N/A
Completed N=113
Technology-assisted Case Management in Adults With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01373489 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Hemoglobin A1c (HbA1c) at 6 Months Post Randomization — 10.0; 9.0 percentage of glycosylated hemoglobin — p=<0.05
Summary
The purpose of this study is to help low income patients achieve and maintain better self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood pressure monitoring system and nurse case management. Patients must be served at a Federally Qualified Health Center (FQHC) in coastal South Carolina.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c (HbA1c) at 6 Months Post Randomization |
10.0; 9.0 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years and receiving care within the Franklin C. Fetter Family Health Center
- Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
- Subject must be willing to use the FORA 2-in-1 system
- Subject must have a working land-line for the duration of the study in order to be able to upload the readings from the FORA 2-in-1 machine
- Subjects must be able to communicate in English
Exclusion Criteria
- Mental confusion on interview suggesting significant dementia
- Participation in other diabetes clinical trials
- Alcohol or drug abuse/dependency using a screening questionnaire
- Active psychosis or acute mental disorder
- Life expectancy <6 months
- Pregnant and/or lactating females
Data sourced from ClinicalTrials.gov (NCT01373489). 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.