Evaluation of a Digital Diabetes Self-Management Education and Support Program

Type 2 Diabetes Clinical Trial

Official title: Randomized Controlled Trial to Evaluate the Efficacy of an Integrated Lifestyle Management Solution With Continuous Glucose Monitoring for Type 2 Diabetes

Status Completed

Clinical Trial Summary

The goal of this study is to examine the efficacy of an integrated solution, defined as a combination of the Abbott FreeStyle Libre 14-day CGM sensor and the Omada care team's receipt of real-time, continuous glucose data from the sensor and incorporation of this data into their care delivery within the context of the Omada for Diabetes program for adults with Type 2 Diabetes (T2D). This randomized control trial will test the impact of the integrated solution on HbA1c, CGM-derived metrics and other relevant diabetes management outcomes over six months compared to the current standard of care.

Clinical Trial Description

Type 2 diabetes (T2D) contributes substantially to morbidity and mortality in the US. Lifestyle management is a fundamental component of care for T2D. This includes self-management education and support, medical nutrition therapy, physical activity, smoking cessation counseling, and psychosocial care for the person with diabetes. Diabetes self-management education and support (DSMES) specifically pertains to helping people acquire the knowledge, skills, and ability for diabetes self-care, and assisting people to engage in the health-related behaviors needed to manage this condition on an ongoing basis. Research has shown that DSMES programs that target behavioral changes with intensive counseling and support lead to improved glucose control. In recent years, technology-enabled platforms have been developed to deliver self-management support and education virtually, and commercial products are common. These platforms allow people with chronic diseases to access self-management support and education through their personal mobile devices (e.g., smartphones, tablets, laptops) and eliminate the need to travel to physical facilities for diabetes education sessions. The increased convenience brings potential to increase access, availability, and acceptability. The development of Continuous Glucose Monitoring (CGM) has further advanced care and management of T2D. In particular, real-time CGM allows the person to view real-time glucose readings and patterns over time, without the need for painful finger sticks. While the majority of studies of CGM have been conducted with people with T2Ds using insulin, some clinical trials have shown that the use of real-time CGM is associated with improvements in glycemic control in people with T2D not using insulin. The current standards of care for diabetes recommend CGM use for people with Type 1 and 2 diabetes when it is coupled with "robust diabetes education, training and support". However, there is a lack of well-integrated solutions that combine the potential benefit of both digitally delivered DSMES and CGM in a seamless way. Therefore, the purpose of this study is to examine the efficacy of a novel integrated solution of a digitally delivered T2D self-management education and support program with a continuous glucose monitor (CGM) built into the digital platform. The randomized control trial will test the impact of the novel solution for improving HbA1c and related CGM-derived outcomes and relevant diabetes management outcomes over six months related to the current standard of care. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT05368454
• Study type: Interventional
• Source: Omada Health, Inc.
• Status: Completed
• Phase: N/A
• Start date: May 31, 2022
• Completion date: January 24, 2024