Diabetes Mellitus, Type 2EDDIT-1NCT05440968
Comparative Effectiveness of POC-A1c vs the Current Standard Based on OGTT for Early Detection DM2 in Colombia
A study testing Point of Care - Glycated Hemoglobin (A1c) and Oral Glucose Tolerance Test in people with Diabetes Mellitus, Type 2, run by Humberto Reynales MD MSc PhD at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Point of Care - Glycated Hemoglobin (A1c) and Oral Glucose Tolerance Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 902 participants
- Where
- 1 siteColombia
- Study dates
- 30 Jun 2022to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Point of Care - Glycated Hemoglobin (A1c), Oral Glucose Tolerance Test
- Keywords
- Early diagnosis, Point of Care, FINDRISC, Screening, OGTT
- Medical subject headings
- Diabetes Mellitus, Type 2, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: Oral Glucose Tolerance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
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
Measured: 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
Measured: 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.
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start30 Jun 2022
- Primary completion2 Nov 2022
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 902 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humberto Reynales MD MSc PhD
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Humberto Reynales MD MSc PhD, Centro de Atencion e Investigacion Medica
- Investigators
- Humberto Reynales, MD MSc PhD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440968
- Sponsor's protocol ID
- CGIS-DM-001-18
- Acronym
- EDDIT-1
- Status last verified
- Aug 2023
- First submitted
- 25 Jun 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no purpose to share participant data with third parties
Publications
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.
PubMed 32175717Khunti 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.
PubMed 29752222American 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.
PubMed 35221470Vandersmissen 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.
PubMed 26190733Barry 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.
PubMed 28052845Barengo 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.
PubMed 27052353Jani 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.
PubMed 237582388. 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.
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.
PubMed 27727004
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05440968
- Acronym / sponsor ID
- EDDIT-1 / CGIS-DM-001-18
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Early diagnosis, Point of Care, FINDRISC, Screening, OGTT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 902 participants (actual)
- Lead sponsor
- Humberto Reynales MD MSc PhDResearch network
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Intervention | Other | Other: Point of Care - Glycated Hemoglobin (A1c), Other: Oral Glucose Tolerance TestA - 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) |
| B - Control | Other | Other: Oral Glucose Tolerance TestB - 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of Care - Glycated Hemoglobin (A1c)Test for diagnosis of Diabetes through a Point of care device | Other | A - Intervention |
| Oral Glucose Tolerance TestRoutinary diagnosis diabetes test by venous blood sample | Other | A - Intervention, B - Control |
Primary outcome
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
3 secondary outcomes
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
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
Describe the causes of non-performance of the confirmatory test throughout a brief questionnaire
Time frame: up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 32175717Khan 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.
- Background: PubMed 29752222Khunti 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.
- Background: PubMed 35221470American 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.
- Background: PubMed 26190733Vandersmissen 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.
- Background: PubMed 28052845Barry 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.
- Background: PubMed 27052353Barengo 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.
- Background: PubMed 23758238Jani 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.
- Background8. 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: PubMed 27727004Barengo 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.
- Individual participant dataSharing planned: No. there is no purpose to share participant data with third parties
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Humberto Reynales, MD MSc PhD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of Care - Glycated Hemoglobin (A1c) and Oral Glucose Tolerance Test in people with Diabetes Mellitus, Type 2, run by Humberto Reynales MD MSc PhD at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05440968, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.