Skip to main content
OpenTrials
Completed

NCT Number: NCT01117831

An Analysis 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Arterial Hypertension Cardiovascular Diseases Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epidemiological intervention

Other

An analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control.

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Center for Diabetes Control, Inc.

Industry

Collaborators

  • Eli Lilly and Company
  • Novo Nordisk A/S

Registry information

Official study title

An Analysis of Variables That Affect Quality of Diabetes Control in Puerto Rico

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
May 6, 2010
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.