RESUMEN
BACKGROUND: Blood glucose management around exercise is challenging for youth with type 1 diabetes (T1D). Previous research has indicated interventions including decision-support aids to better support youth to effectively contextualize blood glucose results and take appropriate action to optimize glucose levels during and after exercise. Mobile health (mHealth) apps help deliver health behavior interventions to youth with T1D, given the use of technology for glucose monitoring, insulin dosing, and carbohydrate counting. OBJECTIVE: We aimed to develop a novel prototype mHealth app to support exercise management among youth with T1D, detail the application of a co-design process and design thinking principles to inform app design and development, and identify app content and functionality that youth with T1D need to meet their physical activity goals. METHODS: A co-design approach with a user-centered design thinking framework was used to develop a prototype mHealth app "acT1ve" during the 18-month design process (March 2018 to September 2019). To better understand and respond to the challenges among youth with diabetes when physically active, 10 focus groups were conducted with youth aged 13-25 years with T1D and parents of youth with T1D. Thereafter, we conducted participatory design workshops with youth to identify key app features that would support individual needs when physically active. These features were incorporated into a wireframe, which was critically reviewed by participants. A beta version of "acT1ve" was built in iOS and android operating systems, which underwent critical review by end users, clinicians, researchers, experts in exercise and T1D, and app designers. RESULTS: Sixty youth with T1D, 14 parents, 6 researchers, and 10 clinicians were engaged in the development of "acT1ve." acT1ve included key features identified by youth, which would support their individual needs when physically active. It provided advice on carbohydrates and insulin during exercise, information on hypoglycemia treatment, pre- and postexercise advice, and an educational food guide regarding exercise management. "acT1ve" contained an exercise advisor algorithm comprising 240 pathways developed by experts in diabetes and exercise research. Based on participant input during exercise, acT1ve provided personalized insulin and carbohydrate advice for exercise lasting up to 60 minutes. It also contains other features including an activity log, which displays a complete record of the end users' activities and associated exercise advice provided by the app's algorithm for later reference, and regular reminder notifications for end users to check or monitor their glucose levels. CONCLUSIONS: The co-design approach and the practical application of the user-centered design thinking framework were successfully applied in developing "acT1ve." The design thinking processes allowed youth with T1D to identify app features that would support them to be physically active, and particularly enabled the delivery of individualized advice. Furthermore, app development has been described in detail to help guide others embarking on a similar project. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001414101; https://tinyurl.com/mu9jvn2d.
RESUMEN
BACKGROUND: Empowering young people with type 1 diabetes (T1D) to manage their blood glucose levels during exercise is a complex challenge faced by health care professionals due to the unpredictable nature of exercise and its effect on blood glucose levels. Mobile health (mHealth) apps would be useful as a decision-support aid to effectively contextualize a blood glucose result and take appropriate action to optimize glucose levels during and after exercise. A novel mHealth app acT1ve was recently developed, based on expert consensus exercise guidelines, to provide real-time support for young people with T1D during exercise. OBJECTIVE: Our aim was to pilot acT1ve in a free-living setting to assess its acceptability and functionality, and gather feedback on the user experience before testing it in a larger clinical trial. METHODS: A prospective single-arm mixed method design was used. Ten participants with T1D (mean age 17.7 years, SD 4.2 years; mean HbA1c, 54 mmol/mol, SD 5.5 mmol/mol [7.1%, SD 0.5%]) had acT1ve installed on their phones, and were asked to use the app to guide their exercise management for 6 weeks. At the end of 6 weeks, participants completed both a semistructured interview and the user Mobile Application Rating Scale (uMARS). All semistructured interviews were transcribed. Thematic analysis was conducted whereby interview transcripts were independently analyzed by 2 researchers to uncover important and relevant themes. The uMARS was scored for 4 quality subscales (engagement, functionality, esthetics, and information), and a total quality score was obtained from the weighted average of the 4 subscales. Scores for the 4 objective subscales were determined by the mean score of each of its individual questions. The perceived impact and subjective quality of acT1ve for each participant were calculated by averaging the scores of their related questions, but were not considered in the total quality score. All scores have a maximal possible value of 5, and they are presented as medians, IQRs, and ranges. RESULTS: The main themes arising from the interview analysis were "increased knowledge," "increased confidence to exercise," and "suitability" for people who were less engaged in exercise. The uMARS scores for acT1ve were high (out of 5) for its total quality (median 4.3, IQR 4.2-4.6), engagement (median 3.9, IQR 3.6-4.2), functionality (median 4.8, IQR 4.5-4.8), information (median 4.6, IQR 4.5-4.8), esthetics (median 4.3, IQR 4.0-4.7), subjective quality (median 4.0, IQR 3.8-4.2), and perceived impact (median 4.3, IQR 3.6-4.5). CONCLUSIONS: The acT1ve app is functional and acceptable, with a high user satisfaction. The efficacy and safety of this app will be tested in a randomized controlled trial in the next phase of this study. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001414101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378373.