Evaluation of the physical, mechanical characteristics and feasibility of using commercial insulin refills in a low-cost insulin infusion pump prototype

• Grant number: 21/14283-0
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: February 01, 2022
• End date: January 31, 2023
• Field of knowledge: Engineering - Biomedical Engineering
• Principal Investigator: Tatiana de Sousa da Cunha Uchiyama
• Grantee: Gabrielle Gonçalves de Andrade
• Company: Aredes Equipamentos Hospitalares Ltda
• CNAE: Atividades de serviços de complementação diagnóstica e terapêutica
• Associated research grant: 18/22094-0 - Development of a low cost insulin infusion pump, AP.PIPE

Abstract

According to data from the Brazilian Diabetes Society, the estimated number of children and adolescents affected by type 1 of Diabetes Mellitus in Brazil is approximately 100 thousand people and the majority are individuals under 14 years old. It is known that type 1 Diabetes Mellitus can generate extremely serious acute and chronic complications when the glycemic control is inadequate. One of the therapies that present a significant positive impact on blood glucose, is the insulin infusion pump, a device controlled by an embedded computational system, that injects in the subcutaneous tissue microdoses of insulin continuously for 24 hours of the day, simulating the pancreatic secretion of this hormone. The benefits of using insulin infusion pumps are promising since studies show the improvement of glycemic control, and reduction of severe hyperglycemia and hypoglycemic episodes compared with conventional treatments. However, the number of patients with access to this type of treatment is quite restricted in Brazil, since insulin infusion pumps commercially available present high costs (about R$15.000,00). Our research group in UNIFESP has been working, over the last few years, with the financial support of FAPESP (subproject that as a part of the Thematic Project FAPESP 2010/51904-9 and PIPE direct Phase 2 FAPESP 2018/22094-0) in development of a low-cost insulin infusion pump prototype (v1, v2, and v3 versions), whose initial tests presented positive and satisfactory results as for accuracy and reliability of device dispensing doses. Although, adjustments in the prototype are necessary to get closer to a viable product for the market. One of them is to offer greater comfort and safety to the patient through the use of insulin pen refills as the hormone reservoir in our device. As this is the first study with this perspective, in this project we will evaluate the physical and mechanical characteristics of commercial insulin pen refills to characterize it and analyze the feasibility of using this item (originally developed to be used in insulin pens) as a hormone insulin reservoir in the low-cost insulin infusion prototype, which is being developed by our research group. It is important to mention that the use of refills containing insulin will represent an advantage in the development of the prototype, reducing not only the costs of insulin pump consumables but also offering greater safety since it will not be necessary to manually fill the reservoir with the hormone.(AU)