Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

Официальное название

Continuous Glucose Monitor Use for Mayo Clinic Advanced Care at Home Patients With Diabetes Mellitus

Обзор

The purpose of this study is to measure differences in diabetes control with the use of continuous glucose monitor (CGM) and diabetes education compared with standard of care for glucose monitoring (glucometer checks) and diabetes education in participants with diabetes mellitus receiving therapy with insulin and being admitted to Mayo Clinic Advanced Care at Home Program (ACH).

Вмешательства

• Устройство Continuous Glucose Monitor Dexcom G6 PRO
  Connected to a smart phone that transmits continuous glucose monitoring data in real time to Advanced Care at Home Command Center for monitoring.

Первичные конечные точки

• Time in Range [Срок оценки: 10 days]
• Mean daily glucose [Срок оценки: 10 days]

Вторичные конечные точки (6)

• Frequency of hypoglycemia episodes [Срок оценки: 10 days]
• Mean absolute relative difference (MARD) variation with Oxygen saturation. [Срок оценки: 10 days]
• Mean absolute relative difference (MARD) variation with Daily hemoglobin. [Срок оценки: 10 days]
• Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR) [Срок оценки: 10 days]
• Mean absolute relative difference (MARD) variation with Arterial blood pressure [Срок оценки: 10 days]
• Percentage of subjects to continue use of continuous glucose monitor [Срок оценки: 40 days]

Критерии участия

Критерии включения

• Patients who are admitted to Advanced Care at Home (ACH) Program and supposed to remain in ACH for at least 72 hours.
• Patients with previous diagnosis of DM type 1 or type 2.
• Patients taking subcutaneous (SQ) insulin either via multidose injections or SQ insulin pump.
• Capable of giving signed informed consent

Критерии исключения

• Actively treated for diabetes ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS).
• Participants taking acetaminophen more than 4g per day or more than 1gm every 6 hours.
• Participants with altered mental status.
• Participants diagnosed with dementia.
• Patients with suicidal ideations or experiencing suicidal behavior.
• Patients with liver cirrhosis.
• Patients with End Stage Renal Disease on dialysis bot hemodialysis or peritoneal dialysis.
• Participants with allergy to medical grade adhesive or medical tape.
• Participants taking hydroxyurea.
• Participants who are pregnant, wanting to become pregnant, or nursing during study period.
• Patients with a planned MRI within the following 10 days after admission to ACH.
• Participants currently using continuous glucose monitor (CGM) to dose insulin or check glucose level.
• Participants with diabetes mellitus (DM) treated with diet alone.
• Participants with DM treated with oral hypoglycemic medications.
• Participants with DM treated with one SQ insulin injection daily.
• Participants enrolled in other studies addressing CGM use.
• Participants physically or emotionally incapable of handling a cell phone with a smart display.
• Participants with hearing impaired to a degree that they are not able to hear a smart phone alert or alarm.
• Patients lacking WIFI or Cellular coverage needed to connect the monitoring cell phone to Internet network.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT05880810 · 23-000733

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗