Dynamically Tailored Behavioral Interventions in Diabetes

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT04226027
Status
Completed

Conditions

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

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)

FacilityCityStateZIPSite coordinators
Clinical Directors NetworkNew YorkNew York10018-
Columbia University Irving Medical CenterNew YorkNew York10032-

Find similar trials in New York, NY

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Clinical Directors Network· New York, NYColumbia University Irving Medical Center· New York, NY

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