Enhancing Digitally Delivered Diabetes Education With Real-Time CGM

Официальное название

Enhancing Digitally Delivered Diabetes Education With Real-Time CGM: A Comparative Study in People With Type 2 Diabetes

Обзор

The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.

Подробное описание

The current research study seeks to investigate the impact of incorporating Continuous Glucose Monitoring (CGM) into the evidence-based text messaging diabetes education program, Dulce Digital, focusing on individuals with Type 2 Diabetes (T2D) who are not on insulin therapy. This innovative approach stems from the rationale that real-time continuous glucose monitoring (CGM) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. In standard care, individuals with T2D, particularly those not on insulin, may not routinely have access to CGM devices. The CGM device, an integral part of recommended diabetes therapy, is FDA approved for use in all people with diabetes. However, reimbursement for CGM devices varies by health plans, and currently, Centers for Medicare \& Medicaid Services (CMS) does not reimburse for their use in non-insulin-using diabetes, except in cases of repeated severe hypoglycemia. Despite this, the investigators hypothesize that there are both clinical and financial benefits to providing a CGM device during diabetes self-management education for individuals with non-insulin-using T2D. This study aims to determine if adding a CGM device for this patient category yields significant benefits, contributing to the understanding of the potential advantages and informing future diabetes care practices.

Вмешательства

• Другое Dulce Digital Text Messaging Intervention
  Text-based education support program: * Participants will receive text messages about diabetes and how to take care of diabetes and health. Participants will receive 2-3 messages every day for first 3 months, and then will slowly decrease over the last 3-months. * Participants will also receive text messages that will ask them to test their blood sugar and text back blood sugar reading.
• Другое CGM Device
  Participants will be provided continuous glucose monitors (Dexcom G7) to actively monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months). In addition, participants will attend an information session (group or individual; in-person or virtual) that will provide instructions on using continuous glucose monitors.

Первичные конечные точки

• HbA1c [Срок оценки: 6 months]

Вторичные конечные точки (5)

• CGM Metric Time in Range [Срок оценки: 6 months]
• CGM Metric Time above Range [Срок оценки: 6 months]
• CGM Metric Time Below Range [Срок оценки: 6 months]
• Summary of Diabetes Self Care Activities (SDSCA) Survey [Срок оценки: 6 months]
• Diabetes Distress Scale [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Diagnosed with type 2 diabetes
• Are not currently using a CGM
• Are not using insulin therapies
• Speak English, Spanish or Arabic
• Have A1c between 7.5% and 12.0% in last 90 days
• Have a cellphone that can receive/send text messages and counts steps

Критерии исключения

• Are using insulin therapies
• Are pregnant
• Are currently using a CGM
• Are currently participating in another diabetes-related study

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

Поддерживающая терапия

Центры проведения

США · 1 центр

• Scripps Whittier Diabetes Institute — San Diego

Идентификаторы

NCT: NCT06296550 · Dulce Digital CGM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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