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An Analysis of Diabetes Control in Puerto Rico

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01117831
Enrollment
600
Registered
2010-05-06
Start date
2010-03-31
Completion date
2013-02-28
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension, Diabetes Mellitus, Hypercholesterolemia

Keywords

Diabetes mellitus

Brief 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 of a disease management program for treatment adherence by patients.

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.

Interventions

OTHEREpidemiological intervention

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

Sponsors

Novo Nordisk A/S
CollaboratorINDUSTRY
Eli Lilly and Company
CollaboratorINDUSTRY
Center for Diabetes Control, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lipids goal achievement2 yearsThe 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
Blood sugar control2 yearsNumbers 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 control2 yearsBlood 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

Secondary

MeasureTime frameDescription
Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus2 yearsType of therapies used by these populations and their relationship with out of goals outcome.

Other

MeasureTime frameDescription
Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus1 yearOutcome 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026