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

Diabetes Mellitus, Type 2 Clinical Trial

— REFLECT2D  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375460
• Other study ID #: STUDY24020141
• Secondary ID: 1R01DK137803-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: June 30, 2029

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: Mary Ellen Vajravelu, MD
• Phone: 412-692-6533
• Email: vajravelume[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2029
• Est. primary completion date: June 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

Inclusion Criteria:

• type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes

• HbA1c =7.0%, stable medication use (=3 months)

• HbA1c 6.0-6.9% without short-acting insulin, any other stable diabetes medication use (=3 months)

• English-speaking (app in English)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Lifestyle
• Physical Inactivity

Intervention

Behavioral:
• 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).
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pittsburgh	Dartmouth College, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), San Diego State University, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose time above 180mg/dL	measured using continuous glucose monitor	daily during micro randomized trial, 90 days
Primary	Mean daily glucose	measured using continuous glucose monitor; mg/dL	daily during micro randomized trial, 90 days
Primary	Maximum daily glucose	measured using continuous glucose monitor; mg/dL	daily during micro randomized trial, 90 days
Primary	Minimum daily glucose	measured using continuous glucose monitor; mg/dL	daily during micro randomized trial, 90 days
Primary	Glucose coefficient of variability	measured using continuous glucose monitor	daily during micro randomized trial, 90 days
Primary	Mean amplitude of glycemic excursions	measured using continuous glucose monitor	daily during micro randomized trial, 90 days
Primary	Hemoglobin A1c	lab-based measure to assess longer-term glycemic control, collected at study visit	through study completion, 6 months average
Primary	Fasting glucose	lab-based measure to assess glycemic control, collected at study visit	through study completion, 6 months average
Primary	Objective physical activity (step count)	step count measured using the Fitbit physical activity tracker	daily during micro randomized trial, 90 days;
Primary	Objective physical activity (moderate-vigorous physical activity)	moderate-vigorous physical activity (>100 steps per minute) will be measured using Fitbit activity tracker	daily during micro randomized trial, 90 days;
Primary	Self-reported physical activity	assessed using PACE+ Adolescent Physical Activity Measure (PACE+) questionnaire to determine days with at least 60 minutes of moderate-vigorous physical activity per week. score ranges from 0-14; lower scores indicate less achievement of physical activity guidelines	through study completion, 6 months average
Primary	Diet quality	24-hour dietary recall will be collected by study staff, who will use the Automated Self Administered 24 Hour Dietary Recall Assessment Tool (ASA24) to record data for diet quality assessment	through study completion, 6 months average
Primary	Capability	Assessed via the Diabetes Empowerment Scale (DES), a measure of self-efficacy. Average score ranges from 28-140; higher scores indicate greater diabetes empowerment	through study completion, 6 months average
Primary	Healthmine app use	Percent of days with app use, per study period will be determined.	during microrandomized trial, observational period
Primary	Continuous glucose monitor use use	Defined as percent of days with CGM data available, per study period.	during microrandomized trial, observational period
Primary	Motivation to engage in diabetes self-management	Measured via Treatment Self-Regulation Questionnaire (TSRQ). score ranges from 15-105; scoring is based on and average between subscales of intrinsic vs. extrinsic motivation.	through study completion, 6 months average
Secondary	Body Mass Index (BMI)	weight and height will be combined to report BMI in kg/m^2	through study completion, 6 months average
Secondary	Diabetes distress	Measured via Problem Areas in Diabetes Scale (PAID-5). Score ranges from 0-20; a total score of 8 or more indicates possible diabetes related emotional distress.	through study completion; 6 months average
Secondary	Diabetes family support and conflict	Measured via Diabetes Family Support and Conflict Scale. Score ranges from 19-57; higher scores indicates a greater conflict.	through study completion; 6 months average