Randomized Clinical Trial to Evaluate the Efficacy of a Digital Intervention for Patients With Type 2 Diabetes

Randomized Clinical Trial to Evaluate the Efficacy of a Digital Intervention for Patients With Type 2 Diabetes.

This study aims to perform a digital intervention in patients with type 2 diabetes to analyze the efficacy of the digital intervention Adhera® Fatigue Digital Program in order to improve diabetes self-management and improve clinical outcomes, including chronic condition-related fatigue. This will be done through a randomized clinical trial in 3 of the main health centers in the city of Xalapa, Veracruz, Mexico.

The digital health intervention is designed to be used for approximately 3 months. The study will enroll 150 participants (75 in control group and 75 in experimental group) who are patients with type 2 diabetes. There will be educational contents and personalized motivational messages through the Adhera Health Recommender System.

Adhera® Fatigue Digital Program (or AFDP) T2D adaptation is a digital health program based on behavioral and emotional change techniques that provides support to patients with type 2 diabetes mellitus. The digital health solution is designed to be used for a period of 3 months and includes a mobile application that provides educational content and sends messages about 10 diabetes mellitus care areas with the aim of improving the quality of life of patients and therefore avoiding the occurrence of complications associated with the disease.

This is a clinical trial with 75 participants in the experimental intervention group and 75 in the control group, which will be carried out in 3 Primary Care Health centers in the City of Xalapa Veracruz, called Marabroto Center, Revolution Center and Miguel Alemán Center.

The researchers will focus on evaluating the main study variables to determine the changes in the indicators in glycosylated hemoglobin, total cholesterol, triglycerides, blood pressure, BMI, waist circumference and use of coping strategies.

The efficacy of the digital intervention will be measured in 2 ways: 1) Through the analysis of each of the study variables, where its decrease or increase represents that it was effective for the control of each indicator analyzed individually, and 2) Through the binary logistic regression model where all the variables of the study as a whole are analyzed and it is determined if the digital intervention had a global efficacy.

We believe that since it is a multifactorial disease, different variables that intervene in the complications of diabetes mellitus should be studied and not exclusively one single primary endpoint.

Inclusion Criteria:

• Patients over 18 years of age with type 2 diabetes mellitus diagnosed and treated in selected urban health centers of the Sanitary Jurisdiction V of Xalapa, Ver.
• Patients with smartphone and cell number.
• Participants must agree on sharing data from their clinical record.
• Participants must sign an informed consent.
• Participants must be willing to and install the mobile solution of the study.

Exclusion Criteria:

• Candidates without a smartphone or not being able to interact with it.
• Patients with type 1 diabetes mellitus, MODY (Maturity Onset Diabetes of the Young) and gestational diabetes.
• Patients who do not wish to participate in the study.