- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01591525
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
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Kelly Lamb, MA
- Phone Number: 617-947-9095
- Email: lambkellyann@gmail.com
Study Contact Backup
- Name: Jean Bonnet, MD
- Phone Number: 6175198176
- Email: jean.bonnet.md@gmail.com
Study Locations
-
-
Massachusetts
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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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults 18 and older
Exclusion Criteria:
- Type I Diabetes.
- Women who are currently pregnant.
Study Plan
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:
one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician.
Other Names:
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:
|
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:
one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician.
Other Names:
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:
|
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:
one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician.
Other Names:
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:
|
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:
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:
|
Collaborators and Investigators
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
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EADCEC-001
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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