Dynamically Tailored Behavioral Interventions in Diabetes
Completed · Not applicable
Conditions studied: Type 2 Diabetes
In brief
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 facts
- Study ID
- NCT04226027
- Run by
- Columbia University
- People needed
- 300
- Starts
- 2020-01-17
- Expected to finish
- 2025-03-30
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Clinical Directors Network — New York, New York, United States
- Columbia University Irving Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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