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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type II Diabetes Mellitus

Intervention / Treatment
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* Other: Use of digital disease management tool in participants with T2DM


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: For inclusion in the study participants must fulfill the following criteria: 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 Exclusion criteria: Participants cannot enter the study if any of the following exclusion criteria are fulfilled: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care + digital disease management cohort<br>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<br>* 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.<br>|
| Standard of Care cohort<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who achieve HbA1c levels <7% at Month 6 | 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 | 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. | From Baseline to 6 months | 
| Proportion of patients in both cohorts who intensify antihyperglycaemic treatment from Visit 1 | 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. | From Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital disease management tool, Type 2 diabetes mellitus/ T2DM, HbA1c, Standard care, PRO questionnaires, Smart phone/ personal computer with internet access