Clinical Trial Details

NCT ID: NCT03090464
Date Last Changed: October 13, 2017

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Type 2 Diabetes Mellitus

Research Study Title

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

Purpose

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.

To Learn more

Recruitment Details

Gender
All
Age
18 to 99 Years
Overall Status
Recruiting
Lead Sponsor
AstraZeneca
Duration
12 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 99 Years

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;

Site Locations (39)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35209 Research Site
United States Arizona Peoria 85381 Research Site
United States Arizona Surprise 85374 Research Site
United States California Montclair 91763 Resezrch Site
United States California North Hollywood 91606 Research Site
United States California Spring Valley 91978 Research Site
United States California Van Nuys 91405 Research Site
United States Colorado Colorado Springs 80906 Research Site
United States Florida Cooper City 33024 Research Site
United States Florida DeLand 32720 Research Site
United States Florida Hialeah 33012 Research Site
United States Florida Jacksonville 32277 Reserarch Site
United States Florida Pembroke Pines 33026 Research Site
United States Florida Port Orange 32127 Research Site
United States Florida Tampa 33634 Research Site
United States Illinois Evanston 60201 Research Site
United States Kentucky Lexington 40503 Research Site
United States Maryland Oxon Hill 20745 Research Site
United States Mississippi Port Gibson 39150 Research Site
United States Nebraska Omaha 68134 Research Site
United States New Mexico Albuquerque 87102 Research Site
United States New York Brooklyn 11235 Research Site
United States New York New Windsor 12553 Research Site
United States New York Westfield 14787 Research Site
United States North Carolina Greensboro 27410 Research Site
United States Pennsylvania Downingtown 19335 Research Site
United States South Carolina Greer 29651 Research Site
United States South Carolina Myrtle Beach 29588 Research Site
United States Tennessee Tullahoma 37388 Research Site
United States Texas Houston 77040 Research Site
United States Texas Houston 77058 Research Site
United States Texas Lampasas 76550 Research Site
United States Texas Plano 75024 Research Site
United States Utah Salt Lake City 84107 Research Site
United States Virginia Burke 22015 Research Site
United States Virginia Manassas 20110 Research Site
United States Virginia Richmond 23235 Research Site
United States Washington Federal Way 98003 Research Site
United States Washington Olympia 98502 Research Site

Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
E-mail:

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