跳至主要内容
临床试验/NCT05766488
NCT05766488Enrolling By Invitation不适用

Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

University of Nebraska2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
2
主要终点
Glycemic Control (Hemoglobin A1c)

研究概览

简要总结

Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. The purpose of this study is to further understand the benefits and barriers associated with CGM use in underserved populations with type 2 diabetes and improve their overall diabetes care.

详细描述

Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. This study will evaluate the perceived and experienced benefits and barriers of continuous glucose monitor (CGM) and traditional glucometer use and identify diabetes related outcomes associated with CGM use relative to usual care with self-monitoring of blood glucose (SMBG) in an underserved population.

Eligible adult (>=19 years of age) patients at participating clinics with type 2 diabetes, A1c >=9%, and concomitant insulin therapy and/or using two or more diabetes medications will be randomly enrolled to one of two groups: Freestyle Libre 2 CGM or traditional glucometer. Pre- and post-surveys will be used to evaluate perceived and experienced benefits and barriers to CGM use and diabetes-related outcomes will be compared between the groups using face-to-face, telephonic, and/or digital avenues. The latter aim will replicate current processes of team-based diabetes care which is blood glucose management from a pharmacist under collaborative practice with the primary care physician. Follow-up will also replicate these clinic processes throughout the 6-month period, including telephone calls and monthly in-clinic visits.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes
  • A1c >9% at recruitment
  • On/initiating insulin or on two or more diabetes medications

排除标准

  • Current use of an insulin pump
  • On dialysis
  • Implanted medical device (e.g., pace-maker, defibrillator)
  • Intellectual or physical disabilities that may interfere with ability to properly use the Continuous Glucose Monitor (CGM)
  • Able to read English

结局指标

主要结局

Glycemic Control (Hemoglobin A1c)

时间窗: Baseline, 3 months, and 6 months.

Glycemic control will be assessed by measuring hemoglobin A1c at baseline, 3 months, and 6 months. Values will be evaluated as a continuous variable and categorized as \<7.0% vs \>7.0% to \<9.0% and \>9.0%. Comparisons of the proportions of participants achieving a minimum of 1 point drop in hemoglobin A1c will be made between study arms.

次要结局

  • Hyperglycemia(6 months)
  • Blood Glucose Capture Rate(6 months)
  • Perceived or Experienced Benefits and Barriers to Device Use(Baseline and 6 months)
  • Hypoglycemia(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验