A smartphone app is associated with improvement in HbA1c levels, but physician involvement with patients and other factors may be the benefit.
A new report affirms the potential for prescriptions digital solutions to help manage type 2 diabetes, but it also highlights the role of physician monitoring in boosting patient adherence.
In the new study, which was published in JMIR Diabetes,1 investigators wanted to know whether a digital therapeutic would be effective at helping patients control their glucose levels when used as an add-on therapy to regular antidiabetic treatment. They enrolled 128 people in India with type 2 diabetes and HbA1c levels of 6.5% or above. Participants were asked to download a smartphone application that connected with devices such as glucose and blood pressure monitors, as well as commercial fitness applications like Google Fit and Apple Health. When vital-sign measures deviated from pre-established parameters, both the patient and his or her physician were alerted. In addition, the app provided users with medication reminders based on the physician’s prescription. Finally, the app used a system of patient education and incentive tools that its designers said was meant to conform to the individual user’s behavior and preferences.
The primary objective of the study was to gauge the application’s impact on patient HbA1c, fasting blood glucose, postprandial blood glucose, body mass index, and Homeostatic Model Assessment for Insulin Resistance index at the end of the 12 weeks.
Overall, the mean change in those parameters was -0.84% for HbA1c, -8.39 mg/dl for fasting blood glucose, -14.97 mg/dL for postprandial blood glucose and -0.24 kg/m2 for body mass index.
In terms of the Homeostatic Model Assessment for Insulin Resistance, however, the study population saw an increase of 0.54.
The digital therapeutic intervention used in the study was developed by Phable Care, which bills itself as India’s largest chronic disease management company. Phable Care’s director of medical strategy, Suhas Patil, M.D., M.B.B.S., was the study’s corresponding author. He and colleagues wrote that the study’s results build on previous evidence showing digital therapeutics can play an important role in addition to traditional therapies.
“A new approach is useful if the majority of patients are benefitting from it and if the benefit is highly probable,” they wrote. In their study, the authors said 76.6% of participants achieved a reduction in HbA1c levels from baseline.
The investigators suggested,though, that the impact may be due to more than just the digital technology. In addition to the application, the study protocol called for regularly scheduled consultations with the patient’s physician, a dietician, and an exercise coach throughout the 12-week study period. Patil and colleagues said part of the benefit of the product might be the accountability facilitated by the technology, in the form of physician alerts.
“The DTI (digital therapeutic intervention) approach used in this study included a significant human component by way of involvement of the primary care physician of the patients, apart from dieticians and health coaches,” they wrote. “The presence of a patient’s physician in the DTI care team may have created the psychological impact that the participant’s health is being monitored by their physician.”
Patil and colleagues are not alone in that assertion. In a 2020 review in npj digital medicine,2 William J. Gordon, MD, of Brigham and Women’s Hospital, and colleagues, noted that digital tools have positive potential in part because they can help patients stay better connected with their healthcare providers. However, they also cautioned that there will be challenges to integrating these types of technologies into the normal healthcare workflow.
“The sheer number of apps available, each with varying functionality, complexity, impact, and cost, creates substantial barriers to the diffusion of these apps into clinical care,” they wrote. They added that many such programs have “scant” clinical evidence to back up their efficacy, and some may even be harmful, they said. That’s one reason firms like Phable Care have sought to conduct clinical trials.
1. Chawla R, Jaggi S, Gupta A, Bantwal G, Patil S
Clinical Utility of a Digital Therapeutic Intervention in Indian Patients With Type 2 Diabetes Mellitus: 12-Week Prospective Single-Arm Intervention Study
JMIR Diabetes 2022;7(4):e41401 doi: 10.2196/41401
2. Gordon, W.J., Landman, A., Zhang, H. et al. Beyond validation: getting health apps into clinical practice. npj Digit. Med. 3, 14 (2020). https://doi.org/10.1038/s41746-019-0212-z