Evaluation of a low-cost insulin infusion pump prototype through in vitro and in vivo assays

• Grant number: 22/08215-5
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: September 01, 2022
• End date: July 31, 2023
• Field of knowledge: Engineering - Biomedical Engineering - Bioengineering
• Principal Investigator: Tatiana de Sousa da Cunha Uchiyama
• Grantee: Carolina Maria Braga de Oliveira
• Host Institution: Instituto de Ciência e Tecnologia (ICT). Universidade Federal de São Paulo (UNIFESP). Campus São José dos Campos. São José dos Campos , SP, Brazil
• Associated research grant: 17/17027-0 - Hormonal systems in renal and cardiovascular diseases: from cell biology to new physiological paradigms with advances for therapeutics, AP.TEM

Abstract

Type 1 Diabetes Mellitus is an autoimmune disease characterized by the progressive loss of pancreatic ²-cells. Such loss induces the absence or deficiency in the production of the hormone insulin and, therefore, consequent high glycemic indexes. The only treatment for the disease is insulin therapy, the recurrent application of doses of insulin. The ways in which patients reach this treatment can occur using syringes and needles, insulin pens or the use of an insulin infusion pump. The insulin infusion pump is a technology that simulates and approaches the endogenous secretion of the hormone insulin, bringing better glycemic control among treatments. However, the number of Brazilians with access to this technology is extremely low, due to the high cost of treatment. The device costs from R$ 15,000.00 and monthly expenses with supplies, such as catheters, cannulas, and insulin refills, reach approximately R$ 3,000.00 per month. Therefore, our research group at the Federal University of São Paulo has been developing a low-cost infusion pump prototype whose estimated value represents a quarter of the average cost of pumps currently available in the Brazilian market. Therefore, the present study aims to evaluate the low-cost prototype through in vitro tests, according to the IEC 60601-2-24 standard, and in vivo, through pre-clinical tests, and compare with the performance of two commercial pumps that will be subjected to the same tests performed with the prototype.