Pharmacist-led Continuous Glucose Monitoring

Официальное название

Investigating the Impact of Pharmacist-led Flash Continuous Glucose Monitoring on Clinical and Behavioral Health Outcomes

Обзор

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: 1. 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). 2. to assess change in continuous glucose monitoring-derived glycemic outcomes among the pharmacist-led continuous glucose monitoring cohort (intervention group) 3. to assess change in health behavior among the pharmacist-led continuous glucose monitoring cohort (intervention group)

Вмешательства

• Устройство FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor
  Subjects included in the intervention group (continuous glucose monitoring) will be recruited from the USF Health Department of Family Medicine. Each subject will be enrolled for 12 weeks.

Первичные конечные точки

• Change in hemoglobin A1c [Срок оценки: Baseline to End of Study (12 weeks)]

Вторичные конечные точки (12)

• Time in Range [Срок оценки: Baseline to End of Study (12 weeks)]
• Mean Sensor Glucose [Срок оценки: Baseline to End of Study (12 weeks)]
• Time Below Range [Срок оценки: Baseline to End of Study (12 weeks)]
• Time Above Range [Срок оценки: Baseline to End of Study (12 weeks)]
• Glycemic Variability [Срок оценки: Baseline to End of Study (12 weeks)]
• Time in Range Increase 5% [Срок оценки: Baseline to End of Study (12 weeks)]
• Time in Range Increase 10% [Срок оценки: Baseline to End of Study (12 weeks)]
• >70% Time in Range [Срок оценки: Baseline to End of Study (12 weeks)]
• Hemoglobin A1c <7% [Срок оценки: Baseline to End of Study (12 weeks)]
• Hemoglobin A1c <8% [Срок оценки: Baseline to End of Study (12 weeks)]
• Summary of Diabetes Self-Care Activities Measure [Срок оценки: Baseline to End of Study (12 weeks)]
• Continuous Glucose Monitoring Survey Responses [Срок оценки: Baseline to End of Study (12 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• USF Health Department of Family Medicine — Tampa

Публикации

• Cowart K, White RT, Olson K, Carris NW, Hanna K, Zgibor J. Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 May 23;14:e67014. doi: 10.2196/67014. PMID 40409747

Идентификаторы

NCT: NCT06572306 · STUDY007451

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗