Comparative Effectiveness of POC-A1c vs the Current Standard Based on OGTT for Early Detection DM2 in Colombia (EDDIT-1)

August 29, 2023 updated by: Humberto Reynales MD MSc PhD

Comparative Effectiveness of Point-of-care Glycosylated Hemoglobin Measurement (POC-A1c) vs the Current Standard Based on Oral Glucose Tolerance Test for Early Detection of Type 2 Diabetes Mellitus (DM2) in Colombia

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

902

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogotá, Colombia, 111631
        • Maria Granados

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A - Intervention
A - After randomization, participants will be offered information on healthy lifestyles according to their score on the FINDRISC questionnaire and subsequently a POC-A1c measurement + a confirmatory test order (Oral Glucose Tolerance Test)
Other: Point of Care - Glycated Hemoglobin (A1c)
Test for diagnosis of Diabetes through a Point of care device
Other: Oral Glucose Tolerance Test
Routinary diagnosis diabetes test by venous blood sample
Other: B - Control
B - After randomization, will be offered the same information on healthy lifestyles according to their FINDRISC score, and will receive an order to an Oral Glucose Tolerance Test.
Other: Oral Glucose Tolerance Test
Routinary diagnosis diabetes test by venous blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance of patients with knowledge of their risk for diabetes type 2 to a confirmatory test, oral glucose tolerance test
Time Frame: up to 90 days
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
up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients attending the confirmatory testing as adherence to their primary care physician's recommendations and clinical practice guidelines
Time Frame: 30 and 90 days
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
30 and 90 days
Describe the causes of non-performance of the confirmatory test throughout a brief questionnaire
Time Frame: up to 90 days
Identification of predictors of non-performance or postponement of the diagnostic test within a maximum of 90 days from the initial recommendation.
up to 90 days
Number of days that determine the application of POC-A1c compared to the current recommendations from the American Academy of Diabetes (OGTT).
Time Frame: 30 to 90 days
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
30 to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humberto Reynales MD MSc PhD

Investigators

  • Principal Investigator: Humberto Reynales, MD MSc PhD, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Actual)

November 2, 2022

Study Completion (Estimated)

September 20, 2023

Study Registration Dates

First Submitted

June 25, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGIS-DM-001-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

there is no purpose to share participant data with third parties

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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