Comparative Effectiveness of POC-A1c vs the Current Standard Based on OGTT for Early Detection DM2 in Colombia

Humberto Reynales MD MSc PhD902 enrolled

Overview

Evaluate the impact of conducting a screening questionnaire (FINDRISC) and the implementation of a point-of-care HBA1c test for those with identified risk to suffer Diabetes in ten years, to improve the proportion of patients attending for a confirmatory test ( oral glucose tolerance test ) and evaluate the impact of such a strategy to minimize type 2 diabetes outcomes.

The physician explains the study´s consistency and obtains informed consent. If the patient accepts, the FINDRISC will be checked, the inclusion and exclusion criteria will be verified and the pertinent data from the patient's medical history will be recorded in a computer. Subsequently, subjects will be included in the study and randomized into two groups. In group A (intervention) participants will be offered information on healthy lifestyles according to their score on the FINDRISC questionnaire and subsequently a POC-A1c measurement. Participants in group B (control) will be offered the same information on healthy lifestyles according to their FINDRISC score. Additionally, all randomized participants will be invited to undergo an oral glucose tolerance test in the CAIMED allied laboratory or in the laboratory of their choice or through their health care provider with the necessary preparation recommendations for the performance of the test. For this purpose, they will be given an order that includes the date of the screening, a follow-up number and a window of time in which they should go (i.e., 30 days and with a second attempt - maximum window at 90 days). After 30 days from the application of the screening from the delivery of the order for the OGTT, a call will be made to the randomized subjects to check the result of the OGTT if the test was taken and request its result in case it was taken, if the test was taken, it should refer the same to the center. Otherwise, the causes of loss to follow-up will be inquired not having previously performed the recommended OGTTand a new call will be made at 90 days. In patients who, if they attended the OGTT and obtained a presumptive result of diabetes (defined as an altered oral glucose tolerance test and/or altered POC - A1C test according to American Diabetes Association guidelines), a close call will be made 30 days after the test was performed to confirm whether they initiated control of their disease. For this, it will be indicated to them that they must attend a consultation by general medicine according to what is contemplated by their benefit plan administration entity, social security administrator, giving completion to the follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

902

Conditions

Diabetes Mellitus, Type 2

Interventions

Point of Care - Glycated Hemoglobin (A1c)OTHER

Test for diagnosis of Diabetes through a Point of care device

Oral Glucose Tolerance TestOTHER

Routinary diagnosis diabetes test by venous blood sample

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult, aged greater than or equal to 18 years and less than or equal to 75 years. * Understands, accepts and agrees to sign the informed consent form. * FINDRISC greater than or equal to 12 Exclusion Criteria: Previous diagnosis of type 1 or type 2 diabetes mellitus. * Pregnancy or breastfeeding at the time of inclusion in the study (referred by the subject). * History of cancer in the subject (must be in remission for 5 years). * Known history of familiar hyperlipidemia. * Chronic use of systemic corticosteroids (Defined as: a dose greater than 5 mg of oral prednisolone or its equivalent and/or consumption greater than one month of the same). * Known history of hemophilia or other coagulation disorders. * Known history of stage IV or V chronic kidney disease. * Known history of HIV (on antiretroviral therapy). * History of sickle cell disease * Known history of glucose-6-phosphate dehydrogenase deficiency * Known history of blood transfusion in the last 3 months * Known history of erythropoietin therapy in the last 6 months

Locations (1)

Maria Granados

Bogotá, Colombia

Outcomes

Primary Outcomes

Attendance of patients with knowledge of their risk for diabetes type 2 to a confirmatory test, oral glucose tolerance test

Through follow up calls and report of oral glucose tolerance test, compare the attendance arm who had Point of care of A1C with the one who didn´t

Time frame: up to 90 days

Secondary Outcomes

Number of days that determine the application of POC-A1c compared to the current recommendations from the American Academy of Diabetes (OGTT).

Through follow up calls and report of oral glucose tolerance test, compare the attendance arm who had Point of care of Hb1Ac with the one who didn´t

Time frame: 30 to 90 days

number of patients attending the confirmatory testing as adherence to their primary care physician's recommendations and clinical practice guidelines

Through follow up calls and report of oral glucose tolerance test, in a window stablished by 30 and 90 days. Compare the attendace arm who had Point of care of Hb1Ac with the one who didn´t

Time frame: 30 and 90 days

Describe the causes of non-performance of the confirmatory test throughout a brief questionnaire

Identification of predictors of non-performance or postponement of the diagnostic test within a maximum of 90 days from the initial recommendation.

Time frame: up to 90 days

Data from ClinicalTrials.gov

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