Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Real-world, Point-of-care, Randomized, Parallel Group, Open, 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus
Type 2 diabetes mellitus 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. The purpose of this study is to evaluate if the use of a digital disease management tool (Smart phone- web portal-based tool), in addition to Standard of Care for T2DM, will improve glycemic control. Other variables important in T2DM (such as weight, blood pressure, and lipid levels), will also be evaluated along with patient-reported outcomes, such as satisfaction with treatment and adherence to their antihyperglycemic treatment. Study duration is 6 months
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.
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