title: Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol.
abstract: 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02370719; https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at http://www.webcitation.org/6jpyjfVRs).
authors.affiliation: Centre for Global eHealth Innovation, Techna Institute, University Health Network, Toronto, ON, Canada. shiv_go@icloud.com.
authors.forename: Shivani
authors.identifier: http://orcid.org/0000-0002-6767-9156
authors.initials: S
authors.lastname: Goyal
authors.forename: Gary
authors.identifier: http://orcid.org/0000-0002-7783-0681
authors.initials: G
authors.lastname: Lewis
authors.forename: Catherine
authors.identifier: http://orcid.org/0000-0003-3892-157X
authors.initials: C
authors.lastname: Yu
authors.forename: Michael
authors.identifier: http://orcid.org/0000-0003-0895-5752
authors.initials: M
authors.lastname: Rotondi
authors.forename: Emily
authors.identifier: http://orcid.org/0000-0002-8723-5915
authors.initials: E
authors.lastname: Seto
authors.forename: Joseph A
authors.identifier: http://orcid.org/0000-0002-3114-4440
authors.initials: JA
authors.lastname: Cafazzo
keywords: blood glucose; diabetes mellitus; evaluation; mobile applications; motivation; randomized controlled trial; self-care; telemedicine; type 2