Piloting the Use of Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Average change in glycemic control 3 months after Pro-CGM use
研究概览
简要总结
The purpose of this study is to assess whether the short-term use of professional continuous glucose monitoring (Pro-CGM) at the Parkland Diabetes Clinic in selected patients with poorly-controlled diabetes due to hyper- and/or hypoglycemia leads to improvements in patients' glycemic control within 3-6 months, subjective understanding of how food, activity, and medications affect blood sugar levels, and diabetes self-care practices. The study will be a prospective cohort study that assesses patients glycemic control and diabetes self-care practices before and 3-6 months after utilization of a Pro-CGM for 10 days. Glycemic control and diabetes self-care practices will be assessed based on hemoglobin A1c measurements and glucose data download from glucometer and Pro-CGM. A short survey will be administered at the end of the 10 days Pro-CGM use to assess whether the Pro-CGM use had a positive impact on patients' understanding of how different activities affect their blood sugar and diabetes self-care practices.
Parkland Diabetes Clinic serves an ethnically diverse, low socioeconomic patient population, the majority of whom do not have access to diabetes technology like continuous glucose monitoring. CGM measures sugar levels every 5 to 15 minutes and have been shown in clinical studies to improve glycemic control. Establishing a professional CGM program at the clinic will provide short-term access to this technology. One of the main reason for conducting this study is to determine if Pro-CGM would be a useful intervention to integrate into the clinic's routine practice in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Patients of the Parkland Diabetes Clinic who meets one or more of the following criteria:
- •Patients with inaccurate HgbA1c due to conditions that affect red blood cell turnover (examples include but not limited to: anemia, hemoglobinopathies, chronic kidney disease)
- •Patients with suspected recurrent hypoglycemia and/or hypoglycemia unawareness
- •Patients with persistently elevated HgbA1c >8% despite reported adherence to medications and lifestyle modifications and after assessment by a Certified Diabetes Care and Education Specialist (CDCES)
- •Patients with inability to do frequent fingersticks for blood glucose checks due to physical limitations (examples include but not limited to: vision loss, dexterity problems)
排除标准
- •Patients who already have their own personal continuous glucose monitoring device
结局指标
主要结局
Average change in glycemic control 3 months after Pro-CGM use
时间窗: 3 months
Glycemic control will be assessed at baseline and 3 months after intervention by measuring hemoglobin A1c and/or obtaining 14-day average glucose from glucometer or CGM blood sugar data download. These data are collected as part of routine diabetes care at the clinic and will be obtained by chart review.
次要结局
- Average change in hypoglycemia frequency 3 months after Pro-CGM use(3 months)
- Average change in frequency of fingerstick blood glucose checks 3 months after Pro-CGM use(3 months)
- Average change in hyperglycemia frequency 3 months after Pro-CGM use(3 months)
- Percentage of positive patient response to the Pro-CGM Questionnaire(The survey will be administered at the end of the 10 days Pro-CGM use. The percentage of positive responses will be calculated at the end of study.)
研究者
Felona Gunawan
Assistant Professor
University of Texas Southwestern Medical Center