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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.
The primary objective of this randomized controlled trial (RCT) is to determine the impact of
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.
The first patient was enrolled on July 28, 2015, and we anticipate completing this study by September, 2018.
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.
ClinicalTrials.gov NCT02370719; https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at http://www.webcitation.org/6jpyjfVRs)
The increasing global prevalence of diabetes is challenging traditional approaches towards diabetes management. It is not sustainable, nor cost effective, to assume that there will be an increase in health care delivery resources to address the growing prevalence of diabetes. Novel self-management tools, which aim to engage patients in daily diabetes care and optimize the role of health care professionals, may facilitate a more robust, scalable, and effective approach to the management of diabetes [
While self-management is a major component of chronic disease management, the majority of patients are not provided, or do not have access to, the tools and personalized education needed to engage in daily self-care practices [
Furthermore, recent policy changes have reduced the reimbursements for test strips for patients who are not treated with insulin, further limiting access to SMBG as a self-monitoring tool [
Recent evidence has shown that when SMBG is performed in a structured manner, and is coupled with appropriate feedback and education, it may lead to positive health behavior change amongst patients with type 2 diabetes mellitus (T2DM) who are not treated with insulin [
The popularity of smartphones has presented an opportunity to deliver this type of intervention in the form of an evidence-based and user-centered diabetes self-management app [
The primary objective of this randomized controlled trial (RCT) is to determine the impact of the evidence-based, patient-centered, mobile app for the self-management of T2DM. Although there are many diabetes-focused electronic health (eHealth) tools currently available, the majority require a third party HCP to facilitate decision making [
The
The primary recruitment strategy for this study is through self-referral at primary care and community practices throughout the Greater Toronto Area. This area includes sites that are situated in urban and suburban settings. The University Health Network Research Ethics Board (REB) approved the study (14-7978-AE). Local institutional REB approvals were also obtained from the following participating sites: St. Joseph’s Health Care Centre (#2015-010), Trillium Health Partners (#698), and North York General (#15-0038). For sites without an institutational REB, namely the Taddle Creek Diabetes Education Program and LMC Diabetes and Endocrinology, approval was obtained from an Institutional Review Board (Pro00016415).
Randomization is being conducted at the patient level, using random block sizes of four and six to reduce the variance across the entire sample, with a 1:1 allocation ratio. Stratificaiton is also conducted by recruitment site. The allocation envelopes contain a piece of paper with either
The participants randomly assigned to the intervention group will receive an iPhone 5S loaded with the
The
We have ensured that all of the appropriate safeguards are in place to protect personal health information. For example, the iPhone requires a passcode to access the app, and the app itself requires a username and password. In the event that the device is lost or stolen, we can remotely wipe the device using mobile data management software (Airwatch, Atlanta, GA). The
The bant2 mobile app enables users to monitor lifestyle behaviors and correlate them to their overall glycemic control.
The inclusion criteria for participants include: definitive diagnosis of T2DM, not treated with insulin, at least 18 years of age, a baseline glycated hemoglobin A1c (A1c) of 7.5% or higher, and ability to speak and read English.
Exclusion criteria include: inability to use a mobile phone (eg, due to vision problems) or to comply with home monitoring (eg, due to suffering from anxiety or depression), and duration of diabetes under one year. Participants who have had diabetes for less than one year are excluded because they typically demonstrate a higher adherence to self-care and have high levels of motivation [
The primary outcome measure is change in A1c from baseline to 12 months. Each recruitment site is provided with a DCA Vantage Analyzer (Siemens, Munich, Germany) point of care A1c device to reduce the variability in the A1c laboratory assays. As secondary end points, A1c measurements are also collected at 3-month intervals (3, 6, and 9 months). Clinical staff within the patient’s circle of care are conducting the point of care A1c tests.
Secondary outcomes include blood pressure (mmHg), weight (pounds), total cholesterol (mmol/L), Low Density Lipoprotein cholesterol (mmol/L), and weight at baseline, 3, 6, 9, and 12 months. The number of participants who achieve optimal glycemic control (A1c <7%), as well as the type and frequency of medication changes, will also be measured. Furthermore, validated instruments described in
Validated instruments administered pre-, mid-, and post-study.
Measure | Description |
Diabetes Distress Scale (DDS) | The DDS is a 17-item instrument that assesses the emotional, physician-related, regimen-related, and interpersonal aspects of diabetes distress, and provides an indication of diabetes-related quality of life [ |
Diabetes Empowerment Scale - Short Form (DES-SF) | The DES-SF is a 28-item instrument used to measure psychosocial self-efficacy of diabetes self-management. This tool focuses on (1) managing diabetes, (2) assessing readiness to change, and (3) willingness to set goals and change behaviors [ |
Summary of Diabetes Self-Care Activities (SDSCA) measure | The SDSCA is a 11-item instrument that assesses individual levels of diabetes self-care, focusing on general diet, specific diet, exercise, medication adherence, blood-glucose testing, smoking, and foot care [ |
The Mobile Application Rating Scale (MARS) App - User Version | The MARS is a 26-item instrument used to evaluate the quality, functionality, and overall satisfaction of the mobile app itself [ |
The sample size estimation was based on detecting a minimum reduction of 0.5% in A1c values. Given our inclusion criteria of A1c >7.5%, we anticipate that A1c levels will be highly clustered around 8.5% (standard deviation 1.0). A minimum of 63 participants per group is necessary to detect a difference of 0.5% in A1c, at an 80% power with a one-sided 5% significance level in all anticipated cases. With a further 15% adjustment for potential dropouts, a final sample size of 150 subjects will be required for both groups, with 75 participants in each study arm. All calculations were performed using the R software package,
The lead physician (or research administration staff) of the recruitment site is first approached by email regarding their interest in the study, and a 20-30 minute presentation is offered as a way to disseminate the study details and gauge interest across the site. If the lead physician is interested in participating, they contact the clinicians within their site, disseminate information regarding the study, and identify the clinicians interested in participating in the study. Upon receiving REB approval, a staff member at the participating site generates a list of eligible participants and has the list vetted by the respective physicians for appropriateness.
The participating sites send invitation letters to eligible and appropriate participants, explaning the study goals and protocol. The letter invites participants to contact the study coordinator directly, either by email or phone call, if they are interested in participating in the study. Upon initial contact, the study coordinator describes the study and answers any of the patient’s study-related questions. If the respondent is interested in participating, the coordinator will schedule an appointment with the respective clinic, and email or mail the patient the consent form in advance for review.
The principal analysis strategy will be the use of linear mixed models in the Statistical Analysis System (Cary, NC, USA) using the PROC MIXED procedure. This approach provides a simple method to incorporate baseline values and the correlation of each participant over time (using a random effect). This model is more powerful than the repeated measures
Secondary contrasts will be used to examine differences from baseline for all other time points; however, these will be of exploratory interest only. Moreover, we will use regression analysis to separate the contribution of the different intervention components (activity monitor, weight scale, SMBG, mobile app features), and determine their independent effects on the primary outcome at 12 months. This approach will identify which aspect of the mHealth intervention contributed to the change in A1c.
This trial is currently open for recruitment. The anticipated completion date for the study is September, 2018.
SMBG is an essential part of managing glycemic control. However, for T2DM patients that are not treated with insulin, the standard approach of simply recommending SMBG without the appropriate guidelines and training will not facilitate behavior change [
This RCT will evaluate the use of the
A considerable limitation of the study is that the iPhone provided to the intervention group is likely to be a secondary device, potentially hindering the complete immersion of the app into daily routines.
At the time of the intervention design, there were no Bluetooth-enabled blood glucose meters available in Canada. In order to facilitate the wireless transfer of blood glucose readings to the app, and reduce burden and errors associated with manual entry, we had to develop a customized Bluetooth adapter [
Furthermore, as outlined by Polonsky [
The results of this study will further our understanding of how an evidence-based behavior modification mobile app can guide patients in the self-management of their diabetes. Specifically, we will be able to assess how various features of the
This RCT is one of the first studies 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 for diabetes self-care, the effectiveness of consumer-grade devices for chronic disease management, the economic model of using incentives to motivate behavior change, and the consumption of test strips when SMBG follows a rigorously structured approach. The findings from this study will inform the next generation of diabetes education, guidelines for SMBG, and potentially inform health policy pertaining to strip reimbursements for T2DM patients that are not treated with insulin.
glycated hemoglobin A1c
Diabetes Distress Scale
Diabetes Empowerment Scale - Short Form
health care provider
Mobile Application Rating Scale
mobile health
randomized controlled trial
Research Ethics Board
Summary of Diabetes Self-Care Activities
self-monitoring of blood glucose
type 1 diabetes mellitus
type 2 diabetes mellitus
The authors would like to acknowledge the Canadian Institutes of Health Research (Grant No. 2921453), the Natural Sciences and Engineering Research Council, and TELUS Healthcare Support through Information Technology Enhancement Strategic Network for funding this study, and Agamatrix for donating blood glucose meters and test strips.
The authors would like to thank all of the recruitment sites and the University of Toronto Practice Based Research Network for their assistance in recruiting patients.
SG developed the concept and led the design of the study, and JC, CY, GL, ES, and MR contributed to the design of the study. SG drafted the manuscript, and JC, CY, GL, ES, and MR edited and reviewed the manuscript. JC is the principal investigator of this study.
None declared.