A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
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
1 other identifier
observational
328
1 country
46
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedStudy Start
First participant enrolled
May 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2018
CompletedMay 9, 2019
May 1, 2019
1 year
March 20, 2017
May 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Percentage of patients who achieve HbA1c levels <7% at Month 6
6 Months
Mean change in body weight (kg) from baseline to Month 6
6 Months
Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1
6 Months
Other Outcomes (12)
Number of times the smart phone- and/or web portal-based tool is accessed per patient
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
6 Months
Mean patient satisfaction with the digital disease management tool
6 Months
- +9 more other outcomes
Study Arms (2)
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
Interventions
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.
Eligibility Criteria
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (46)
Research Site
Birmingham, Alabama, 35209, United States
Research Site
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kevin Sooben
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2017
First Posted
March 24, 2017
Study Start
May 8, 2017
Primary Completion
May 21, 2018
Study Completion
May 21, 2018
Last Updated
May 9, 2019
Record last verified: 2019-05