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A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM

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ClinicalTrials.gov Identifier: NCT03090464
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
Type 2 diabetes mellitus is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus. The purpose of this study is to evaluate if the use of a digital disease management tool (Smart phone- web portal-based tool), in addition to Standard of Care for T2DM, will improve glycemic control. Other variables important in T2DM (such as weight, blood pressure, and lipid levels), will also be evaluated along with patient-reported outcomes, such as satisfaction with treatment and adherence to their antihyperglycemic treatment. Study duration is 6 months

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Other: Use of digital disease management tool

Detailed Description:

Type 2 diabetes mellitus (T2DM) is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus. A digital disease-management tool, smart phone- and web-based portal, has been developed that incorporates the following features aimed at improving patient and population outcomes:

Treatment management to help patients remember to take medications and track adherence; Goal setting, including medical nutrition therapy, appropriately prescribed physical activity, and weight loss for those patients who are overweight or obese; Tracking and data collection for blood glucose, weight, and exercise, as entered by the patient or automatically for activity via Bluetooth pedometer or activity tracker; Assessments to capture patient beliefs in order to tailor personalized content to individual needs; educational and motivational content in the form of short messages, text, and videos covering T2DM and its treatment, and lifestyle advice; Web portals to display collected data back to the patient and healthcare practitioner in real-time to allow better and timely management of diabetes.

This tool is added to the Standard of Care for T2DM. Data are collected for patients utilizing this tool, compared with those who are not. Clinical assessments as part of the Standard of Care are collected, as well as standard Patient Reported Outcomes for this disease.

Glycemic control is considered to be the goal of a T2DM disease management plan.


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Study Type : Observational
Actual Enrollment : 328 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : May 21, 2018
Actual Study Completion Date : May 21, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Change from baseline to end of study (Month 6) in HbA1c levels [ Time Frame: 6 months ]
    Assessed from blood samples taken at visits per standard of care


Secondary Outcome Measures :
  1. Percentage of patients who achieve HbA1c levels <7% at Month 6 [ Time Frame: 6 Months ]
    Assessed from blood samples taken at visits per standard of care

  2. Mean change in body weight (kg) from baseline to Month 6 [ Time Frame: 6 Months ]
    Measures taken at visits per standard of care

  3. Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1 [ Time Frame: 6 Months ]
    Defined as an increase in dose or addition of a new antihyperglycemic agent not received at baseline


Other Outcome Measures:
  1. Number of times the smart phone- and/or web portal-based tool is accessed per patient [ Time Frame: 6 Months ]
    Calculated by adding the total number of discrete log-in attempts to the tool for each patient using the tool at least once

  2. Length of time from first to last usage of smart phone- and/or web portal-based tool across the course of the study [ Time Frame: 6 Months ]
    Determined by calculating the time from first to last log-in attempt for each patient accessing the tool at least twice during the course of the study

  3. Mean patient satisfaction with the digital disease management tool [ Time Frame: 6 Months ]
    Assessed by the User Satisfaction Survey

  4. Mean percent change from baseline to Month 6 in systolic blood pressure [ Time Frame: 6 Months ]
    Measures taken at visits per standard of care

  5. Mean percent change from baseline to Month 6 in low-density lipoprotein-cholesterol (LDL-C) [ Time Frame: 6 Months ]
    Assessed from blood samples taken at visits per standard of care

  6. Percent of patients who achieve blood pressure <140/90 mmHg at Month 6 [ Time Frame: 6 Months ]
    Measures taken at visits per standard of care

  7. Percent of patients who achieve LDL-C <100 mg/dL at Month 6 [ Time Frame: 6 Months ]
    Assessed from blood samples taken at visits per standard of care

  8. Differences in primary care office visits between active and control group during the 6-month study period [ Time Frame: 6 Months ]
    As reported in patient records

  9. Differences in Emergency Room visits between active and control group during the 6-month study period as reported in patients at the end of the study [ Time Frame: 6 Months ]
    As reported by patients at the end of the study

  10. Change in baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version score [ Time Frame: 6 Months ]
    As assessed in the Patient Reported Outcome measure Diabetes Treatment Satisfaction Questionnaire - Status version at the point-of-care visits

  11. Change in baseline to Month 6 in Diabetes Self-Management Questionnaire score (16-question) (patient perception on ability to manage their disease) [ Time Frame: 6 Months ]
    As assessed in the Patient Reported Outcomes measure Diabetes Self-Management Questionnaire at the point-of-care visits

  12. Change in baseline to Month 6 in Morisky Medication Adherence Scale (8-item) (adherence) [ Time Frame: 6 Months ]
    As assessed in the Patient Reported Outcome measure Morisky Medication Adherence Scale at the point-of-care visits



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
Criteria

Inclusion Criteria:

  • Provision of written informed consent;
  • Diagnosed with T2DM;
  • Male or female aged >/= 18 years at time of consent;
  • Treatment with 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment;
  • Own or 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;
  • HbA1c levels must be obtained at the enrollment visit or up to 14 days prior to Visit 1 and must be >/=7.5% and </=11.0%. Most of the hbA1c values obtained within the past 9 months must also be within this range;
  • Body mass index >/= 25 and </=55 kg/mm2 within the last 3 months;
  • Ability to communicate in English;
  • Judged by their primary care physician 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 for female subjects of childbearing potential.

Exclusion Criteria:

  • Pregnancy;
  • Insulin use at baseline;
  • Current use of a smart phone- or web portal-based tool designed to help with management of T2DM;
  • History of Type 1 diabetes or ketoacidosis;
  • Currently taking weight loss medication;
  • Involvement in the planning and/or conduct of this study;
  • Previous enrollment in the present study;
  • Participation in a clinical study with an investigational product or a disease state management program during the last 30 days;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090464


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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: Kevin Sooben AstraZeneca

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03090464     History of Changes
Other Study ID Numbers: D1841C00004
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Type 2 diabetes mellitus
Digital disease management
T2DM
Hyperglycemia
Diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases