PMID- 37480092
OWN - NLM
STAT- MEDLINE
DCOM- 20231027
LR  - 20231027
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 24
IP  - 1
DP  - 2023 Jul 22
TI  - Efficacy of a smartphone application for helping individuals with type 2 diabetes 
      mellitus manage their blood glucose: a protocol for factorial design trial.
PG  - 468
LID - 10.1186/s13063-023-07489-5 [doi]
LID - 468
AB  - BACKGROUND: China 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. METHODS: This 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 
      (HbA(1c)) 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 HbA(1c) 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. DISCUSSION: This 
      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 REGISTRATION: 
      Registration in the Chinese Clinical Trial Registry (ChiCTR) under registration 
      number ChiCTR2100042297: https://www.chictr.org.cn/bin/userProject . 17 January 
      2021.
CI  - (c) 2023. The Author(s).
FAU - Tang, Hongxia
AU  - Tang H
AD  - School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 
      Chengdu, 610083, Sichuan, China.
AD  - Hepatobiliary Vascular Surgery, The First Affiliated Hospital of Chengdu Medical 
      College, Chengdu, 610500, Sichuan, China.
FAU - Qin, Hua
AU  - Qin H
AD  - Division of Endocrinology and Metabolism, The First Affiliated Hospital of 
      Chengdu Medical College, Chengdu, 610500, Sichuan, China.
FAU - Zhang, Mingjiao
AU  - Zhang M
AD  - School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 
      Chengdu, 610083, Sichuan, China.
AD  - West China Second University Hospital, Sichuan University, Chengdu, 610065, 
      Sichuan, China.
FAU - Zhang, Jihong
AU  - Zhang J
AD  - The School Hospital, Southwest Petroleum University, Chengdu, 610599, Sichuan, 
      China.
FAU - Tan, Huiwen
AU  - Tan H
AD  - Division of Endocrinology and Metabolism, West China Hospital Sichuan University, 
      Chengdu, 610000, Sichuan, China.
FAU - Chen, Mengjie
AU  - Chen M
AD  - School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 
      Chengdu, 610083, Sichuan, China.
FAU - Kong, Laixi
AU  - Kong L
AD  - School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 
      Chengdu, 610083, Sichuan, China.
FAU - Guo, Maoting
AU  - Guo M
AD  - School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 
      Chengdu, 610083, Sichuan, China.
FAU - Hu, Fenghui
AU  - Hu F
AD  - Division of Endocrinology and Metabolism, The First Affiliated Hospital of 
      Chengdu Medical College, Chengdu, 610500, Sichuan, China.
FAU - Wang, Qin
AU  - Wang Q
AD  - School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 
      Chengdu, 610083, Sichuan, China.
FAU - Wang, Xiaoxia
AU  - Wang X
AD  - School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 
      Chengdu, 610083, Sichuan, China.
FAU - Zhang, Kun
AU  - Zhang K
AD  - Nursing Department, The First Affiliated Hospital of Chengdu Medical College, 278 
      Baoguang Avenue, Chengdu, 610500, Sichuan, China. 2895167579@qq.com.
FAU - Xiong, Zhenzhen
AU  - Xiong Z
AUID- ORCID: 0000-0001-8409-8727
AD  - School of Nursing, Chengdu Medical College, No. 601 Tianhui Road, Rongdu Avenue, 
      Chengdu, 610083, Sichuan, China. xzz62308631@163.com.
LA  - eng
GR  - 2020-507/Beijing Dnurse Technology Ltd/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20230722
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Blood Glucose)
SB  - IM
MH  - Adolescent
MH  - Humans
MH  - Blood Glucose
MH  - Blood Glucose Self-Monitoring/methods
MH  - *Diabetes Mellitus, Type 2/diagnosis/therapy
MH  - *Mobile Applications
MH  - Smartphone
MH  - Adult
MH  - Randomized Controlled Trials as Topic
PMC - PMC10362696
OTO - NOTNLM
OT  - Blood glucose management
OT  - Blood glucose monitoring
OT  - Chinese
OT  - Diabetes app
OT  - Factorial design trial
OT  - Type 2 diabetes mellitus
COIS- The authors declare that they have no competing interests.
EDAT- 2023/07/22 10:41
MHDA- 2023/10/23 00:44
PMCR- 2023/07/22
CRDT- 2023/07/21 23:40
PHST- 2023/04/21 00:00 [received]
PHST- 2023/07/01 00:00 [accepted]
PHST- 2023/10/23 00:44 [medline]
PHST- 2023/07/22 10:41 [pubmed]
PHST- 2023/07/21 23:40 [entrez]
PHST- 2023/07/22 00:00 [pmc-release]
AID - 10.1186/s13063-023-07489-5 [pii]
AID - 7489 [pii]
AID - 10.1186/s13063-023-07489-5 [doi]
PST - epublish
SO  - Trials. 2023 Jul 22;24(1):468. doi: 10.1186/s13063-023-07489-5.