RESUMO
Background: Insulin icodec is a novel, long-acting, once-weekly basal insulin analog. Its comparative efficacy and safety with basal once-daily insulins in type 2 diabetes mellittus is uncertain. Objective: Evaluate potential efficacy, benefits and risks associated with icodec compared to once-daily basal insulin analogs (degludec or glargine). Methods: We systematically searched PubMed, Cochrane, and Embase for randomized controlled trials (RCTs) published until June 2023 comparing icodec versus long-acting insulin analogs (degludec and glargine) in type 2 diabetes mellitus (T2DM) with at least 12 weeks of follow-up. Binary endpoints were assessed with risk ratios (RRs) and continuous endpoints were compared using mean differences (MDs), with 95% confidence intervals (CIs). The protocol was registered in PROSPERO (CRD42023452468). Results: A total of seven RCTs and 3286 patients with T2DM were included, of whom 1509 (60.6%) received icodec treatment. The follow-up period ranged from 16 to 78 weeks. Compared with once-daily basal insulin analogs, icodec led to a greater improvement in HbA1c (MD -0.15%; 95% CI -0.21, -0.10; p < 0.0001; I2 = 0%) and time in range (TIR) (MD 2.83%; 95%CI 0.94; 4.71; p = 0.003; I2 = 22%). Body weight was increased with icodec treatment (MD 0.78 Kg; 95%CI 0.42, 1.15; p < 0.01; I2 = 86%). There was also a higher rate of injection site reactions (RR 1.89; 95%CI 1.12, 3.18; p = 0.016; I2 = 0%) and nasopharyngitis (RR 1.94; 95%CI 1.11, 3.38; p = 0.020; I2 = 0%) in the icodec group, compared with once-daily regimens. There was no significant difference between groups in fasting plasma glucose. Conclusions: In this meta-analysis of RCTs, insulin icodec led to better control of HbA1c and TIR as compared with once-daily insulin regimens, albeit with increased weight gain and a higher rate of injection site reaction in the Icodec group.
RESUMO
OBJECTIVE: Diabetic foot ulcers can have serious consequences, including amputation. This project aimed to develop and validate a diabetes care management model-a pocket guide on the prevention of foot ulceration to assist health professionals and scientific societies. METHODS: An adaptation of the Iowa method of evidence-based practice to promote high-quality care was employed. After problems are identified, the Iowa method supports the development of an action plan for addressing them. An evidence-based protocol based on the five cornerstones of the 2015 guidance on the diabetic foot by the International Working Group on the Diabetic Foot was developed in two phases and validated using the Delphi technique. RESULTS: A model was developed to promote these five cornerstones, which are the main recommendations for managing the diabetic foot. These are: foot examination; risk assessment for ulceration; education in diabetes; appropriate footwear; and treatment of pre-ulcerative lesions. To adapt this into a health information document, the management model was synthesised and designed as a pocket guide. The model's individual and global content validity indices surpass 0.78 and 0.90 respectively. CONCLUSION: A management model was created and validated, and produced as a pocket guide to deliver instructions on the care and prevention of diabetic foot problems in people with diabetes.
