Comparing Electronic Versus In-Person Access to Specialty Diabetes Expertise
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c (A1c) at baseline
研究概览
简要总结
Flash glucose monitoring is an FDA-approved and widely clinically available, glucose monitoring technology that is worn on the body and measures glucose values every 15 minutes, storing this data for up to 14 days. The Freestyle Libre Pro is already used as a diagnostic technology in clinical care. It provides a full 24-hour glucose profile for each day that the sensor is worn and that can be correlated with daily activities, medication administration, food intake, and other factors that are contextually relevant in meeting glycemic goals for an individual patient.
In this study, patients referred to Endocrinology for specialty diabetes care will be randomized to an in-person visit as is typically done or to wear the Freestyle Libre Pro placed by staff at their primary care clinic. Patients who wear the Freestyle Libre Pro will have a professional interpretation of their glucose data completed by an endocrinologist as well as a remote eConsult completed using this glucose data and information from their medical record. The recommendations from the eConsult regarding medication and lifestyle adjustment as well as potential referral on to see Endocrinology will be implemented by the primary care physician at their clinical discretion.
The investigators will utilize glycemic measures including hemoglobin A1c, number of clinical visits (outpatient, inpatient and emergency department) for diabetes care, patient reported outcomes including self-efficacy, and patient and provider assessments of burden to determine if eConsults utilizing flash glucose monitoring technology are non-inferior to in-person visits with a diabetes specialist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Male and female subjects age 18-80, inclusive
- •Diagnosed with type 2 diabetes at least 6 months prior to screening
- •Not previously seen within the prior three years in the endocrinology clinic for diabetes management
- •Referred to endocrinology for diabetes care directly from primary care
- •Willing to wear an Abbott® FreeStyle Libre Pro for 7-14 days
- •English speaking
- •Able and willing to complete questionnaires
排除标准
- •Planned travel or surgery during the time of libre wear
- •Patients without a diagnosis of type 2 diabetes, including individuals with type 1 diabetes and gestational diabetes
- •Women referred for diabetes care during pregnancy, or while breastfeeding or who intend to become pregnant during involvement in this trial
- •Currently using real time CGM or FGM system
- •Concurrent involvement in another clinical trial using diabetes pharmacotherapy
- •Individuals with active malignancy undergoing treatment with chemotherapy and/or high dose glucocorticoids
- •Individuals with rheumatic disease undergoing treatment with high dose glucocorticoids
- •Planned magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment during the time of Libre wear
- •Any cognitive or other disorders, in the investigator's opinion, that may interfere with participation or ability to follow the study protocol
结局指标
主要结局
Hemoglobin A1c (A1c) at baseline
时间窗: baseline
A1c will be obtained as standard of care and values documented in the medical record.
Percentage change in A1c to 12 months
时间窗: baseline, 12 months
The percent change in A1c will be calculated from baseline to 12 months
Proportion of patients with A1c <8%
时间窗: 6 months, 12 months
The proportion of participants with A1c \<8% (ADA target) will be calculated.
Glycemic control based on A1c
时间窗: 12 months
A1c reduction of \> 1% with 20% non-inferiority margin
Hemoglobin A1c (A1c) at 6 months
时间窗: 6 months
A1c will be obtained as standard of care and values documented in the medical record.
Hemoglobin A1c (A1c) at 12 months
时间窗: 12 months
A1c will be obtained as standard of care and values documented in the medical record.
Proportion of patients with A1c <7%
时间窗: 6 months, 12 months
The proportion of participants with A1c \<7% (ADA target) will be calculated.
Hemoglobin A1c (A1c) at 3 months
时间窗: 3 months
A1c will be obtained as standard of care and values documented in the medical record.
Percentage change in A1c to 6 months
时间窗: baseline, 6 months
The percent change in A1c will be calculated from baseline to six months
次要结局
- Efficacy of embedded clinical pharmacists(baseline, 3, 6, and 12 months)
- Provider assessment of acceptability(at baseline, 6 months, and completion of study period)
- Number of clinical visits for diabetes care(12 months)
- Patient assessment of care burden(within 2 weeks of the physician visit or eConsult)
- Patient self efficacy and disease burden based on diabetes self management questionnaire and problem areas in diabetes short five-item short form questionnaire(at baseline and 6 months)
- Cost effectiveness analysis (CEA)(12 months)