Real-time Engagement for Learning to Effectively Control Type 2 Diabetes

Обзор

This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period.

Подробное описание

The objective of REFLECT2D (Real-time Engagement For Learning to Effectively Control Type 2 Diabetes) is to evaluate whether pairing real-time glycemic and health behavior data leads to improved glycemic control among adolescents and young adults with type 2 diabetes. Participants will use a mobile app that integrates continuous glucose monitor data, Fitbit activity tracker data, and diet logging, with the aim of increasing capability to interpret glycemic data (including impacts of physical activity and dietary intake), providing opportunity to plan and implement behavior change, and increasing motivation to engage in health behaviors. After a session with a Registered Dietitian and Diabetes Educator who will support participants in forming diet and activity goals, a 90-day micro-randomized trial (MRT) period will involve once daily randomization of each participant to: 1) physical-activity focused prompt, 2) dietary intake-focused prompt, or 3) no prompt. Prompts will include reviews of glycemic trends in the past 24 hours (e.g., periods of hyperglycemia, max glucose) and will ask participants to use visual summaries of activity or diet and glucose to reflect on and revise their behavioral management goals as needed. After the MRT, a 90-day observation period without prompts but with ongoing availability of continuous glucose monitor data, Fitbit, and Healthmine app will examine persistence of glycemic and behavior changes. In addition to daily micro-randomization, participants will be randomized 1:1 at study start to proactive outreach from the study team in the case of 3 or more days of missing data, versus no outreach for missing data.

Вмешательства

• Поведенческое Focused App Prompt
  Prompts are designed to develop knowledge and self-efficacy in diabetes-related health behaviors (capability). The paired glycemic and behavior data will provide the opportunity to reflect and to plan diet or exercise for the following day (self-reflective motivation).
• Поведенческое No App Prompt
  No app prompts are designed to assess whether health behaviors are affected without being prompted to reflect and change those behaviors related to glycemic control.
• Поведенческое Outreach for Missing Data
  For participants randomized to proactive outreach, after 3 or more days of missing CGM data, the study team will reach out to participants by phone and/or text message to troubleshoot and support participants in re-connecting with CGM and apps. For participants randomized to not receive proactive outreach, participants will be instructed to reach out to the study team at their discretion when help is needed related to CGM or app connection.

Первичные конечные точки

• Glucose time above 180mg/dL [Срок оценки: daily during micro randomized trial, 90 days]
• Mean daily glucose [Срок оценки: daily during micro randomized trial, 90 days]
• Maximum daily glucose [Срок оценки: daily during micro randomized trial, 90 days]
• Minimum daily glucose [Срок оценки: daily during micro randomized trial, 90 days]
• Glucose coefficient of variability [Срок оценки: daily during micro randomized trial, 90 days]
• Mean amplitude of glycemic excursions [Срок оценки: daily during micro randomized trial, 90 days]
• Hemoglobin A1c [Срок оценки: through study completion, 6 months average]
• Fasting glucose [Срок оценки: through study completion, 6 months average]
• Objective physical activity (step count) [Срок оценки: daily during micro randomized trial, 90 days;]
• Objective physical activity (moderate-vigorous physical activity) [Срок оценки: daily during micro randomized trial, 90 days;]

Вторичные конечные точки (2)

• Body Mass Index (BMI) [Срок оценки: through study completion, 6 months average]
• Diabetes distress [Срок оценки: through study completion; 6 months average]

Критерии участия

Критерии включения

• type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
• HbA1c ≥7.0%, stable medication use
• HbA1c 6.0-6.9% without short-acting insulin, any other stable diabetes medication use
• English-speaking (app in English)

Критерии исключения

• Current pregnancy
• Hydroxyurea use (CGM sensor inaccuracies)
• Cognitive impairment or severe psychiatric condition that could interfere with participation in behavioral intervention for diabetes self-management
• Current or previously diagnosed eating disorder

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Children's Hospital of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06375460 · STUDY24020141 · 1R01DK137803-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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