A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM

Type 2 diabetes mellitus (T2DM) is a complex, chronic disease that requires a comprehensive
treatment plan aimed at meeting multitude therapeutic targets associated with micro- and
macro-vascular risk reduction. There is evidence that patient support in various forms can
have a significant positive impact on adherence to treatment and the meeting of targets in
patients with type 2 diabetes mellitus. A digital disease-management tool, smart phone- and
web-based portal, has been developed that incorporates the following features aimed at
improving patient and population outcomes:

Treatment management to help patients remember to take medications and track adherence; Goal
setting, including medical nutrition therapy, appropriately prescribed physical activity, and
weight loss for those patients who are overweight or obese; Tracking and data collection for
blood glucose, weight, and exercise, as entered by the patient or automatically for activity
via Bluetooth pedometer or activity tracker; Assessments to capture patient beliefs in order
to tailor personalized content to individual needs; educational and motivational content in
the form of short messages, text, and videos covering T2DM and its treatment, and lifestyle
advice; Web portals to display collected data back to the patient and healthcare practitioner
in real-time to allow better and timely management of diabetes.

This tool is added to the Standard of Care for T2DM. Data are collected for patients
utilizing this tool, compared with those who are not. Clinical assessments as part of the
Standard of Care are collected, as well as standard Patient Reported Outcomes for this
disease.

Glycemic control is considered to be the goal of a T2DM disease management plan.

Inclusion Criteria:

- Provision of written informed consent;

- Diagnosed with T2DM;

- Male or female aged >/= 18 years at time of consent;

- Treatment with 1 or more non-insulin antihyperglycemic medications for at least 6
months prior to enrollment;

- Own or have access to a smart phone with internet access and have access to the
internet via a tablet or personal computer at least once a day;

- HbA1c levels must be obtained at the enrollment visit or up to 14 days prior to Visit
1 and must be >/=7.5% and 9 months must also be within this range;

- Body mass index >/= 25 and
- Ability to communicate in English;

- Judged by their primary care physician to have suitable hearing, vision, manual
dexterity, ability to understand instructions, and ability to use and understand smart
phone and internet applications;

- Negative pregnancy test for female subjects of childbearing potential.

Exclusion Criteria:

- Pregnancy;

- Insulin use at baseline;

- Current use of a smart phone- or web portal-based tool designed to help with
management of T2DM;

- History of Type 1 diabetes or ketoacidosis;

- Currently taking weight loss medication;

- Involvement in the planning and/or conduct of this study;

- Previous enrollment in the present study;

- Participation in a clinical study with an investigational product or a disease state
management program during the last 30 days;