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Completed Phase 4 Interventional Accepts healthy volunteers Results available

Diabetes Self-Management Models to Reduce Health Disparities

ClinicalTrials.gov ID: NCT01221090

Public ClinicalTrials.gov record NCT01221090. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 11:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Employing Diabetes Self-Management Models to Reduce Health Disparities in Texas

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 majority of clinicians will be willing to let their patients enroll in the study and will reinforce intervention protocols; and 8) These interventions can be embedded into existing health care structures. At the end of the study, Scott and White will institutionalize cost-effective treatment protocols.

Study identification

NCT ID
NCT01221090
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
376 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2008
Primary completion
Apr 30, 2012
Completion
Apr 30, 2012
Last update posted
Oct 13, 2013

2009 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Scott & White Clinic Temple Texas 76504

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01221090, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 13, 2013 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01221090 live on ClinicalTrials.gov.

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