Study identifier:D1841C00004
ClinicalTrials.gov identifier:NCT03090464
EudraCT identifier:N/A
CTIS identifier:N/A
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
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No
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All
328
Observational
18 Years - 99 Years
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 May 2019 by AstraZeneca
AstraZeneca
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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.
Location
Location
Plano, TX, United States, 75024
Location
Montclair, CA, United States, 91763
Location
Houston, TX, United States, 77058
Location
Surprise, AZ, United States, 85374
Location
Richmond, VA, United States, 23235
Location
Spring Valley, CA, United States, 91978
Location
Pembroke Pines, FL, United States, 33026
Location
Cooper City, FL, United States, 33024
Arms | Assigned Interventions |
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Standard of Care (SOC) Participants have standard of care with no access to digital disease management tool | - |
SOC + digital disease management Participants have access to the digital disease management tool in addition to standard of care | Other: Use of digital disease management tool The purpose of the study is to evaluate if the provision of a digital disease management tool, in addition to SOC for T2DM, will improve glycemic control. The impact of the tool will be assessed in comparison to a Control group who will receive SOC alone. All participants will complete the PRO assessments. This is a real world study carried out at the point of care. |
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