Digital therapeutics and the need for regulation: how to develop products that are innovative, patient-centric and safe

Park

et al. 2023

Preprint

Background: Temporomandibular disorder (TMD) is a common condition that affects the temporomandibular joint (TMJ) and the muscles of the jaw, resulting in pain and dysfunction. TMD is affected by both behavioral and psychological factors. However, the effectiveness of conservative treatments varies among patients. Digital therapeutics (DTx) is a new treatment approach where a software based medical device is used such as smartphone application. DTx can expect therapeutic effects by controlling behavioral factors through delivery of appropriate intervention and cognitive behavioral therapy. DTx have emerged as a promising alternative treatment option for various chronic conditions, but the development of DTx and the efficacy for TMD have not been fully evaluated. Objective: The aim of this study is to evaluate the efficacy of a DTx for TMD called ‘Clickless®’, which is the first DTx using a smartphone application for TMD. Methods: We recruited 40 participants diagnosed with TMD who visited the Bundang Seoul National University Hospital from March to May 2022. Participants were randomly divided into an intervention test group (DTx use) and a control group. The intervention group received the usual treatment process for TMD in addition to the use of the DTx. The control group received the usual treatments only. The patients were followed up in 3-4 weeks for both groups, and the outcome data were collected and analyzed. Result: The intervention group showed a significant reduction in pain score as measured by the numeral rating scale (NRS) (mean difference 0.82, p = 0.038). Additionally, the intervention test group showed a statistically significant increase in maximal mouth opening compared to the control group. (mean difference 1.38(mm), p = 0.040] However, there was no significant difference of improvement in jaw functional limitation scale, oral behavior checklist, and patient health questionnaire-4 between the two groups. Conclusion: DTx is an effective treatment option for TMD patients when it applied with the conventional treatments, however further research is necessary to confirm its efficacy and wider application.

Section: Discussionmentioning

confidence: 99%

Open label randomized controlled trial of a digital therapeutics in temporomandibular disorder (TMD) patients: A preliminary study

Park

et al. 2023

Preprint

Bioengineering & Transla Med

“…As patients are not required to be in a clinical setting to experience therapeutic relief, the use of DTx also broadens the accessibilities of treatment to a broader audience 26 . In addition, there might be lower risks associated with DTx when compared to conventional drug‐based therapies 7 ; developers of the software must ensure that the product is safe for patient use in an ethical manner. DTx products are presented as high‐quality software that are designed to treat, manage, or prevent a medical condition 27,28 .…”

Section: Mechanism Of Action Potential and Applications Of Dtxmentioning

confidence: 99%

Digital therapeutics in the clinic

Phan

Mitragotri

Zhao

2023

Digital therapeutics are emerging as a new form of therapeutic interventions. Unlike conventional therapeutics, digital therapeutics deliver interventions directly to patients using an evidence‐based, clinically evaluated software to treat, manage, or prevent diseases. Digital therapeutics manifest in diverse forms such as web‐based applications, mobile applications on smart devices, virtual reality, and video games. As its own product category for FDA approval, digital therapeutics can function as stand‐alone treatments or in combination with conventional therapeutics to improve adherence and/or efficacy. Here, we review the clinical landscape of digital therapeutics. We summarize FDA‐approved products and their clinical use, overview >300 ongoing clinical trials, and discuss challenges for their clinical translation and strategies to overcome the same.

“…Digital therapeutic platforms provide evidence-based therapeutic interventions with the use of high-quality software to prevent, manage, or treat a medical disorder or disease [ 21 ]. Digital therapeutic platforms have been shown to provide diabetes care independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes [ 22 ].…”

Section: Introductionmentioning

confidence: 99%

Fitterfly Diabetes CGM Digital Therapeutics Program for Glycemic Control and Weight Management in People With Type 2 Diabetes Mellitus: Real-world Effectiveness Evaluation

Joshi¹,

Verma²,

Lathia³

et al. 2023

JMIR Diabetes

Background Digital therapeutic platforms facilitate health care through patient-centered strategies based on multidisciplinary teams and shared decision-making. Such platforms can be used for developing a dynamic model of diabetes care delivery, which can help in improving glycemic control by promoting long-term behavior changes in people with diabetes. Objective This study aims to evaluate the real-world effectiveness of the Fitterfly Diabetes CGM digital therapeutics program for improving glycemic control in people with type 2 diabetes mellitus (T2DM) after the completion of 90 days in the program. Methods We analyzed deidentified data of 109 participants in the Fitterfly Diabetes CGM program. This program was delivered through the Fitterfly mobile app coupled with continuous glucose monitoring (CGM) technology. This program consists of 3 phases: the first phase is observation, wherein the patient’s CGM readings are observed for 7 days (week 1); the second phase is the intervention; and the third phase aims at sustaining the lifestyle modification introduced during the second phase. The primary outcome of our study was the change in the participants’ hemoglobin A1c (HbA1c) levels after program completion. We also evaluated the changes in participant weight and BMI after the program, changes in the CGM metrics in the initial 2 weeks of the program, and the effects of participant engagement in the program on improving their clinical outcomes. Results At the end of the 90 days of the program, the mean HbA1c levels, weight, and BMI of the participants were significantly reduced by 1.2% (SD 1.6%), 2.05 (SD 2.84) kg, and 0.74 (SD 1.02) kg/m2 from baseline values of 8.4% (SD 1.7%), 74.45 (SD 14.96) kg, and 27.44 (SD 4.69) kg/m2 in week 1, respectively (P<.001). The average blood glucose levels and time above range values showed a significant mean reduction by 16.44 (SD 32.05) mg/dL and 8.7% (SD 17.1%) in week 2 from week 1 baseline values of 152.90 (SD 51.63) mg/dL and 36.7% (SD 28.4%), respectively (P<.001 for both). Time in range values significantly improved by 7.1% (SD 16.7%) from a baseline value of 57.5% (SD 25%) in week 1 (P<.001). Of all the participants, 46.9% (50/109) showed HbA1c reduction ≥1% and 38.5% (42/109) showed weight loss ≥4%. The average number of times the mobile app was opened by each participant during the program was 108.80 (SD 127.91) times. Conclusions Our study shows that participants in the Fitterfly Diabetes CGM program showed a significant improvement in their glycemic control and reduction in weight and BMI. They also showed a high level of engagement with the program. Weight reduction was significantly associated with higher participant engagement with the program. Thus, this digital therapeutic program can be considered as an effective tool for improving glycemic control in people with T2DM.