A Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus

Summary

A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to evaluate if the provision of a digital disease management tool improves glycaemic control in participants with type 2 diabetes mellitus (T2DM), as measured by change from baseline to End of Study (Month 6) in glycosylated haemoglobin (HbA1c) levels. Clinical assessments for this study will be conducted as part of normal, standard care. The main objective of this study is to evaluate the effect of adding this tool to participants' current standard care for T2DM on glycaemic control, other variables of importance in T2DM (eg, weight, blood pressure, and lipid levels), and participant-reported outcomes (PROs), such as satisfaction with treatment and adherence to their antihyperglycaemic treatment

Conditions

• Type II Diabetes Mellitus

Interventions

OTHER

Use of digital disease management tool in participants with T2DM

The purpose of this study is to evaluate if the provision of a digital disease management tool in addition to standard care for T2DM, will improve glycaemic control. The impact of the tool will be assessed in comparison to a Control group who will receive standard care alone. All participants will complete the PRO assessments. This is a real-world study carried out at the point of care intended to assist health care practitioners and managed care providers to make evidence-based decisions about how to improve participant self-management of their diabetes.

Sponsors & Collaborators

• Parexel

  collaborator INDUSTRY

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• Manesh Saxena · Barts and the London, Queen Mary School of Medicine and Dentistry

• Deepak Bhatnagar · Penine Acute Hospitals Trust

• Aled Roberts · Cardiff and Vale NHS Trust - University Hospital of Wales

• Melanie Davies · Leicester General Hospital

• See Kwok · Barlow Medical Centre

• Keith Richardson · Bridge House Medical Centre

• Deborah Wake · Ninewells Hospital and Medical School

• Ruth Leese · Muirhead Medical Centre

• Neela Chatakondu · Marches Medical Practice

• Tom Hoyland · Ashgrove Surgery

• Allan Copland · Auchtermuchty Health Centre

• Calum MacKenzie · Loanhead Medical Practice

• Simon Barrett · Quarryfoot Medical Practice

• John Shewring · Llanderyn Health Centre

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-03

Primary Completion

2016-10-13

Completion

2016-10-13

Countries

• United Kingdom

Study Locations