A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
8 de mayo de 2019 actualizado por: AstraZeneca
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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
328
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35209
- Research Site
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Birmingham, Alabama, Estados Unidos, 35216
- Research Site
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Arizona
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Peoria, Arizona, Estados Unidos, 85381
- Research Site
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Surprise, Arizona, Estados Unidos, 85374
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California
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Lincoln, California, Estados Unidos, 95648
- Research Site
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Montclair, California, Estados Unidos, 91763
- Resezrch Site
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North Hollywood, California, Estados Unidos, 91606
- Research Site
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Spring Valley, California, Estados Unidos, 91978
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Van Nuys, California, Estados Unidos, 91405
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80906
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Florida
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Cooper City, Florida, Estados Unidos, 33024
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DeLand, Florida, Estados Unidos, 32720
- Research Site
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Hialeah, Florida, Estados Unidos, 33012
- Research Site
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Jacksonville, Florida, Estados Unidos, 32277
- Reserarch Site
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Lake City, Florida, Estados Unidos, 32055
- Research Site
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Ormond Beach, Florida, Estados Unidos, 32174
- Research Site
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Pembroke Pines, Florida, Estados Unidos, 33026
- Research Site
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Port Orange, Florida, Estados Unidos, 32127
- Research Site
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Tampa, Florida, Estados Unidos, 33634
- Research Site
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Illinois
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Evanston, Illinois, Estados Unidos, 60201
- Research Site
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
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Maryland
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Oxon Hill, Maryland, Estados Unidos, 20745
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68134
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89128
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
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New York
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Brooklyn, New York, Estados Unidos, 11235
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New Windsor, New York, Estados Unidos, 12553
- Research Site
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Westfield, New York, Estados Unidos, 14787
- Research Site
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North Carolina
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Greensboro, North Carolina, Estados Unidos, 27410
- Research Site
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Ohio
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Franklin, Ohio, Estados Unidos, 45005
- Research Site
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Pennsylvania
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Downingtown, Pennsylvania, Estados Unidos, 19335
- Research Site
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29407
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Greer, South Carolina, Estados Unidos, 29651
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Myrtle Beach, South Carolina, Estados Unidos, 29588
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Spartanburg, South Carolina, Estados Unidos, 29301
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Tennessee
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Tullahoma, Tennessee, Estados Unidos, 37388
- Research Site
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Texas
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Houston, Texas, Estados Unidos, 77058
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Houston, Texas, Estados Unidos, 77040
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Lampasas, Texas, Estados Unidos, 76550
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Plano, Texas, Estados Unidos, 75024
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Utah
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Salt Lake City, Utah, Estados Unidos, 84107
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Virginia
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Burke, Virginia, Estados Unidos, 22015
- Research Site
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Manassas, Virginia, Estados Unidos, 20110
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Richmond, Virginia, Estados Unidos, 23235
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Washington
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Federal Way, Washington, Estados Unidos, 98003
- Research Site
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Olympia, Washington, Estados Unidos, 98502
- Research Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 99 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
Descripción
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;
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Standard of Care (SOC)
Participants have standard of care with no access to digital disease management tool
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SOC + digital disease management
Participants have access to the digital disease management tool in addition to standard of care
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline to end of study (Month 6) in HbA1c levels
Periodo de tiempo: 6 months
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Assessed from blood samples taken at visits per standard of care
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of patients who achieve HbA1c levels <7% at Month 6
Periodo de tiempo: 6 Months
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Assessed from blood samples taken at visits per standard of care
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6 Months
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Mean change in body weight (kg) from baseline to Month 6
Periodo de tiempo: 6 Months
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Measures taken at visits per standard of care
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6 Months
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Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1
Periodo de tiempo: 6 Months
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Defined as an increase in dose or addition of a new antihyperglycemic agent not received at baseline
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6 Months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of times the smart phone- and/or web portal-based tool is accessed per patient
Periodo de tiempo: 6 Months
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Calculated by adding the total number of discrete log-in attempts to the tool for each patient using the tool at least once
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6 Months
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Length of time from first to last usage of smart phone- and/or web portal-based tool across the course of the study
Periodo de tiempo: 6 Months
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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
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6 Months
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Mean patient satisfaction with the digital disease management tool
Periodo de tiempo: 6 Months
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Assessed by the User Satisfaction Survey
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6 Months
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Mean percent change from baseline to Month 6 in systolic blood pressure
Periodo de tiempo: 6 Months
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Measures taken at visits per standard of care
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6 Months
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Mean percent change from baseline to Month 6 in low-density lipoprotein-cholesterol (LDL-C)
Periodo de tiempo: 6 Months
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Assessed from blood samples taken at visits per standard of care
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6 Months
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Percent of patients who achieve blood pressure <140/90 mmHg at Month 6
Periodo de tiempo: 6 Months
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Measures taken at visits per standard of care
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6 Months
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Percent of patients who achieve LDL-C <100 mg/dL at Month 6
Periodo de tiempo: 6 Months
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Assessed from blood samples taken at visits per standard of care
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6 Months
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Differences in primary care office visits between active and control group during the 6-month study period
Periodo de tiempo: 6 Months
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As reported in patient records
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6 Months
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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
Periodo de tiempo: 6 Months
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As reported by patients at the end of the study
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6 Months
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Change in baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version score
Periodo de tiempo: 6 Months
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As assessed in the Patient Reported Outcome measure Diabetes Treatment Satisfaction Questionnaire - Status version at the point-of-care visits
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6 Months
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Change in baseline to Month 6 in Diabetes Self-Management Questionnaire score (16-question) (patient perception on ability to manage their disease)
Periodo de tiempo: 6 Months
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As assessed in the Patient Reported Outcomes measure Diabetes Self-Management Questionnaire at the point-of-care visits
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6 Months
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Change in baseline to Month 6 in Morisky Medication Adherence Scale (8-item) (adherence)
Periodo de tiempo: 6 Months
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As assessed in the Patient Reported Outcome measure Morisky Medication Adherence Scale at the point-of-care visits
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6 Months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Kevin Sooben, AstraZeneca
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de mayo de 2017
Finalización primaria (Actual)
21 de mayo de 2018
Finalización del estudio (Actual)
21 de mayo de 2018
Fechas de registro del estudio
Enviado por primera vez
20 de marzo de 2017
Primero enviado que cumplió con los criterios de control de calidad
20 de marzo de 2017
Publicado por primera vez (Actual)
24 de marzo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de mayo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
8 de mayo de 2019
Última verificación
1 de mayo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D1841C00004
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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