determinants of health, such as access to health care services, social support, and socio-economic conditions that hinder access to quality care. The system improves the opportunity for nurses and other care providers to work with patients and gives patients greater control over their health (Rubeis, Schochow, & Steger, 2017; Ng, Alexander, & Frith, 2018).
- Patient Outcomes
The Freestyle Libre 14 Day Flash Glucose Monitoring System has improved the accuracy, speed and the cost of monitoring levels of glucose in type 1 diabetes.
- Pros and Cons of the Technology
Unlike other continuous glucose monitoring (CGM) systems, the Freestyle Libre 14 Day Flash Glucose Monitoring System eliminates the need for the daily finger‐stick (Paris et al., 2018). However, unlike the past systems that draw blood samples, the product is restricted from specific populations, such as critically-ill patients, pregnant women and individuals on dialysis.
- Plans for Expanded Use
Expansion plans include making the system applicable to the pediatric population since it is currently approved for use by individuals 18 years and above.
- Summary
The Freestyle Libre 14 Day Flash Glucose Monitoring System is an innovative technology that will improve glucose monitoring to support self-care and disease management. The system can improve patient outcomes for those with diabetes to prevent adverse outcomes, such as severe and chronic eventualities.
References
Garg, S. K., & Akturk, H. K. (2017). Flash glucose monitoring: the future is here. 19:S1‐S3.
Mancini, G., Berioli, M. G., Santi, E., Rogari, F., Toni, G., Tascini, G., … & Esposito, S. (2018). Flash glucose monitoring: a review of the literature with a special focus on type 1 diabetes. Nutrients, 10(8), 992.
Ng, Y., Alexander, S., Frith, K. (2018). Integration of mobile health applications in health information technology initiatives: Expanding opportunities for nurse participation in population health. Computers, Informatics, Nursing, 36(5), 209-213.
Paris, I., Henry, C., Pirard, F., Gérard, A. C., & Colin, I. M. (2018). The new FreeStyle libre flash glucose monitoring system improves the glycaemic control in a cohort of people with type 1 diabetes followed in real‐life conditions over a period of one year. Endocrinology, diabetes & metabolism, 1(3), e00023.
Rubeis, G., Schochow, M., & Steger, F. (2017). Patient autonomy and quality of care in telehealth care. Science and Engineering Ethics, 24, 93-107. doi.org/10.1007/s11948-017-9885-3