WellDoc is collaborating with leading companies in the diabetes community to conduct a multi-center, randomized clinical trial (RCT) to test the efficacy of its mobile diabetes management platform. The RCT will include a total of 260 patients, ages 18-75, who will use WellDoc's system for 12-months. The trial is currently underway and expected to conclude in 1Q09. We will be reporting interim analysis prior to the RCTs conclusion.

RCT Aims

Primary Aim

To compare the 3, 6 and 12 month changes in HbA1c (operationalized to detect 0.5% decrease) among patients with diabetes assigned to the WellDoc solution compared to HbA1c changes among patients with diabetes who are assigned to usual care.

Secondary Aims

  1. To compare the diabetes-related costs incurred per patient (to be measured in conjunction with health outcome measurements), in order to gauge the value proposition of WellDoc's solution.
  2. To compare the medication (diabetes medications) prescribing behaviors (i.e. titration patterns, drugs added/removed, etc) of HCPs assigned to the WellDoc solution to those assigned to usual care.
  3. To compare medication adherence among patients with diabetes assigned to the WellDoc Solution to those of patients assigned to usual care.
  4. To compare the WellDoc Solution patient group to the usual care group with respect to patient utilization of diabetes-related health care services, including hospitalizations, emergency room use, and HCP office visits during a one-year period.
  5. To compare the self-reported SMBG practices among patients with diabetes assigned to the WellDoc Solution to those of patients with diabetes assigned to usual care.
  6. To assess patient and HCP satisfaction with the usability of the overall WellDoc Solution and to evaluate the utility of and satisfaction with various components of the system.