Evaluate the Effect of a Digital Disease Management Tool in DM Patient

  • Research type

    Research Study

  • Full title

    A real-world, point-of-care, randomised, parallel group, open, 6-month clinical study to evaluate the effect of a digital disease management tool in patients with type 2 diabetes mellitus

  • IRAS ID

    193306

  • Contact name

    Nicola Turvey

  • Contact email

    nicola.turvey@parexel.com

  • Sponsor organisation

    AstraZeneca AB

  • Clinicaltrials.gov Identifier

    NCT03090464

  • Duration of Study in the UK

    0 years, 11 months, 2 days

  • Research summary

    Type 2 diabetes mellitus (T2DM) is a disease that develops when cells in the body are unable to produce enough insulin or when insulin that is produced does not work properly. Insulin is a hormone that works as a chemical messenger to help the body use the glucose in the blood to give us energy. It is important that diet, weight and physical activity are carefully managed in patients with T2DM. \nPatient support in various forms can improve adherence to treatment and the meeting of targets in patients with T2DM. According to the recently updated National Institute for Health and Care Excellence (NICE) guidelines, Diabetes Self-Management Education and Support programs, are associated with improved diabetes knowledge, self-care behaviour, and clinical outcomes. In the current technological environment, smart phone-and web portal-based tools have great potential to efficiently assist patients in disease self-management on a daily basis.\nThe aim of the study is to evaluate the effect of a smart phone tool and a web portal tool on the management of T2DM along with the standard of care treatment in participants with T2DM. \nAstraZeneca is the sponsor of this study which will take place in the United Kingdom (UK). It is anticipated that approximately 466 participants will be recruited across the UK. \n

  • REC name

    London - City & East Research Ethics Committee

  • REC reference

    16/LO/0152

  • Date of REC Opinion

    21 Mar 2016

  • REC opinion

    Further Information Favourable Opinion