Clinical trial NCT03090464: A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Digital disease management
T2DM
Hyperglycemia
Diabetes mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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;

Primary outcomes:
measure: Change from baseline to end of study (Month 6) in HbA1c levels
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of patients who achieve HbA1c levels <7% at Month 6
timeFrame: 6 Months
measure: Mean change in body weight (kg) from baseline to Month 6
timeFrame: 6 Months
measure: Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1
timeFrame: 6 Months
Other outcomes:
measure: Number of times the smart phone- and/or web portal-based tool is accessed per patient
timeFrame: 6 Months
measure: Length of time from first to last usage of smart phone- and/or web portal-based tool across the course of the study
timeFrame: 6 Months
measure: Mean patient satisfaction with the digital disease management tool
timeFrame: 6 Months
measure: Mean percent change from baseline to Month 6 in systolic blood pressure
timeFrame: 6 Months
measure: Mean percent change from baseline to Month 6 in low-density lipoprotein-cholesterol (LDL-C)
timeFrame: 6 Months
measure: Percent of patients who achieve blood pressure <140/90 mmHg at Month 6
timeFrame: 6 Months
measure: Percent of patients who achieve LDL-C <100 mg/dL at Month 6
timeFrame: 6 Months
measure: Differences in primary care office visits between active and control group during the 6-month study period
timeFrame: 6 Months
measure: 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
timeFrame: 6 Months
measure: Change in baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version score
timeFrame: 6 Months
measure: Change in baseline to Month 6 in Diabetes Self-Management Questionnaire score (16-question) (patient perception on ability to manage their disease)
timeFrame: 6 Months
measure: Change in baseline to Month 6 in Morisky Medication Adherence Scale (8-item) (adherence)
timeFrame: 6 Months
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Surprise
country: United States
facility: Research Site
state: Arizona
city: Lincoln
country: United States
facility: Research Site
state: California
city: Montclair
country: United States
facility: Resezrch Site
state: California
city: North Hollywood
country: United States
facility: Research Site
state: California
city: Spring Valley
country: United States
facility: Research Site
state: California
city: Van Nuys
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Cooper City
country: United States
facility: Research Site
state: Florida
city: DeLand
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Reserarch Site
state: Florida
city: Lake City
country: United States
facility: Research Site
state: Florida
city: Ormond Beach
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Port Orange
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Oxon Hill
country: United States
facility: Research Site
state: Maryland
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New Windsor
country: United States
facility: Research Site
state: New York
city: Westfield
country: United States
facility: Research Site
state: New York
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Franklin
country: United States
facility: Research Site
state: Ohio
city: Downingtown
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Tullahoma
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Lampasas
country: United States
facility: Research Site
state: Texas
city: Plano
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Burke
country: United States
facility: Research Site
state: Virginia
city: Manassas
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Federal Way
country: United States
facility: Research Site
state: Washington
city: Olympia
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: AstraZeneca
name: Kevin Sooben
role: STUDY_CHAIR
References: