Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Aug 19;5(3):e174.
doi: 10.2196/resprot.5959.

Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol

Shivani Goyal  1 , Gary Lewis, Catherine Yu, Michael Rotondi, Emily Seto, Joseph A Cafazzo
Affiliations

Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol

Shivani Goyal et al. JMIR Res Protoc. .

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.

Trial registration: ClinicalTrials.gov NCT02370719; https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at http://www.webcitation.org/6jpyjfVRs).

Keywords: blood glucose; diabetes mellitus; evaluation; mobile applications; motivation; randomized controlled trial; self-care; telemedicine; type 2.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
The bant2 mobile app enables users to monitor lifestyle behaviors and correlate them to their overall glycemic control.
See this image and copyright information in PMC

References

    1. Lamprinos I, Demski H, Mantwill S. Modular ICT-based patient empowerment framework for self-management of diabetes: design perspectives and validation results. Int J Med Inform. 2016 Jul;91:31–43. doi: 10.1016/j.ijmedinf.2016.04.006. - DOI - PubMed
    1. Klein H, Lippa K. Type 2 diabetes self-management: controlling a dynamic system. J Cogn Eng Decis. 2008 Apr 01;2(1):48–62. doi: 10.1518/155534308X284363. - DOI
    1. Polonsky W, Fisher L. Self-monitoring of blood glucose in noninsulin-using type 2 diabetic patients. Diabetes Care. 2013;36(1):82. doi: 10.2337/dc12-0731. - DOI - PMC - PubMed
    1. Schnell O, Barnard K, Bergenstal R, Bosi E, Garg S, Guerci B, Haak T, Hirsch IB, Ji L, Joshi SR, Kamp M, Laffel L, Mathieu C, Polonsky WH, Snoek F, Home P. Clinical utility of SMBG: recommendations on the use and reporting of SMBG in clinical research. Diabetes Care. 2015 Sep;38(9):1627–33. doi: 10.2337/dc14-2919.38/9/1627 - DOI - PubMed
    1. Delamater AM. Improving patient adherence. Clinical Diabetes. 2006 Apr 01;24(2):71–77. doi: 10.2337/diaclin.24.2.71. - DOI

Associated data

LinkOut - more resources