Diabetes MellitusNCT01117831
An Analysis of Diabetes Control in Puerto Rico
An observational study of Diabetes Mellitus and Arterial Hypertension, run by Center for Diabetes Control, Inc..
Trial summary
Project: An analysis of Diabetes Control in Puerto Rico Hypothesis: This project seeks to determine the causes for: i) poor adherence to prescribed treatment by patients, ii) low compliance by providers with national guidelines iii) barriers impose by health insurance in control of diabetes mellitus iv) effectiveness… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Arterial Hypertension, Hypercholesterolemia
- What is being tested?
- Epidemiological intervention
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Feb 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This epidemiologic study will analyzed a 600 type 1 and 2 Diabetic patients under medication. The populations to be analyzed is composed of female and male subjects under therapy with anti diabetic medication. The population will be selected from four high density cities in the Island of Puerto Rico. Puerto Ricans are considered as hispanic populations with a mix of white hispanic, african people on a basis of indians ancestry. Subjects will be invited to participate in the study.
Who may be able to join
- Type 1 and 2 diabetic patients older tha 18 years old
Who cannot join
- 1. Hemophilia.
- 2. Persons younger than 18.
- 3. Persons in research studies of some drug.
- 4. Persons using steroids.
- 5. Patients with acute infections.
- 6. Pregnant diabetic patients.
About this study
Official title: An Analysis of Variables That Affect Quality of Diabetes Control in Puerto Rico
Project: An analysis of Diabetes Control in Puerto Rico Hypothesis: This project seeks to determine the causes for: i) poor adherence to prescribed treatment by patients, ii) low compliance by providers with national guidelines iii) barriers impose by health insurance in control of diabetes mellitus iv) effectiveness of a disease management program for treatment adherence by patients.
Read the detailed description
Method (s) The study will consist of three phases:
- assessment phase, ii) multimedia health education campaign for patients, providers and local health insurances for adherence improvement iii) reassessment phase.
Target Population:
Phase I: 600 Hispanic, male and female, residents of Puerto Rico with a diagnosis of type 1 and 2 diabetes mellitus older than 18 of age.
Phase II: 600 patients identified in phase I with individualize health education interventions on the importance of adherence to prescribed medical treatment. 2) Spanish speaking population of Puerto Rico, health service providers, and health insurance companies through a multimedia health education campaign.
Phase III: reassessment of the 600 patients of Phase I.
Data Collection Tools:
- Demographic information will be obtained by an interview questionnaire. Patients will be assigned a control number automatically by the data system. ii) Laboratory blood samples for A1C, lipids (total cholesterol, triglycerides and HDL cholesterol), and serum creatinine. iii) A comprehensive educational adherence program with different media strategies such as: radio spots, newspaper articles, public service announcements, telemedicine services.
Data Analysis: Data will be analyzed using SPSS for Windows.
- Being tested
- Epidemiological intervention
- Keywords
- Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiological interventionOther
An analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control.
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sugar control
Numbers of Patients with Hg A1C on control (less than 7%). Those with A1c greater than 7% will be considered as not meeting the goal
Measured: 2 years
Blood pressure control
Blood Pressure Control: Patients will be considered out of blood pressure control if they have a systolic blood pressure greater than 130 mm Hg or a diastolic blood pressure greater than 80 mg Hg
Measured: 2 years
Lipids goal achievement
The following lipids results will be considered out of goal for this population: LDL cholesterol greater than 100 mg/dL, HDL cholestero lower than 40 mg/dL in male and lower than 50 mg/dL in women, and serum triglycerides greater than 150 mg/dL
Measured: 2 years
Secondary outcomes (1)
Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus
Type of therapies used by these populations and their relationship with out of goals outcome.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Diabetes Control, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novo Nordisk A/S, Eli Lilly and Company
- Responsible party
- Principal investigator, Efrain Rodriguez-Vigil, MD, Center for Diabetes Control, Inc.
- Investigators
- Efrain Rodriguez-Vigil, MD, Principal investigator, Center for Diabetes Control, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117831
- Sponsor's protocol ID
- CD0108
- Status last verified
- Jul 2017
- First submitted
- 4 May 2010
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: National Journal, Physician meeting, Press release
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Variables That Affect Quality of Diabetes Control in Puerto Rico
- ClinicalTrials.gov ID
- NCT01117831
- Acronym / sponsor ID
- CD0108
- Keywords
- Diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Center for Diabetes Control, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novo Nordisk A/S, Eli Lilly and Company
- Study start
- Mar 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 May 2010 (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.
Project: An analysis of Diabetes Control in Puerto Rico Hypothesis: This project seeks to determine the causes for: i) poor adherence to prescribed treatment by patients, ii) low compliance by providers with national guidelines iii) barriers impose by health insurance in control of diabetes mellitus iv) effectiveness of a disease management program for treatment adherence by patients.
Detailed description
Method (s) The study will consist of three phases:
- assessment phase, ii) multimedia health education campaign for patients, providers and local health insurances for adherence improvement iii) reassessment phase.
Target Population:
Phase I: 600 Hispanic, male and female, residents of Puerto Rico with a diagnosis of type 1 and 2 diabetes mellitus older than 18 of age.
Phase II: 600 patients identified in phase I with individualize health education interventions on the importance of adherence to prescribed medical treatment. 2) Spanish speaking population of Puerto Rico, health service providers, and health insurance companies through a multimedia health education campaign.
Phase III: reassessment of the 600 patients of Phase I.
Data Collection Tools:
- Demographic information will be obtained by an interview questionnaire. Patients will be assigned a control number automatically by the data system. ii) Laboratory blood samples for A1C, lipids (total cholesterol, triglycerides and HDL cholesterol), and serum creatinine. iii) A comprehensive educational adherence program with different media strategies such as: radio spots, newspaper articles, public service announcements, telemedicine services.
Data Analysis: Data will be analyzed using SPSS for Windows.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This epidemiologic study will analyzed a 600 type 1 and 2 Diabetic patients under medication. The populations to be analyzed is composed of female and male subjects under therapy with anti diabetic medication. The population will be selected from four high density cities in the Island of Puerto Rico. Puerto Ricans are considered as hispanic populations with a mix of white hispanic, african people on a basis of indians ancestry. Subjects will be invited to participate in the study.
Key inclusion criteria (1 listed)
- Type 1 and 2 diabetic patients older tha 18 years old
Key exclusion criteria (6 listed)
- 1. Hemophilia.
- 2. Persons younger than 18.
- 3. Persons in research studies of some drug.
- 4. Persons using steroids.
- 5. Patients with acute infections.
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 |
|---|---|---|
| Epidemiological interventionAn analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control. | Other | – |
Primary outcome
Blood sugar control
Time frame: 2 years
Numbers of Patients with Hg A1C on control (less than 7%). Those with A1c greater than 7% will be considered as not meeting the goal
Blood pressure control
Time frame: 2 years
Blood Pressure Control: Patients will be considered out of blood pressure control if they have a systolic blood pressure greater than 130 mm Hg or a diastolic blood pressure greater than 80 mg Hg
Lipids goal achievement
Time frame: 2 years
The following lipids results will be considered out of goal for this population: LDL cholesterol greater than 100 mg/dL, HDL cholestero lower than 40 mg/dL in male and lower than 50 mg/dL in women, and serum triglycerides greater than 150 mg/dL
1 secondary outcome
Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: Yes. National Journal, Physician meeting, Press release
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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.
Efrain Rodriguez-Vigil, MD principal investigator
Center for Diabetes Control, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Arterial Hypertension, run by Center for Diabetes Control, Inc..
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 6 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: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sugar control (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 21 Jul 2017.