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Идёт набор NCT07529366

Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

— Наблюдательное Prediabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dexcom Stelo CGM.
Кому может быть актуально
Состояния в реестре: Prediabetes. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change

Обзор

The goal of this observational study is to determine if a pharmacist-led program involving continuous glucose monitoring (CGM) improves glucose control and health behavior in people with prediabetes. The main questions it aims to answer are: 1. Determine impact of pharmacist-led CGM on glycemic control in people with prediabetes. Researchers will compare change in hemoglobin A1c at 12 weeks with pharmacist-led CGM versus a historical cohort of subjects with prediabetes receiving no CGM. The investigators will also assess change in CGM-derived glycemic metrics from baseline to end of the CGM wear period in the intervention group. 2. Evaluate impact of pharmacist-led CGM on health behavior change in people with prediabetes in the intervention group. Participants will be asked to complete the Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF-36) at baseline, at the end of week 4, and at the end of the study so that researchers can measure the effects in the intervention group on health behavior change.

Вмешательства

  • Устройство Dexcom Stelo CGM
    Subjects included in the intervention group will be recruited from the USF Health Department of Family Medicine. Each subject will be enrolled for 12 weeks. The CGM sensors are worn on the upper arm and changed every 15 days.

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 Week 4 (CGM wear period)]
  • Time in Euglycemic Range [Срок оценки: Baseline to End of Week 4 (CGM wear period)]
  • Mean Sensor Glucose [Срок оценки: Baseline to End of Week 4 (CGM wear period)]
  • Time Below Range [Срок оценки: Baseline to End of Week 4 (CGM wear period)]
  • Time Above Range [Срок оценки: Baseline to End of Week 4 (CGM wear period)]
  • Glycemic Variability [Срок оценки: Baseline to End of Week 4 (CGM wear period)]
  • Time in Range Increase 5% [Срок оценки: Baseline to End of Week 4 (CGM wear period)]
  • Time in Range Increase 10% [Срок оценки: Baseline to End of Week 4 (CGM wear period)]
  • Time in Euglycemic Range Increase 5% [Срок оценки: Baseline to End of Week 4 (CGM wear period)]
  • Time in Euglycemic Range Increase 10% [Срок оценки: Baseline to End of Week 4 (CGM wear period)]
  • >70% Time in Range [Срок оценки: Baseline to End of Week 4 (CGM wear period)]
  • >70% Time in Euglycemic Range [Срок оценки: Baseline to End of Week 4 (CGM wear period)]

Критерии участия

Критерии включения

  • adults 18-70 years of age
  • prediabetes (HbA1c 5.7-6.4%)
  • compatible smartphone with the Dexcom Stelo sensor system
  • have not have worn a CGM in the last 6 months prior to enrollment

Критерии исключения

  • any of the following forms of diabetes: type 1 diabetes, type 2 diabetes, monogenic diabetes, cystic fibrosis-related diabetes, post- transplant diabetes, latent autoimmune diabetes
  • problematic hypoglycemia in the prior 6 months \[defined as recurrent (more than one) level 2 hypoglycemic events (glucose <54mg/dL ) that persist despite multiple attempts to adjust medication(s) and/or modify the diabetes/treatment plan or a history of one level 3 hypoglycemic event (glucose <54mg/dL) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia\]
  • pregnant, or planning to become pregnant during the study time frame
  • currently receiving or planned to receive dialysis during the study time frame - current use of systemic steroids for any condition
  • a known allergy to medical grade adhesives,
  • use of any CGM device in the past 6 months
  • history of a diagnosed eating disorder
  • current use of a second-generation antipsychotic at the time of consent (aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)
  • subjects lacking capacity to provide informed consent

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 · 2 центра
  • USF Health Department of Family Medicine - Morsani Center for Advanced Health Care — Tampa
  • USF Health Department of Family Medicine - University Partnership Center — Tampa

Идентификаторы

NCT: NCT07529366 · STUDY009771

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗