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

Terminated

• Conditions: Type II Diabetes Mellitus
• Interventions: Other: Use of digital disease management tool in participants with T2DM

• Registration Number: NCT02749435
• Lead Sponsor: AstraZeneca

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

Detailed Description

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. This is an open design study, in which the patients will be aware of the guidance they are receiving via the provided support tool. Study duration of 6 months has been chosen, as a reasonable amount of time to evaluate the tool. Glycaemic control is considered to be the goal of a T2DM disease management plan. In T2DM, long-term goals may not be achieved because participants fail to adhere to their management plan after an initial period of compliance. The study will compare the group receiving the digital disease management tool added to standard care for T2DM to a concurrent control group receiving standard care. Standard of Care cohort: Participants will have standard care with no access to the digital disease management tool. Clinical assessments for this study will be conducted as part of normal, standard care. Participants in the Standard of Care + digital disease management cohort will be taken through their standard T2DM management plan by their HCP (Health Care Provider) and trained in the use of the digital disease management tool. All participants will complete the PRO assessments. This study also aims at helping the health care practitioners and managed care providers to make evidence-based decisions about how to improve patient self-management of their diabetes. Participants diagnosed with T2DM and on one or more non-insulin antihyperglycaemic medications will be offered participation in the study at their point of care. Participants in the Standard of Care cohort will be taken through their T2DM management plan with their HCP per standard care. It is not anticipated that the use of this patient tool will be associated with any increase in risk to participating patients. The study will be performed in accordance with ethical principles that are consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP), applicable regulatory requirements, and the AZ policy of bioethics.

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-25
• Study Start: 2016-05-03
• Primary Completion: 2016-10-13
• Study Completion: 2016-10-13
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of Care + digital disease management cohort	Use of digital disease management tool in participants with T2DM	Participants will have access to the smart phone- and web portal-based digital disease management tool in addition to standard care.
Standard of Care cohort	Use of digital disease management tool in participants with T2DM	Participants will have standard care with no access to the digital disease management tool.

Primary Outcome Measures

Name	Time	Method
Mean Change from baseline to Month 6 in HbA1c	From Baseline to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who achieve HbA1c levels <7% at Month 6	Month 6 of study participation	Proportion of participants who achieve HbA1c levels \<7% at Month 6
Mean change in Body weight (kg) from baseline to Month 6	From Baseline to 6 months	Mean change in Body weight (kg) from baseline to Month 6.; Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.
Proportion of patients in both cohorts who intensify antihyperglycaemic treatment from Visit 1	From Baseline to 6 months	Proportion of participants in both cohorts who intensify antihyperglycaemic treatment from Visit 1, defined as an increase in dose or addition of a new antihyperglycaemic agent not received at baseline.; Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Stockport, United Kingdom