Diabetes and Women’s Health

by Vishnu Gotika | May 11, 2022 | Blog, Consulting Group, Diabetes, Digital Health, Engineering, FDA, Food, Genetics, Medical Devices, Pharmaceuticals, Quality, Testing, Treatment, Women, Women's Health

With increased blood sugar levels, diabetes is an autoimmune lifestyle disease affecting about 15 million women in the US. Although the exact cause of diabetes is unknown, changes in lifestyle, genetic factors, and gender could act as some predisposing conditions primarily associated with the disease’s state[i]. The diabetic population continues to increase even though the majority of cases be prevented with simple lifestyle changes[ii].

In women, diabetes is said to be associated with other complications and comorbid conditions. They are at higher risk of developing heart disease, blindness, stroke, kidney damage, and neuropathy as comorbid complications with diabetes. Diabetes can also develop during pregnancy and can lead to health complications for the mother and baby if not controlled or left untreated. The under-diagnosis of diabetes leads to lower survival rates and decreased quality of life leading to depression^1,2.

Over the last 80 years, treatment strategies have evolved with vast advancements in technology. There has been a new era in the development of drug therapies and medical devices to monitor your blood sugar levels, keep track of insulin levels, and treat the disease state. With the existing therapies in place, there is an utmost clinical need to diagnose, prevent and mitigate the comorbid conditions associated with diabetes. In the battle against diabetes, the American Diabetes Association has funded over 250 research projects in 123 research institutions to support scientific innovations that lead to healthier lives and a cure for the disease[iii]. Therefore, there is a significant need for the technologies under development to meet the quality, safety, and effectiveness requirements. If you have questions or need guidance, please call us at 248-987-4497 or email us at info@emmainternational.com to strategize your product life cycle.

[i] Womenshealth.gov. 2021. Diabetes | Office on Women’s Health. [online] Available at: <https://www.womenshealth.gov/a-z-topics/diabetes> [Accessed 11 May 2022].

[ii] Fda.gov. 2008. Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. [online] Available at: <https://www.fda.gov/media/71297/download> [Accessed 11 May 2022].

[iii] Professional.diabetes.org. 2021. Research & Grants | American Diabetes Association. [online] Available at: <https://professional.diabetes.org/research-grants> [Accessed 11 May 2022].

Vishnu Gotika

Vishnu is a Regulatory Affairs Specialist at EMMA International. She has experience in R&D product development, regulatory submissions, and compliance activities with pharmaceuticals, medical devices, and IVDs. She holds a Master of Science in Pharmacology and a Master of Science in Regulatory Affairs from Northeastern University.