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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Use of digital disease management tool


Participation Criteria
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Eligibility Criteria
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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 </=11.0%. Most of the hbA1c values obtained within the past 9 months must also be within this range; Body mass index >/= 25 and </=55 kg/mm2 within the last 3 months; 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care (SOC)<br>Participants have standard of care with no access to digital disease management tool | |
| SOC + digital disease management<br>Participants have access to the digital disease management tool in addition to standard of care | Other: Use of digital disease management tool<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to end of study (Month 6) in HbA1c levels | Assessed from blood samples taken at visits per standard of care | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who achieve HbA1c levels <7% at Month 6 | Assessed from blood samples taken at visits per standard of care | 6 Months | 
| Mean change in body weight (kg) from baseline to Month 6 | Measures taken at visits per standard of care | 6 Months | 
| Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1 | Defined as an increase in dose or addition of a new antihyperglycemic agent not received at baseline | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Digital disease management, T2DM, Hyperglycemia, Diabetes mellitus