Economic Evaluation of Fasting Mimicking Diet Versus Standard Care in Diabetic Patients on Dual or Triple Medications at Baseline in the United States: A Cost-Utility Analysis

This is an economic modelling study, not a trial. The authors built a computer microsimulation model in TreeAge, using a published US-specific diabetes model, and no one was enrolled, treated or followed. They used it to estimate the 10-year quality-of-life effects, cost implications and cost-effectiveness, from the perspective of a US payer, of adding a 3-year course of Fasting Mimicking Diet (FMD) cycles to standard diabetes care in a diabetic population on dual or triple medications at baseline. The model was populated using outcome data from two earlier FMD studies in people with type 2 diabetes and publicly available clinical and economic data on diabetes complications, use of diabetes medications, hypoglycemia incidence, direct medical costs in 2021 USD, quality of life and mortality.

The model produced estimates, over the 10-year simulation period, of diabetes complications, overall diabetes medication use, hypoglycemia events, quality-adjusted life years and costs per simulated patient.

These estimates are outputs of a simulation, not something measured in people. They describe simulated patients under the authors' model and the data they entered into it. They cover a 10-year horizon, the perspective of a US payer and costs in 2021 USD, in a population already on dual or triple diabetes medications, and they do not show what would happen in other settings or populations. The study does not evaluate Prolon directly.