Randomized Controlled Trials

WellDoc believes in evidenced based medicine, and therefore, conducts clinical trials for our products.  The following trials serve as landmark evidence for the use of mobile medical technology to improve health. 

Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control

Published in Diabetes Care, this randomized controlled trial demonstrated statistically significant improvements in A1c among intervention patients with usual care vs. patients who were treated with usual care alone.  View the abstract of this landmark study.

WellDoc Mobile Diabetes Management Randomized Controlled Trial: Change in Clinical and Behavioral Outcomes and Patient and Physician Satisfaction

Published in Diabetes Technology and Therapeutics, this pilot study demonstrated statistically significant improvements in A1c among intervention patients along with statistically significant changes in healthcare provider prescribing behaviors.  View the abstract of the pilot study.

 

Trials

Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control

Objective

To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes.

Research design and methods

A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled and included in analysis. The primary outcome was change in glycated hemoglobin levels over a one year treatment period. Secondary outcomes were changes in patient-reported diabetes symptoms, diabetes distress, depression, and other clinical (blood pressure) and laboratory (lipid) values. Maximal treatment was a mobile and web-based self–management patient coaching system and provider decision support. Patients received automated, real–time educational and behavioral messaging in response to individually analyzed blood glucose values, diabetes medications, and lifestyle behaviors communicated by mobile phone. Providers received quarterly reports summarizing patient’s glycemic control, diabetes medication management, lifestyle behaviors, and evidence-based treatment options.

Results

The mean declines in glycated hemoglobin were 1.9% in the maximal treatment group and 0.7% in the usual are group, a difference of 1.2% (P < 0.001) over 12 months.

Conclusions

The combination of patient behavioral mobile coaching with blood glucose data, lifestyle behaviors, and patient self-management data individually analyzed and presented with evidence-based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year.

Charlene C. Quinn, RN, Ph.D., Michelle D. Shardell, Ph.D., Michael L. Terrin, MD, MPH, Erik A. Barr, BA, Shoshana H. Ballew, BA, Ann Gruber-Baldini, Ph.D.

Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.


WellDoc™ Mobile Diabetes Management RCT: Change in Clinical and Behavioral Outcomes, Patient and Physician Satisfaction

Diabetes outlook

It is estimated that there are 21 million people affected with diabetes in the United States and 171 million people worldwide.1,2 It is estimated by the year 2030, 366 million people worldwide will have diabetes. 1 In the United States alone, the annual direct costs of diabetes are estimated to be $92 billion.4

Objective

The primary study aim was to assess the impact on A1c of a cell phone based diabetes management software system used in conjunction with Web based data analytics and therapy optimization tools. Secondary aims included examining health care provider (HCP) adherence to recommended prescribing guidelines and assessing HCPs adoption of the technology.

Research design and methods

Thirty patients with type 2 diabetes were recruited from three community physician practices for a three month study and evenly randomized to an intervention or control group. The intervention group received cell phone based software designed by endocrinologists and certified diabetes educators (WellDoc Communications, Inc, "WellDoc"). The software provided real time feedback on patients' blood glucose (BG) levels, displayed patients' medication regimens, incorporated hypo and hyperglycemia treatment algorithms, and requested additional data needed to evaluate diabetes management. Patient data was captured and transferred to WellDoc's servers. The data was analyzed by WellDoc's statistical algorithms and diabetes team. WellDoc sent computer generated logbooks (with suggested treatment plans based on WellDoc's analysis) to intervention patients' HCPs.

Results

The average decrease in A1c for intervention patients was 2.03%, compared to 0.68% (p<.02, one tailed) for control patients. 84% of intervention patients had their medications titrated or changed by their HCP compared to 23% of control patients (p=0.002). Intervention patients' HCPs reported that WellDoc's analysis facilitated treatment decisions, provided organized data, and reduced logbook review time.

Conclusions

Adults with type 2 diabetes using WellDoc's software achieved statistically significant improvements in A1c. HCP and patient satisfaction with the system was clinically and statistically significant

Charlene C. Quinn, RN, Ph.D.,1 Suzanne Sysko Clough, M.D.2, James M. Minor, Ph.D., Ph.D.,2 Dan Lender, M.D.,3 Maria C. Okafor, MCG.,1 Ann Gruber-Baldini, Ph.D.,1

1 Division of Gerontology, Department of Epidemiology and Preventive Medicine, University of Maryland School of     Medicine, Baltimore, MD

2 WellDoc Communications, Inc. Baltimore, MD

3 Joslin Diabetes Center, University of Maryland Medical System and School of Medicine, University of Maryland, Baltimore, MD

4 Hogan P, Dall T, Nikolov P; American Diabetes Association




Publication

Integration of a Mobile-Integrated Therapy with Electronic Health Records: Lessons Learned

Background

Mobile technology provides a new platform for data collection and patient–provider communication. The mobile device represents a personalized platform that is available to the patient on a 24/7 basis. Mobile-integrated therapy (MIT) is the convergence of mobile technology, clinical and behavioral science, and scientifically validated clinical outcomes. In this article, lessons learned from functional integration of a FDA cleared, type 2 diabetes MIT into the electronic health record (EHR) of a multi-physician practice within a large, urban, academic medical center are highlighted.

Results

Findings from the diverse stakeholder group of a MIT–EHR integration project indicate that user workflow, software system persistence, environment configuration, device connectivity and security, organizational processes, and data exchange heuristics are key issues that must be addressed.

Conclusions

Mobile-integrated therapy that integrates patient self-management data with medical record data provides the opportunity to understand the potential benefits of bidirectional data sharing and reporting that are most valuable in advancing better health and better care in a cost-effective way that is scalable for all chronic diseases. View the abstract of this publication.

Malinda M. Peeples, M.S., R.N., Anand K. Iyer, Ph.D., M.B.A., and Joshua L. Cohen, M.D., Journal of Diabetes Science and Technology
Volume 7, Issue 3, May 2013