In an effort to improve its solutions and demonstrate solution efficacy, WellDoc continuously conducts clinical trials and pilots.  Below are some of the programs we have completed and published and others that we are actively conducting. 

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.  To view the abstract of the pilot study, click here.

Mobile Diabetes Intervention Study: Testing a Personalized Treatment/Behavioral Communication Intervention for Blood Glucose Control

WellDoc is conducting a randomized controlled trial with CareFirst, The University of Maryland School of Medicine, Sprint, and LifeScan.  The protocol for the RCT was Published in Contemporary Clinical Trials.  The study intervention has ended and the data is being analyzed.  To view the abstract of the protocol publication, click here

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

Mobile diabetes intervention study: Testing a personalized treatment/behavioral communication intervention for blood glucose control

Background

National data find glycemic control is within target (A1cb7.0%) for 37% of patients with diabetes, and only 7% meet recommended glycemic, lipid, and blood pressure goals.

Objectives

To compare active interventions and usual care for glucose control in a randomized clinical trial (RCT) among persons with diabetes cared for by primary care physicians (PCPs) over the course of 1 year.

Methods

Physician practices (n=36) in 4 geographic areas are randomly assigned to 1 of 4 study groups. The intervention is a diabetes communication system, using mobile phones and patient/physician portals to allow patient-specific treatment and communication. All physicians receive American Diabetes Association (ADA) Guidelines for diabetes care. Patients with poor diabetes control (A1c≥7.5%) at baseline (n=260) are enrolled in study groups based on PCP randomization. All study patients receive blood glucose (BG) meters and a year's supply of testing materials. Patients in three treatment groups select one of two mobile phone models, receive one-year unlimited mobile phone data and service plan, register on the web-based individual patient portal and receive study treatment phone software based on study assignment. Control group patients receive usual care from their PCP. The primary outcome is mean change in A1c over a 12-month intervention period.

Conclusion

Traditional methods of disease management have not achieved adequate control for BG and other conditions important to persons with diabetes. Tools to improve communication between patients and PCPs may improve patient outcomes and be satisfactory to patients and physicians. This RCT is ongoing.

Charlene C. Quinn ^a, Ann L. Gruber-Baldini ^a, Michelle Shardell ^a, Kelly Weed ^a, Suzanne S. Clough ^b, Malinda Peeples ^b, Michael Terrin ^a, Lauren Bronich-Hall ^b, Erik Barr ^a, Dan Lender ^b

^a Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, 660 W. Redwood Street, Baltimore, MD 21201, United States

^b WellDoc Communications, Inc., Baltimore, MD, United States