A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM

Completed

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID: NCT03090464
Run by: AstraZeneca
People needed: 328
Starts: 2017-05-08
Expected to finish: 2018-05-21
Last updated by the study team: 2019-05-09

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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;

Where it is running

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

Full record on ClinicalTrials.gov

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