A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial

Abstract

BackgroundWhile optimal blood glucose control is known to reduce the long-term complications associated with type 1 diabetes mellitus, adolescents often struggle to achieve their blood glucose targets. However, their strong propensity toward technology presents a unique opportunity for the delivery of novel self-management interventions. To support type 1 diabetes self-management in this population, we developed the diabetes self-management app bant, which included wireless blood glucose reading transfer, out-of-range blood glucose trend alerts, coaching around out-of-range trend causes and fixes, and a point-based incentive system.ObjectiveThe primary objective was to evaluate bant ’s effect on hemoglobin A1c (HbA1c) through a randomized controlled trial (RCT). Secondary measures (eg, self-monitoring of blood glucose [SMBG]) were also collected to assess bant ’s impact on the self-management behaviors of adolescents with type 1 diabetes.MethodsWe enrolled 92 adolescents into a 12-month RCT, with 46 receiving usual care and 46 receiving usual care plus bant. Clinical outcome data were collected at quarterly research visits via validated tools, electronic chart review, glucometer downloads, and semistructured interviews. App satisfaction was assessed at 6 and 12 months, and at trial end, users ranked bant components based on perceived usefulness. Mobile analytics captured frequency of blood glucose uploads, which were used to categorize participants into high, moderate, low, or very low engagement levels.ResultsLinear mixed models showed no changes in primary and secondary clinical outcomes. However, exploratory regression analysis demonstrated a statistically significant association between increased SMBG and improved HbA1c in the intervention group. For a subgroup of bant users taking SMBG ≥5 daily, there was a significant improvement in HbA1c of 0.58% (P=.02), while the parallel subgroup in the control arm experienced no significant change in HbA1c (decrease of 0.06%, P=.84). Although app usage did diminish over the trial, on average, 35% (16/46 participants) were classified as moderately or highly engaged (uploaded SMBG ≥3 days a week) over the 12 months.ConclusionAlthough primary analysis of clinical outcomes did not demonstrate differences between the bant and control groups, exploratory analysis suggested that bant may positively impact the use of SMBG data and glycemic control among youth. The next generation of bant will aim to remove barriers to use, such as deploying the app directly to personal devices instead of secondary research phones, and to explore the utility of integrating bant into routine clinical care to facilitate more frequent feedback. Future evaluations of mHealth apps should consider more robust research tools (eg, ResearchKit) and alternative RCT study designs to enable more rapid and iterative evaluations, better suited to the nature of rapidly evolving consumer technology.Trial RegistrationClinicalTrials.gov NCT01899274; https://clinicaltrials.gov/ct2/show/NCT01899274 (Archived by We...

Testing a Smartphone App (Young with Diabetes) to Improve Self-Management of Diabetes Over 12 Months: Randomized Controlled Trial (Preprint)

“…Similar to our results, the three studies found no improvement in HbA1c compared to the control group. However, one study [34] found a statistically significant association between increased self-monitored blood glucose and improved HbA1c. Unfortunately, comparability is limited by the small number of existing studies and differences in intervention design.…”

“…Berndt et al [33] tested an application to collect data and provide clinical support in a four-week RCT (n=68; ages 8-18). Finally, Goyal et al [34] tested an mHealth application in a 12-month RCT (n=92; ages 12-15). The application facilitated feedback on the transfer of blood glucose readings from a glucometer, rewarding action.…”

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“…Overall the site with the highest app usage site spent the greatest time and resources on implementation. It is increasingly evident that digital health apps designed to improve chronic disease self-management require ongoing patient engagement with the app as a key determinant of clinical impact [28][29][30][31][32]. Therefore, a successful implementation and evaluation of these apps requires careful consideration of factors that impact patient app utilization [32].…”

“…Instead of downloading the app, participants were given the intervention on a second phone they used for the duration of the study in an attempt to standardize implementation by the funder. However, the use of a second phone to deliver e-health interventions has been a noted barrier to usage in previous studies and future mobile app evaluations would likely benefit from allowing participants to utilize their own smart phones when possible [30]. Given previous evidence on the benefits of strong PCP participation in diabetes self-management apps, the use of DEPs as the primary site of recruitment likely had a negative impact on enrollment, usage and clinical impact [41,42].…”

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“…Researchers must assess the efficacy of medical strategies rather than focusing on patients' failures to adhere to recommendations of questionable therapeutic value [4]. Effective healthcare management may not only prevent chronic disease complications but also reduce overall disease cost and family burden and improve patients' quality of life [1,[5][6][7].…”