Improving Diabetes Self management Using Digital Therapeutics: Insights into User Engagement from a Randomized Controlled Trial in Urban Aligarh
Keywords:
Digital Therapeutic Intervention (DTI), Digital Therapeutics, Self-Monitoring of Blood Glucose (SMBG), Type 2 Diabetes mellitus (T2DM), Randomized Controlled Trial (RCT), User Engagement, Mobile App, Aligarh/IndiaAbstract
Introduction: Diabetes mellitus, one of the greatest contributors of global burden, and its aftermath necessitates a holistic perspective for its treatment and prevention. Self-Monitoring of Blood glucose encompasses all the fundamental principles and approaches of Diabetic management. Applying novel digital innovation in SMBG can improve clinical outcomes and quality of life.
Aims: To assess user engagement and acceptability of DTI and SMBG and also identify potential association with outcome results
Settings and Design: Randomized Controlled Trial in urban Aligarh
Methods and Material: After enrollment of 132 participants, they were allocated into 3 groups by randomization- (1) No SMBG (2) SMBG thrice weekly (3) thrice weekly SMBG users with digital feedback by Simple Random Sampling followed by Randomization. Data was captured on socio-demographic correlates at the begging of study and user engagement and feedback using Mobile Application Rating Score was collected at the end of study.
Statistical analysis used: Descriptive statistics
Results: Among those who received DTI along with SMBG, 72.5% of the users were highly engaged and 27.5% users were lowly engaged. More than half of the participants rated between 2 and 3 for most of the parameters. The difficulties faced by the participants while using the app, which were fear of security issues (59%), user issues (26%) and operational and technical issues (15%). Overall rating of the app was acceptable.
Conclusion: The study highlights the potential of SMBG and DTI to be a valuable adjunct to conventional diabetes management. It reinforces the need to bridge the gap between available technology and real-world application in patient care.
Downloads
References
World Health Organization. Diabetes [Internet]. 2024. Available from: https://www.who.int/health-topics/diabetes#tab=tab_1
Krishnan V, Thirunavukkarasu J. Assessment of Knowledge of Self Blood Glucose Monitoring and Extent of Self Titration of Anti-Diabetic Drugs among Diabetes Mellitus Patients - A Cross Sectional, Community Based Study. J Clin Diagn Res. 2016;10(3):FC09-FC11. Available from: https://doi.org/10.7860/JCDR/2016/18387.7396
Sia HK, Kor CT, Tu ST, Liao PY, Wang JY. Self-monitoring of blood glucose in association with glycemic control in newly diagnosed non-insulin-treated diabetes patients: a retrospective cohort study. Sci Rep. 2021;11(1):1176. Available from: doi: 10.1038/s41598-021-81024-x. PMID: 33441946; PMCID: PMC7806592.
Grant P. Management of diabetes in resource-poor settings. Clin Med (Lond). 2013;13(1):27-31. doi: 10.7861/clinmedicine.13-1-27. PMID: 23472490; PMCID: PMC5873700.
Patnaik L, Panigrahi SK, Sahoo AK, Mishra D, Muduli AK, Beura S. Effectiveness of Mobile Application for Promotion of Physical Activity Among Newly Diagnosed Patients of Type II Diabetes - A Randomized Controlled Trial. Int J Prev Med. 2022 ;13:54.
Koot D, Goh PSC, Lim RSM, Tian Y, Yau TY, Tan NC, Finkelstein EA. A Mobile Lifestyle Management Program (GlycoLeap) for People With Type 2 Diabetes: Single-Arm Feasibility Study. JMIR Mhealth Uhealth. 2019;7(5):e12965.
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. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9664320/
Gupta K, Roy S, Altameem A, Kumar R, Saudagar AKJ, Poonia RC. Usability Evaluation and Classification of mHealth Applications for Type 2 Diabetes Mellitus Using MARS and ID3 Algorithm. Int J Environ Res Public Health. 2022 Jun 8;19(12):6999. doi: 10.3390/ijerph19126999. PMID: 35742248; PMCID: PMC9222518.
Shrivastava TP, Wagdhare S, Saboo B, Goyal RK. Quality, functionality, and features of a newly developed smartphone app for diabetes: A comparative analysis using Mobile app rating scale. Digit Health. 2025;11:20552076251343700. doi: 10.1177/205520.
Ewunetu M, Belay BM, Abere Y, Melkamu B, Eshetie Y, Dires T. Home self monitoring of blood glucose using a glucometer and its determinants among diabetes mellitus. Sci Rep. 2025;15(1):17217. doi: 10.1038/s41598-025-02196-4. PMID: 40382440; PMCID: PMC12085629.
Makkar B, Kumar V, Saboo B, Agarwal S. RSSDI Clinical Practice Recommendations for the Management of Type 2 Diabetes Mellitus. Int J Diabetes Dev Ctries. 2022; 42(Suppl 1): 1–143.
Zovi A, Ferrara F, Gelmi M, Messina N, Pagani AAM, Patti T et al. Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies. Expert Rev Med Devices. 2025 ;22(2):141-147. doi: 10.1080/17434440.2025.2457468. Epub 2025 Jan 25. PMID: 39846979.
Alodhialah AM, Almutairi AA, Almutairi M. Short-Term Impact of Digital Mental Health Interventions on Psychological Well-Being and Blood Sugar Control in Type 2 Diabetes Patients in Riyadh. Healthcare (Basel). 2024;12(22):2257. Available from: doi: 10.3390/healthcare12222257. PMID: 39595455; PMCID: PMC11593722.
Lim SL, Tay MHJ, Ong KW, Johal J, Yap QV, Chan YH et al. Association Between Mobile Health App Engagement and Weight Loss and Glycemic Control in Adults With Type 2 Diabetes and Prediabetes (D'LITE Study): Prospective Cohort Study. JMIR Diabetes. 2022;7(3):e35039. doi: 10.2196/35039. PMID: 36178718; PMCID: PMC9568822.
Laird B, Van Tongeren DR, Hook JN, Do B, Hall T, Huberty J. Exploring User Perceptions of a Mobile App for Religious Practices. J Relig Health. 2024;63(3):2068-2090. Available from: doi: 10.1007/s10943-024-02004-9. Epub 2024 Feb 15. PMID: 38358455; PMCID: PMC11061027.
Kerr D, Ahn D, Waki K, Wang J, Breznen B, Klonoff DC. Digital Interventions for Self-Management of Type 2 Diabetes Mellitus: Systematic Literature Review and Meta-Analysis. J Med Internet Res. 2024 ;26:e55757. doi: 10.2196/55757. PMID: 39037772; PMCID: PMC11301119.
Oh SW, Kim KK, Kim SS, Park SK, Park S. Effect of an Integrative Mobile Health Intervention in Patients With Hypertension and Diabetes: Crossover Study. JMIR Mhealth Uhealth. 2022;10(1):e27192.Available from: doi: 10.2196/27192. PMID: 35014961; PMCID: PMC8790692.
Fundoiano-Hershcovitz Y, Hirsch A, Dar S, Feniger E, Goldstein P. Role of Digital Engagement in Diabetes Care Beyond Measurement: Retrospective Cohort Study. JMIR Diabetes. 2021;6(1):e24030. Available from: doi: 10.2196/24030. PMID: 33599618; PMCID: PMC7932839.
Kleinman NJ, Shah A, Shah S, Phatak S, Viswanathan V. Improved Medication Adherence and Frequency of Blood Glucose Self-Testing Using an m-Health Platform Versus Usual Care in a Multisite Randomized Clinical Trial Among People with Type 2 Diabetes in India. Telemed J E Health. 2017;23(9):733-740. Available from: doi: 10.1089/tmj.2016.0265. Epub 2017 Mar 6. PMID: 28328396.
Walle AD, Ferede TA, Shibabaw AA, Wubante SM, Guadie HA, Yehula CM, Demsash AW. Willingness of diabetes mellitus patients to use mHealth applications and its associated factors for self-care management in a low-income country: an input for digital health implementation. BMJ Health Care Inform. 2023;30(1):e100761. doi: 10.1136/bmjhci-2023-100761. PMID: 37236653; PMCID: PMC10230908.
Potter E, Burstein F, Flynn D, Hwang ID, Dinh T, Goh TY et al. Physician-Authored Feedback in a Type 2 Diabetes Self-management App: Acceptability Study. JMIR Form Res. 2022;6(5):e31736. doi: 10.2196/31736. PMID: 35536614; PMCID: PMC9131138.
Huda RK, Chowhan RS, Seervi D. Effectiveness of mobile health technology-enabled interventions to improve management and control of hypertension and diabetes in India- a systematic review. Prev Med Rep. 2025 ;54:103094. Available from: doi: 10.1016/j.pmedr.2025.1030.
Shabir H, D’Costa M, Mohiaddin Z, Moti Z, Rashid H, Sadowska D et al. The Barriers and Facilitators to the Use of Lifestyle Apps: A Systematic Review of Qualitative Studies. Eur J Investig Health Psychol Educ. 2022;12(2):144-165.
Agarwal P, Mukerji G, Desveaux L, Ivers NM, Bhattacharyya O, Hensel JM et al. Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 ;7(1):e10321. Available from: doi: 10.2196/10321. PMID: 30632972; PMCID: PMC6329896.
Young LA, Buse JB, Weaver MA, Vu MB, Mitchell CM, Blakeney T, Grimm K, Rees J, Niblock F, Donahue KE; Monitor Trial Group. Glucose Self-monitoring in Non-Insulin-Treated Patients with Type 2 Diabetes in Primary Care Settings: A Randomized Trial. JAMA Intern Med. 2017 Jul 1;177(7):920-929.Available from: doi: 10.1001/jamainternmed.2017.1233. PMID: 28600913; PMCID: PMC5818811.
Spaulding EM, Marvel FA, Piasecki RJ, Martin SS, Allen JK. User Engagement With Smartphone Apps and Cardiovascular Disease Risk Factor Outcomes: Systematic Review. JMIR Cardio. 2021;5(1):e18834. doi: 10.2196/18834. PMID: 33533730; PMCID: PMC8411427.
Published
How to Cite
License
Copyright (c) 2026 Mohammad Salman Shah, Chelsea, Hamid Ashraf, Mohammad Athar Ansari, Salman Khalil

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.