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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090464
• Other study ID #: D1841C00004
• Status: Completed
• Start date: May 8, 2017
• Est. completion date: May 21, 2018

Study information

• Verified date: May 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: May 21, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Birmingham	Alabama
United States	Research Site	Birmingham	Alabama
United States	Research Site	Brooklyn	New York
United States	Research Site	Burke	Virginia
United States	Research Site	Charleston	South Carolina
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Cooper City	Florida
United States	Research Site	DeLand	Florida
United States	Research Site	Downingtown	Pennsylvania
United States	Research Site	Evanston	Illinois
United States	Research Site	Federal Way	Washington
United States	Research Site	Franklin	Ohio
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Greer	South Carolina
United States	Research Site	Hialeah	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Reserarch Site	Jacksonville	Florida
United States	Research Site	Lake City	Florida
United States	Research Site	Lampasas	Texas
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lexington	Kentucky
United States	Research Site	Lincoln	California
United States	Research Site	Manassas	Virginia
United States	Resezrch Site	Montclair	California
United States	Research Site	Myrtle Beach	South Carolina
United States	Research Site	New Windsor	New York
United States	Research Site	North Hollywood	California
United States	Research Site	Olympia	Washington
United States	Research Site	Omaha	Nebraska
United States	Research Site	Ormond Beach	Florida
United States	Research Site	Oxon Hill	Maryland
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Peoria	Arizona
United States	Research Site	Plano	Texas
United States	Research Site	Port Orange	Florida
United States	Research Site	Richmond	Virginia
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Spring Valley	California
United States	Research Site	Surprise	Arizona
United States	Research Site	Tampa	Florida
United States	Research Site	Tullahoma	Tennessee
United States	Research Site	Van Nuys	California
United States	Research Site	Westfield	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Mean patient satisfaction with the digital disease management tool	Assessed by the User Satisfaction Survey	6 Months
Other	Mean percent change from baseline to Month 6 in systolic blood pressure	Measures taken at visits per standard of care	6 Months
Other	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
Other	Percent of patients who achieve blood pressure <140/90 mmHg at Month 6	Measures taken at visits per standard of care	6 Months
Other	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
Other	Differences in primary care office visits between active and control group during the 6-month study period	As reported in patient records	6 Months
Other	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
Other	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
Other	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
Other	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
Primary	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	Percentage of patients who achieve HbA1c levels <7% at Month 6	Assessed from blood samples taken at visits per standard of care	6 Months
Secondary	Mean change in body weight (kg) from baseline to Month 6	Measures taken at visits per standard of care	6 Months
Secondary	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

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