Development of an information system and mobile application for the care of type 2 diabetes patients at the primary care level for the health sector in Mexico: study protocol for a randomized controlled, open-label trial.

BACKGROUND: Providing optimal care for type 2 diabetes (DM2) patients remains a challenge for all healthcare systems. Patients often encounter various barriers in adhering to self-management programs due to lack of knowledge and understanding of self-care activities, lack of individualized and coordinated care, inconvenient and costly education sessions, and poor patient-provider communication. Mobile technologies such as cell phones/smartphones, handheld tablets, and other wireless devices offer new and exciting opportunities for addressing some of these challenges. The purpose of this study is to compare a diabetes management strategy using an information board and a mobile application versus standard care in patients with uncontrolled DM2. METHOD: The SANENT (Sistema de Análisis de Enfermedades No Transmisibles) trial is a primary care-based, prospective, two-arm, randomized controlled, open-label, blinded-endpoint study. We aim to recruit 1440 DM2 patients during a period of 6 months until the requested number of participants has been achieved. The total length of the intervention will be 1 year. Both men and women treated for DM2 with an HbA1c > 8.5% and ≥ 20 years of age are eligible to participate in the study. The primary outcome of the study is improved diabetes control measured by changes in HbA1c in the study participants. HbA1c will be measured at baseline, 3-month, 6-month, 9-month, and 12-month follow-up visits in all participants. The main analysis will be based on the intention-to-treat principle. The primary endpoint of the study will be the change in HbA1C within the groups and the differences between the groups. This will be assessed by a repeated measurement approach based on mixed models which contain both fixed effects and random effects. DISCUSSION: The overall goal of this project is to contribute to the evidence for the use of mobile technology to improve the treatment and regulation of poorly controlled DM2 patients living in Mexico. Our proposed project will show how mobile health technology tools can be used in the treatment of patients with uncontrolled DM2 in primary health care in a Latin American population, and particularly how they could help diabetes patients take better care of themselves. TRIAL REGISTRATION: ClinicalTrials.gov , US National Institutes of Health NCT04974333 . Prospectively registered on July 13, 2021. Protocol version number 1, dated August 15th, 2021.

Mobile Health Technology in the Primary Prevention of Type 2 Diabetes: a Systematic Review.

PURPOSE OF REVIEW: The objective of this review was to summarize the current scientific evidence of mobile health technology in the primary prevention of type 2 diabetes in patients with prediabetes derived from randomized clinical trials. RECENT FINDINGS: Few randomized clinical trials are available using mobile health technologies in the prevention of type 2 diabetes. There is heterogeneity in regard to the main study outcomes, duration of interventions, and study findings. Inconsistent findings have been reported whether mobile health technologies are effective in reducing HbA1C levels or the incidence of type 2 diabetes in patients with prediabetes. However, results are promising that mobile health interventions may decrease body weight. Future study may consistently measure changes in glycemic indicators as well as develop elements that better address behavior changes.