A Randomized Clinical Trial of a Secure Website Shared Between Patients and Providers for Blood Glucose Monitoring in Type-2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Subject and provider satisfaction with the intervention.
研究概览
简要总结
Currently, diabetic patients who receive their care at the diabetes clinic self monitor their blood glucose using a portable glucometer, under the direction of care providers at the clinic. We propose to conduct a randomized controlled trial to examine the effect of the "Diabetes Connected Health" tool, which is a secure website shared between patients of Type-2 Diabetes and their providers and displays (subjects') blood glucose values in graphical format. The study will be carried out through multiple primary care practices within the Partners/PCHI Network. We hypothesize that implementation of the Diabetes Connected Health Tool will result in overall better Diabetes Care, in terms of improved patient-provider interaction, and better patient satisfaction towards their care.
详细描述
The study will be carried out at multiple practices within Partners HealthCare system and will have one Intervention and one control arm.
Subjects enrolled into the intervention arm will use a OneTouch Ultra2 glucometer and an iMetrikus modem device which will upload the blood glucose readings to a secure, login-enabled web-based portal. Subjects will be given login information to access to their own individual Internet site, where they can view their readings and detailed graphical representation of their blood glucose levels over time, read educational material regarding diabetes management and receive personalized tips and feedback from their physicians (who will also have access to their patients' information on the web portal).
Subjects enrolled into the control arm will have access to the same glucometer and modem, and will have access to another individual internet website (the "Basic Site") which will show their glucose readings and graphical representation of glucose levels. Each patient will be enrolled for 3 months. and the primary outcome measure will patient and provider satisfaction with the Diabetes Connected Health tool.The specific aims along with hypothesis of the study are:
- To develop a web-based application ("Diabetes Connected Health") that will enable home-based glucose monitoring results to be readily incorporated into clinical glycemic management.
Hypothesis: We hypothesize that through a development process incorporating interactive feedback loops between software developers, patients, clinicians, and other stakeholders, we can create a web-based clinical application that will be adopted by clinical practices. 2. To test the impact of the "Diabetes Connected Health" tool in a randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria for Partners HealthCare practices:
- •Manage type-2 Diabetes patients.
- •Have at least one non-Physician provider (nurse practitioner, nurse, diabetes educator) with responsibility for diabetes patient care
- •Inclusion Criteria for subject selection:
- •Diagnosis of type 2 diabetes
- •Age 18 years or older
- •English speaking/able to read English
- •Last measured Hemoglobin A1c (HbA1c) > 7.5 % in the last 12 months.
- •Prescribed glucose self-monitoring, and either currently self monitoring or willing to monitor their blood glucose, as prescribed by their care provider, using the OneTouch Ultra2 portable glucometer.
- •Access to the Internet for the 6 months the study will run.
- •Access to a compatible analog telephone line at either their work place or home such that the subjects are able to upload the glucometer readings to the website.
- •Access to an active email account.
- •Receiving diabetes care primarily within the practice.
排除标准
- •for subject selection:
- •Subjects having mental health, cognitive or physical impairments that would preclude the set up and use of the modem, glucometer or computer.
- •Subjects are not candidates for guideline-based diabetes care.
研究组 & 干预措施
Diabetes Connected Health Tool "Deluxe"
Subjects enrolled into the intervention arm will measure their glucose levels by using a glucometer. An iMetrikus modem will upload the blood glucose readings to a secure, web-based portal. Participants will be given login information to access this portal, where they can view their glucose readings and detailed graphical representation of their blood glucose levels over time, read educational material regarding diabetes management and receive personalized tips and feedback from their physicians (who will also have access to these subjects' information on the web portal).
干预措施: Subject/Provider Portal "Diabetes Connected Health" tool - Deluxe (Other)
Diabetes Connected Health Tool "Basic"
Control group will measure their glucose levels by using a glucometer. An iMetrikus modem will upload the blood glucose readings to a secure, web-based portal. Participants will be given login information to access this portal. where they can view their glucose readings in tabular form. Their physicians will not have access to this information.
干预措施: Subject only Portal "Diabetes Connected Health Tool" Basic (Other)
结局指标
主要结局
Subject and provider satisfaction with the intervention.
时间窗: Upon completion of the trial.
次要结局
- Subject knowledge of diabetes and motivation(On completion of the trial)
研究者
Joseph C. Kvedar
Director, Center for Connected Health
Massachusetts General Hospital