Efficacy of a smartphone application for helping individuals with type 2 diabetes mellitus manage their blood glucose: a protocol for factorial design trial

Trials

Study Protocol

Hua Qin¹  Fenghui Hu¹  Huiwen Tan²  Kun Zhang³  Zhenzhen Xiong⁴  Mengjie Chen⁴  Laixi Kong⁴  Maoting Guo⁴  Qin Wang⁴  Xiaoxia Wang⁴  Hongxia Tang⁵  Mingjiao Zhang⁶  Jihong Zhang⁷ 

[1] Division of Endocrinology and Metabolism, The First Affiliated Hospital of Chengdu Medical College, 610500, Chengdu, Sichuan, China;Division of Endocrinology and Metabolism, West China Hospital Sichuan University, 610000, Chengdu, Sichuan, China;Nursing Department, The First Affiliated Hospital of Chengdu Medical College, 278 Baoguang Avenue, 610500, Chengdu, Sichuan, China;School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 610083, Chengdu, Sichuan, China;School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 610083, Chengdu, Sichuan, China;Hepatobiliary Vascular Surgery, The First Affiliated Hospital of Chengdu Medical College, 610500, Chengdu, Sichuan, China;School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 610083, Chengdu, Sichuan, China;West China Second University Hospital, Sichuan University, 610065, Chengdu, Sichuan, China;The School Hospital, Southwest Petroleum University, 610599, Chengdu, Sichuan, China;

关键词: Type 2 diabetes mellitus;    Diabetes app;    Factorial design trial;    Chinese;    Blood glucose management;    Blood glucose monitoring;   

DOI  :  10.1186/s13063-023-07489-5

 received in 2023-04-21, accepted in 2023-07-01,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundChina has the largest number of individuals with type 2 diabetes mellitus (T2DM) in the world, and most lack knowledge about glycemic control and health management. This trial will examine whether a smartphone application can improve blood glucose management among individuals with T2DM.MethodsThis will be a 2-center, factorial design, equal proportional distribution, superiority trial conducted in outpatient endocrinology clinics at two tertiary hospitals in Chengdu, China. The trial will enroll smartphone-literature individuals at least 18 years old who have been diagnosed with T2DM based on glycosylated hemoglobin (HbA1c) of at least 7.0%. Individuals will be randomly assigned to receive routine care with standard education about T2DM and glycemic control (Control), routine care as well as weekly telephone reminders to self-monitor blood glucose (Reminder), routine care and a smartphone application providing information about glycemic control and health management with T2DM (App), or the combination of routine care, the smartphone application, and weekly telephone reminders (App + Reminder). After 6 months of these interventions, participants will be analyzed for the primary outcome of HbA1c as well as the secondary outcomes of blood glucose monitoring frequency, body mass index, blood pressure, knowledge about diabetes, health beliefs related to diabetes, diabetes self-management behavior, and satisfaction with the smartphone application.DiscussionThis trial will determine whether a smartphone application can improve glycemic management among Chinese with T2DM. The findings may help guide the development of effective applications in China and elsewhere.Trial registrationRegistration in the Chinese Clinical Trial Registry (ChiCTR) under registration number ChiCTR2100042297: https://www.chictr.org.cn/bin/userProject. 17 January 2021.

【 授权许可】

CC BY   
© The Author(s) 2023

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