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

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.