PMID- 38303057
OWN - NLM
STAT- MEDLINE
DCOM- 20240205
LR  - 20240206
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 25
IP  - 1
DP  - 2024 Feb 1
TI  - Effect of emerging digital technologies and methodologies combined with 
      incentives on HbA1c in patients with type 2 diabetes mellitus: study protocol for 
      a parallel, open randomized controlled trial.
PG  - 100
LID - 10.1186/s13063-024-07950-z [doi]
LID - 100
AB  - BACKGROUND: Type 2 diabetes mellitus (T2DM) is a common metabolic disease that 
      requires long-term management and treatment. Digital intervention, as an emerging 
      medical model, has been widely used in the treatment of T2DM patients. Behavioral 
      economics theory provides a favorable perspective for studying the effect of 
      digital intervention because it can reveal the decision-making mechanisms behind 
      human behavior and provide more effective interventions for digital intervention. 
      The purpose of this trial is to evaluate the impact of behaviorally based digital 
      intervention on T2DM patients' HbA1c, self-monitoring of blood glucose (SMBG) 
      testing rate, diabetes self-efficacy, and other indicators compared to 
      conventional treatment. METHODS: This trial is a prospective randomized 
      controlled trial conducted at the First People's Hospital of Kunshan City from 
      April 1, 2023, to December 31, 2024, with a follow-up period of 3 months. The 
      specific randomization method was established and implemented through the EDC 
      clinical trial center's randomization system. We will measure and collect 
      baseline data from three groups, including Group A: digital intervention + 
      virtual incentives + conventional treatment, Group B: digital intervention + 
      physical incentives + conventional treatment, and Group C: conventional 
      treatment. HbA1c, weight, SMBG testing rate, diabetes self-efficacy, and 
      diabetes-related medical expenses will be recorded at baseline, 1 month, 2 
      months, and 3 months for all three groups. The Shapiro-Wilk test will be used to 
      test for normality, and Pearson correlation analysis will be used for correlation 
      analysis. Dropouts will be analyzed separately. Analysis of variance or exact 
      probability calculation will be used to compare demographic data and other 
      baseline indicators. DISCUSSION: This study is a novel clinical trial that 
      integrates multiple disciplines (economics and medicine) and uses digital 
      technology to deliver the intervention. Most published studies were offline 
      interventions based on behavioral economics theory, but very few were on online 
      interventions for T2DM patients. This study has both novelty and social value. 
      TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2300070753. Registered 
      on 2023/04/22.
CI  - (c) 2024. The Author(s).
FAU - Zhong, Shao
AU  - Zhong S
AD  - Department of Endocrinology, First People's Hospital of Kunshan Affiliated With 
      Jiangsu University, Kunshan, 215300, China.
FAU - Jiang, Jingyi
AU  - Jiang J
AD  - Department of Endocrinology, First People's Hospital of Kunshan Affiliated With 
      Jiangsu University, Kunshan, 215300, China.
FAU - Liu, Hongying
AU  - Liu H
AD  - Hangzhou Kang Ming Information Technology Co., Ltd, Hangzhou, 310000, China. 
      hongyingliu@91jkys.com.
FAU - Pan, Ying
AU  - Pan Y
AD  - Department of Endocrinology, First People's Hospital of Kunshan Affiliated With 
      Jiangsu University, Kunshan, 215300, China. py97183@163.com.
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20240201
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Glycated Hemoglobin)
SB  - IM
MH  - Humans
MH  - *Diabetes Mellitus, Type 2/diagnosis/therapy
MH  - Glycated Hemoglobin
MH  - Digital Technology
MH  - Motivation
MH  - Prospective Studies
MH  - Randomized Controlled Trials as Topic
PMC - PMC10835894
OTO - NOTNLM
OT  - Behavioral economics
OT  - Digital health
OT  - Type 2 diabetes mellitus
COIS- The authors declare that they have no competing interests.
EDAT- 2024/02/02 06:43
MHDA- 2024/02/05 06:43
PMCR- 2024/02/01
CRDT- 2024/02/02 00:10
PHST- 2023/11/08 00:00 [received]
PHST- 2024/01/22 00:00 [accepted]
PHST- 2024/02/05 06:43 [medline]
PHST- 2024/02/02 06:43 [pubmed]
PHST- 2024/02/02 00:10 [entrez]
PHST- 2024/02/01 00:00 [pmc-release]
AID - 10.1186/s13063-024-07950-z [pii]
AID - 7950 [pii]
AID - 10.1186/s13063-024-07950-z [doi]
PST - epublish
SO  - Trials. 2024 Feb 1;25(1):100. doi: 10.1186/s13063-024-07950-z.