Type II DiabetesNCT01591525
Diabetes Mellitus Community Based Screening in Minority Populations
An observational study of Type II Diabetes and Diabetes Mellitus, run by Ethnicity and Disease Community Empowerment Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes, Diabetes Mellitus
- What is being tested?
- Education on risk factors for Type II Diabetes, Education on Type II Diabetes and Education on regular visits to a Primary Care Provider
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents in Boston Public Housing
Who may be able to join
- Adults 18 and older
Who cannot join
- Type I Diabetes.
- Women who are currently pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lower Mills
Dorchester, Massachusetts, 02124
Kelly Lamb, MA, 617-947-9095
James Morgan, MD
About this study
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.
- Conditions
- Type II Diabetes, Diabetes Mellitus
- Being tested
- Education on risk factors for Type II Diabetes, Education on Type II Diabetes, Education on regular visits to a Primary Care Provider
- Keywords
- Type II Diabetes, Minorities, Diabetes Mellitus, Community based screening
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on risk factors for Type II DiabetesBehavioural
Also called educational intervention
one-on-one education provided by a nurse practitioner or physician
Education on Type II DiabetesBehavioural
Also called educational intervention
one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician.
Education on regular visits to a Primary Care ProviderBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Uncontrolled Diabetic | Individuals who were previously diagnosed with Type II Diabetes, but have a HgA1C greater than 7.0% Receives: Behavioral: Education on risk factors for Type II Diabetes; Behavioral: Education on Type II Diabetes; Behavioral: Education on regular visits to a Primary Care Provider | |
| Newly diagnosed Type II Diabetic | Individuals who have never been diagnosed with Type II Diabetes, but have an HgA1c greater than 7.0% Receives: Behavioral: Education on risk factors for Type II Diabetes; Behavioral: Education on Type II Diabetes; Behavioral: Education on regular visits to a Primary Care Provider | |
| Newly diagnosised pre-diabetics | Individuals who have never been diagnosed with Type II Diabetes, but have a HgA1C of 6.0%-6.9% Receives: Behavioral: Education on risk factors for Type II Diabetes; Behavioral: Education on Type II Diabetes; Behavioral: Education on regular visits to a Primary Care Provider | |
| Controlled | Diabetic or non-diabetic individuals with RPCG of less than 130 mg/dl. Receives: Behavioral: Education on risk factors for Type II Diabetes; Behavioral: Education on regular visits to a Primary Care Provider |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethnicity and Disease Community Empowerment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Steward Carney Hospital, Boston Public Housing Authority
- Responsible party
- Sponsor
- Investigators
- Kelly Lamb, MA, Study director, Ethnicity and Diseasse Community Empowerment CenterJean Bonnet, MD, Principal investigator, Ethnicity and Disease Community Empowerment CenterJames Morgan, MD, Principal investigator, Steward Carney Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591525
- Sponsor's protocol ID
- EADCEC-001
- Status last verified
- May 2012
- First submitted
- 2 May 2012
- Last updated
- 4 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Mellitus Community Based Screening in Minority Populations
- ClinicalTrials.gov ID
- NCT01591525
- Acronym / sponsor ID
- EADCEC-001
- Conditions
- Type II Diabetes, Diabetes Mellitus
- Keywords
- Type II Diabetes, Minorities, Diabetes Mellitus, Community based screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ethnicity and Disease Community Empowerment CenterUniversity, hospital or other
- Collaborators
- Steward Carney Hospital, Boston Public Housing Authority
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 4 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Uncontrolled Diabetic | – | Behavioral: Education on risk factors for Type II Diabetes, Behavioral: Education on Type II Diabetes, Behavioral: Education on regular visits to a Primary Care ProviderIndividuals who were previously diagnosed with Type II Diabetes, but have a HgA1C greater than 7.0% |
| Newly diagnosed Type II Diabetic | – | Behavioral: Education on risk factors for Type II Diabetes, Behavioral: Education on Type II Diabetes, Behavioral: Education on regular visits to a Primary Care ProviderIndividuals who have never been diagnosed with Type II Diabetes, but have an HgA1c greater than 7.0% |
| Newly diagnosised pre-diabetics | – | Behavioral: Education on risk factors for Type II Diabetes, Behavioral: Education on Type II Diabetes, Behavioral: Education on regular visits to a Primary Care ProviderIndividuals who have never been diagnosed with Type II Diabetes, but have a HgA1C of 6.0%-6.9% |
| Controlled | – | Behavioral: Education on risk factors for Type II Diabetes, Behavioral: Education on regular visits to a Primary Care ProviderDiabetic or non-diabetic individuals with RPCG of less than 130 mg/dl. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents in Boston Public Housing
Key inclusion criteria (1 listed)
- Adults 18 and older
Key exclusion criteria (2 listed)
- Type I Diabetes.
- Women who are currently pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on risk factors for Type II DiabetesAlso: educational interventionone-on-one education provided by a nurse practitioner or physician | Behavioural | Controlled, Newly diagnosed Type II Diabetic, Newly diagnosised pre-diabetics, Uncontrolled Diabetic |
| Education on Type II DiabetesAlso: educational interventionone-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician. | Behavioural | Newly diagnosed Type II Diabetic, Newly diagnosised pre-diabetics, Uncontrolled Diabetic |
| Education on regular visits to a Primary Care ProviderAlso: educational interventionone-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. | Behavioural | Controlled, Newly diagnosed Type II Diabetic, Newly diagnosised pre-diabetics, Uncontrolled Diabetic |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Lamb, MA study director
Ethnicity and Diseasse Community Empowerment Center
Jean Bonnet, MD principal investigator
Ethnicity and Disease Community Empowerment Center
James Morgan, MD principal investigator
Steward Carney Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Diabetes and Diabetes Mellitus, run by Ethnicity and Disease Community Empowerment Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Lamb, MA (617-947-9095, lambkellyann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2012.