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

NCT02749435 | Terminated

• 1 other identifier: D1841C00002
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 14

Brief 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

Keywords

Digital disease management tool; Type 2 diabetes mellitus/ T2DM; HbA1c; Standard care; PRO questionnaires; Smart phone/ personal computer with internet access

Outcome Measures

Primary Outcomes (1)

• Mean Change from baseline to Month 6 in HbA1c

  The primary outcome measure is the mean change from baseline to Month 6 in HbA1c. Mean changes from baseline to intermediate visits (if any occur) will also be determined. Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.

  From Baseline to 6 months

Secondary Outcomes (3)

• Proportion of participants who achieve HbA1c levels <7% at Month 6

  Month 6 of study participation

• Mean change in Body weight (kg) from baseline to Month 6

  From Baseline to 6 months

• Proportion of patients in both cohorts who intensify antihyperglycaemic treatment from Visit 1

  From Baseline to 6 months

Other Outcomes (11)

• Number of times smart phone- and/or web portal-based tool accessed per patient

  From Baseline to 6 months

• Mean percent change from baseline to Month 6 in SBP

  From Baseline to 6 months

• Proportion of patients who achieve BP <140/90 mmHg at Month 6

  From Baseline to 6 months

Study Arms (2)

Standard of Care + digital disease management cohort

Participants will have access to the smart phone- and web portal-based digital disease management tool in addition to standard care.

Other: Use of digital disease management tool in participants with T2DM

Standard of Care cohort

Participants will have standard care with no access to the digital disease management tool.

Other: Use of digital disease management tool in participants with T2DM

Interventions

Use of digital disease management tool in participants with T2DM OTHER

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.

Standard of Care + digital disease management cohort; Standard of Care cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with a prior diagnosis of Type II Diabetes Mellitus.

You may qualify if:

• Provision of written informed consent prior to any study-specific procedures.
• Female or male aged ≥18 years at time of consent.
• Diagnosed with T2DM.
• Treatment with one or more non-insulin antihyperglycaemic medication(s) for at least 6 months prior to enrolment
• Own/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. At the HCP's discretion, a patient may be without access to their smart phone service, data connection, and internet access for a period of time that should be ≤2 consecutive weeks
• HbA1c levels ≥8.0% and ≤11.0% within the last 6 months. If more than 1 value is available during the 6-month time period, all values must be within this range
• Body mass index (BMI) ≥25 and ≤55 kg/m2 within the last 3 months
• Ability to communicate in English
• Judged by their HCP 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 (urine or serum) for female patients of childbearing potential

You may not qualify if:

• Pregnancy
• Insulin use at baseline
• Current use of a smart phone- or web portal-based tool to help with management of T2DM
• History of type I diabetes or ketoacidosis
• Currently taking a weight loss medication
• Involvement in the planning and/or conduct of the study (applies to both AZ staff and/or staff and affiliates at the study site)
• Previous enrolment in the present study
• Participation in a clinical study with an investigational product or a disease state management program during the last 30 days

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (14)

Research Site

Dundee, Angus, United Kingdom

Location

Research Site

Cardiff, Cardiff [Caerdydd Gb-crd], United Kingdom

Location

Research Site

Muirhead, Dundee City, United Kingdom

Location

Research Site

Flintshire, Flintshire [Sir Y Fflint Gb-ff, United Kingdom

Location

Research Site

London, Harrow, United Kingdom

Location

Research Site

Manchester, Lancashire, United Kingdom

Location

Research Site

Oldham, Manchester, United Kingdom

Location

Research Site

Mid Glamorgan, Mid Glamorgan, United Kingdom

Location

Research Site

Bonnyrigg, Midlothian, United Kingdom

Location

Research Site

Edinburgh, Midlothian, United Kingdom

Location

Research Site

Fife, United Kingdom

Location

Research Site

Leicester, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Stockport, United Kingdom

Location

Related Links

• D1841C00002 Synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Manesh Saxena

  Barts and the London, Queen Mary School of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

• Deepak Bhatnagar

  Penine Acute Hospitals Trust

  PRINCIPAL INVESTIGATOR

• Aled Roberts

  Cardiff and Vale NHS Trust - University Hospital of Wales

  PRINCIPAL INVESTIGATOR

• Melanie Davies

  Leicester General Hospital

  PRINCIPAL INVESTIGATOR

• See Kwok

  Barlow Medical Centre

  PRINCIPAL INVESTIGATOR

• Keith Richardson

  Bridge House Medical Centre

  PRINCIPAL INVESTIGATOR

• Deborah Wake

  Ninewells Hospital and Medical School

  PRINCIPAL INVESTIGATOR

• Ruth Leese

  Muirhead Medical Centre

  PRINCIPAL INVESTIGATOR

• Neela Chatakondu

  Marches Medical Practice

  PRINCIPAL INVESTIGATOR

• Tom Hoyland

  Ashgrove Surgery

  PRINCIPAL INVESTIGATOR

• Allan Copland

  Auchtermuchty Health Centre

  PRINCIPAL INVESTIGATOR

• Calum MacKenzie

  Loanhead Medical Practice

  PRINCIPAL INVESTIGATOR

• Simon Barrett

  Quarryfoot Medical Practice

  PRINCIPAL INVESTIGATOR

• John Shewring

  Llanderyn Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 25, 2016
• Study Start: May 3, 2016
• Primary Completion: October 13, 2016
• Study Completion: October 13, 2016
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

GB (14)