Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01221090 · ClinicalTrials.gov registry record · Phase 4

Diabetes Self-Management Models to Reduce Health Disparities

A Phase 4 study, sponsored by Scott and White Hospital & Clinic.

Completed
Registry status
Phase 4
Development phase
376
Enrollment target

NCT01221090: Completed Phase 4 study, sponsored by Scott and White Hospital & Clinic.

NCT01221090 is a Phase 4 study that has completed, run by Scott and White Hospital & Clinic. The registered enrollment target is 376 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01221090, a Phase 4 study, has completed, sponsored by Scott and White Hospital & Clinic.

COMPLETED
Registry status
Phase 4
Development phase
376 participants
Enrollment target

Study Summary

To evaluate the effectiveness of two different diabetes self-management approaches (Personal Digital Assistant-based intervention \& Chronic Disease Self-Management Program) to reduce health disparities in minority, rural residents, and other underserved populations with type 2 diabetes in Central Texas. We hypothesise that: 1) Racial/ethnic minority patients with T2DM will be found to experience disparities in diabetes self-management treatment protocols and clinical outcomes, which persist even when controlling for age, gender, obesity, and insurance status; 2) Patients with T2DM who reside in more rural areas will be found to experience disparities in diabetes self-management treatment protocols and clinical outcomes as compared to more urban counterparts, controlling for age, gender, race/ethnicity, obesity, and insurance status; 3) The introduction of CSDMP and HIT protocols will improve diabetes-related self management behaviors, reduce HBA1c values, and increase quality of life in persons with T2DM as compared to controls. A combined intervention approach will result in the greatest reductions; 4) Health improvements following the introduction of CDSMP, HIT or CDSMP/HIT protocols in persons with T2DM compared to controls will be more marked in racial/ethnic minority patients and those patients residing in rural areas; 5) The introduction of self-management interventions will be cost-effective in reducing HbA1c values over time, and associated health care utilization including overall reduction in ER and acute care hospital admissions; 6) Although there is little prior research in this area to guide specific hypotheses, we hypothesize that, overall, there will be no significant cost-effective differential in CDSMP as compared to HIT approaches, although the cost-effective ratio may be stronger in particular subpopulations. The combined approach will have higher costs, but is also anticipated to have a higher cost-benefit ratio for minority populations; 7) The

Primary Outcome

Measures of HbA1c were collected from electronic health records dating back six months prior to orientation to the last day of study participation (45 days after the 12-month follow-up period). If a participant did not have any HbA1c value within the electronic health record for any particular follow-up visit, a lab test was scheduled to obtain a measure. Of the HbA1c collected six months prior to orientation, the value measured closest to the orientation date was considered as the baseline HbA1

Interventions

  • BEHAVIORAL PDA
  • BEHAVIORAL CDSMP
  • BEHAVIORAL PDA/CDSMP

Trial Details

FieldValue
Enrollment Target 376 participants
Start Date 2009-01
Est. Completion 2012-05
Phase Phase 4

What the finished NCT01221090 record still lists

NCT01221090 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (27% lower).

The record links to 0 conditions, and to 3 interventions - of which PDA is the first listed.

NCT01221090 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01221090 about?

NCT01221090 is a clinical study titled "Diabetes Self-Management Models to Reduce Health Disparities". To evaluate the effectiveness of two different diabetes self-management approaches (Personal Digital Assistant-based intervention \& Chronic Disease Self-Management Program) to reduce health disparities in minority, rural residents, and other underserved populations with type 2 diabetes in Central T...

What is the current status of trial NCT01221090?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 376 participants. The study started on 2009-01. Estimated completion is 2012-05.

What interventions are being tested in trial NCT01221090?

The interventions under investigation include: PDA (BEHAVIORAL), CDSMP (BEHAVIORAL), PDA/CDSMP (BEHAVIORAL).

Who is sponsoring clinical trial NCT01221090?

This trial is sponsored by Scott and White Hospital & Clinic, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01221090's enrollment target sits among peer trials

376 222nd of 2000 higher than 1,778 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03102125 · 376 participants · Phase 4

    Allograft Dysfunction in Heart Transplant

  • NCT05055297 · 376 participants · NA

    SELUTION4BTK Trial

  • NCT05912647 · 376 participants · NA

    Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes

  • NCT05963971 · 376 participants · NA

    A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01221090, the US trial registry maintained by the National Library of Medicine. NCT01221090 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.