Glu-COACH: a Peer-mentoring Intervention to Reduce Disparities in Continuous Glucose Monitor (CGM) Use

Обзор

This is a study to develop and evaluate a peer mentoring intervention for Black and Latinx adolescents with type 1 diabetes to increase the initiation and maintenance of a continuous glucose monitoring (CGM) device. This device is a standard of care to improve diabetes management related to diet, exercise, and insulin. Use of CGM has been shown to improve health outcomes, but is not used by adolescents of color. Peer mentors may help improve usage.

Подробное описание

In Phase 1, investigators developed the intervention with a stakeholder advisory group. In Phase 2, investigators will conduct a small clinical trial to evaluate the intervention. Phase 1 is complete with the focus of this registration being Phase 2, the clinical trial.

All study procedures will be conducted remotely by ZOOM, including consent/assent, device and training, and peer mentor sessions.

Вмешательства

• Поведенческое Glu-COACH
  peer-mentoring support from a peer of the same cultural identity and access to a private social media group for all Black and Latinx teens

Первичные конечные точки

• Mean hours per week CGM worn [Срок оценки: 3 months and 6 months]

Вторичные конечные точки (12)

• CGM Mean glucose [Срок оценки: baseline, 3 months and 6 months]
• CGM Percentage time in range (70-180mg/dL) [Срок оценки: baseline, 3 months and 6 months]
• Mean A1C concentration [Срок оценки: baseline, 3 months and 6 months]
• Number of Adverse diabetes-related events (diabetic ketoacidosis) [Срок оценки: baseline, 3 months and 6 months]
• Number of Adverse diabetes-related events (severe hypoglycemia) [Срок оценки: baseline, 3 months and 6 months]
• Mean score in Diabetes Distress using Problem Areas in Diabetes-Teen (PAID-T) survey [Срок оценки: baseline, 3 months and 6 months]
• Mean score Diabetes self-efficacy using Diabetes Management Self-Efficacy scale (DMSES) [Срок оценки: baseline, 3 months and 6 months]
• Mean score Depressive symptoms using Patient Health Questionnaire-2 (PHQ-2) [Срок оценки: baseline, 3 months and 6 months]
• Mean score Anxiety symptoms using General Anxiety Disorder-7 (GAD-7) [Срок оценки: baseline, 3 months and 6 months]
• Mean score Family conflict using Diabetes Family Conflict Scale (DFCS) [Срок оценки: baseline, 3 months and 6 months]
• Mean score Benefits and burdens of CGM use [Срок оценки: baseline, 3 months and 6 months]
• Mean Score Technology Attitudes [Срок оценки: baseline, 3 months and 6 months]

Критерии участия

Критерии включения

• Diagnosis of type 1 diabetes, as determined clinically by the presence of ketosis or ketoacidosis at presentation and/or the presence of at least one diabetes-related auto-antibody
• Self-identification as Black and/or Latinx.
• Ability of participant to comprehend and communicate in written and spoken English, in order to complete surveys and participate in mentioning sessions and other interview (parents/caregivers do not need to have English fluency)
• Access to personal cellphone or tablet to participate in remote video sessions with the peer mentor
• using CGM <50% of the time over the last 3 months

Критерии исключения

• Participants with a prior severe skin reaction to CGM sensor or adhesive.
• Current use of CGM
• Current or planned pregnancy
• Inability to comprehend or communicate in spoken/written English
• Subjects with other medical or mental health conditions that would, in the opinion of the investigators, interfere with the conduct of the study or present additional risk to the individual.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Yale Children's Diabetes Clinic — New Haven

Идентификаторы

NCT: NCT06171412 · 2000033606 · 1R01DK134977-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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