Dynamically Tailored Behavioral Interventions in Diabetes

NCT04226027 | Completed DMC

• 2 other identifiers: AAAS5528R01DK113189
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Mobile health; Mhealth; T2.coach; Smartphone app

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c value

  Hemoglobin A1c

  Baseline, 6 months, 12 months

Secondary Outcomes (4)

• DPSI Score

  Baseline, 6 months, 12 months

• SCA-I Score

  Baseline, 6 months, 12 months

• DSES Score

  Baseline, 6 months, 12 months

• PAID Score

  Baseline, 6 months, 12 months

Study Arms (2)

T2.coach

EXPERIMENTAL

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.

Behavioral: T2.coach

Control

NO INTERVENTION

Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center).

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.

T2.coach

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient of the health center for ≥ 6 months and a diagnosis of T2DM
• HbA1c ≥ 8.0,
• Aged 18 to 65 years
• Attends diabetes education program at the health center
• Owns a basic mobile phone
• Proficient in either English or Spanish

You may not qualify if:

• Pregnant
• Presence of severe cognitive impairment (recorded in patient chart),
• Existence of other serious illnesses (e.g. cancer diagnosis with active treatment, advanced stage heart failure, dialysis, multiple sclerosis, advanced retinopathy, recorded in patient chart),
• Plans for leaving the FQHC in the next 12 months,
• Participation in the previous trial of diabetes self-management technologies

Sponsors & Collaborators

• Columbia University: lead
• Clinical Directors Network: collaborator
• University of Colorado, Denver: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Clinical Directors Network

New York, New York, 10018, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Olena Mamykina, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the nature of the intervention (smartphone app), masking is not possible.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biomedical Informatics

Model Details: Two-arm RCT with 1:1 randomization at participant level, with stratified randomization to balance by clinical site, sex, and language, evaluate the efficacy of the T2.coach intervention

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: January 17, 2020
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)