Diabetes is a disease in which the body’s ability to produce insulin is impaired. According to the World Health Organization, 422 million people were diagnosed with diabetes in 2014 and 1.5 million deaths were caused by diabetes. By 2030, it is projected that diabetes will be the 7th leading cause of death (World Health Organization, 2017). Due to the rising number of individuals diagnosed with diabetes and the major impacts of diabetes, such as damage to blood vessels, kidneys, eyes, and feet, diabetes has caught the attention of many public health officials.
While analyzing public health issues, officials often use the P.E.R.I.E. framework, which is an acronym for problem, etiology, recommendation, implementation, and evaluation. In this method, public health officials want to accurately identify the health problem. Questions such as “What is the burden of the disease and how has it changed over time?” are often asked. Then the etiology, the contributory causes, of the disease are analyzed. Etiology points towards questions such as, “Has an association been established at the individual level?” or “How do the cause and effect relate to each other?” Following etiology, recommendations are made. Recommendations test to see what works to reduce the health impacts and focuses on the benefits and harms associated with the recommendation. Then, implementation answers the question of how a job is done. When should the implementation occur, at whom should it be directed towards, and how should the interventions be implemented are all major questions to focus on at this stage. Finally, an evaluation is conducted to assess the effectiveness of the intervention. However, it is important to understand that the P.E.R.I.E framework is an ongoing process. If the evaluation suggests that more needs to be done, then the process is repeated.
On January 23, 2015, the Federal Drug Administration released the permission of the first system of mobile medical application for continuous glucose monitoring. This system allows people with diabetes to “automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone” (Federal Drug Administration, 2015).
In the article published by the Federal Drug Administration, the problem is the effects of diabetes and its increasing prevalence. Diabetes is a serious condition in which the body is unable to “convert glucose into the energy needed to carry out daily activities” (Federal Drug Administration, 2015) and thus managing diabetes has become a global issue. Only in the United States, about 25.8 million people, of which 215,000 of them are under the age of 20, have diabetes. If not managed properly, high blood glucose levels, also known as hyperglycemia, can lead to serious long-term problems such as stroke, heart disease, and damage to the eyes, kidneys and nerves (Federal Drug Administration, 2015).
After identifying the problem, it is important to analyze the etiology, the contributory causes of the disease. While this article does not focus on the etiology of diabetes, it introduces a new system available to make managing diabetes less complicated. However, it is important to note that finding contributory causes for a disease, such as diabetes, can be challenging for reasons of ethics. Nonetheless, according to the National Institute of Health, although there is no core cause, type 1 and 2 diabetes are caused by genes, environmental, and lifestyle factors (2016). For example, having a history of diabetes in the family, makes it more likely that other family members will develop diabetes. Moreover, those who do not often engage in exercise and make poor nutritional choices are more likely to develop diabetes than those who exercise and have healthy diets.
In the article, the Federal Drug Administration highlights recommendations for diabetics in order to manage their lifestyles more effectively and efficiently. To make managing diabetes simpler, a continuous glucose monitor (CGM) is introduced. A CGM is a device that includes a “small, wire-like sensor inserted just under the skin that provides a steady stream of information about glucose levels in the fluid around the cells” (Federal Drug Administration, 2015). CGMs continuously display an estimate of blood glucose levels, and the direction and rate of change of the estimates. Continuous glucose monitor information can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels (Federal Drug Administration, 2015). Furthermore, in order to make the CGMs more efficient, the Dexcom Share system is introduced in which data from the CGM System is displayed and can be shared between parties, such as patient and physician. Through the use of the Dexcom Share application, diabetics are able to directly share blood sugar results with their doctors or other relevant parties, thus making communication simple and efficient.
Recommendations without implementation will not produce results. In order to increase the implementation of the device and system, the Federal Drug Administration has classified the device as “class II exempt from premarket submissions” (Federal Drug Administration, 2015). Alberto Gutierrez, the director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, says “Exempting devices from premarket review is part of the FDA’s effort to ensure these products provide accurate and reliable results while still encouraging the development of devices that meet the needs of people living with diabetes and their caregivers” (Federal Drug Administration, 2015). Therefore, by exempting the device from premarket review, manufacturers who wish to market devices such as the Dexcom Share, will not need “premarket clearance” by the FDA and thus are able to notify the public of such interventions in a much faster manner.
While the intervention program aims to improve the quality of life of diabetics and help manage diabetes in a much simpler fashion, the evaluations show some challenges. The Dexcom Share system “does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring” (Federal Drug Administration, 2015). Furthermore, the system is not intended to be used in place of a primary display device. Therefore, although continuous glucose monitors and the Dexcom Share system makes managing diabetes simpler, it does not substitute for the standard glucose meters. In other words, diabetics must still check their blood sugars at least twice a day, in the morning and at bedtime. Additionally, the values displayed by continuous glucose monitors alone do not determine the dosing of diabetes medications and therefore, before taking medications, one must still check their blood sugars with the standard blood glucose meter. Finally, CGMs must be “calibrated by blood glucose meters” (Federal Drug Administration, 2015). This is done so by checking blood sugar values in the morning and at bedtime with the standard blood glucose meter.
While the continuous glucose monitors and the Dexcom Share system do not completely replace glucose monitors, they do make managing diabetes better as it continuously records blood sugars and thus notifies diabetics of their blood sugar values at all times. Furthermore, the system makes communicating blood sugar values between parties much faster and more efficient. “This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely,” said Alberto Gutierrez.(Federal Drug Administration, 2015).
Through the use of the P.E.R.I.E. method, public health officials were able to identify a problem and come up with possible interventions. The P.E.R.I.E framework is an essential part of evidence based public health through which many public health issues are analyzed and evaluated. Not only does the P.E.R.I.E framework bring our attention to rising issues, but it also focuses on the root causes of the issue, finding interventions in response to the issue, the implementation of the intervention, and in the evaluation of its successes.