Investigating the Impact of Pharmacist-led Flash Continuous Glucose Monitoring on Clinical and Behavioral Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Change in hemoglobin A1c
研究概览
简要总结
This is a pilot study. The goal of this prospective cohort study is to determine impact of pharmacist-led continuous glucose monitoring on glycemic control and health behavior change in people with type 2 diabetes. The main questions it aims to answer are:
- to assess change in hemoglobin A1c in people with type 2 diabetes using continuous glucose monitoring under a pharmacist-led approach as compared to a pharmacist-led approach utilizing no continuous glucose monitoring (only self-monitoring blood glucose with a glucometer).
- to assess change in continuous glucose monitoring-derived glycemic outcomes among the pharmacist-led continuous glucose monitoring cohort (intervention group)
- to assess change in health behavior among the pharmacist-led continuous glucose monitoring cohort (intervention group)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •type 2 diabetes
- •hemoglobin A1c ≥ 8%
- •compatible smartphone with FreeStyle Libre 2 or Libre 3+ continuous glucose monitoring system
- •current use and access to a glucometer for self-monitoring of blood glucose
排除标准
- •any continuous glucose monitor use within 6 months prior to study enrollment
- •pregnant and planning to become pregnant during study time frame
- •history of hypoglycemia requiring third party assistance
- •history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to study enrollment
- •known allergy to medical grade adhesives
- •current use of systemic steroids for any medical condition
- •current use of dialysis
研究组 & 干预措施
Continuous glucose monitoring cohort (intervention)
Freestyle libre 2 or 3+ sensor devices will be used to monitor glucose. The sensors are worn on the upper arm and changed every 14 (libre 2) or 15 (libre 3+) days. Each subject will have 5 visits with a pharmacist over 12 weeks. Subjects meeting inclusion criteria will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8%. Subjects must have a compatible smartphone with the freestyle libre 2 sensor system. Subjects must have access to a glucometer to check blood glucose. Subjects must not have worn a continuous glucose monitor in the last 6 months to be eligible.
干预措施: FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor (Device)
Self-monitoring of blood glucose cohort (historical cohort)
A retrospective chart review will be performed on patients seen by a clinic pharmacist between 1/1/2020-7/1/2024. Subjects in this group will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8% and using a glucometer to monitor blood sugar. Exclusion criteria will be use of any continuous glucose monitoring device within the prior 6 months of the index date (defined as first visit with a pharmacist during study time frame).
结局指标
主要结局
Change in hemoglobin A1c
时间窗: Baseline to End of Study (12 weeks)
Between-group difference in change in hemoglobin A1c at 12 weeks, %, compared between intervention and historical cohort
次要结局
- Hemoglobin A1c <7%(Baseline to End of Study (12 weeks))
- Time in Range(Baseline to End of Study (12 weeks))
- Mean Sensor Glucose(Baseline to End of Study (12 weeks))
- Time Below Range(Baseline to End of Study (12 weeks))
- Time Above Range(Baseline to End of Study (12 weeks))
- Time in Range Increase 5%(Baseline to End of Study (12 weeks))
- Time in Range Increase 10%(Baseline to End of Study (12 weeks))
- Hemoglobin A1c <8%(Baseline to End of Study (12 weeks))
- Summary of Diabetes Self-Care Activities Measure(Baseline to End of Study (12 weeks))
- Glycemic Variability(Baseline to End of Study (12 weeks))
- >70% Time in Range(Baseline to End of Study (12 weeks))
- Continuous Glucose Monitoring Survey Responses(Baseline to End of Study (12 weeks))
研究者
Kevin Cowart
Associate Professor
University of South Florida