Journal Article

A Novel Mobile Health App to Educate and Empower Young Adults With Type 1 Diabetes to Exercise Safely: Prospective Single-Arm Pre-Post Noninferiority Clinical Trial

Jones, Timothy W, Shetty, Vinutha Beliyurguthu, Soon, Wayne H K, Smith, Grant J, Fournier, Paul A, Teo, Shaun, Lim, Rachel, Davis, Elizabeth A, Roby, Heather C, G Roberts, Alison

2025

Overview

A novel mobile health (mHealth) app \"acT1ve,\" developed using a co-design model, provides real-time support during exercise for young people with type 1 diabetes (T1D). This study aimed to demonstrate the noninferiority of acT1ve compared with \"treatment as usual\" with regard to hypoglycemic events. Thirty-nine participants living with T1D (age: 17.2, SD 3.3 years; HbA1c: 64, SD 6.0 mmol/mol) completed a 12-week single-arm, pre-post noninferiority study with a follow-up qualitative component. During the intervention, continuous glucose monitoring (CGM) and physical activity were monitored while participants used acT1ve to manage exercise. CGM data were used to assess the number of hypoglycemic events (<3.9 mmol/L for ≥15 minutes) in each phase. Using a mixed effects negative binomial regression, the difference in the rates of hypoglycemia between the preapp and app-use phases was analyzed. Participants completed both a semistructured interview and the user Mobile Application Rating Scale (uMARS) questionnaire postintervention. All interviews were audio-recorded for transcription, and a deductive content analysis approach was used to analyze the participant interviews. The uMARS Likert scores for each subscale (engagement, functionality, esthetics, and information) were calculated and reported as medians with IQRs. The rates of hypoglycemia were similar for both the preapp and app-use phases (0.79 and 0.83 hypoglycemia events per day, respectively). The upper bound of the CI of the hypoglycemia rate ratio met the prespecified criteria for noninferiority (rate ratio=1.06; 95% CI 0.91-1.22). The uMARS analysis showed a high rating (≥4 out of 5) of acT1ve by 80% of participants for both functionality and information, 72% for esthetics, and 63% for overall uMARS rating. Content analysis of the interview transcripts identified 3 main themes: \"Provision of information,\" \"Exercising with the App,\" and \"Targeted Population.\" The mHealth app \"acT1ve,\" which was developed in collaboration with young people with T1D, is functional, acceptable, and safe for diabetes management around exercise. The study supports the noninferiority of acT1ve compared with \"treatment as usual\" with regards to hypoglycemic events.

• Publisher: JMIR Publications
• Subject: Apps, Mobile, Wearables for Diabetes / Diabetes Education and Self-Management in Childhood and Adolescence / Diabetes Self-Management / Exercise / Exercise and Diet Tracking for Diabetes Patients / Formative Evaluation of Digital Health Interventions / Glucose Tracking and Self-Monitoring of Blood Glucose / mHealth for Symptom and Disease Monitoring, Chronic Disease Management / Original Paper / Patient Experiences with Diabetes Technology / Teenagers / Telemedicine / Young adults