We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Analysis of Diabetes Control in Puerto Rico

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01117831
First Posted: May 6, 2010
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Novo Nordisk A/S
Eli Lilly and Company
Information provided by (Responsible Party):
Efrain Rodriguez-Vigil, MD, Center for Diabetes Control, Inc.
  Purpose
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.

Condition Intervention
Diabetes Mellitus Arterial Hypertension Hypercholesterolemia Other: Epidemiological intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Analysis of Variables That Affect Quality of Diabetes Control in Puerto Rico

Further study details as provided by Efrain Rodriguez-Vigil, MD, Center for Diabetes Control, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus [ Time Frame: 2 years ]
    Type of therapies used by these populations and their relationship with out of goals outcome.


Other Outcome Measures:
  • Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus [ Time Frame: 1 year ]

    Outcome measure assessment: Descriptive analysis will be computed to describe the demographic and health services characteristic of the participants.

    Bivariate analysis using contingency tables and the Pearson Chi-square test and independent samples t-tests will be conducted to determine whether or not there were differences between adults with diabetes and A1C levels lower than 7% and those with A1C levels greater than 7% in term of demographics, health services characteristics, health insurance type, type of providers, type of medication (insulin or pills) and comorbidities. For statistical analysis, alpha will be set at p < 0.05.



Enrollment: 600
Study Start Date: March 2010
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Epidemiological intervention
    An analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control.
Detailed Description:

Method (s) The study will consist of three phases:

i) 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:

i) 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Type 1 and 2 diabetic patients older tha 18 years old

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117831


Sponsors and Collaborators
Center for Diabetes Control, Inc.
Novo Nordisk A/S
Eli Lilly and Company
Investigators
Principal Investigator: Efrain Rodriguez-Vigil, MD Center for Diabetes Control, Inc.
  More Information

Responsible Party: Efrain Rodriguez-Vigil, MD, Medical Director, Center for Diabetes Control, Inc.
ClinicalTrials.gov Identifier: NCT01117831     History of Changes
Other Study ID Numbers: CD0108
First Submitted: May 4, 2010
First Posted: May 6, 2010
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: National Journal, Physician meeting, Press release
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 2 years

Keywords provided by Efrain Rodriguez-Vigil, MD, Center for Diabetes Control, Inc.:
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Hypercholesterolemia
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases