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

NCT05440968 | Unknown DMC

• 1 other identifier: CGIS-DM-001-18
• Study Type: interventional
• Target: 902
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Early diagnosis; Point of Care; FINDRISC; Screening; OGTT

Outcome Measures

Primary Outcomes (1)

• 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

  up to 90 days

Secondary Outcomes (3)

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

  30 to 90 days

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

  30 and 90 days

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

  up to 90 days

Study Arms (2)

A - Intervention

OTHER

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); Other: Oral Glucose Tolerance Test

B - Control

OTHER

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

Interventions

Point of Care - Glycated Hemoglobin (A1c) OTHER

Test for diagnosis of Diabetes through a Point of care device

A - Intervention

Oral Glucose Tolerance Test OTHER

Routinary diagnosis diabetes test by venous blood sample

A - Intervention; B - Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous diagnosis of type 1 or type 2 diabetes mellitus.
• 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

Sponsors & Collaborators

• Humberto Reynales MD MSc PhD: lead

Study Sites (1)

Maria Granados

Bogotá, 111631, Colombia

Location

Related Publications (9)

• Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.

  PMID: 32175717 BACKGROUND

• Khunti K, Gavin JR 3rd, Boulton AJM, Blickstead R, McGill M, Ceriello A, Raz I, Sadikot S, Wood DA, Cos X, Kalra S, Das AK, Espinosa Lopez C; Berlin Declaration Steering Group. The Berlin Declaration: A call to improve early actions related to type 2 diabetes. Why is primary care important? Prim Care Diabetes. 2018 Oct;12(5):383-392. doi: 10.1016/j.pcd.2018.04.003. Epub 2018 May 8.

  PMID: 29752222 BACKGROUND

• American Diabetes Association. Standards of Medical Care in Diabetes-2022 Abridged for Primary Care Providers. Clin Diabetes. 2022 Jan;40(1):10-38. doi: 10.2337/cd22-as01. No abstract available.

  PMID: 35221470 BACKGROUND

• Vandersmissen GJ, Godderis L. Evaluation of the Finnish Diabetes Risk Score (FINDRISC) for diabetes screening in occupational health care. Int J Occup Med Environ Health. 2015;28(3):587-91. doi: 10.13075/ijomeh.1896.00407.

  PMID: 26190733 BACKGROUND

• Barry E, Roberts S, Oke J, Vijayaraghavan S, Normansell R, Greenhalgh T. Efficacy and effectiveness of screen and treat policies in prevention of type 2 diabetes: systematic review and meta-analysis of screening tests and interventions. BMJ. 2017 Jan 4;356:i6538. doi: 10.1136/bmj.i6538.

  PMID: 28052845 BACKGROUND

• Barengo NC, Tuomilehto JO. How can we identify candidates at highest risk--to screen or not to screen? Herz. 2016 May;41(3):175-83. doi: 10.1007/s00059-016-4417-5.

  PMID: 27052353 BACKGROUND

• Jani IV, Peter TF. How point-of-care testing could drive innovation in global health. N Engl J Med. 2013 Jun 13;368(24):2319-24. doi: 10.1056/NEJMsb1214197. No abstract available.

  PMID: 23758238 BACKGROUND

• 8. Mariano Cantillo HJ, Ocampo DF, Cuello Santana KL. Uso del instrumento FINDRISK para identificar el riesgo de prediabetes y diabetes mellitus tipo 2. Revista Repertorio de Medicina y Cirugía. 2019 Oct 25;28(3):157-63.

  BACKGROUND

• Barengo NC, Tamayo DC, Tono T, Tuomilehto J. A Colombian diabetes risk score for detecting undiagnosed diabetes and impaired glucose regulation. Prim Care Diabetes. 2017 Feb;11(1):86-93. doi: 10.1016/j.pcd.2016.09.004. Epub 2016 Oct 7.

  PMID: 27727004 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Disease

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Humberto Reynales, MD MSc PhD

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator - MD MSc PhD

Study Record Dates

• First Submitted: June 25, 2022
• First Posted: July 1, 2022
• Study Start: June 30, 2022
• Primary Completion: November 2, 2022
• Study Completion: September 20, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)