Primary documentation on the scientific study of indicators of continuous monitoring and flash monitoring of glycemia in children and adolescents with type 1 diabetes mellitus

The main purpose of creating an electronic database was to evaluate the performance of continuous glucose monitoring (CGM) and flash monitoring (FMS) in children and adolescents diagnosed with type 1 diabetes mellitus. The database is intended for entering, systematizing, storing and displaying patient data (date of birth, age, date of diagnosis of type 1 diabetes mellitus, length of illness, date of first visit to an endocrinologist, with the installation of a CGM or FMS), glycated hemoglobin indicators initially , during the study and ultimately, as well as CGM, FMS data (average glucose level, glycemic variability, percentage of cases above the target range, percentage of cases within the target range, percentage of cases below the target range, number of hypoglycemic episodes and their average duration, frequency of daily scans and frequency of sensor readings). The database is the basis for comparative statistical analysis of dynamic monitoring indicators in groups of patients with the presence or absence of diabetic complications (neuropathy, retinopathy and nephropathy). The database presents the results of a prospective, open, controlled, clinical study obtained over a year and a half. The database includes information on 307 patients (adolescent children) aged 3 to 17 years inclusive. During the study, the observed patients were divided into two groups: Group 1 - patients diagnosed with type 1 diabetes mellitus and with diabetic complications, 152 people, Group 2 – patients diagnosed with type 1 diabetes mellitus and with no diabetic complications, 155 people. All registrants of the database were assigned individual codes, which made it possible to exclude personal data (full name) from the database. The database is executed in the Microsoft Office Excel program and has the character of a depersonalized summary table, which consists of two blocks-sheets: patients of groups 1 and 2 and is structured according to the following sections: "Patient number"; "Patient code"; "Date of birth"; "Age of the patient"; section "Date of diagnosis of DM1" indicates the date of the official diagnosis of type 1 diabetes mellitus at the first hospitalization of the patient, this information is borrowed from medical information systems; section "Length of service DM1" reflects information about the duration of the patient's illness; the section "Date of the first visit" contains information about the date of the registrant's visit to the endocrinologist with the installation of FMS / CGM devices; the section "Frequency of self-monitoring with a glucometer" contains information about the frequency of measuring blood glucose levels by the patient at home using a glucometer until the establishment of FMS / CGM. Sections "HbA1c initially (GMI)", "HbA1c (GMI)", "HbA1c final (GMI)", display the indicators of the level of glycated hemoglobin from the total for the period of the beginning of the study, at the intermediate stages of the study and at the end of observation. The database structure has a number of sections accumulating information obtained with CGM/FMS, in particular: the section "Average glucose level"; the section "% above the target range", reflecting the percentage of the patient's stay with glycemia above the target indicators during the day; the section "% within the target range", reflecting the percentage of the patient's stay within the target glycemia indicators per day; the section "% below the target range", reflecting the percentage of the patient's stay with glycemia below the target indicators during the day; the section "Hypoglycemic phenomena", reflecting the number of cases of hypoglycemia in patients within 2 weeks; the section "Average duration", reflecting the average duration of hypoglycemic phenomena registered in the patient; the section "Sensor data received", indicating the percentage of time the patient was with an active device sensor; the section "Daily scans" show the frequency of scans of the patient's glycemic level (once a day); the section "%CV" displays the variability of the patient's glycemia recorded by the device. The listed sections are repeated in the database in accordance with the number of follow-up visit. Also in the database there is a section "Mid. values", which contains indicators of the average values of patient data for all of the above sections, both in the first and in the second group of patients. When working with the database, the use of filters (in the "Data" tab) containing the names of indicators allows you to enter information about new registrants in a convenient form or correct existing data, as well as sort and search for one or more specified indicators. The electronic database allows you to systematize a large volume of results, distribute data into categories, search for any field or set of fields in the input format, systematize the selected array, makes it possible to directly use this data for statistical analysis, as well as to view and print information on specified conditions with the location of fields in a convenient sequence.本电子数据库的构建初衷为评估持续葡萄糖监测（continuous glucose monitoring, CGM）与闪光式葡萄糖监测（flash monitoring, FMS）在确诊1型糖尿病（type 1 diabetes mellitus）的儿童及青少年群体中的应用效能。该数据库用于录入、系统化整理、存储及展示患者相关数据，包括出生日期、年龄、1型糖尿病确诊日期、病程时长、首次就诊内分泌科医师并安装CGM或FMS的日期；初始、研究期间及最终的糖化血红蛋白（glycated hemoglobin）指标；以及CGM、FMS相关数据，具体涵盖平均血糖水平、血糖变异性、超出目标范围的血糖占比、处于目标范围内的血糖占比、低于目标范围的血糖占比、低血糖事件次数及其平均持续时长、每日扫描频率与传感器读取频率。 本数据库为针对伴或不伴糖尿病并发症（神经病变、视网膜病变及肾病）的患者群体开展的动态监测指标比较性统计分析提供基础。其数据源自一项为期一年半的前瞻性、开放、对照临床研究。 数据库共纳入307名年龄介于3至17岁（含两端）的青少年患者。研究期间，入组患者被分为两组：第1组为确诊1型糖尿病且伴有糖尿病并发症的患者，共计152例；第2组为确诊1型糖尿病但无糖尿病并发症的患者，共计155例。所有数据库注册患者均被分配唯一标识码，以此实现患者个人信息（姓名）的脱敏处理。 本数据库采用微软Excel（Microsoft Office Excel）构建，为脱敏汇总表格，包含两个分组工作表（第1组与第2组患者），并按以下模块进行结构化设计：“患者编号”“患者标识码”“出生日期”“患者年龄”；“DM1确诊日期”模块：记录患者首次住院时官方确诊1型糖尿病的日期，该信息源自医疗信息系统；“DM1病程时长”模块：反映患者的糖尿病患病时长；“首次就诊日期”模块：记录注册患者首次就诊内分泌科并安装FMS/CGM设备的日期；“家用血糖仪自测频率”模块：涵盖患者在安装FMS/CGM前，居家使用血糖仪自测血糖的频率信息。 “初始糖化血红蛋白（GMI）”“研究期间糖化血红蛋白（GMI）”“最终糖化血红蛋白（GMI）”模块，分别展示研究起始、研究中期及观察结束阶段的整体糖化血红蛋白水平。 数据库结构中包含多个用于归集CGM/FMS监测数据的模块，具体如下：“平均血糖水平”模块；“超出目标范围占比”模块：反映患者每日血糖超出目标阈值的时长占比；“处于目标范围占比”模块：反映患者每日血糖处于目标阈值范围内的时长占比；“低于目标范围占比”模块：反映患者每日血糖低于目标阈值的时长占比；“低血糖事件”模块：统计患者两周内的低血糖发作次数；“平均持续时长”模块：展示患者记录到的低血糖事件的平均持续时间；“有效传感器数据占比”模块：标注患者设备传感器处于激活状态的时长占比；“每日扫描次数”模块：体现患者每日血糖扫描频率（每日一次）；“血糖变异系数（%CV）”模块：展示设备记录的患者血糖变异性。上述模块将根据随访次数重复设置于数据库中。 数据库还包含“平均指标”模块，汇总两组患者所有上述模块的平均数据。 使用数据库时，通过“数据”选项卡中的指标筛选功能，可便捷录入新注册患者信息、修正现有数据，同时支持对指定指标进行排序与检索。 本电子数据库可系统化处理海量监测结果，将数据按类别划分，支持按输入格式检索任意单个或多个字段，对选定数据集进行结构化整理，可直接用于统计分析，并可按照指定条件查看、打印信息，且字段排布符合便捷操作的逻辑顺序。