An observational study in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 46 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-05-09.
Sponsored by AstraZeneca · Observational
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 328 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
Exclusion Criteria:
Participants have standard of care with no access to digital disease management tool
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.
Change from baseline to end of study (Month 6) in HbA1c levels
Assessed from blood samples taken at visits per standard of care
Time frame: 6 months
Percentage of patients who achieve HbA1c levels <7% at Month 6
Assessed from blood samples taken at visits per standard of care
Time frame: 6 Months
Mean change in body weight (kg) from baseline to Month 6
Measures taken at visits per standard of care
Time frame: 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
Time frame: 6 Months
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
Time frame: 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
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
Time frame: 6 Months
Mean patient satisfaction with the digital disease management tool
Assessed by the User Satisfaction Survey
Time frame: 6 Months
Mean percent change from baseline to Month 6 in systolic blood pressure
Measures taken at visits per standard of care
Time frame: 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
Time frame: 6 Months
Percent of patients who achieve blood pressure <140/90 mmHg at Month 6
Measures taken at visits per standard of care
Time frame: 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
Time frame: 6 Months
Differences in primary care office visits between active and control group during the 6-month study period
As reported in patient records
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 Months
Plan to share: Undecided
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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