PMID- 27542325
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160820
LR  - 20200930
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 5
IP  - 3
DP  - 2016 Aug 19
TI  - Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management 
      of Type 2 Diabetes: Randomized Controlled Trial Protocol.
PG  - e174
LID - 10.2196/resprot.5959 [doi]
LID - e174
AB  - BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) struggle with the 
      management of their condition due to difficulty relating lifestyle behaviors with 
      glycemic control. While self-monitoring of blood glucose (SMBG) has proven to be 
      effective for those treated with insulin, it has been shown to be less beneficial 
      for those only treated with oral medications or lifestyle modification. We 
      hypothesized that the effective self-management of non-insulin treated T2DM 
      requires a behavioral intervention that empowers patients with the ability to 
      self-monitor, understand the impact of lifestyle behaviors on glycemic control, 
      and adjust their self-care based on contextualized SMBG data. OBJECTIVE: The 
      primary objective of this randomized controlled trial (RCT) is to determine the 
      impact of bant2, an evidence-based, patient-centered, behavioral mobile app 
      intervention, on the self-management of T2DM. Our second postulation is that 
      automated feedback delivered through the mobile app will be as effective, less 
      resource intensive, and more scalable than interventions involving additional 
      health care provider feedback. METHODS: This study is a 12-month, prospective, 
      multicenter RCT in which 150 participants will be randomly assigned to one of two 
      groups: the control group will receive current standard of care, and the 
      intervention group will receive the mobile phone app system in addition to 
      standard of care. The primary outcome measure is change in glycated hemoglobin 
      A1c from baseline to 12 months. RESULTS: The first patient was enrolled on July 
      28, 2015, and we anticipate completing this study by September, 2018. 
      CONCLUSIONS: This RCT is one of the first to evaluate an evidence-based mobile 
      app that focuses on facilitating lifestyle behavior change driven by 
      contextualized and structured SMBG. The results of this trial will provide 
      insights regarding the usage of mobile tools and consumer-grade devices for 
      diabetes self-care, the economic model of using incentives to motivate behavior 
      change, and the consumption of test strips when following a rigorously structured 
      approach for SMBG. TRIAL REGISTRATION: ClinicalTrials.gov NCT02370719; 
      https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at 
      http://www.webcitation.org/6jpyjfVRs).
FAU - Goyal, Shivani
AU  - Goyal S
AUID- ORCID: 0000-0002-6767-9156
AD  - Centre for Global eHealth Innovation, Techna Institute, University Health 
      Network, Toronto, ON, Canada. shiv_go@icloud.com.
FAU - Lewis, Gary
AU  - Lewis G
AUID- ORCID: 0000-0002-7783-0681
FAU - Yu, Catherine
AU  - Yu C
AUID- ORCID: 0000-0003-3892-157X
FAU - Rotondi, Michael
AU  - Rotondi M
AUID- ORCID: 0000-0003-0895-5752
FAU - Seto, Emily
AU  - Seto E
AUID- ORCID: 0000-0002-8723-5915
FAU - Cafazzo, Joseph A
AU  - Cafazzo JA
AUID- ORCID: 0000-0002-3114-4440
LA  - eng
SI  - ClinicalTrials.gov/NCT02370719
PT  - Journal Article
DEP - 20160819
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC5010649
OTO - NOTNLM
OT  - blood glucose
OT  - diabetes mellitus
OT  - evaluation
OT  - mobile applications
OT  - motivation
OT  - randomized controlled trial
OT  - self-care
OT  - telemedicine
OT  - type 2
COIS- Conflicts of Interest: None declared.
EDAT- 2016/08/21 06:00
MHDA- 2016/08/21 06:01
PMCR- 2016/08/19
CRDT- 2016/08/21 06:00
PHST- 2016/05/10 00:00 [received]
PHST- 2016/07/20 00:00 [accepted]
PHST- 2016/07/14 00:00 [revised]
PHST- 2016/08/21 06:00 [entrez]
PHST- 2016/08/21 06:00 [pubmed]
PHST- 2016/08/21 06:01 [medline]
PHST- 2016/08/19 00:00 [pmc-release]
AID - v5i3e174 [pii]
AID - 10.2196/resprot.5959 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2016 Aug 19;5(3):e174. doi: 10.2196/resprot.5959.