Diabetes Mellitus Community Based Screening in Minority Populations

The purpose of the type II diabetes (T2D) screening study is to improve diabetes care in minority communities by identifying undiagnosed and uncontrolled T2D patients, as well as help patients without a regular primary care physician (PCP) find one within their community. These goals will be achieved first through a glucose measurement. Individuals with a high glucose measurement will be confirmed with a rapid hemoglobin A1c (HgA1c) test. The HgA1c test will tell us about the patients average blood sugar over the past 3 months, which will allow us to immediately diagnose new and uncontrolled type II diabetics. All participants will fill out a survey on healthcare seeking behaviors before glucose testing. All patients who enter the study will receive education on T2D and the value of regularly visiting their PCP, and will be provided a list of PCP currently accepting new patients within a 3 mile radius. Follow-up visits at 4 and 8 months will help us determine the success this community based screening.

The investigators hypothesis is that community based screening designed with adequate education and follow-up, and performed by qualified medical professionals will improve diabetes care in minority communities as assessed through hemoglobin A1c levels over 8 months, and in the change in the number patients who visit/obtain their PCP within the study period.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Massachusetts
      • Dorchester, Massachusetts, United States, 02124
        • Lower Mills
        • Contact:
          • Kelly Lamb, MA
          • Phone Number: 617-947-9095
        • Principal Investigator:
          • James Morgan, MD
        • Sub-Investigator:
          • Jean Bonnet, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents in Boston Public Housing

Description

Inclusion Criteria:

  • Adults 18 and older

Exclusion Criteria:

  • Type I Diabetes.
  • Women who are currently pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Uncontrolled Diabetic
Individuals who were previously diagnosed with Type II Diabetes, but have a HgA1C greater than 7.0%
one-on-one education provided by a nurse practitioner or physician
Other Names:
  • educational intervention
one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician.
Other Names:
  • educational intervention
one-on-one education about the importance of visiting a primary care provider (PCP) on a regular basis. Patients are also provided a list of PCP's accepting new patients within a 3 mile radius.
Other Names:
  • educational intervention
Newly diagnosed Type II Diabetic
Individuals who have never been diagnosed with Type II Diabetes, but have an HgA1c greater than 7.0%
one-on-one education provided by a nurse practitioner or physician
Other Names:
  • educational intervention
one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician.
Other Names:
  • educational intervention
one-on-one education about the importance of visiting a primary care provider (PCP) on a regular basis. Patients are also provided a list of PCP's accepting new patients within a 3 mile radius.
Other Names:
  • educational intervention
Newly diagnosised pre-diabetics
Individuals who have never been diagnosed with Type II Diabetes, but have a HgA1C of 6.0%-6.9%
one-on-one education provided by a nurse practitioner or physician
Other Names:
  • educational intervention
one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician.
Other Names:
  • educational intervention
one-on-one education about the importance of visiting a primary care provider (PCP) on a regular basis. Patients are also provided a list of PCP's accepting new patients within a 3 mile radius.
Other Names:
  • educational intervention
Controlled
Diabetic or non-diabetic individuals with RPCG of less than 130 mg/dl.
one-on-one education provided by a nurse practitioner or physician
Other Names:
  • educational intervention
one-on-one education about the importance of visiting a primary care provider (PCP) on a regular basis. Patients are also provided a list of PCP's accepting new patients within a 3 mile radius.
Other Names:
  • educational intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Kelly Lamb, MA, Ethnicity and Diseasse Community Empowerment Center
  • Principal Investigator: Jean Bonnet, MD, Ethnicity and Disease Community Empowerment Center
  • Principal Investigator: James Morgan, MD, Steward Carney Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 3, 2012

First Posted (Estimate)

May 4, 2012

Study Record Updates

Last Update Posted (Estimate)

May 4, 2012

Last Update Submitted That Met QC Criteria

May 3, 2012

Last Verified

May 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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