Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management

Официальное название

Empowering Adults With Diabetes: Achieving Self-management Success Through Data-Driven Behavior Change, Pilot Randomized Control Trial

Обзор

Day-to-day self-management by adults with type 2 diabetes, including glucose monitoring, taking medications, and healthy habits, is essential to avoid diabetes complications, yet, despite the rapidly expanding availability of wearable glucose and activity monitors, successful self-management remains challenging for many. This research aims to develop and test an approach to help adults use their personal diabetes information from wearable devices to achieve and sustain health diabetes self-management, which will reduce diabetes complications, and improve health and quality of life for people with type 2 diabetes.

Подробное описание

MPowerHub trial protocol feasibility will be assessed by randomizing 80 adults with type 2 diabetes and glycemic levels above clinical goals to MPowerHub (MPowerHub platform + continuous glucose monitoring \& activity monitoring), continuous glucose monitor alone, or activity monitor alone for four months. Mixed quantitative and qualitative assessments will examine recruitment, engagement, and retention metrics and feedback. Finally, changes in self-management behaviors (measured using semi-structured interview) and clinic glycemic levels (obtained from participants' electronic health record or finger-stick by study research staff) from pre- to post-monitoring will be compared between arms.

Вмешательства

• Устройство MPowerHub
  The MPowerHub app allows participants to visualize combined trends from a continuous glucose monitor (CGM) and activity monitor as well as daily self-reports in a display that the participant can customize to overlay the behavioral data they would like to compare to intraday and daily glucose data. Summary data will be displayed over time to allow users to identify potential associations between activity, sleep, stress, diet, and medication adherence and time-in-range and blood glucose variabili
• Устройство Continuous Glucose Monitor (CGM)
  A CGM is a wearable device that collects frequent data on glucose levels. It includes an integrated sensor that is inserted under the skin and is connected to a small transmitter that automatically sends information to a smart device, allowing the user to track changes in glucose levels.
• Устройство Activity Monitor
  A wearable activity monitor will be used to track activity (e.g., steps) and sleep levels. Data can be viewed on the activity monitor or a smart device.

Первичные конечные точки

• Percent of eligible individuals who enroll in the study [Срок оценки: Pre-baseline]
• Percent of days wearable device data is collected [Срок оценки: From 0 to 4 months]
• Percent participants retained in study to the 4-month outcome assessment [Срок оценки: From 0 to 4 months]

Вторичные конечные точки (12)

• Percent of individuals contacted who enroll in the study [Срок оценки: Pre-baseline]
• Percent of days self-report data is collected [Срок оценки: From 0 to 4 months]
• Percent of weeks participant responds to goal-setting prompts [Срок оценки: From 0 to 4 months]
• Participant satisfaction with intervention [Срок оценки: 4 months]
• Change in hemoglobin A1c [Срок оценки: Baseline vs 4-6 Months]
• Change in diabetes medication regimen [Срок оценки: From baseline to 4-6 months]
• Started on insulin [Срок оценки: From baseline to 4-6 months]
• Change in medication adherence [Срок оценки: Baseline vs. 4 Months]
• Change in healthy eating [Срок оценки: Baseline vs 4 Months]
• Change in fruit and vegetable intake per day [Срок оценки: Baseline vs 4 months]
• Change in physical activity [Срок оценки: Baseline vs 4 Months]
• Change in goal setting [Срок оценки: Baseline vs 4 months]

Критерии участия

Критерии включения

• Received outpatient care in the participating health system in the last 12 months
• Has a diagnosis of type 2 diabetes mellitus (ICD10 codes E08.xx, E09.xx, E11.xx, E13.xx,O24.1x , O24.3x, O24.8x, O24.9x)
• Last Hemoglobin A1c (HbA1c) value obtained in the last 6 months was ≥7.5%
• Currently prescribed at least one non-insulin diabetes medication
• Able to provide informed consent
• Able to interact with a simple smartphone application
• Owns or has access to a smartphone that is able to access an internet website
• Did not participate a prior study related to this protocol

Критерии исключения

• Originally was diagnosed with type 2 diabetes before the age of 21 years
• Has a diagnosis of type 1 diabetes mellitus
• Has a diagnosis of gestational diabetes without any other diabetes diagnoses
• Is currently prescribed insulin
• Currently is using a CGM device
• Has a diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder
• Has a life-limiting severe illness (e.g., chronic obstructive pulmonary disease requiring oxygen)
• Is pregnant or planning to become pregnant within the next 6 months
• Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)
• Currently is enrolled in another diabetes management intervention 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

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06848361 · STUDY23080053 · 1R01DK136788-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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