MicroMass Launches Clinical Trial to Test Efficacy of New App for Helping Patients With Type 2 Diabetes Meet HbA1c Targets
CARY, N.C.--(BUSINESS WIRE)--True to its 20-year experience in shaping human health behavior and demonstrating evidence-based outcomes, MicroMass Communications has embarked on a pre-launch clinical trial to determine if a newly developed mobile app can help people with Type 2 diabetes manage the disease more effectively in their everyday lives.
“Diabetes takes a huge toll on Americans and nearly half of diabetic patients fail to meet their HbA1c targets. If we can help address those numbers through our behavioral science expertise, it's certainly worth putting our work to the test.”
Partnering with employer groups and health systems in North Carolina, the MicroMass trial, titled the PROMISE in Diabetes Research Study, will monitor participants over a six-month period to determine if the behavior-change techniques featured in the app help patients meet their HbA1c targets. Through a simple blood test, HbA1c, or glycated hemoglobin, shows a person's average level of blood sugar over the previous three months, indicating how effectively that individual's diabetes is being controlled.
The app being studied in the trial is Time2Focus, a progressive skill-building platform developed by MicroMass for possible use in a variety of chronic diseases. Using gamification principles to keep users engaged and evidence-based techniques such as problem-solving and goal-setting to build new skills, the app guides patients through a series of real-world experiences related to diabetes control, focusing on glucose monitoring, physical activity and healthy eating.
Interactive experiences such as "Create your plate” and "Making decisions away from home" are among the quests, challenges, videos, articles, tracking tools and weekly progress reports featured in the app. Patients earn points by advancing through increasingly difficult levels as they successfully build and apply real-world diabetes management skills.
"Time2Focus is significantly different from other diabetes apps," says Jessica Brueggeman, vice president of the Health Behavior Group at MicroMass. "It's designed to help people build skills and confidence, make better day-to-day decisions, and adopt new behaviors. By contrast, most other diabetes apps have limited utility and do little more than provide information, reminders or tracking tools. These alone do not change behavior."
Brueggeman says that MicroMass hopes the results of the PROMISE trial will demonstrate to healthcare providers, diabetes educators and pharmaceutical companies that mobile apps geared toward behavior change can make a meaningful difference in patient outcomes, independent of medical therapy.
"Diabetes takes a huge toll on Americans and nearly half of diabetic patients fail to meet their HbA1c targets. If we can help address those numbers through our behavioral science expertise, it's certainly worth putting our work to the test."
The full name of the MicroMass trial is the PROMISE (Promoting Real-world Outcomes by Motivating Improvements in Self-management Effectiveness) in Diabetes Research Study. Patient recruitment is being conducted in partnership with 18 employer groups and a major health center in North Carolina, where MicroMass is headquartered. Patients interested in joining the trial may also visit time2focus.micromass.com/mmc to see if they qualify. Diabetes is now the seventh leading cause of death in North Carolina and accounts for billions of dollars annually in medical costs and lost productivity.
The primary clinical endpoint of the PROMISE trial is measurement of HbA1c. Participants will have their levels checked at the beginning of the study, again after completing the 12-week Time2Focus app, and at a follow-up meeting three months later.
Participants will use the app at their own pace and convenience, either via their personal iPhones or through a trial-provided iPod Touch. The trial is expected to begin this summer, with early results announced later this year and full results reported in early 2015.
About MicroMass Communications, Inc.
MicroMass is a healthcare communications agency with unique expertise in human health behavior. Specializing in patient support and engagement, professional and consumer relationship marketing, medical communications and behavioral consulting, the company draws on extensive experience and intellectual property to help healthcare organizations and providers deliver optimal health outcomes. Founded in 1994 and headquartered in Cary, N.C., MicroMass has created award-winning programs for some of the most respected names in the life sciences. For more information, visit www.micromass.com.