A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
NCT ID: NCT03090464
Last Updated: 2019-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
328 participants
OBSERVATIONAL
2017-05-08
2018-05-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support
NCT02160639
Episodic to Real-Time Care in Diabetes Self-Management
NCT03012074
Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment
NCT03112343
A Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control
NCT02934893
Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c
NCT03092882
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care (SOC)
Participants have standard of care with no access to digital disease management tool
No interventions assigned to this group
SOC + digital disease management
Participants have access to the digital disease management tool in addition to standard of care
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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;
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kevin Sooben
Role: STUDY_CHAIR
AstraZeneca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Peoria, Arizona, United States
Research Site
Surprise, Arizona, United States
Research Site
Lincoln, California, United States
Resezrch Site
Montclair, California, United States
Research Site
North Hollywood, California, United States
Research Site
Spring Valley, California, United States
Research Site
Van Nuys, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Cooper City, Florida, United States
Research Site
DeLand, Florida, United States
Research Site
Hialeah, Florida, United States
Reserarch Site
Jacksonville, Florida, United States
Research Site
Lake City, Florida, United States
Research Site
Ormond Beach, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Evanston, Illinois, United States
Research Site
Lexington, Kentucky, United States
Research Site
Oxon Hill, Maryland, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Brooklyn, New York, United States
Research Site
New Windsor, New York, United States
Research Site
Westfield, New York, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Franklin, Ohio, United States
Research Site
Downingtown, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Greer, South Carolina, United States
Research Site
Myrtle Beach, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Tullahoma, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Lampasas, Texas, United States
Research Site
Plano, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Burke, Virginia, United States
Research Site
Manassas, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Federal Way, Washington, United States
Research Site
Olympia, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D1841C00004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.