N/A
Completed N=300
Dynamically Tailored Behavioral Interventions in Diabetes
Type 2 Diabetes
Source: ClinicalTrials.gov NCT04226027 ↗
Enrolled (actual)
300
Serious AEs
2.7%
Results posted
May 2026
Primary outcomePrimary: Mean HbA1c Value — 9.84; 10.17; 8.91; 9.23 % of hemoglobin bound to glucose — p=0.0085
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean HbA1c Value |
9.84; 10.17; 8.91; 9.23; 8.72; 9.32 | 0.0085 sig |
| SECONDARY SCA-I Score |
65.54; 68.86; 73.89; 74.75; 73.81; 74.16 | 0.83 |
| SECONDARY DSES Score |
5.73; 5.91; 5.98; 6.14; 6.27; 6.05 | 0.18 |
| SECONDARY PAID Score |
29.62; 31.16; 26.24; 23.81; 26.43; 25.2 | 0.68 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04226027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.