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COMPLETED
NCT04226027
NA

Dynamically Tailored Behavioral Interventions in Diabetes

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

In this project, the investigators will evaluate the efficacy of a novel approach to personalizing behavioral interventions for self-management of type 2 diabetes (T2DM) to individuals' behavioral and glycemic profiles discovered using computational learning and self-monitoring data. This study is a two-arm randomized controlled trial with n=280 participants recruited from the participating Federally Qualified Health Centers (FQHCs). The participants will be randomly assigned to the intervention group and the usual care (control) group with 1-1 allocation ratio. Half of the participants (n=140) will be randomly assigned to a usual care (control) group. Both groups will receive standard diabetes education at their respective FQHC site. In addition, the experimental group will receive instructions to use T2.coach for a minimum of 6 months.

Official title: Dynamically Tailoring Interventions for Problem-Solving in Diabetes Self-Management Using Self-Monitoring Data - a Randomized Controlled Trial (RCT)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2020-01-17

Completion Date

2025-03-30

Last Updated

2026-05-13

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

T2.coach

T2.coach is a smartphone app for low-burden capture of diet and blood glucose (BG) levels and for reviewing past records, integrated with FitBit for captured of physical activity and sleep. All captured data are sent to the computational inference engine that uses machine learning methods and expert system to formulate personalized behavioral goals. Examples of behavioral goals include the following: "For high carbohydrate breakfasts, reduce your carbs to be about 1 carb choice. Examples of 1 carb choice are 1 slice of whole wheat toast, 1 cup of oatmeal, or 1 apple." The T2.coach chatbot companion uses text messages to help individuals set goals that are consistent with evidence based guidelines for diabetes self-management, inferences on data captured with T2.coach, and their own preferences, as well as send individuals goal reminders and prompts for reflection on goal achievement.

Locations (2)

Clinical Directors Network

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States