A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
8 de maio de 2019 atualizado 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
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Observacional
Inscrição (Real)
328
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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
- Research Site
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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
- Research Site
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Van Nuys, California, Estados Unidos, 91405
- Research Site
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80906
- Research Site
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Florida
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Cooper City, Florida, Estados Unidos, 33024
- Research Site
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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
- Research Site
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Maryland
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Oxon Hill, Maryland, Estados Unidos, 20745
- Research Site
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68134
- Research Site
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89128
- Research Site
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
- Research Site
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New York
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Brooklyn, New York, Estados Unidos, 11235
- Research Site
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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
- Research Site
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Greer, South Carolina, Estados Unidos, 29651
- Research Site
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Myrtle Beach, South Carolina, Estados Unidos, 29588
- Research Site
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Spartanburg, South Carolina, Estados Unidos, 29301
- Research Site
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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
- Research Site
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Houston, Texas, Estados Unidos, 77040
- Research Site
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Lampasas, Texas, Estados Unidos, 76550
- Research Site
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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
- Research Site
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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
- Research Site
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Richmond, Virginia, Estados Unidos, 23235
- Research Site
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 99 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
Descrição
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;
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline to end of study (Month 6) in HbA1c levels
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of patients who achieve HbA1c levels <7% at Month 6
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of times the smart phone- and/or web portal-based tool is accessed per patient
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Kevin Sooben, AstraZeneca
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de maio de 2017
Conclusão Primária (Real)
21 de maio de 2018
Conclusão do estudo (Real)
21 de maio de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
20 de março de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de março de 2017
Primeira postagem (Real)
24 de março de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de maio de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de maio de 2019
Última verificação
1 de maio de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D1841C00004
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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