Clinical Research

Welldoc® and investigators at Northwestern University in Chicago partnered to demonstrate the safety of an investigational insulin bolus calculator (IBC*), based on continuous glucose monitoring (CGM) data. This IBC was designed to help people with diabetes dose their insulin. The IBC, embedded into Welldoc's FDA cleared BlueStar® mobile phone app, was designed to translate CGM data into simple trend arrows, indicating bolus insulin dose recommendations. The study demonstrated the saftey of the IBC, with no reported increased hypoglycemia measurements.

Welldoc® in collaboration with Dexcom developed a study to show how the utilization of a real-time CGM (rtCGM) system, Dexcom G6, in combination with Welldoc’s digital health solution, BlueStar®, can help support individuals with diabetes taking medications, lower their A1C. The study concluded that the combination of rtCGM and a digital health solution significantly improved an individual’s A1C after 12 and 24 weeks of use, regardless of baseline A1C or degree of CGM wear. Even though there was a decrease in A1C for all study participants, individuals who started with a high A1C, along with those who continuously used CGM, saw a greater decrease in their A1C.

Welldoc® and Carey Business School of Johns Hopkins University (formerly CHIDS, University of Maryland) worked together to study how continuous glucose monitoring (CGM) and a digital health solution can help support better glycemic outcomes for individuals with type 1 and type 2 diabetes. A Glycemia Risk Index (GRI) metric was applied to this study to assist with the basic clinical interpretation of CGM data. GRI was calculated for each individual and classified into the five GRI zones from lowest (A: best) to highest (E: worst), with a breakdown by gender, age, and diabetes type. Our results showed that diabetes type was not a factor in GRI improvement, but, individuals whose baseline GRI started in higher zones improved GRI by at least 1 zone—supporting the use of CGM and a digital health solution in self-managing glycemia. In addition, the demographic data shows that GRI was significantly lower in females and individuals 65 years and older. The culmination of GRI and demographic data can help healthcare professionals support and manage individuals and populations with diabetes.

Welldoc® and the Carey Business School of Johns Hopkins University (formerly CHIDS at University of Maryland) continue to research how a digital health solution, combined with CGM data, can help individuals living with diabetes improve lifestyle factors and support better glycemic outcomes. In this study, we applied the Glycemia Risk Index (GRI) metric to assist with the basic clinical interpretation of CGM data. Our findings show that the average individual with type 1 and type 2 diabetes improved their GRI by 6 points during the first 14 days of use of the combined CGM and digital health tool. Individuals with type 2 diabetes that engage in digital health features like medications and lifestyle increased the probability of improved GRI, whereas individuals with type 1 diabetes saw improvement based on CGM wear time. The continued use of the GRI metric will help us demonstrate self-management and behavior outcomes of individuals using a combination of a digital health solution and CGM while extending support for diabetes populations.

Individuals living with type 2 diabetes were enrolled in a program that provided the Dexcom G6 system and BlueStar to understand how engagement with the combined solution influenced the Association of Diabetes Care and Education Specialists’ 7 self-care (ADCES7) behaviors. Data showed that those who continuously used real-time CGM (rtCGM) engaged with the app 13% more than those who used it intermittently. In addition, this data showed that engagement with a digital solution, coupled with continuous rtCGM use, can help individuals with T2D — even those who are not prescribed insulin — improve adherence to ADCES7 behaviors.

Welldoc partnered with The Montana Diabetes Digital Health Learning Network (MDDHLN) to introduce the BlueStar app was into their Diabetes Care and Education Specialist (DCES) program. People with diabetes (PWD) who engaged with the app saw A1C improvement after 6 months of use and 87% of the population with an A1C of 8 or less demonstrated positive health outcomes. The average persistence in app use is 18 months with 20% of people still using the app at 2 years. In addition to this sustained engagement, over 53% of the participants sent the SMART Visit ReportTM to their DCES at least once per month showing ongoing support for DCES’ between office visits. This data shows that using a digital health solution can not only support diabetes education for PWD between office visits but that use also creates value in the information and feedback they receive, thus generating continued engagement.