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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 328

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Research Site
    • Birmingham, Alabama, United States, 35216
      • Research Site
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Research Site
    • Surprise, Arizona, United States, 85374
      • Research Site
  • California
    • Lincoln, California, United States, 95648
      • Research Site
    • Montclair, California, United States, 91763
      • Resezrch Site
    • North Hollywood, California, United States, 91606
      • Research Site
    • Spring Valley, California, United States, 91978
      • Research Site
    • Van Nuys, California, United States, 91405
      • Research Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80906
      • Research Site
  • Florida
    • Cooper City, Florida, United States, 33024
      • Research Site
    • DeLand, Florida, United States, 32720
      • Research Site
    • Hialeah, Florida, United States, 33012
      • Research Site
    • Jacksonville, Florida, United States, 32277
      • Reserarch Site
    • Lake City, Florida, United States, 32055
      • Research Site
    • Ormond Beach, Florida, United States, 32174
      • Research Site
    • Pembroke Pines, Florida, United States, 33026
      • Research Site
    • Port Orange, Florida, United States, 32127
      • Research Site
    • Tampa, Florida, United States, 33634
      • Research Site
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Research Site
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Research Site
  • New York
    • Brooklyn, New York, United States, 11235
      • Research Site
    • New Windsor, New York, United States, 12553
      • Research Site
    • Westfield, New York, United States, 14787
      • Research Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27410
      • Research Site
  • Ohio
    • Franklin, Ohio, United States, 45005
      • Research Site
  • Pennsylvania
    • Downingtown, Pennsylvania, United States, 19335
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Research Site
    • Greer, South Carolina, United States, 29651
      • Research Site
    • Myrtle Beach, South Carolina, United States, 29588
      • Research Site
    • Spartanburg, South Carolina, United States, 29301
      • Research Site
  • Tennessee
    • Tullahoma, Tennessee, United States, 37388
      • Research Site
  • Texas
    • Houston, Texas, United States, 77058
      • Research Site
    • Houston, Texas, United States, 77040
      • Research Site
    • Lampasas, Texas, United States, 76550
      • Research Site
    • Plano, Texas, United States, 75024
      • Research Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Research Site
  • Virginia
    • Burke, Virginia, United States, 22015
      • Research Site
    • Manassas, Virginia, United States, 20110
      • Research Site
    • Richmond, Virginia, United States, 23235
      • Research Site
  • Washington
    • Federal Way, Washington, United States, 98003
      • Research Site
    • Olympia, Washington, United States, 98502
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to end of study (Month 6) in HbA1c levels	Assessed from blood samples taken at visits per standard of care	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who achieve HbA1c levels <7% at Month 6	Assessed from blood samples taken at visits per standard of care	6 Months
Mean change in body weight (kg) from baseline to Month 6	Measures taken at visits per standard of care	6 Months
Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1	Defined as an increase in dose or addition of a new antihyperglycemic agent not received at baseline	6 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of times the smart phone- and/or web portal-based tool is accessed per patient	Calculated by adding the total number of discrete log-in attempts to the tool for each patient using the tool at least once	6 Months
Length of time from first to last usage of smart phone- and/or web portal-based tool across the course of the study	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	6 Months
Mean patient satisfaction with the digital disease management tool	Assessed by the User Satisfaction Survey	6 Months
Mean percent change from baseline to Month 6 in systolic blood pressure	Measures taken at visits per standard of care	6 Months
Mean percent change from baseline to Month 6 in low-density lipoprotein-cholesterol (LDL-C)	Assessed from blood samples taken at visits per standard of care	6 Months
Percent of patients who achieve blood pressure <140/90 mmHg at Month 6	Measures taken at visits per standard of care	6 Months
Percent of patients who achieve LDL-C <100 mg/dL at Month 6	Assessed from blood samples taken at visits per standard of care	6 Months
Differences in primary care office visits between active and control group during the 6-month study period	As reported in patient records	6 Months
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	As reported by patients at the end of the study	6 Months
Change in baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version score	As assessed in the Patient Reported Outcome measure Diabetes Treatment Satisfaction Questionnaire - Status version at the point-of-care visits	6 Months
Change in baseline to Month 6 in Diabetes Self-Management Questionnaire score (16-question) (patient perception on ability to manage their disease)	As assessed in the Patient Reported Outcomes measure Diabetes Self-Management Questionnaire at the point-of-care visits	6 Months
Change in baseline to Month 6 in Morisky Medication Adherence Scale (8-item) (adherence)	As assessed in the Patient Reported Outcome measure Morisky Medication Adherence Scale at the point-of-care visits	6 Months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Chair: Kevin Sooben, AstraZeneca

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): May 21, 2018
• Study Completion (Actual): May 21, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Hyperglycemia; Type 2 diabetes mellitus; Diabetes mellitus; T2DM; Digital disease management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D1841C00004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No