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
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: Humberto Reynales MD MSc PhD

Page 1 of 21 
EDDIT-1 STUDY 
 
 
Comparative effectiveness of point-of-care glycosylated 
hemoglobin measurement (POC-A1c), vs. the current 
standard based on oral glucose tolerance test, for the early 
detection of Type 2 Diabetes Mellitus (T2DM) in Colombia.  
EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
 
 Overview  Page 
 
 
 
 Study name 
    Comparative 
effectiveness 
of 
point-of-care 
glycosylated hemoglobin measurement (POC-A1c), vs. 
the current standard based on oral glucose tolerance test, for 
the early detection of Diabetes Mellitus type 2 
(DM2)  in Colombia.  EDDIT-1 STUDY 
 Protocol Identification   Number 
CGIS-DM-001-18 
Date 
 February 2022 
Authors 
- 
Humberto Reynales, Caimed 
- 
Ramon Abel Castaño, Caimed 
- 
Maria Angelica Granados, Caimed 
- 
Andrea Arjona, Caimed 
- 
Patrizia Trasmondi, Caimed 
- 
Rossmary Gonzalez, Caimed 
- 
Sebastian Cardona, Caimed 
Name and address of Founder Organization 
Sanofi 
Address: Tranv.  23 # 97-73 Floor 8 Supervisor: Centro de 
Atención e Investigación Médica CAIMED S.A.S 
Address: 
Calle 
24 
N°3-02 
este 
Chía, 
Cundinamarca. 
Persons 
authorized 
to 
sign
 
the protocol and its amendments 
- 
Humberto Reynales, Caimed 
Participating clinical laboratories 
VITA - Professionals  Center  , second floor 
Carrera 4ª Este # 24 65, Chia, Cundinamarca, Colombia 

Page 2 of 21 
EDDIT-1 STUDY 
 
 
Comparative effectiveness of point-of-care glycosylated 
hemoglobin measurement (POC-A1c), vs. the current 
standard based on oral glucose tolerance test, for the early 
detection of Type 2 Diabetes Mellitus (T2DM) in Colombia.  
EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
 
Table of Contents 
Overview  Page  ............................................................................................................................................................ 1 
Table of Contents ......................................................................................................................................................... 2 
List of tables ............................................................................................................................................................... 4 
List of figures .............................................................................................................................................................. 4 
List of abbreviations ..................................................................................................................................................... 4 
Protocol Synopsis  ....................................................................................................................................................... 5 
Title .......................................................................................................................................................................... 7 
Theoretical framework .................................................................................................................................................. 7 
Background for  Protocol ............................................................................................................................................... 8 
Description of the products used ..................................................................................................................................... 8 
Purpose and justification............................................................................................................................................... 8 
Primary objectives ........................................................................................................................................................ 10 
Secondary objectives  .............................................................................................................................................. 10 
Study Design  ............................................................................................................................................................. 10 
General Considerations ..........................................................................................................................................10 
Justification of the main elements of Protocol  ................................................................................................................. 10 
Setting primary  outcome  point  .................................................................................................................................... 10 
Choosing comparator  .................................................................................................................................................10 
Design type  ...............................................................................................................................................................10 
Study Procedures  ........................................................................................................................................................11 
Study population  ........................................................................................................................................................11 
Inclusion criteria  ........................................................................................................................................................11 
Exclusion criteria  ......................................................................................................................................................... 11 
Criteria and procedures for the withdrawal or suspension of subjects ........................................................................................ 12 
Type and time  of data collection corresponding to withdrawn subjects ............................................................................... 12 
Whether  to   replace subjects  and how .......................................................................................................................... 12 
Follow-up of  withdrawn subjects .................................................................................................................................. 12  
Criteria for   study discontinuation  ................................................................................................................................ 12 
Interventions  ........................................................................................................................................................ 12 

Page 3 of 21 
EDDIT-1 STUDY 
 
 
Comparative effectiveness of point-of-care glycosylated 
hemoglobin measurement (POC-A1c), vs. the current 
standard based on oral glucose tolerance test, for the early 
detection of Type 2 Diabetes Mellitus (T2DM) in Colombia.  
EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
Non-invasive measurements ......................................................................................................................................... 12 
Biochemical measurements ..........................................................................................................................................12 
Participant listing  ....................................................................................................................................................... 12 
Allocation of intervention  ............................................................................................................................................ 13 
Patient Instructions  .................................................................................................................................................... 13 
Scheduling of study visits (schedule) ............................................................................................................................ 14  
Bias Control  ............................................................................................................................................................... 14 
Statistical  analysis plan  .............................................................................................................................................. 15 
Description of  statistical methods  ................................................................................................................................ 15 
Sample size   .............................................................................................................................................................. 15 
Significance level ........................................................................................................................................................16 
How to: Explain  Missing Data  ...................................................................................................................................... 16 
Selection of subjects to  be included  in the analyses  ....................................................................................................... 16 
Ethical considerations .................................................................................................................................................16 
Data management  and record keeping   ......................................................................................................................... 16 
Financing and insurance (budget and schedule of activities) .............................................................................................. 16 
Publication policy   ...................................................................................................................................................... 16 
Annexes ................................................................................................................................................................ 16 
Annex 1: Flow of interventions and procedures .................................................................................................................... 17 
Annex 2: Informed consent ........................................................................................................................................... 17 
Annex 3: FINDRISC Questionnaire  ................................................................................................................................ 18 
Annex 4: Table of variables ........................................................................................................................................... 19 
Annex 5.  Schedule of activities ..................................................................................................................................... 21 
References ............................................................................................................................................................ 22 

Page 4 of 21 
EDDIT-1 STUDY 
 
 
Comparative effectiveness of point-of-care glycosylated 
hemoglobin measurement (POC-A1c), vs. the current 
standard based on oral glucose tolerance test, for the early 
detection of Type 2 Diabetes Mellitus (T2DM) in Colombia.  
EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
 
 
 
List of tables 
Table 1: Scheduling of study visits 
 
List of figures 
Figure 1: Flow of interventions and procedures (Annex 1) 
 
List of abbreviations: 
• 
ADA: American Diabetes Association 
• 
CLIA: Clinical Laboratory   Improvement Amendments 
• 
DANE: National Administrative Department of Statistics 
• 
DCCT: Diabetes Control and Complications Trial 
• 
DM2: Type 2 Diabetes Mellitus 
• 
FINDRISC: Risk model for diabetes mellitus in Finnish population 
• 
GAA:  Impaired Fasting Glucose 
• 
GB: Basal glycemia  
• 
GPC:  Clinical Practice Guidelines 
• 
GI: Glucose intolerance  
• 
NGSP: Glycosylated Hemoglobin Standardization Program  
• 
WHO: World Health Organization 
• 
POC-A1c: Measurement of glycosylated hemoglobin at the point of care 
• 
OGTT: Oral Glucose    Tolerance Test 

Page 5 of 21 
EDDIT-1 STUDY 
 
 
Comparative effectiveness of point-of-care glycosylated 
hemoglobin measurement (POC-A1c), vs. the current 
standard based on oral glucose tolerance test, for the early 
detection of Type 2 Diabetes Mellitus (T2DM) in Colombia.  
EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
 
Protocol Synopsis  
Title 
Comparative effectiveness of point-of-care glycosylated hemoglobin measurement 
(POC-A1c), vs. the current standard based on oral glucose tolerance test, for the early 
detection of Type 2 Diabetes Mellitus (T2DM) in Colombia.  EDDIT-1 STUDY 
Purpose and justification 
In order to significantly increase the early detection of patients with T2DM, it is necessary 
to explore alternative strategies for actively searching for patients with prediabetes or 
undiagnosed diabetes.  These alternatives may include taking a screening questionnaire 
and a point-of-care test to improve the proportion of patients attending a confirmatory 
test.   The objective of this study is to evaluate the impact of such a strategy. 
Objectives 
In patients at risk identified by FINDRISC (i.e., score greater than or equal to 12), 
determine the difference in the number of patients who attend a confirmatory test 
(GTT) after the isolated application of the screening questionnaire versus the 
completion of the supplemented questionnaire by POC-A1c. 
 Study design 
 Prospective, open label, randomized, controlled study. 
Population 
 Adult patients with no known diagnosis of diabetes 
 Inclusion criteria 
• 
Adult, aged over or equal to 18 years and less than or equal to 75 years. 
• 
Understand, accept, and sign informed consent 
• 
FINDRISC greater than or equal to 12 
 Exclusion  criteria 
• 
 Previous diagnosis of type 1 or type 2 diabetes mellitus 
• 
Pregnancy or lactation 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 familial 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 thereof).  
• 
Known history of hemophilia or other bleeding 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 past 3 months 
• 
Known history of erythropoietin therapy in the past 6 months. 
Duration of the study 
Each subject will participate in the study approximately 4 months, in addition, each 
patient will   be given a follow-up call 30 days and 90 days from the date of inclusion in 
the study. 

Page 6 of 21 
EDDIT-1 STUDY 
 
 
 
 Comparative effectiveness of point-of-care glycosylated 
hemoglobin measurement  (POC-A1c), vs. the current 
standard based on oral glucose tolerance test, for the early 
detection of Type 2  Diabetes Mellitus (T2DM) in 
Colombia.  EDDIT-1 STUDY 
Version: 3.0 
Date: February  15, 2022 
Procedures 
The doctor explains what the study consists of and obtains informed consent.  If the 
patient accepts, the FINDRISC will be verified, the inclusion and exclusion criteria are 
verified and the relevant data from their medical history will be recorded. 
Subsequently, the subjects will be included in the study and randomized into two 
groups.  In the participants of group A (intervention) they will be offered information on 
healthy lifestyles according to their result in the FINDRISC questionnaire and then a 
measurement of POC-A1c.  In the participants of group B (control) they will be offered 
the same information on healthy lifestyles according to their FINDRISC result. 
In   addition, all randomized participants will be invited to perform a GPOT in the 
allied work of CAIMED or in the laboratory of their choice with the necessary 
preparation recommendations for the realization of the same. For this purpose, 
they will be given an order that includes the date of screening, a tracking number 
and time window in which they must go (i.e., 30 days and with a second attempt-
maximum window at 90 days). 
After 30 days from the delivery of the order for the PGTO, a call will be made 
to the randomized subjects to check if the exam was taken and its result 
requested in case it has done so, if the examination, you must send it to the 
center.   Otherwise, the causes of not having made the previously recommended 
GTT will be investigated, and a new call will be made after 90 days. In patients who, 
if they attended the performance of the OGTT and obtained a presumptive result of 
diabetes (defined as an impaired oral glucose tolerance test and/or impaired 
POCA1C test according to the ADA guidelines), a closing call will be made 30 days 
after the test was done to confirm if they started to control their disease.  For this, 
it will be instructed to attend consultation by general medicine according to what 
is contemplated by its entity administering benefit  plans, ending  the follow-
up. 
 Analysis plan 
For the primary objectives, the proportion of patients who attended the 
performance of the PGTT in each of the groups will be obtained and the statistical 
significance test for superiority in the follow-up ratio of the intervention 
group (A) over the control group (B) will be applied.  Additionally, descriptive 
statistics will be obtained regarding the dynamics of application of the confirmatory 
test (i.e., latency time). 
Security monitoring and 
assessments 
For the application of the FINDRISC screening questionnaire it is required to 
take  non-invasive anthropometric measurements and to establish the status of 
prediabetes or undiagnosed diabetes, blood samples are required. The   safety 
follow-up to these procedures will be carried out in accordance with current 
standards. 
 

Page 7 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
 
 
Title 
Comparative effectiveness of point-of-care glycosylated hemoglobin measurement   (POC-A1c), vs. the current standard based on  oral 
glucose  tolerance test  , for the early detection of Type 2  Diabetes Mellitus (T2DM) in Colombia.  EDDIT-1 STUDY 
 
Theoretical framework 
 Type 2 diabetes mellitus (T2DM) is a growing public health problem in the world and in Colombia.  In 2020, this pathology was 
considered the ninth cause of mortality in the world according to the global burden of disease (GBD) with more than 1 million deaths 
per year directly caused by diabetes (1). In Latin America, 1 in 3 adults living with diabetes are undiagnosed and in Colombia the 
behavior is similar, as reports from the High-Cost Account indicate that 3 out of every 100 Colombians have diabetes mellitus. 
However, the Ministry of Health and Social Protection estimates that the number is much higher and one in 10 people in Colombia 
suffers from this disease, this because at least half of the population does not know they have this pathology. 
To reduce the gap of undiagnosed people, it is necessary to design and implement strategies for early detection of T2DM. The Berlin 
Declaration (2), published in October 2016 and supported by the IDF as well as other organizations, has identified early detection as a 
priority line and has set a goal for achieving this priority (2). This statement proposes to increase by 50% the number of people taking 
a risk test for T2DM and by 50% the number of high-risk people receiving a diagnostic test for T2DM. 
 According to this, it is important to consider the diagnostic criteria set forth by the American Diabetes Association (ADA) in 2022 (3): 
- Fasting blood glucose (fasting - absence of caloric intake for at least 8 continuous hours) ≥ 126 mg/dL 
or 
-  Oral   Glucose Tolerance Test (according to WHO guidelines with an equivalent of 75 g of anhydrous glucose dissolved in 
water) at 2 hours: ≥ 200 mg/dL 
or 
- HBA1C ≥ 6.5% 
or 
- In patients with classic symptoms of hyperglycaemia or hyperglycaemia crisis, or random glycaemia ≥ 200 mg/dL 
*Note: To make the definitive diagnosis, it is necessary to perform two tests (the same or different) and that both are impaired.  
Likewise, itdefines as pre-diabetes, those patients who have impaired values of plasma glycemia as follows: 
- Fasting plasma blood glucose: 100-125 mg/dL or 
- Plasma glycaemia between 144-199 mg/dL 2 hours post OGTT 
or 
- HbA1c between 5.7% to 6.4% 
In this way, and in accordance with the guidelines of the Colombian Clinical Practice Guidelines, an adequate and timely approach to the patient 
suffering from this disease avoiding serious long-term outcomes. 
Background for the protocol 
The   risk score to predict the occurrence of DM2 was developed based on a prospective follow-up record conducted after a 
baseline survey from a census sample Finland's national of 4,450 subjects aged 34-74 years followed over 10 years. The validity, 

Page 8 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
specificity and predictive power  of the risk score was initially assessed, both with cross-sectional data from the study and by 
comparing the scores with the results of the oral glucose tolerance study conducted on the same people. It was also validated with 
another population survey with a prospective five-year follow-up.  The findings confirmed the high specificity and low false positive 
rate of the risk score for probability of development of DM2 (4). 
As for the measurement of glycaemic levels, although a recent review by Barry et al. points out that screening with glycosylated 
hemoglobin (A1c) and basal glycaemia is imprecise (5), it is clear that in the Cases that    are detected early, interventions can be 
made that prevent or delay the onset of diabetes and its complications.  For their part, Barengo and Tuomilehto point out the 
importance of early detection of prediabetic patients with post-load glucose intolerance, to induce lifestyle changes that prevent the 
progression to diabetes (6). 
  Finally, the Clinical Practice Guide (CPG) of DM2 published in Colombia by the Ministry of Health cites the study of Simmons and 
collaborators which shows that the subjects who were invited and attended to the invitation to   perform the screening between 1990 
and 1992 had alower morbidity compared to subjects who did not undergo screening (6). On the other hand, subjects who were 
invited to perform the screening test but did not heed the invitation showed significantly higher mortality (6). 
 
Description of the products used 
Today there is availability of equipment that performs the measurement of glycosylated hemoglobin at the point of care (POC-A1c) and that 
meets the standards proposed by the "National Glycohemoglobin Standardization Program" (NGSP) and the "Diabetes Control and 
Complications" Trial" (DCCT). This equipment can perform POC-A1c tests in contexts outside of central laboratories, although in 
the United States it is only authorized to be used in contexts of "Moderate Complexity" according to the classification of "Clinical 
Laboratory Improvement Amendments" (CLIA). 
The personnel who handle the equipment must be trained and the environmental conditions for its correct operation are predefined by the 
equipment in such a way that they do not operate if these conditions are not met. The restriction of equipment to environments of moderate complexity 
is applicable only to the United States, but in derived contexts equipment performing point-of-care testing offers a great opportunity to make 
immediate diagnoses without losing patients, as demonstrated by sub-Saharan Africa's experience in HIV detection and the immediate 
onset of HIV screening treatment (7). 
The laboratory where the Oral Glucose Tolerance Test (OGTT) is performed must comply with the standardized 
recommendations for the collection of samples according to local regulations and guarantee the equipment and packages available 
in the country. 
 
Purpose and justification 
With the aim of increasing the number of people detected early with DM2, it is currently recommended as an initial   screening 
tool, the application of the FINDRISC questionnaire, in Colombia this questionnaire counts   with validation studies demonstrating significant 
sensitivity and specificity when predicting diabetes (8). If that questionnaire yields a score greater than or equal to 12, a diagnostic test for 
DM2 should be performed. GPC considers three diagnostic tests: basal glycemia (GB), oral   glucose tolerance test (OGPT), and 
glycosylated hemoglobin (A1c).  Each test of these has advantages and disadvantages as well as their respective sensitivity and 
specificity, according to this, the economic evaluation of the different alternatives allows us to conclude that the recommended strategy is 
FINDRISC plus GB and OGTT (6) 

Page 9 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
The economic evaluation of the CPG estimated the costs and benefits based on   a decision tree that assumes that all individuals detected 
at risk in FINDRISC are subsequently tested.   However, this assumption is questionable because the performance of a complementary test 
implies that the patient has  to go to a site de taking samples on an empty stomach,   which  generates barriers derived from the time and 
money that this requires.  Additionally, there are other barriers such as the difficulty of fasting and the process of taking the sample itself.   
Overall, it is reasonable to propose that the proportion of patients completing the process is less than 100%. 
If it is assumed that the loss of follow-up to patients is not trivial, an alternative confirmation strategy must be designed to reduce this loss. One 
possibility is to perform an A1c test at the very moment the patient answers the FINDRISC questionnaire and is classified as a  patient at 
risk.  La GPC does not explicitly consider performing point-of-care A1c testing (POC-A1c) and refers to performing it in a centralized 
laboratory. 
As noted above, in resource-limited contexts, point-of-care testing teams enable immediate diagnoses without losing patients, as 
demonstrated by sub-Saharan Africa's experience in HIV detection and immediate initiation of treatment (7). 
One disadvantage that has been pointed out about point-of-care testing is that its unit cost is higher compared to tests performed in a 
processing center. However, this agreement only considers the direct cost of the test and does not know the impact that the immediate 
diagnosis generates on other costs, such as the need for successive consultations and the avoidable morbidity that occurs because 
of the loss of follow-up to the patient. 
Additionally, to make point-of-care testing affordable, it is necessary to design and implement an operating model that is very different from 
the traditional central laboratory model, for this, it is necessary to contemplate the screening of populations that go to other health services 
in those that have been identified as having an increased risk. For example, it has been documented that periodontal disease is associated 
with diabetes so that in adults over 30 years of age who attend general dentistry consultations, up to 30% patients with alterations of the 
glycemic profile can be found (9). 
In this frame of reference, it is proposed that to significantly increase the early detection of patients with DM2 it is necessary to explore 
alternatives for active search for patients with prediabetes or undiagnosed diabetes. These alternatives may include the completion 
of a screening questionnaire and a confirmatory test at the point of care, however, to achieve a higher rate of early detection it is 
necessary to find a balance between adequate sensitivity and specificity with less loss of follow-up. 
 
 Primary objectives 
• 
In patients at risk identified by FINDRISC (i.e., score greater than or equal to 12), determine 
the difference in the number of patients attending a confirmatory test (GTT) after the isolated application of the 
screening questionnaire versus the completion of the questionnaire supplemented by POC-A1c. 
 Secondary objectives 
• 
To determine the   probability of attending a confirmatory test (GTT) for DM2, in the population at risk identified by 
FINDRISC. 
• 
To determine the probability    of attending a confirmatory test (GTT) for DM2, in the risk population identified by 
FINDRISC in whom POC-A1c was applied. 
• 
Determine the performance in terms of time and adherence of the application of POC-A1c against the 
current recommendations in the GPC (ADA). 
• 
 Describe the causes of non-performance of the confirmatory test and identification of predictors of non-performance 
or postponement of the diagnostic test within a maximum period of 90 days from   the initial recommendation. 
 Study design  
Overview 
Study, prospective, open, randomized, controlled. 
 

Page 10 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
Justification of the main elements of the protocol 
The FINDRISC screening questionnaire has been previously studied and validated, can be applied quickly, economically and its low 
complexity makes them widely available (5,10). Similarly, previous studies have shown that periodontal disease is related to the 
appearance of alterations in the glycemic profile so that up to 30% of adults over 30 years of age who attend general dentistry 
consultations are identified as a population at risk (3). 
 Despite the drawbacks to its mass   application, OGTT  remains included within the current CPGs and continues to be a reference test for 
the diagnosis of patients with DM2 (3). 
Measurement of A1c may be more convenient than OGTT, particularly if performed at the point of care (POC-A1c).  
Additionally, the characteristics for its implementation and its technical profile are clearly established. However, its impact on the 
screening algorithm under real conditions of use is unknown and its profile for inclusion within a mass screening system has not yet 
been established.  
Setting the   primary endpoint 
While it is possible to perform screening using any of the validated questionnaires, in real conditions of their implementation a second 
visit of the patient is required to perform a confirmatory test (GTT) and the loss to follow-up isrequired a major challenge for health systems.  
It is proposed that the implementation of POC-A1c can contribute to improving the follow-up rate in the context of population 
screening and facilitate the successful implementation of large-scale screening campaigns.  
  Therefore, the primary outcome is the probability of going to OGTT according to the strategy implemented. 
Choice of comparator 
Currently, the screening guidelines contemplate the completion of the FINDRISC questionnaire followed by a confirmatory test carried 
out in the centralized laboratory. Because of this, the recommended practice is established as a comparator. 
Type of design 
 Prospective, open label, randomized, controlled study in adults with no known diagnosis of diabetes. 
 
Study procedures 
A Pre-Screening activity will be carried out, with prior authorization of use of personal data, where the   FINDRISC test will be applied 
to different population groups and in case the subjects obtain 12 points or more, they will be invited to participate in the study.   
Otherwise, participants with 11 points or less   according to the application of FINDRISC will receive brief information on healthy 
lifestyles according to their risk group, ending the activity. 
 
 Once the Pre-Screening activity has been carried out, to carry out each day, a work site will be installed in the different places 
established to carry out the screening of the disease that will be attended by a doctor, bacteriologist, and nursing assistant. Subjects 
at risk identified by FINDRISC will be explainedwhat the study consists of; if they wish to participate in it, and understand, 
accept, and sign the informed consent: the doctor will proceed to record the relevant data in their medical record, evaluate 
inclusion and exclusion criteria. 
Subsequently, the participants will be randomized into 2 groups. Participants in group A (intervention) will be offered 
information on healthy lifestyles according to their outcome and will be given a measurement of POC-A1c*.  In the 
participants of group B (control) they will be offered the same information on healthy lifestyles according to their 
FINDRISC result.  
*The work site will have a properly covered cubicle, in which a POC-A1c equipment will be available with the necessary   
requirements of  location and operation to guarantee the validity of the test. In this cubicle will be a laboratory assistant 
who executes the pre-analytical and post-analytical phase. 

Page 11 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
In addition, all randomized participants will   be invited to perform a GPOT in the   CAIMED partner laboratory or in the 
laboratory of their choice with the preparation recommendations necessary for the realization of the same.  For this purpose, 
they will be given an order that includes the date of screening, a tracking number and time window in which they must go 
(i.e., 30 days and with a second attempt-maximum window to 90 days). 
 
After 30 days from the application of the screening, a call will be made to the randomized subjects to check if they performed the 
indicated diagnostic test and the result of the OGTT, if the examination has been carried out, must be sent to the center (either by 
scanning, photographing, or bringing it to the research center).     Otherwise, the causes of non-realization of the same will be investigated 
and a new call will be made after 90 days.  In  patients who, if they attended  the performance of the OGTT and obtained a presumptive 
result of diabetes, a closing call will be made 30 days after the test was performed to confirm if they began control of their disease. 
For this, you will be instructed to attend a consultation by general medicine according to what is contemplated by your entity 
administering benefit plans, ending the follow-up. 
 
 Study population 
   Adult patients with no known diagnosis of diabetes attending a health care facility. 
 Inclusion criteria 
• 
Adult, aged 18 years or older and under or equal to 75 years old  
• 
Understand, accept, and sign informed consent 
• 
FINDRISC greater than or equal to 12 
 
 Exclusion criteria 
• 
 Previous diagnosis of type 1 or type 2 diabetes mellitus 
• 
Pregnancy or lactation 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 familial 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 thereof). 
• 
Known history of hemophilia or other bleeding disorders 
• 
Known history of stage IV or V chronic kidney disease 
• 
Known history of HIV 
• 
  Known history of sickle cell disease  
• 
Known history of 6 phosphate dehydrogenase deficiency 
• 
Known history of blood transfusion in the past 3 months 
• 
Known history of erythropoietin therapy in the past 6 months. 
Criteria and procedures for the withdrawal or suspension of subjects 
Type and time of data collection corresponding to withdrawn subjects  
The subject who decides to participate in the study can choose to withdraw at any time, since no therapeutic interventions are 
being applied, only guidance will be offered to the subject regarding their risk condition as has been established until that moment 
of the study and the moment in that its follow-up is terminated. 
 Whether to replace subjects and how 
 Withdrawn subjects will not be replaced.  
Follow-up of withdrawn subjects  
 Once the subject expresses his intention to withdraw, the follow-up will be terminated. 

Page 12 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
Criteria for the interruption of the study. 
 Since the intervention     is not therapeutic and the technical conditions for performing laboratory tests are standardized, no a priori 
termination criteria are established. 
 
Interventions 
Description of interventions  
The FINDRISC (applied in Pre-Screening activity) will be verified; for this it is necessary to take anthropometricas well as non-
invasive measurements. Additionally, to establish the diagnosis of prediabetes or undiagnosed diabetes, invasive activities such as 
blood sampling are required. 
 Non-invasive measurements 
Body weight (at 0.1 g precision) in lightweight underwear, without footwear, will be recorded at the screening visit as well as height (at 
0.5 cm precision), that is, both measurements will be obtained at the beginning of the study. The waist and hip circumference will 
be taken twice, then the average of both measurements will be made. 
Biochemical measurements 
The PGTT will be carried out according to the standards of the allied laboratory or of preference by the patient, and under 
the local regulations of the country with the recommendations of the WHO.  Ideally, the loading solution should contain 75 g of 
anhydride glucose and 1.6 g of citric acid,   the first sample of glycemia will be obtained after 8 -  12 hours of fasting and the second sample 
will be obtained 2 hours after glucose loading. All this according to the recommendations described by the WHO. 
     PoC-A1c will be measured at the screening site using validated equipment that complies with international standards. 
Kits  and  processing methods will be ensured to be certified by the NGSP and standardized with the DCCT assay. The POC-A1c 
test shall be considered impaired for any value equal to or greater than 5.7% (3). 
Enumeration of the participant 
The enumeration of patients will be sequential since it is performed in a single center. 
Allocation of the intervention 
Once the participant has accepted and signed the informed consent, the doctor will verify the FINDRISC questionnaire 
previously applied in prescreening activities), as well as inclusion and exclusion criteria and random assignment will be carried out 
by the research team. 
The   random allocation sequence will be automatically generated through the platform intended for this purpose.  A member 
of the research team will record the group to which the participant was assigned on the data logging platform. 
Instructions to the patient 
In Pre-Screening activities, a member of the research team must give the participant a flyer with educational information 
about healthy lifestyles, regardless of the participant's score. In addition to all participants who enter the study, they will be given 
an order for the realization of the PWG with the relevant indications for the taking of the sample and the flyer mentioned above. 
 
In this documentation must be the sequence number that was assigned to the patient, as well as their identification 
number so that when they go to the sampling site (CAIMED allied laboratory/Laboratory of their preference) they are identified 
as a participant in the study. This will make it possible to monitor which participants have already completed the GGP. 30 days 
after applying the screening questionnaire or the completion of the GTT, the follow-up call is made. 
The script is as follows: 
"Good morning / good afternoon / good evening, Madam/Sir (name of the subject).  My name is (Contributor Name) 
I am (Position) We are calling you on behalf of the diabetes early detection study.  As you recall, on the day (date 

Page 13 of 21 
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Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
of inclusion in the study) you participated in the site (inclusion site to the study) in the diabetes study.  I would like 
to know if you had the sugar test indicated by the doctor (corresponding to the day of completion of window 1 for 
the OGTT). 
(Wait for a reply) 
If the patient replies that the test was performed, the date and result should be confirmed and ask: "Could you please send us a 
photo or any proof of the report?  Finally, the call should end like this: "Thank you very much Ms./Mr. (name of the 
subject).  Remember to consult your doctor or your EPS to initiate timely management of the disease (in case it is impaired) 
or monitor the risk at least annually."  
If the answer is I have not taken the test: Could you please tell us why you have not taken the sugar test?  Wait for a 
response, and document it, end the call like this: "Remember that we will call you in 2 months again to confirm if 
the test was done." 
*The answers are recorded by the platform and will be analyzed qualitatively by the researchers. 
 
 Scheduling of study visits (schedule)  
Responsible 
Prescreening 
Visit 1 
Phone Call  1 
(30 days ± 3 
days) 
 Phone Call  2 (90 
days ± 3 days) 
 Phone Call 3 (30 days 
after reporting to the 
center 
± 
3 
days, 
if 
applicable) 
Doctor 
– 
Bacteriologist 
– 
 
 
Research Assistant 
Conferences of 
application
 
of 
FindRisc 
as 
risk screening 
Doctor 
Explanation 
of 
the 
study, its procedures 
and obtaining 
the 
consent 
informed.  Review of   
eligibility criteria. 
Research Assistant 
VERIFICATION 
of 
FINDRISC, 
Randomization and data 
processing   on the 
platform 
Research Assistant 
Data processing on the 
platform 
to 
the 
corresponding group 
Laboratory 
Implementation of POC-A1c 

Page 14 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
CRS 
 
 
Follow-up call   30 
days after the PGT 
request. 
 
 
Follow-up call - 30- 
90 
days 
after 
admission to the  
study in patients 
not 
attending 
OGTT. 
 Verification call 30 days from 
the report of the result of the 
requested test. To those 
who present an impaired 
OGMP and have requested a 
control  
doctor. 
 
 
 Bias Control 
 
• Bias derived from the randomization process: it is carried out through the Office - Excel platform by means of algorithms for the 
generation of random numbers and their assignment to the specific group, by means of a simple impaired randomization; in order to maintain 
the masking of the assignment, a number (1-2) will be assigned to classify the intervention and its comparator, keeping this hidden 
from  most   researchers. 
 
• Bias due to deviations from planned interventions: from study design, with simple randomization, the subject who has received 
a group assignment cannot move on to the other. 
• Bias due to the lack of outcome data: The number of stratified lost data of intervened versus non-intervened will be evaluated, if 
it exceeds 5% analysis and data imputation will be made. 
 
• Bias in outcome measurement: the outcome of the OGTT sampling is sufficiently robust not to be affected by the research team, 
the participant itself or external factors. 
 
• Bias in the selection of the reported result: at this point it is mentioned how the creation of surrogate outcomes not proposed 
in the protocol will be avoided and how consistency will be maintained in terms of the applicability of statistical terms, that is, only what 
is proposed in the data analysis will be carried out. 
 
Statistical analysis plan 
Description of statistical methods 
  For the   primary objectives, the proportions of patients who attended the performance of   the   GTT in each of the groups will 
be obtained and the statistical significance test will be applied for superiority in the follow-up ratio of the intervention group (A) 
over the control group (B). Additionally, descriptive statistics will be obtained regarding the dynamics of application of the 
confirmatory test (i.e., latency time). 
The variables will be checked for normality using the Kolmogorov-Smirnoff test. For quantitative variables, data shall be expressed 
as mean and standard deviation, or median and interquartile range 25%-75%, as the case may be. 
For qualitative variables, proportions (%) will be determined. The continuous data between both groups will be analyzed with the T 
test if the distribution of the variables is normal or with the Mann-Whitney test if they are not. The analysis of the categorical data 
between two groups will be carried out with the chi-Square or Fisher test as appropriate. 
An   analysis will be    carried out on the conditional probability of reaching a OGTT test: P(perform OGTT |  
FINDRISC >= 12) 
P(perform OGTT |  POC-A1c >=5.7% and FINDRISC >=12) 
An analysis will be performed  to identify risk factors for   not performing the PGT, the dependent variable will be dichotomous. The 
main independent variable will be dichotomous corresponding to the control and intervention group.  The control variables will be: age, 

Page 15 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
gender, type of affiliation, FINDRISC score and POC-A1c value (for those in which it is available) and others that are 
considered possible variables of confusion. 
In order to analyze these associated factors, it is proposed to carry out a generalized linear model of binomial type or poison type with 
robust errors, in order to evaluate the influence of the factoris sociodemographic and with relevance / biological and contextual plausibility 
in the aforementioned outcome (non-realization of OGTT).  The partnership measures   will be presented through RR with their corresponding 
95% confidence interval.  A bivariate and multivariate analysis will be carried out to identify possible confusion or interaction for which the 
probability of performing the OGTT should be adjusted. Under the methodology proposed by Furnival-Wilson (1974) a reduced model 
will be estimated, using the logarithmic probabilities of the candidate models in order to establish the most parsimonious model. The 
goodness of fit of the models and the assumptions underlying the selected methodology will be evaluated.  The statistical package 
where the analyses will be carried out is Stata 16MP. 
 Sample   size 
The study is designed to detect a 10% difference in going to the laboratory for OGPT between the intervention group (60%) and the 
control group (50%) considering a power of 80% and a confidence interval range of 95%. 
Considering that some people with positive FINDRISC (i.e., greater than or equal to 12) will have a normal APOC-A1c, the 
number of participants in the intervention group (i.e., group A) will be increased by 30% to ensure sufficient subjects available for 
analysis with completely positive classification. This percentage corresponds to patients without glycemic alterations or DM2 
identified in the FINDRISC validation study (9). 
 According to this and considering that the primary endpoint is a categorical variable, an initial sample of 784 randomized subjects 
(392 in each arm) was calculated, after the adjustments the sample is of 902 subjects distributed asymmetricallye (510 in group A 
or intervention and 392 in group B or control). 
It is expected that the proportion of patients with FINDRISC greater than or equal to 12 will be 30% of the patients to whom 
the questionnaire is applied, according to this the expected total of Sieved patients is 3005.  However, the total number of patients 
screened can be extended to complete the goal of randomized patients. 
Level of significance 
 According to the described methodology, the significance level for the primary objective is 0.05. 
Procedure to Explain Missing Data 
Any deviation from the statistical plan will be discussed with all authors for approval. 
Selection of subjects to be included in the analyses  
The final analysis will include all individuals with complete data. 
 
 Ethical considerations 
The research group will submit to the Ethics Committee for consideration all required documentation from the study, explain 
the risks and benefits and ask for their written consent. Each participant shall have the right to leave the study when he/she so 
arranges. The study will follow the Good Clinical Practice regulations of the Helsinki Declaration. An adverse effects data 
collection sheet will be used, it is estimated that possible adverse effects will be related to      taking capillary puncture for 
POCA1C (puncture site infection and pain or dizziness/vomiting).  
  Data management and   record keeping 
Data management and record keeping will be carried out in accordance with the current procedures of MetricsMed and a 
specific parameterization is contemplated for the implementation of this project.  
 
Financing and insurance (budget and schedule of activities) 

Page 16 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
See annex budget 5. 
 
 Publication   Policy 
The publications will be based on data from the center, analyzed according to the protocol. Researchers undertake not to 
publish data obtained in a centre or in a small group of centers before the main publication (or updates of the same), unless they are 
formally accepted by all other researchers. Authorship, order of authors, publications and results of the study shall be determined 
in accordance with the authors according to international  standards for publications. 
 
Annexes 
1. Flow of interventions and procedures 
2.  Informed consent 
3.  FINDRISC Questionnaire 
4. Table of variables 
5. Schedule of activities – Budget 
Annex 1: Flow of interventions and procedures 
 
 
Annex 2: Informed consent 
 View attachment 
Adult older than 18 and 
younger than 75 who accepts 
to participate and signs Cl  
Verification of 
Eligibility Criteria  
FINDRISIC >=12  
Randomization 
Information and education 
based on the results  
OGTT Order 
End of monitoring  
Information and education 
based on the results  
POC-A1c performance 
OGTT Order 
End of Monitoring 

Page 17 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
 
Annex 3: FINDRISC Questionnaire 
FINDRISIC QUESTIONNAIRE 
1. 
Age 
<45 years old ……….. 0 points 
45-54 years old …….. 2 points 
55-64 years old …….. 3 points 
>65 years old ………. 4 points 
2.  IMC (kg/m2) 
 
 
<25 ………………….. 0 points 
 
 
25-30 ………………... 1 point 
 
 
>30 ………………….. 3 points 
3. Waist permitter 
 
 
Men 
 
 
Women 
 
 
<94 cm …………………………….<80 cm ………..0 points 
 
 
94-102 cm ………………………… 80-88 cm ……. 3 points 
 
 
>102 cm …………………………… >88 cm ……… 4 points 
4. Do they performs at least 30 minutes of physical activity at work on free time? 
 
 
YES …………………. 0 points 
 
 
NO …………………… 2 points 
5.How often do they eat fruits or vegetables? 
 
 
Every day …………… 0 points 
 
 
Not every day ………. 1 points 
6.Do they have high-blood pressure or take daily medication for hypertension?  
 
 
NO …………………… 0 points 
 
 
YES …………………. 2 points 
7.Have they ever had high glucose levels? 
 
 
NO …………………… 0 points 
 
 
YES …………………. 5 points 
8.Has any of their family members or relatives ever been diagnosed with diabetes? 
 
 
NO ………………………………………………… 0 points 
 
 
YES… grandparents, uncles, aunts, cousins…3 points 
 
 
YES … parents, siblings, children …………… 5 points 
 
Taken from ScienceDirect, Spanish clinical magazine, Volume 210, Issue 9, October 2010, pages 448-453 

Page 18 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
 
Annex 4: Table of variables. 
Variable 
 Conceptual Definition 
 Operational Definition 
Measurement 
scale 
Demographics 
 
Identification 
  Citizenship Card Number 
 Integers 
Discrete 
Quantitative Ratio 
 Health 
Coverage  
Health care provider   according to Colombian 
legislation, can be subsidized, contributory 
according to the social stratum of the person. 
EPS –S (Subsidized) 
EPS –C (Contributory) 
Other (Exception Regime) 
Qualitative 
Dichotomou
s 
Gender 
Sex of the patient 
 Male 
Female 
Qualitative  
Nominal 
Dichotomou
s 
Date 
of 
Birth 
 Main facts about the birth of a 
person according to the data issued in the official 
record or document. 
Day 
Month  
Year 
Quantitative 
 Discrete 
 Marital 
Status 
Permanent status of a natural (natural) person in relation to 
his or her personal circumstance and legislation. 
Single 
Married 
Widower 
Divorced 
Free Union  
Separate 
Qualitative 
Dichotomous  
Nominal 
Last grade of 
schooling 
obtained 
Degree of instruction by the school, parents, or 
caregiver. 
Primary 
Secondary 
Technical 
Technology 
University 
Without 
studies 
Qualitative 
Dichotomous 
Nominal 
 
Employment 
Status  
Set of activities that are carried out with the aim of 
reaching a goal, solving a problem or producing 
goods and services to meet human needs.  Are 
you?  Doing any paid (paid) work right now? 
Yes 
No 
Qualitative 
Dichotomous 
Nominal 
Socio-
economic 
stratum 
Classification into strata of residential properties that must 
receive public services 
1 
2 
3 
4 
5 
6 
Qualitative  
Ordinal 
 Anthropometric (non-invasive) measurements 
Weight 
Magnitude in kilograms of a subject 
Measured in kilograms (Kg) 
Continuous 
Quantitative of 
Reason 
Size 
Height in centimeters of a subject 
Measured in centimeters (Cm) 
with conversion to meters (mt) 
Continuous 
Quantitative of 
Reason 

Page 19 of 21 
EDDIT-1 STUDY 
 
 
Effectiveness comparison of the hemoglobin measurement 
glycosylated at the point of care (POC-A1c), vs the standard 
current based on tolerance test oral to glucose, for the 
detection early of Diabetes Mellitus guy 2 (DM2) in 
Colombia. EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
 

Page 20 of 21 
EDDIT-1 STUDY 
 
 
 
 Comparative effectiveness of point-of-care glycosylated 
hemoglobin measurement  (POC-A1c), vs. the current 
standard based on oral glucose tolerance test, for the early 
detection of Type 2  Diabetes Mellitus (T2DM) in 
Colombia.  EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
Waist 
   Circumference measurement performed 1cm below 
the navel to determine abdominal obesity and 
 expressed in centimeters. 
Measured in centimeters (Cm) 
Continuous 
Quantitativ
e 
Reason 
 
of 
BMI 
  Weight in kilograms divided over the size in meters 
squared 
Measured in kg/m2 
 Continuous 
Quantitative of 
Reason 
 Family History 
Family 
member 
over 18 
years of 
age 
 
wit
h Diagnosis 
of DM 
History of 
Diabetes 
Mellitus 
in 
direct family  
Have any of your close 
relatives or other relatives been 
diagnosed with diabetes? 
No 
Yes: grandparents, aunt, 
uncle , first cousin (not parents, 
siblings or children) 
Yes: parents or siblings 
Nominal 
qualitativ
e  
Risk factors  
Diabetes 
Mellitus 
Disease where   
there is excess 
blood 
sugar 
(glucose) from 
Pancreatic 
failure 
(Endocrine organ) 
Has a doctor, nurse, or other 
health professional ever   told  
you  that you have or had 
Diabetes or  high  blood sugar?   
Ye
s 
No 
Dichotomo
us 
qualitative 
Treatment 
Medicine that 
regulates the 
 blood pressure 
Do you take
 
medication 
for 
hypertension regularly? 
the Ye
s 
No 
Dichotomo
us 
qualitative 
for 
the 
Hipertension 
 Physical 
activity 
Any body 
movement 
produced by 
skeletal 
muscles, with 
the  
consequent 
consumption of 
energy. 
Usually perform at least 30 minutes 
of physical activity, at work and / 
or in free time? 
Ye
s 
No 
Dichotomo
us 
qualitative 
Consumptio
n of fruits 
and 
vegetables 
 Feeding from 
fruits 
and 
vegetables 
How often do you eat 
vegetables or fruits? 
Every day Not 
every day 
 
Dichotomo
us 
qualitative 
 Biochemical Variables 
POC-A1c 
Glycosylated 
Hemoglobin at 
Point of Care 
  PoC-A1c result 
% or mmol/mol 
 
Quantitative 
Continuous 
Ratio 
 
of 

Page 21 of 21 
EDDIT-1 STUDY 
 
 
OGTT 
 Oral 
glucose 
tolerance test. 
Result of the OGTT 
mg / dl 
 
Quantitative 
Continuous 
Ratio 
 
of 
Date 
Take 
OGTT 
 of 
Date 
of 
performing the 
test 
Date of OGTT Test 
day/month/year 
 Discrete 
Quantitative 
 Risk  calculation 

Page 22 of 21 
EDDIT-1 STUDY 
 
 
 
 Comparative effectiveness of point-of-care glycosylated 
hemoglobin measurement  (POC-A1c), vs. the current 
standard based on oral glucose tolerance test, for the early 
detection of Type 2  Diabetes Mellitus (T2DM) in 
Colombia.  EDDIT-1 STUDY 
Version: 3.0 
Date: February 15, 2022 
Screening 
result by 
FINDRISC 
Scale to detect 
patients 
at 
higher risk of 
developing 
T2DM in the 
next 
ten years 
 Final result of FINDRISC 
Points.  Integer numeric value 
(discrete) 
Quantitative  
Discrete 
 Final Diagnosis 
Patient 
presents 
Diabetes 
Disease where   
there is excess 
blood 
sugar 
(glucose)from 
pancreatic 
failure 
(endocrine 
organ) as of 
performed 
diagnosis test. 
 
Result according to OGTT or 
POC A1C and guidelines of clinical 
practice guidelines -, ADA  
Ye
s 
No 
Qualitative 
Dichotomou
s 
 
Annex 5.  Schedule of activities 
• 
Schedule 
o 
Enlistment November 2021- January 2022 
o 
Start of Prescreening December 2021 
o 
 Recruitment May - September 2022 
o 
Database review    and debugging – February 2023 
o 
Information analysis -  February 2023 
o 
Clinical study report –March 2023 
o 
Final report (article ready for publication) April-May 2023 

Page 23 of 21 
EDDIT-1 STUDY 
 
 
 
 Comparative effectiveness of point-of-care glycosylated 
hemoglobin measurement  (POC-A1c), vs. the current 
standard based on oral glucose tolerance test, for the early 
detection of Type 2  Diabetes Mellitus (T2DM) in 
Colombia.  EDDIT-1 STUDY 
 
Version: 3.0 
Date: February 15, 2022 
References 
1. 
Abdul M, Khan B, Hashim MJ, King JK, Govender RD, Mustafa H, et al. Epidemiology of Type 2 Diabetes – Global Burden of Disease and Forecasted 
Trends.  Journal of Epidemiology and Global Health.  2020;10:107–11. 
2. 
Khunti K, Gavin JR, Boulton AJM, Blickstead R, McGill M, Ceriello A, et al. The Berlin Declaration: A call to improve early actions related to type 
2 diabetes. Why is primary care important? Vol. 12, Primary Care Diabetes. Elsevier Ltd; 2018. p. 383–92. 
3. 
Standards of Medical Care in Diabetes—2022 Abridged for Primary Care Providers. Clinical Diabetes [Internet]. 2022 Jan 1;40(1):10–38. Available 
from: https://diabetesjournals.org/clinical/article/40/1/10/139035/Standards-of-Medical-Care-in-Diabetes-2022 
4. 
Vandersmissen GJM, Godderis L. Evaluation of the finnish diabetes risk score (FINDRISC) for diabetes screening in occupational health 
care.  International  Journal of Occupational Medicine and Environmental Health. 2015 Jun 1;28(3):587–91. 
5. 
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 (Online). 2017;356. 
6. 
Barengo NC, Tuomilehto JO.  Wie können wir Personen mit dem höchsten Diabetesrisiko identifizieren – screenen oder nicht screenen?  Herz.  
2016 May 1;41(3):175–83. 
7. 
Jani I v, Peter TF. How Point-of-Care Testing Could Drive Innovation in Global Health.  Vol.  24, n engl j med.  2013. 
8. 
Mariano Cantillo HJ, Ocampo DF, Cuello Santana KL.  Use of the FINDRISK instrument to identify the risk of prediabetes and type diabetes mellitus 
2. Journal  Repertoire of Medicine and Surgery.  2019 Oct 25;28(3):157–63. 
9. 
Barengo NC, Tamayo DC, Tone T, Tuomilehto J. A Colombian diabetes risk score for detecting undiagnosed diabetes and impaired 
glucose regulation. Primary Care Diabetes. 2017 Feb 1;11(1):86–93. 
 
 
 
 
 
 
I, the undersigned, do hereby certify that I am fluent and competent in both, the English and Spanish languages, and that I have made the above translation from the original 
document in the Spanish language and the same is a true and complete translation to the best of my knowledge, ability, and belief. CAYETANO EDUARDO FORERO OROZCO, 
Sworn Translator and Interpreter Resolution # 502, – National University of Colombia – Bogotá, D.C. Place, and date of this translation: Bogotá, Colombia, 06-24-2022. Mobile 
telephone number: (57) 318 848 1431 Email: eduardoforeroo@gmail.com - Sworn Translation # 4917. 
 
www.traductores.com.co 
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