A 6-month clinical study to evaluate the effect of a digital disease management tool in patients with T2DM
Study identifier:D1841C00004
ClinicalTrials.gov identifier:NCT03090464
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official 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
Medical condition
Type 2 Diabetes Mellitus
Phase
-
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
328
Study type
Observational
Age
18 Years - 99 Years
Date
Study Start Date: 08 May 2017
Primary Completion Date: 21 May 2018
Study Completion Date: 21 May 2018
Study design
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 May 2019 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Standard of Care (SOC) Participants have standard of care with no access to digital disease management tool | - |
| SOC + digital disease management Participants have access to the digital disease management tool in addition to standard of care | Other: Use of digital disease management tool The purpose of the study is to evaluate if the provision of a digital disease management tool, in addition to SOC for T2DM, will improve glycemic control. The impact of the tool will be assessed in comparison to a Control group who will receive SOC alone. All participants will complete the PRO assessments. This is a real world study carried out at the point of care. |
Contacts
Investigators
Principal Investigator
Kevin Sooben
AstraZeneca
