Dynamically Tailored Behavioral Interventions in Diabetes

Conditions

• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• T2.coach — BEHAVIORAL
  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.

Study Details

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.

Key Dates

First listed

Jan 13, 2020

Start date

Jan 17, 2020

Status verified

Apr 2026

Primary completion

Mar 30, 2025

Completion

Mar 30, 2025

Study Design

Enrollment

300 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: T2.coach
  Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and are asked to use T2.coach for 6 months.
• No Intervention: Control
  Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center).

Primary Outcome Measure

Mean HbA1c Value [ Time Frame: Baseline, 6 months, 12 months ]

Locations (2)

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