Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, Digital disease management, T2DM, Hyperglycemia, Diabetes mellitus
Brief 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.
Interventions
OTHERUse 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.
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to end of study (Month 6) in HbA1c levels | 6 months | Assessed from blood samples taken at visits per standard of care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in body weight (kg) from baseline to Month 6 | 6 Months | Measures taken at visits per standard of care |
| Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1 | 6 Months | Defined as an increase in dose or addition of a new antihyperglycemic agent not received at baseline |
| Percentage of patients who achieve HbA1c levels <7% at Month 6 | 6 Months | Assessed from blood samples taken at visits per standard of care |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean percent change from baseline to Month 6 in systolic blood pressure | 6 Months | Measures taken at visits per standard of care |
| Mean percent change from baseline to Month 6 in low-density lipoprotein-cholesterol (LDL-C) | 6 Months | Assessed from blood samples taken at visits per standard of care |
| Percent of patients who achieve blood pressure <140/90 mmHg at Month 6 | 6 Months | Measures taken at visits per standard of care |
| Percent of patients who achieve LDL-C <100 mg/dL at Month 6 | 6 Months | Assessed from blood samples taken at visits per standard of care |
| Differences in primary care office visits between active and control group during the 6-month study period | 6 Months | As reported in patient records |
| 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 | 6 Months | As reported by patients at the end of the study |
| Change in baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version score | 6 Months | As assessed in the Patient Reported Outcome measure Diabetes Treatment Satisfaction Questionnaire - Status version at the point-of-care visits |
| Change in baseline to Month 6 in Diabetes Self-Management Questionnaire score (16-question) (patient perception on ability to manage their disease) | 6 Months | As assessed in the Patient Reported Outcomes measure Diabetes Self-Management Questionnaire at the point-of-care visits |
| Change in baseline to Month 6 in Morisky Medication Adherence Scale (8-item) (adherence) | 6 Months | As assessed in the Patient Reported Outcome measure Morisky Medication Adherence Scale at the point-of-care visits |
| Length of time from first to last usage of smart phone- and/or web portal-based tool across the course of the study | 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 |
| Number of times the smart phone- and/or web portal-based tool is accessed per patient | 6 Months | Calculated by adding the total number of discrete log-in attempts to the tool for each patient using the tool at least once |
| Mean patient satisfaction with the digital disease management tool | 6 Months | Assessed by the User Satisfaction Survey |
Countries
United States
Outcome results
None listed