NCT04226027Completed
Dynamically Tailored Behavioral Interventions in Diabetes
Dynamically Tailoring Interventions for Problem-Solving in Diabetes Self-Management Using Self-Monitoring Data - a Randomized Controlled Trial (RCT)
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 9 Jan 2020
- Start date
- 17 Jan 2020
- Primary completion date
- 30 Mar 2025
- Lead sponsor
- Columbia University
- Diseases
- Type 2 diabetes
- NCT number
- NCT04226027
What you commit to
- Study type: Interventional
- Participants enrolled: 300
- From 17 Jan 2020 to the primary completion date, 30 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in the previous trial of diabetes self-management technologies
Other illness
- 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),
Other
- Pregnant
- Plans for leaving the FQHC in the next 12 months,
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Clinical Directors Network Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.