A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
2019年5月8日 更新者：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
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
328
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35209
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Birmingham、Alabama、美国、35216
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Arizona
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Peoria、Arizona、美国、85381
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Surprise、Arizona、美国、85374
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California
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Lincoln、California、美国、95648
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Montclair、California、美国、91763
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North Hollywood、California、美国、91606
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Spring Valley、California、美国、91978
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Van Nuys、California、美国、91405
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Colorado
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Colorado Springs、Colorado、美国、80906
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Florida
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Cooper City、Florida、美国、33024
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DeLand、Florida、美国、32720
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Hialeah、Florida、美国、33012
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Jacksonville、Florida、美国、32277
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Lake City、Florida、美国、32055
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Ormond Beach、Florida、美国、32174
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Pembroke Pines、Florida、美国、33026
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Port Orange、Florida、美国、32127
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Tampa、Florida、美国、33634
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Illinois
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Evanston、Illinois、美国、60201
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Kentucky
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Lexington、Kentucky、美国、40503
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Maryland
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Oxon Hill、Maryland、美国、20745
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Nebraska
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Omaha、Nebraska、美国、68134
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Nevada
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Las Vegas、Nevada、美国、89128
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New Mexico
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Albuquerque、New Mexico、美国、87102
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New York
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Brooklyn、New York、美国、11235
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New Windsor、New York、美国、12553
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Westfield、New York、美国、14787
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North Carolina
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Greensboro、North Carolina、美国、27410
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Ohio
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Franklin、Ohio、美国、45005
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Pennsylvania
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Downingtown、Pennsylvania、美国、19335
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South Carolina
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Charleston、South Carolina、美国、29407
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Greer、South Carolina、美国、29651
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Myrtle Beach、South Carolina、美国、29588
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Spartanburg、South Carolina、美国、29301
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Tennessee
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Tullahoma、Tennessee、美国、37388
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Texas
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Houston、Texas、美国、77058
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Houston、Texas、美国、77040
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Lampasas、Texas、美国、76550
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Plano、Texas、美国、75024
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Utah
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Salt Lake City、Utah、美国、84107
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Virginia
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Burke、Virginia、美国、22015
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Manassas、Virginia、美国、20110
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Richmond、Virginia、美国、23235
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Washington
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Federal Way、Washington、美国、98003
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Olympia、Washington、美国、98502
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 99年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
描述
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;
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline to end of study (Month 6) in HbA1c levels
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of patients who achieve HbA1c levels <7% at Month 6
大体时间：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
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of times the smart phone- and/or web portal-based tool is accessed per patient
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 学习椅：Kevin Sooben、AstraZeneca
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月8日
初级完成 (实际的)
2018年5月21日
研究完成 (实际的)
2018年5月21日
研究注册日期
首次提交
2017年3月20日
首先提交符合 QC 标准的
2017年3月20日
首次发布 (实际的)
2017年3月24日
研究记录更新
最后更新发布 (实际的)
2019年5月9日
上次提交的符合 QC 标准的更新
2019年5月8日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.