PMID- 36827350
OWN - NLM
STAT- MEDLINE
DCOM- 20230228
LR  - 20230409
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 18
IP  - 2
DP  - 2023
TI  - A data-driven approach to manage type 2 diabetes mellitus through digital health: 
      The Klivo Intervention Program protocol (KIPDM).
PG  - e0281844
LID - 10.1371/journal.pone.0281844 [doi]
LID - e0281844
AB  - 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.
CI  - Copyright: (c) 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.
FAU - de Oliveira, Camila Maciel
AU  - de Oliveira CM
AUID- ORCID: 0000-0001-6823-7395
AD  - Klivo LLC, Sao Paulo, Brazil.
FAU - Bolognese, Luiza Borcony
AU  - Bolognese LB
AD  - Health Innovation Program, Medical School, The Pontifical Catholic University of 
      Minas Gerais, Pocos de Caldas, Brazil.
FAU - Balcells, Mercedes
AU  - Balcells M
AD  - Institute for Medical Engineering and Science, Massachusetts Institute of 
      Technology, Cambridge, MA, United States of America.
FAU - Aragon, Davi Casale
AU  - Aragon DC
AUID- ORCID: 0000-0003-1019-3654
AD  - University of Sao Paulo, Ribeirao Preto, Brazil.
FAU - Zagury, Roberto Luis
AU  - Zagury RL
AUID- ORCID: 0000-0003-0438-223X
AD  - State Institute of Diabetes and Endocrinology Luiz Capriglione (IEDE), Rio de 
      Janeiro, Brazil.
FAU - Nobrega, Clemente
AU  - Nobrega C
AD  - Klivo LLC, Sao Paulo, Brazil.
FAU - Liu, Chunyu
AU  - Liu C
AD  - Framingham Heart Study, Framingham, MA, United States of America.
AD  - Department of Biostatistics, Boston University, Boston, MA, United States of 
      America.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230224
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (Blood Glucose)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Diabetes Mellitus, Type 2
MH  - Glycated Hemoglobin
MH  - Quality of Life
MH  - Blood Glucose
MH  - Life Style
PMC - PMC9956061
COIS- 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.
EDAT- 2023/02/25 06:00
MHDA- 2023/03/03 06:00
PMCR- 2023/02/24
CRDT- 2023/02/24 13:59
PHST- 2022/09/16 00:00 [received]
PHST- 2023/01/19 00:00 [accepted]
PHST- 2023/02/24 13:59 [entrez]
PHST- 2023/02/25 06:00 [pubmed]
PHST- 2023/03/03 06:00 [medline]
PHST- 2023/02/24 00:00 [pmc-release]
AID - PONE-D-22-24671 [pii]
AID - 10.1371/journal.pone.0281844 [doi]
PST - epublish
SO  - PLoS One. 2023 Feb 24;18(2):e0281844. doi: 10.1371/journal.pone.0281844. 
      eCollection 2023.