NCT02370719.

Trial name or title	Evaluation of an mHealth behavioural intervention for the self‐management for type 2 diabetes
Methods	Type of study: efficacy study Allocation: randomised Intervention model: parallel assignment Masking: open label Primary purpose: treatment
Participants	Condition: type 2 diabetes, emotional distress, stress Enrollment: 150 Inclusion criteria: English‐speaking individuals Diagnosed with non‐insulin requiring type 2 diabetes Outpatients Baseline A1c of 7.5% or higher Exclusion criteria: Patients who are deemed unable to use a mobile phone (e.g. due to vision problems), and/or to comply with home monitoring (e.g. suffering from anxiety or depression) Diabetes duration < 1 year
Interventions	Intervention(s): mobile application for diabetes self‐management Comparator(s): standard of care
Outcomes	Timepoint(s): baseline, 3, 6, 9 and 12 months Primary outcome(s): HbA1c Secondary outcome(s): Blood pressure Weight Cholesterol (LDL and total) Medication changes Glycaemic excursions BMI DDS Diabetes Empowerment Scale Summary of Diabetes Self‐Care Activities Other outcome(s): —
Starting date	Trial start date: June 2015 Trial completion date: July 2017
Contact information	Responsible party/principal investigator: University Health Network, Toronto, Canada/Joseph A Cafazzo
Study identifier	NCT number: NCT02370719
Official title	Evaluation of an mHealth behavioural intervention for the self‐management for type 2 diabetes mellitus
Stated purpose of study	Quote: "The purpose of this study is to evaluate a patient‐centered diabetes self‐management mobile application (app), which was developed with feedback from both patients and healthcare providers. During the 12 month participants in the intervention group will be provided with a mobile phone and commercial home medical devices, such as a weight scale, glucometer and activity monitor. The measurements taken from the medical devices will wirelessly transfer to the mobile phone, where the app will assess the data and provide patients with actionable self‐management knowledge."
Notes	This study is currently recruiting participants. Contact: Shivani Goyal, sgoyal@ehealhinnovation.org