JMIR Publications

ABSTRACT

Background:

: 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).

Objective:

This study aimed to demonstrate the non-inferiority of acT1ve compared to ‘treatment as usual” with regards to hypoglycaemic events.

Methods:

Thirty-nine participants living with T1D (age:17.2±3.3years; HbA1c: 64±6.0mmol/mol) completed a 12-week single-arm, pre-post non-inferiority 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. Participants completed both a semi-structured interview and the user Mobile Application Rating Scale (uMARS) questionnaire post-intervention. The CGM data was used to assess the number of hypoglycaemic events (<3.9mmol/L for ≥15minutes) in each phase. The uMARS Likert scores for each subscale (engagement, functionality, aesthetics, information) were calculated and reported as medians with interquartile ranges (IQRs).

Results:

The rates of hypoglycaemia were similar for both the Pre-App and App-use phases (0.79 and 0.83 events/day, respectively). The upper bound of the confidence interval of the hypoglycaemia rate ratio met the pre-specified criteria for non-inferiority (rate ratio=1.06, 95%CI: 0.91, 1.22). The uMARS analysis showed high rating (≥4 out of 5) of acT1ve by 80% of participants for both functionality and information, 72% for aesthetics, and 63% for overall uMARS rating. Content analysis of the interview transcripts identified three main themes: ‘Provision of information’; ‘Exercising with the App’; and ‘Targeted Population’.

Conclusions:

“acT1ve”, a mHealth App which was developed in collaboration with young people with T1D, is functional, acceptable, and safe for diabetes management around exercise. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN12620001066976.