Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups
研究概览
简要总结
The investigators aim is to conduct a randomized clinical trial in an underserved population who are either uninsured or on Medicaid and taking at least one injection of insulin daily. The investigators believe that this study will lead to considerable alleviation of health disparities and provide better care for an underserved population. This will be a pilot study to evaluate the feasibility of such a trial in this population before doing a larger multicenter trial.
详细描述
This study is a randomized open label trial with study participants being randomized to either a continuous glucose monitoring group (intervention) or a self-monitoring group (control) after a period of two-week run-in and followed for 6 months. All participants regardless of assignment will be provided diabetes education. Participants randomized to the self-monitoring group will be given an opportunity to wear the CGM sensor for 3 months at the conclusion of the 6-month follow-up as an optional follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Type 2 diabetes mellitus
- •HbA1C ≥ 7.5%
- •At least on 1 insulin injection therapy daily
- •Patients established with primary care clinic or endocrinology clinic or diabetes clinics in the New Orleans and surrounding areas
- •Patients with Medicaid or free care or uninsured
- •Patients must be able to speak and understand English and be capable of providing informed consent to participate in the study
排除标准
- •Type 1 diabetes mellitus
- •Currently on CGM or using insulin pump
- •Advanced renal disease or Estimated Glomerular Filtration Rate (eGFR) <40
- •Serious co-morbidities which in the investigator's opinion, will make it challenging for patients to participate
- •The patient has been diagnosed with end-stage renal disease, is on dialysis, or has had a kidney transplant, Hemoglobinopathies, iron therapy or other condition that interferes with HbA1c measurement
研究组 & 干预措施
Continuous Glucose Monitoring (CGM)
The study participants will be randomized to the continuous glucose monitoring group (intervention).
干预措施: Continuous Glucose Monitoring (CGM) (Device)
Self-Monitoring of Blood Glucose (SMBG)
The study participants will be randomized to the self-monitoring group (control) after a period of two-week run-in and followed for 6 months. They will be given an opportunity to wear the CGM sensor for 3 months at the conclusion of the 6-month follow-up as an optional follow-up.
干预措施: Continuous Glucose Monitoring (CGM) (Device)
结局指标
主要结局
Change in Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups
时间窗: Baseline, 6 months
The investigators will take blood samples at baseline and at the 6 months visit to measure the HbA1c levels. Change in the level of HbA1c at 6 months will be compared between the 2 groups to assess the outcome.
次要结局
- Change in Time in Range (TIR)(Baseline, 6 months)
- Change in documented hypoglycemia <70 mg/ dl and severe hypoglycemia - <54 mg/dl(Baseline, 6 months)