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INNOSC Theranostics and
            Pharmacological Sciences                                          Digital therapeutics for obesity management



               glucose control. Diabetes Care. 2011;34:1934-1942.     doi: 10.1089/tmj.2008.0099
               doi: 10.2337/dc11-0366                          18.  Ku EJ, Park JI, Jeon HJ, Oh T, Choi HJ. Clinical efficacy
                                                                  and plausibility  of a  smartphone-based integrated online
            7.   Wang C, Lee C, Shin H. Digital therapeutics from bench to   real-time diabetes care system via glucose and diet data
               bedside. NPJ Digit Med. 2023;6(1):38.
                                                                  management: A pilot study. Intern Med J. 2020;50:1524-1532.
               doi: 10.1038/s41746-023-00777-z
                                                                  doi: 10.1111/imj.14738
            8.   European  Data  Protection  Supervisor.  Digital  Therapeutics   19.  Guo H, Zhang Y, Li P, Zhou P, Chen LM, Li SY. Evaluating
               (DTx); 2022. Available from:  https://edps.europa.eu/  the effects of mobile health intervention on weight
               press-publications/publications/techsonar/digital-  management, glycemic control and pregnancy outcomes
               therapeuticsdtx_en [Last accessed on 2024 Jun 02].
                                                                  in patients with gestational diabetes mellitus. J Endocrinol
            9.   Ministry of Food and Drug Safety (Korea). Guideline   Invest. 2019;42:709-714.
               on Review and Approval of Digital Therapeutics (For      doi: 10.1007/s40618-018-0975-0
               Industry); 2020.  Available  from:  https://www.mfds.go.kr/
               eng/brd/m_40/view.do?seq=72624&srchfr=&srchto   20.  Kirwan M, Vandelanotte C, Fenning A, Duncan MJ. Diabetes
               =& sr c hw o r d=& sr c ht p =&i t m _s e q_ 1=0 &i t m_  self-management smartphone application for adults with
               seq_2=0&multi_itm_seq=0&company_cd=&company_       type 1 diabetes: Randomized controlled trial. J Med Internet
               nm=&page=1 [Last accessed on 2024 Jun 02].         Res. 2013;15:e235.
            10.  Digital Therapeutics Alliance. Digital Therapeutics Definition      doi: 10.2196/jmir.2588
               and Core Principles; 2019. Available from: https://dtxalliance.  21.  Kim M, Kim Y, Go Y,  et al. Multidimensional cognitive
               org [Last accessed on 2024 Jun 02].                behavioral therapy for obesity applied by psychologists
            11.  Dang A, Arora D, Rane P. Role of digital therapeutics and   using a digital platform: Open-label randomized controlled
               the changing future of healthcare. J Family Med Prim Care.   trial. JMIR Mhealth Uhealth. 2020;8:e14817.
               2020;9(5):2207-2213.                               doi: 10.2196/14817
               doi: 10.4103/jfmpc.jfmpc_105_20                 22.  Sepah SC, Jiang L,  Ellis RJ, McDermott K, Peters AL.
            12.  Lottes AE, Cavanaugh KJ, Chan YY, et al. Navigating the   Engagement and outcomes in a digital diabetes prevention
               regulatory pathway for medical devices-a conversation   program:  3-year  update.  BMJ  Open  Diabetes  Res  Care.
               with the FDA, clinicians, researchers, and industry experts.   2017;5(1):e000422.
               J Cardiovasc Transl Res. 2022;15(5):927-943.       doi: 10.1136/bmjdrc-2017-000422
               doi: 10.1007/s12265-022-10232-1                 23.  May CN, Cox-Martin M, Ho AS,  et al. Weight loss
            13.  Kepplinger EE. FDA’s expedited approval mechanisms for   maintenance  after  a digital commercial  behavior  change
               new drug products. Biotechnol Law Rep. 2015;34(1):15-37.  program (Noom Weight): Observational cross-sectional
                                                                  survey study. Obes Sci Pract. 2023;9(5):443-451.
               doi: 10.1089/blr.2015.9999
                                                                  doi: 10.1002/osp4.666
            14.  Burns  L,  Le  Roux  N,  Kalesnik-Orszulak  R,  et al.  Real-
               world evidence for regulatory decision-making: Updated   24.  Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC,
               guidance  from  around  the  world.  Front Med  (Lausanne).   Gruber-Baldini A. WellDoc mobile diabetes management
               2023;10:1236462.                                   randomized controlled trial: Change in clinical and
                                                                  behavioral outcomes and patient and physician satisfaction.
               doi: 10.3389/fmed.2023.1236462                     Diabetes Technol Ther. 2008;10(3):160-168.
            15.  Castelnuovo  G, Pietrabissa  G, Manzoni GM,  et al.      doi: 10.1089/dia.2008.0283
               Cognitive behavioral therapy to aid weight loss in obese
               patients: Current perspectives.  Psychol Res Behav Manag.   25.  Kumbara AB, Iyer AK, Green CR, et al. Impact of a combined
               2017;10:165-73.                                    continuous glucose monitoring-digital health solution on
                                                                  glucose metrics and self-management behavior for adults
               doi: 10.2147/PRBM.S113278                          with type 2 diabetes: Real-world, observational study. JMIR
                                                                  Diabetes. 2023;8:e47638.
            16.  Garabedian LF, Ross-Degnan D, Wharam JF. Mobile
               phone and smartphone technologies for diabetes care and      doi: 10.2196/47638
               selfmanagement. Curr Diab Rep. 2015;15:109.
                                                               26.  Levine BJ, Close KL, Gabbay RA. Reviewing U.S. Connected
               doi: 10.1007/s11892-015-0680-8                     diabetes care: The newest member of the team.  Diabetes
            17.  Holtz B, Lauckner C. Diabetes management via mobile   Technol Ther. 2020;22:1-9.
               phones: A  systematic review.  Telemed J E Health.   27.  Arigo D, Jake-Schoffman DE, Wolin K, Beckjord E,
               2012;18:175-184.                                   Hekler  EB, Pagoto SL. The history and future of digital


            Volume 7 Issue 4 (2024)                         9                                doi: 10.36922/itps.4042
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