2.1. Study Design
diabetic diet, Diabetic diet preemptive, Diabetic, diabetic diets, Diabetes
GROUP B, DIABETES
This study was a validated, prospective, randomized, single-blind, crossover, comparative study (single-blinding was carried out in participants). In the present exploratory study, we designed a crossover comparative study comparing the intervention and control groups in the same subjects in order to conduct a detailed study with a limited number of cases. We took into account that this method has the advantage that the effects of individual differences can be properly assessed. On the other hand, as a precaution for crossover comparative trials, we planned a statistical analysis of the washout period using the method described below, although it was necessary to check for carryover effects. This study enrolled 24 patients who were admitted to Kagawa University Hospital between December 2019 and August 2022. Patients were randomly divided into groups A and B. The allocation of study subjects to each group was carried out using the envelope method. Between these two groups, blood glucose levels during the study period were measured using the isCGM device FreeStyle Libre (software version 2.2.13,0.94, Abbott Japan Diabetes Care Inc., Tokyo, Japan) (Group A: Diabetic diet preemptive group. Diabetic patients in the hospital were fed a diabetic diet three times daily for two days. After a washout period of at least one day, a diabetic diet containing D-allulose was provided three times a day for two days.Group B: D-allulose-containing diabetic diet prior group. Diabetic patients in the hospital were fed a diabetic diet containing D-allulose three times daily for two days, followed by a washout period of at least one day and a diabetic diet three times daily for two days.The D-allulose content in the rare sugar-containing diabetic diets used in this study was 8.5 g D-allulose per meal. The medications used prior to the study were continued during the study. The number of insulin units was not adjusted, nor were oral hypoglycemic drugs added, changed, or dose adjusted during the study period. We obtained prior written informed consent from all participants prior to enrolment in the study. The study was conducted in compliance with the Declaration of Helsinki (latest version) of the World Medical Association and the Japanese Clinical Research Act. This study was approved by the Clinical Research Review Committee of Kagawa University Hospital (approval number: CRB6200005, Recognition date: 29 September 2020). This study was registered with the Japan Registry of Clinical Trials (trial registration number: jRCTs061200022).In the study, the patients participated over a period of five days. During this period, blood glucose levels were measured using isCGM, which consisted of a two-day period on a regular diabetic diet, a washout period of at least one day, and a two-day period on a diabetic diet containing D-allulose.