A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Use of digital disease management tool
Intervention type(s): Other
Intervention description(s): 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.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic
        medications for at least 6 months prior to enrollment.
      
Keywords: Type 2 diabetes mellitus; Digital disease management; T2DM; Hyperglycemia; Diabetes mellitus