T4/T3 Therapy in Hypothyroidism

Modified Project Summary/Abstract Section
Day-to-day self-management by adults with type 2 diabetes is essential to avoid diabetes complications, yet successful self-management behaviors remain difficult for many to achieve and sustain. Adults with diabetes have rapidly evolving ways to track their behaviors, and the glucose levels their behaviors impact, but despite having more information, people with diabetes still find it challenging to use their information to make healthy behavior changes. The MPower Hub platform leverages evidence-based behavior change techniques, including Self-Determination Theory-based personal data visualizations to increase autonomous motivation for change, and Self-Regulation Theory-based goal setting and action planning, to empower adults with diabetes with the information and support needed to achieve healthy diabetes self-management behaviors. MPower Hub is a web-based platform that integrates rich real-time data from commercially-available continuous glucose and activity monitors with patient-reported data about medication taking and other self-management behaviors. MPower Hub prompts patients to choose behavioral goals based on their insights from interactive visualizations of their information, then make action plans to reach their goals. This project is designed to respond to the NIDDK PAS 23-086 call for "Small R01" pilot trials. The goal of this project is to optimize the MPower Hub intervention protocol for adults with type 2 diabetes in preparation for a future multi-site efficacy trial. First, the ability of the MPower Hub intervention protocol to support diabetes self-management will be optimized via iterative enhancements, with 12 adults with diabetes who will use the platform for two months each. Then, MPower Hub trial protocol feasibility will be assessed by randomizing 80 adults with type 2 diabetes and glycemic levels above clinical goals to MPower Hub, continuous glucose monitor alone, or activity monitor alone for four months. Mixed quantitative and qualitative assessments will examine recruitment, engagement, and retention metrics and feedback. Changes in self-management behaviors and glycemic levels will be compared between arms. Successful completion of this project will produce a theoretically-grounded, rigorously pilot-tested self-management intervention optimized for a fully-powered clinical efficacy trial. MPower Hub is uniquely designed to produce new knowledge about how evidence-based behavior change techniques can be integrated with data from increasingly available wearable monitors to empower healthy behavior change. Results of this study will directly inform a future multi-site clinical efficacy trial, with the long-term goal to produce scalable tools to effectively improve diabetes self-management, increase the ability of adults with diabetes to reach treatment goals, and reduce risks for diabetes complications.

Grant Number: 5R01DK137207-03
NIH Institute/Center: NIH
Principal Investigator: ANNE CAPPOLA