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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of digital disease management tool | Other | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of times the smart phone- and/or web portal-based tool is accessed per patient | Calculated by adding the total number of discrete log-in attempts to the tool for each patient using the tool at least once | 6 Months |
| Length of time from first to last usage of smart phone- and/or web portal-based tool across the course of the study |
Inclusion Criteria:
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Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Sooben | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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|
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 |
Determined by calculating the time from first to last log-in attempt for each patient accessing the tool at least twice during the course of the study |
| 6 Months |
| Mean patient satisfaction with the digital disease management tool | Assessed by the User Satisfaction Survey | 6 Months |
| Mean percent change from baseline to Month 6 in systolic blood pressure | Measures taken at visits per standard of care | 6 Months |
| Mean percent change from baseline to Month 6 in low-density lipoprotein-cholesterol (LDL-C) | Assessed from blood samples taken at visits per standard of care | 6 Months |
| Percent of patients who achieve blood pressure <140/90 mmHg at Month 6 | Measures taken at visits per standard of care | 6 Months |
| Percent of patients who achieve LDL-C <100 mg/dL at Month 6 | Assessed from blood samples taken at visits per standard of care | 6 Months |
| Differences in primary care office visits between active and control group during the 6-month study period | As reported in patient records | 6 Months |
| Differences in Emergency Room visits between active and control group during the 6-month study period as reported in patients at the end of the study | As reported by patients at the end of the study | 6 Months |
| Change in baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version score | As assessed in the Patient Reported Outcome measure Diabetes Treatment Satisfaction Questionnaire - Status version at the point-of-care visits | 6 Months |
| Change in baseline to Month 6 in Diabetes Self-Management Questionnaire score (16-question) (patient perception on ability to manage their disease) | As assessed in the Patient Reported Outcomes measure Diabetes Self-Management Questionnaire at the point-of-care visits | 6 Months |
| Change in baseline to Month 6 in Morisky Medication Adherence Scale (8-item) (adherence) | As assessed in the Patient Reported Outcome measure Morisky Medication Adherence Scale at the point-of-care visits | 6 Months |
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Research Site | Peoria | Arizona | 85381 | United States |
| Research Site | Surprise | Arizona | 85374 | United States |
| Research Site | Lincoln | California | 95648 | United States |
| Resezrch Site | Montclair | California | 91763 | United States |
| Research Site | North Hollywood | California | 91606 | United States |
| Research Site | Spring Valley | California | 91978 | United States |
| Research Site | Van Nuys | California | 91405 | United States |
| Research Site | Colorado Springs | Colorado | 80906 | United States |
| Research Site | Cooper City | Florida | 33024 | United States |
| Research Site | DeLand | Florida | 32720 | United States |
| Research Site | Hialeah | Florida | 33012 | United States |
| Reserarch Site | Jacksonville | Florida | 32277 | United States |
| Research Site | Lake City | Florida | 32055 | United States |
| Research Site | Ormond Beach | Florida | 32174 | United States |
| Research Site | Pembroke Pines | Florida | 33026 | United States |
| Research Site | Port Orange | Florida | 32127 | United States |
| Research Site | Tampa | Florida | 33634 | United States |
| Research Site | Evanston | Illinois | 60201 | United States |
| Research Site | Lexington | Kentucky | 40503 | United States |
| Research Site | Oxon Hill | Maryland | 20745 | United States |
| Research Site | Omaha | Nebraska | 68134 | United States |
| Research Site | Las Vegas | Nevada | 89128 | United States |
| Research Site | Albuquerque | New Mexico | 87102 | United States |
| Research Site | Brooklyn | New York | 11235 | United States |
| Research Site | New Windsor | New York | 12553 | United States |
| Research Site | Westfield | New York | 14787 | United States |
| Research Site | Greensboro | North Carolina | 27410 | United States |
| Research Site | Franklin | Ohio | 45005 | United States |
| Research Site | Downingtown | Pennsylvania | 19335 | United States |
| Research Site | Charleston | South Carolina | 29407 | United States |
| Research Site | Greer | South Carolina | 29651 | United States |
| Research Site | Myrtle Beach | South Carolina | 29588 | United States |
| Research Site | Spartanburg | South Carolina | 29301 | United States |
| Research Site | Tullahoma | Tennessee | 37388 | United States |
| Research Site | Houston | Texas | 77040 | United States |
| Research Site | Houston | Texas | 77058 | United States |
| Research Site | Lampasas | Texas | 76550 | United States |
| Research Site | Plano | Texas | 75024 | United States |
| Research Site | Salt Lake City | Utah | 84107 | United States |
| Research Site | Burke | Virginia | 22015 | United States |
| Research Site | Manassas | Virginia | 20110 | United States |
| Research Site | Richmond | Virginia | 23235 | United States |
| Research Site | Federal Way | Washington | 98003 | United States |
| Research Site | Olympia | Washington | 98502 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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