Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Continuous Glucose Monitor (CGM)
  A Freestyle Libre 2 continuous glucose monitor (CGM) will be provided in the experimental arm of this study for 6 months.
• Устройство Self-monitoring Blood Glucose (SMBG)
  A traditional glucometer device will be assigned in the active comparitor arm of this study for 6 months.

Первичные конечные точки

• Glycemic Control (Hemoglobin A1c) [Срок оценки: Baseline, 3 months, and 6 months.]

Вторичные конечные точки (4)

• Hypoglycemia [Срок оценки: 6 months]
• Hyperglycemia [Срок оценки: 6 months]
• Blood Glucose Capture Rate [Срок оценки: 6 months]
• Perceived or Experienced Benefits and Barriers to Device Use [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

• Current use of an insulin pump
• On dialysis
• Pregnant
• 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

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Nebraska Medicine — Omaha

Идентификаторы

NCT: NCT05766488 · 0314-22-FB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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