Protocol of a Series of N-of-1 trials for Exploring Personalized Blood Glucose Responses to Different Staple Foods in Patients with Diabetes.

BACKGROUND

Effective control of postprandial glucose responses (PPGRs) is essential for managing the progression of type 2 diabetes mellitus (T2DM). Carbohydrate-rich staple foods are known to induce significant variability in PPGR among individuals.

OBJECTIVES

This study aimed to investigate the personalized PPGR to various staple foods among patients with diabetes using an N-of-1 trial design.

METHODS

A single-center, randomized, crossover N-of-1 trial is planned. Participants will receive 5 different staple foods (white rice, germ rice, brown rice, rice noodles, and pasta) 3 times in a randomized order. Continuous glucose monitoring will track PPGR at 5-min intervals. The primary outcome will be the postprandial blood glucose peak. The Bayesian analysis will be conducted at both individual and group levels to access the PPGR for staple foods.

DISCUSSION: By using the N-of-1 trial methodology, this study is anticipated to reveal substantial interindividual variations in PPGR and to identify staple foods that are most effective in stabilizing blood glucose concentrations for individual patients, providing insights into personalized nutritional management for T2DM.This trial was registered at Chinese Clinical Trial Register as ChiCTR2400090138 (24 September, 2024).