CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT The aim of this study was to examine the effectiveness of a freely available smartphone application combined with text-message feedback from a certified diabetes educator to improve glycemic control and other diabetes-related outcomes in adult patients with type 1 diabetes in a two-group randomized controlled trial. Patients were recruited through an online type 1 diabetes support group and letters mailed to adults with type 1 diabetes throughout Australia. In a sixmonth intervention, followed by a three-month follow-up, patients (n=72) were randomized to usual care (control group) or usual care and the use of a smartphone application (Glucose Buddy) with weekly text-message feedback from a certified diabetes educator (intervention group). All outcome measures were collected at baseline and every three months over the study period. Patients’ glycosylated hemoglobin levels (HbA1c) were measured with a blood test and diabetes-related self-efficacy, self-care activities, and quality of life were measured with online questionnaires. 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT In a six-month intervention, followed by a three-month follow-up, patients (n=72) were randomized to usual care (control group) or usual care and the use of a smartphone application (Glucose Buddy) with weekly text-message feedback from a certified diabetes educator (intervention group). All outcome measures were collected at baseline and every three months over the study period. Patients’ glycosylated hemoglobin levels (HbA1c) were measured with a blood test and diabetes-related self-efficacy, self-care activities, and quality of life were measured with online questionnaires. 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT In a six-month intervention, followed by a three-month follow-up, patients (n=72) were randomized to usual care (control group) or usual care and the use of a smartphone application (Glucose Buddy) with weekly text-message feedback from a certified diabetes educator (intervention group). All outcome measures were collected at baseline and every three months over the study period. Patients’ glycosylated hemoglobin levels (HbA1c) were measured with a blood test and diabetes-related self-efficacy, self-care activities, and quality of life were measured with online questionnaires. 1b-iv) RESULTS section in abstract must contain use data Results: The mean age of patients was 35.20±10.43 years (28 male /44 female), 39% (28/72) were male, and patients had been diagnosed with type 1 diabetes for a mean of 18.94±9.66 years. Of the initial 72 patients, 53 completed the study (25 intervention, 28 control group). The intervention group significantly improved glycemic control (HbA1c) from baseline (9.08±1.18%) to nine-month follow-up (7.80±0.75%), compared to the control group (baseline 8.47±0.86%, follow-up 8.58±1.16%). No significant change over time was found in either group in relation to self-efficacy, self-care activities, and quality of life. 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Primary outcome did change.