A data-driven approach to manage type 2 diabetes mellitus through digital health: The Klivo Intervention Program protocol (KIPDM).

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  • Additional Information
    • Source:
      Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
    • Publication Information:
      Original Publication: San Francisco, CA : Public Library of Science
    • Subject Terms:
      Diabetes Mellitus, Type 2*; Adult ; Humans ; Glycated Hemoglobin ; Quality of Life ; Blood Glucose ; Life Style
    • Abstract:
      Background: Digital therapeutics, an emerging type of medical approach, is defined as evidence-based therapeutic interventions through qualified software programs that help prevent, manage, or treat chronic diseases such as type 2 diabetes mellitus (T2DM), which has high social and economic burden. Klivo, a startup certified by the Brazilian Society of Diabetes, developed the first digital therapeutic product for managing T2DM in Brazil, reaching 21 of 24 states. Klivo has continuously been improving its model of behavior change on the basis of an intensive lifestyle intervention method that addresses individuals' needs-the Klivo Intervention Program for T2DM (KIPDM). To test the most recent version of the KIPDM, we will evaluate the ongoing management of daily life habits in patients with T2DM by measuring clinically significant outcomes. To improve the transparency of further results, here we will present the study protocol and detail the plan for the research project, including the study design and the analysis strategies.
      Methods: The KIPDM will be sponsored by health plans and healthcare provider organizations and will be free for patients (adults aged ≥ 18 years and <65 years; and glycated hemoglobin ≥ 7%). The program will be based on a 6-month management process that will supervise patients remotely. The program will include educational classes via the Klivo app, text messages, or e-mails. Evaluation will include objectively assessing clinical, laboratory, and behavioral outcomes such as health-related quality of life, mental health, medication adherence, and healthcare utilization. For this, validated electronic questionnaires will be available through the Klivo app. The primary outcome will be glycated hemoglobin (HbA1c) values. The secondary outcome will be time in target blood glucose range (TIR) estimated by capillary glycemia. Other outcomes of interest will be evaluated at baseline and stipulated time points (3 and 6 months after the start of the program).
      Expected Outcomes: KIPDM patients should present improved HbA1c and TIR along the intervention as compared to baseline values. Findings from this study will provide insights into the health improvement of T2DM and other cardiometabolic conditions such as hypertension, dyslipidemia, and obesity by using a digital therapeutic strategy. By analyzing the patient's health over time, this study will also contribute to understanding comorbidities associated with this chronic condition in the Brazilian population.
      Competing Interests: Our author team were either employees of or consultants to or collaborators to Klivo LLC at the time of first submission. This does not alter our adherence to PLOS ONE policies on sharing data and materials. All the author have no competing interest regarding to this project.
      (Copyright: © 2023 de Oliveira et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
    • References:
      Arq Bras Cardiol. 2021 Mar;116(3):516-658. (PMID: 33909761)
      J Am Med Inform Assoc. 2017 Sep 01;24(5):1024-1035. (PMID: 28379397)
      J Med Internet Res. 2017 Jul 11;19(7):e234. (PMID: 28698167)
      Trials. 2021 Apr 26;22(1):305. (PMID: 33902656)
      JAMA Netw Open. 2020 Nov 2;3(11):e2025488. (PMID: 33231638)
      Diabetes Care. 2017 Oct;40(10):1409-1419. (PMID: 28754780)
      Med Care. 1986 Jan;24(1):67-74. (PMID: 3945130)
      Diabetes Technol Ther. 2016 Feb;18 Suppl 1:S56-68. (PMID: 26836430)
      J Diabetes Res. 2018 May 16;2018:3961730. (PMID: 29888288)
      Clin Diabetes. 2022 Jan;40(1):10-38. (PMID: 35221470)
      Comput Methods Programs Biomed. 2021 Sep;209:106319. (PMID: 34364181)
      Psychother Psychosom. 2015;84(3):167-76. (PMID: 25831962)
      J Occup Environ Med. 2021 Oct 1;63(10):847-851. (PMID: 34138824)
      Diabetes Res Clin Pract. 2019 Nov;157:107843. (PMID: 31518657)
      Diabet Med. 2016 Jun;33(6):835-43. (PMID: 26287511)
      Diabetes Metab J. 2020 Dec;44(6):819-827. (PMID: 33389956)
      Diabet Med. 2020 Dec;37(12):2009-2018. (PMID: 32124488)
      J Gen Intern Med. 2001 Sep;16(9):606-13. (PMID: 11556941)
    • Accession Number:
      0 (Glycated Hemoglobin)
      0 (Blood Glucose)
    • Publication Date:
      Date Created: 20230224 Date Completed: 20230228 Latest Revision: 20230409
    • Publication Date:
      20231215
    • Accession Number:
      PMC9956061
    • Accession Number:
      10.1371/journal.pone.0281844
    • Accession Number:
      36827350