A Randomized, Controlled, Open-label, Multi-center Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 129
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
The benefit of drug therapy to persons with diabetes has been well established in clinical trials in terms of reducing cardiovascular risk, microvascular complications and mortality. However, treatment adherence and treatment effectiveness continue to be challenges in diabetes management.
Rimidi Diabetes has developed software algorithms to simulate the effect of anti-diabetic medications on an individual's glucose profile, allowing the clinician and their patient to visualize the anticipated outcome of a medical intervention. Use of this technology should allow for more targeted decision-making by the clinician and should facilitate a shared decision-making process with the PwD who is now privy to the thought process behind their medical management.
The proposed study is designed to test whether adding a decision support capability (Diabetes+Me Rx) that allows for modeling the anticipated effect of medication adjustments leads to improved glycemic control and a perceived benefit by healthcare providers and PwDs.
详细描述
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Recruitment
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Recruitment of persons with diabetes through a community diabetes management center according to inclusion and exclusion criteria below.
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This is a three-armed study. Enrollees will be randomized to continue diabetes care with standard diabetes management in the Medication Management Clinic or the Intervention Group and compared to a matched cohort managed through their primary care physician (PCP) and standard of care.
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The Intervention Group will be standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me with a connected glucometer.
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Upon recruitment, PwD will be oriented to the Diabetes+Me application and instructed on how to complete a glucose profile and how to enter data into the application. Baseline hemoglobin A1C will be measured.
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Enrollees will complete a brief survey of satisfaction with their diabetes management.
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Study visits
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The first study visit will be 2 weeks following enrollment.
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Weight, number of medications, number of medication titrations, the presence of insulin and blood pressure will be measured at each study visit. Frequency of hypoglycemia in the preceding week will be documented at each visit. Adherence to medical prescription to be documented at each visit.
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If the PwD has not entered data into Diabetes+Me this will be done at the beginning of each study visit.
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At the first study visit, the HCP will review the glucose profile from the previous week, identify areas where the PwD is not meeting targets and model adjustments to their medications to achieve the desired anticipated effect. If indicated, a new prescription will be issued and the PwD instructed to collect a new glucose profile the week preceding the next visit.
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The second study visit will occur 5 weeks following the initial visit. The HCP and PwD will review the glucose profile from the previous week, identify areas where the PwD is not meeting targets and model adjustments to their medications to achieve the desired anticipated effect. If indicated, a new prescription will be issued and the PwD instructed to collect a new glucose profile the week preceding the final visit.
The third and final study visit will occur 5 weeks following the second visit. The HCP and PwD will review the glucose profile from the previous week and identify if the PwD is meeting targets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of type 1 or type 2 diabetes
- •Glycated hemoglobin > 9% within 3 months
- •Age 18-80
- •Not currently managed by study clinicians
排除标准
- •Active substance abuse
- •Severe hearing or visual impairment
- •No internet or email access
结局指标
主要结局
Hemoglobin A1C
时间窗: change from baseline to 12 weeks
次要结局
- Patient satisfaction questionnaire(through patient study completion, an average of 12 weeks)
- Number of hypoglycemic events per week(change from 1st week to twelfth week)
- Healthcare provider satisfaction(through study completion, an average of 1 year)
- Medication titrations needed(12 weeks)
- Blood pressure(change from baseline to 12 weeks)
- BMI(change from baseline to 12 weeks)
- A1C target attainment(at 12 weeks)