Epidemiological profile and diabetes control of Type 1 Diabetes Mellitus patients in Karbala Governorate, Iraq

Background: Type1 Diabetes Mellitus is a common chronic diseases among children, and associated with morbidity, mortality, and enormous healthcare expenditures. Objectives; to estimate the prevalence, incidence, and describe the epidemiological characteristics of Type 1 Diabetes Mellitus among children in Karbala governorate. Methods: A cross-sectional study was conducted among all children who attended the main DM center in Karbala Teaching Hospital for Children, Public Clinics, and Primary Health Care centers. Data was collected by structured questionnaire and biochemical and anthropometric measurements. The statistical analysis data entry was conducted using Statistical Package for Social Sciences. Results: Total number of Type 1 Diabetes Mellitus patients aged 0-15 years in Karbala in 2015 was 199; making 44.66/100 5. Fifty-four patients were newly diagnosed patients making an incidence of 12.11/100 5. There was nearly equal distribution among both sexes. Most of the cases were from urban areas and most of the patients had a Family history of Type 2 Diabetes Mellitus. Diabetic ketoacidosis was reported in 16.8% of the patients. Only 31.6% of patients had HbA1c < 7%. Half of the patients had a history of admission to the hospital for diabetes. Logistic regression analysis revealed that the only independent variables significantly correlated with poor glycemic control were lack of Self-Monitoring Blood Glucose, irregular visits to the Diabetic Center, and positive family history of diabetes. Conclusion: Only one-third of T1DM children in Karbala city had controlled blood sugar. Lack of regular blood glucose monitoring and irregular contact with health care providers were the main determinants of uncontrolled blood sugar.


Introduction
Type 1 diabetes mellitus (T1DM), is one of the most frequent chronic diseases among children and represents a public health challenge for many reasons globally the incidence, which represents about 10% of the diabetes cases all over the world.It is increasing especially among children below 15 years old and is increases 3% yearly worldwide.The first presentation of 10-70% of newly diagnosed children with DM1 is Diabetic Ketoacidosis (DKA). 1,2The incidence rates differ in different populations, the lowest is observed in Venezuela and China while the highest in Sardinia and Finland.Regarding T1D incidence among Arab countries, several studies reported low incidence in Oman (2.54/100,000) and high incidence in Saudi Arabia (29/100,000).In general, the Arab countries show higher incidence and prevalence estimates in areas where DKA rates are high. 3High DKA incidence results in increased hospital admission and emergency department (ED) visits and contributes to the high costs of care for children with T1DM.In Iraq, the prevalence of T1DM increased from 7.8 in 1995 to 14.2/100000 in 2000 and to 24.7/100000 in 2014 under 15 years old children. 4Daily management of T1DM presents numerous challenges to achieving satisfactory metabolic control including multiple daily insulin injections, frequent blood glucose monitoring, frequent contact with medical professionals, and careful regulation of exercise, meal schedules, social status, and the educational level of the parents. 4,5tudies in Iraq conducted on adolescents and children with Type 1 diabetes mellitus have shown that both patient and family education was associated with a lack in several emergency room visits and hospitalizations, a reduction in overall healthcare expense.Glycemic control in adolescents and children with type 1 diabetes mellitus in post-conflict in Iraq is low.They are poor in these diagnoses in pre-school age, adolescents, and obese children (23.8% of diabetic children had glycemic control), and it is much higher reported cases in Basrah, south of Iraq (10%). 5,6While the Iraq Ministry of Health had some data on type 2 DM, there is scarce data on T1DM epidemiology.Availability of such data can help identify the burden of the problem and provide evidence that helps in the planning of health programs and allocation of financial and human resources, logistics, and treatment facilities.As the Karbala population is not different from the remaining Iraqi population, data from this study can be extrapolated and generalized to estimate corresponding figures representing Iraq.The aim of this study is to estimate the incidence and prevalence and to describe the epidemiological characteristics and the control status of T1DM among young patients in Karbala Governorate, Iraq.

Methods
Setting: Karbala Governorate is located 100 Km to the south of Baghdad, the capital of Iraq with an estimated population of 1,122,400; 445,628 of them aged ≤15 years.

Study design:
A cross-sectional study to measure the prevalence and identify basic socio-demographic data and complications.Also, a longitudinal incidence design was used to measure the incidence of the disease over one year.

Study Population:
This study involved all T1DM patients who lived and registered in Karbala governorate, aged ≤15 years.

Data Sources
Data of T1DM patients have been obtained from the following sources: 1) Karbala Teaching Hospital for Children where the main DM center is located, and the majority of young DM patients attended to seek medical support.2) Public Clinics are distributed in all cities and towns throughout the country and they are the main health outlets where all patients with chronic diseases (including DM) receive their medications for a very subsidized cost.3) Primary Health Care Centers (PH Care Cs) are distributed in all localities and provide all PHC services including school health services.Part of the activities of the school health program in these PHCs is to have a list of all students with chronic diseases (including DM) in the schools within the catchment areas of these PHCCs.

Data Collection Tools
A data collection form was developed to compile data on all patients with T1DM from the registries of the diabetes center in Karbala Teaching hospital for Children, all the Popular Clinics, and all the PHCs Karbala governorate.These registries were useful in developing a list of patients currently diagnosed with T1DM, and the newly registered cases during 2013.Deceased patients during this year were first looked for at the Popular Clinics by identifying defaulters from the monthly medication supply lists.Information wars were verified through telephone communication with the families and school health programs in the PHCs.Clinical and epidemiological data were collected through the direct intervention of the patients using a structured questionnaire.The questionnaire was pre-tested on a sample of 10 patients from the target study population in the Diabetes Center.The measured parameters were the following anthropometric measures: Bodyweight, using a weighting digital scale (Seca) with light clothes without shoes and the weight was approximated to the nearest 100g), Height, using a portable measure (Seca), and height was approximated nearest 1cm.Body Mass Index (BMI) is calculated using the following equation: weight (in kilogram)/squared height (in meter).Moreover, measured fasting blood glucose (using Randox kit) using the colorimetric method), and Glycosylated hemoglobin (HbA1C) (using StandBio kit, using the spectrophotometric method).

Ethical approval
Written informed consent was obtained from the caregiver of each participant before data collection.Confidentiality of the data was maintained throughout the study.Official approval was granted from the Karbala Directorate of Health.
Statistical analysis: Statistical Package for Social Sciences was used for data entry and statistical analysis.The frequency data were expressed in suitable tables, and graphs.The statistical association was tested using the chi-square test of independence and Fisher's exact probability test when needed.Quantitative data were analyzed using an unpaired t-test.Logistic regression analysis was used to identify the significant independent determinants.A less than 0.05 of p-value of is considered significant statistically.

Consent
Written informed consent for publication was obtained.The requirement for ethical approval was waived by the Medical Ethics Review Committee of the Academic Medical Center.Patients were treated according to guidelines of the Iraq Medical Association (KNMG).Medication was administered under Karbala Teaching Hospital and Primary Health Care Centers.

Results
A total of 190 T1DM patients aged 0-15 years were identified making a prevalence of 44.66/10 5 .Fifty-four patients were newly diagnosed patients during 2013, making an incidence of 12.11/10 5 .The Mean age was 8.8 (AE3.6)years; 55.8% were more than eight years old and 14.2% were less than five years.About 53% were females and 68% were urban residents.Breastfeeding was reported by 93.2% of the patients; 77% of them continued breastfeeding for more than six months.Positive family history of T1DM and exposure to significant stressful life events were reported in 20.5% and 21.5%, respectively.As shown in Table 1, more than one-fifth (23%) of the patients presented with diabetic ketoacidosis (DKA) as a first manifestation of the disease, and around 22% had the disease for more than six years.Only one-third of the patients (31.6%) had controlled diabetes as reflected by HBA1c; 28% had a history of severe acute complications (hypoglycemia or DKA) and 51.5% required admission either to the ER or the inpatient ward.
To identify the determinants of the control status of the disease among the young T1DM patients, we compared patients with controlled diabetes as reflected by normal HBA1c, with the group of uncontrolled disease by several sociodemographic and clinical characteristics and certain behavioral factors as demonstrated in Tables 2 and 3.The proportion of controlled disease was significantly higher among children aged ≤8 years (P=0.008),with better mothers' and fathers' education (P<0.001),employed fathers (P=0.017), and children with a duration of disease <6 years (P=0.034).(Table 2).Also, controlled diabetes was significantly higher among patients with regular attendance at the diabetes center (P< 0.001), blood glucose self-monitoring (P< 0.001), adherence to insulin treatment, and controlled dietary intake by the parents (P< 0.001).(Table 3).Logistic regression analysis was applied considering the poorly controlled status as the dependent variable and all the variables that were found significant in the binary analysis were included as the independent variables in the model.Three factors were found statistically significant: self-monitoring of blood glucose (OR:10.41,95% CI:2.24-47.62)irregular attendance to the diabetes center (OR:5.62,95%CI: 5.62-171.32),and family history with positive DM (OR:1.86;95% CI:1.01-3.41).

Sociodemographic characteristic
Most of our patients aged more than 8 years, most of them from rural areas, Sex nearly equal distribution with only slight female predominance.A study from Al-Madinah/Saudi Arabia has reported a higher incidence for the 10-12-year age group than in younger children.Furthermore, they have reported a higher incidence of T1DM in girls than in boys and most patients from urban areas, 7,10 in the current study most of the mothers were housewives, with low educational levels, in constituent with another study in Egypt in which 85% of the patients with not work mothers and about two-thirds of them had low educational level.

Rate control
Achieving the ideal blood glucose level is very difficult for many patients with diabetes, therefore, in the current study, the rate of optimal glycemic control (HbA1C <7%) represented around 31.6% of the patients comprised in other studies in Kenya (28%), 12 Saudi Arabia (31.2%),Egypt (60%) and two-thirds of Italian children with T1DM have HbA1c>8% despite a regionalized centers, free access to appropriate diabetes care, multidisciplinary team approach, frequent blood glucose monitoring, education and multiple insulin injections. 13nder, Residence, Age of patients, and marital status of their parents Good glycemic control is associated with age < 8 years, urban residence, not affected by gender, reflecting the same complex the social and economic environment in which both genders are living, another study in Saudi Arabia confirmed the same result. 13other studies found better control associated with older age 14 and a few studies shows that the mean of HbA1C in girls was significantly higher than in boys. 15another study from the UK showed a linear association between residence and glycemic control in type 1 diabetes 16 and Our results reflected a very low incidence of divorce in the study group, so there was no significant correlation between glycemic state and marital status of the parents.
Self-Monitoring of Blood Glucose (SMBG) & Regularity of Visits to Diabetic Center In the current study, good blood glucose monitoring (BGM), adherence, and regularity of clinic attendance were significantly associated with better HbA1c, in agreement with several studies. 14,17The clinic visits frequently is recommended to allow for better frequent adjustment of insulin regimens, and an increases number of opportunity for motivation and education.
Education, Occupation of the parents, and family history More knowledgeable parents on diabetes with better education are able to cope more effectively and maintain better glycemic control of their diabetic children, results in other studies showed a significant relationship between low education of parents and poor glycemic control, 11,18 majority of our patients had housewife mothers and most of their fathers were self-employed, such type of life does not permit optimal looking after the diabetic Childs, then consequently it turns to uncontrolled status of HbA1C levels, we found that positive family history of T2DM was more frequent than type 1 or both, other study found that only 10-15% of the patients have a first-or second-degree relative with T1DM, 1 while family history of type 1 diabetes mellitus is highly prevalent among other studied patients. 19Acute complications and Hospitalization 16.8% of the patients had DKA, 8.9% had hypoglycemia, in 2013, and by the ranking of countries according to the frequency of DKA, the current study demonstrated that the result was lower than the frequencies were observed in Saudi Arabia (44.9%), the United Arab Emirates (80%), Hungary (23%) and Finland (22%).The lowest frequencies for DKA presentation of T1DM is reported in Sweden (14%). 9Initially, a classical type of presentation was found in about twothirds of our patients, In comparison to a study conducted in Brazil, approximately 20% of patients with previously undiagnosed DM1 initially presented with DKA 21 while another study found 68% of children had DKA. 22About half of diabetic patients are admitted to the hospital, in Sweden children newly diagnosed with type 1 diabetes mellitus are admitted to the hospital for metabolic stabilization and training, even if they are not acutely ill, diabetic ketoacidosis and hypoglycemia often lead to an emergency department (ED) visit and hospital admission.In another study, in Sudan, most of the children (81%) had a history of hospital admission with DKA. 23Mortality in patients with childhood-onset type 1 diabetes in the current study was zero, during the time of the study.No chronic complication was found in all patients.Despite the developments in clinical care in recent years, the mortality risk for people developing type 1 diabetes in childhood remains high in young adult life before the onset of chronic complications. 24,25

Conclusion
Poor glycemic control was in around two-thirds of the patients and about 25% of them had acute complications and problems in school achievement.About half of the patients were admitted to the hospital.The most important co-varieties of the uncontrolled glycemic state of the patients were older age children, low educational level of the parents, and rural residence factors.SMBG, irregular visits to the Diabetic Center, and family history of diabetes were significant predictors of poor rate control.

Recommendations
The result of this study suggests that the pediatrician and endocrinologists must be critically assess the care required to these group with considering any new approaches to improve controlling their glycemic level.Special attention should be taken to develop a public health intervention strategy to educate the population and increases their awareness about the risk factors of diabetes complications.Stress on the practice of regular visit to the care Center for the proper monitoring of the disease and preventing any complication.Our finding is confirmed the need to develop a national registry for T1DM and the need for further multicenter epidemiological research studies covering the entire country to define the nationwide T1DM incidence for the related health data in Iraq.
The article is well-structured.
The most important concern is that the methodology needs to be more clearly described.How and in which time frame were participants recruited (were all T1DM patients invited or those that visited the clinics within a certain timeframe)?How high was the participation rate?Who performed the anthropometrics (the research team or was this information retrieved from the patient files)?Were lab analyses specifically performed for the study or also retrieved from patient files?
In addition, the article might benefit from language editing.

If applicable, is the statistical analysis and its interpretation appropriate? Yes
Are all the source data underlying the results available to ensure full reproducibility?
No source data required

Are the conclusions drawn adequately supported by the results? Yes
Competing Interests: No competing interests were disclosed.

Introduction
The introduction currently lacks a smooth and directive flow.It would be more effective to explicitly discuss the problem being addressed by the study, using a funnel approach that starts broad and narrows down to the specific research aims.The introduction should also incorporate a detailed explanation of the current situation, supported by relevant literature, and link these to the study's objectives.Additionally, the introduction should explain the factors influencing the variables included in the logistic regression analysis, supported by evidence from the literature.This will help set the stage for the analysis and interpretation of results.

Suggestions:
Improve Structural Flow: Revise the introduction to ensure each section logically leads to the next, connecting background information to research questions and objectives.
○ Contextualize Variables: Explain the factors influencing the variables in the logistic regression model with supporting literature.

Consistency in Terminology:
To avoid confusion, use terms like "glycemic control," "blood sugar control," and "HbA1c levels" consistently throughout the introduction.

Methods
The methods section requires reordering, with the statistical analysis discussed before the ethical approval.Additionally, not all variables included in the logistic regression analysis are explained in detail.A thorough explanation of each variable, including how they were measured and why they were included in the regression model, is crucial for the reader's understanding.

Suggestions:
Reorder Sections: Present the statistical analysis methods before discussing ethical approval to follow a logical sequence.
○ Detailed Variable Explanation: Provide a clear rationale for including each variable in the logistic regression model and describe how each was measured.
○ Clarity in Ethical Considerations: Clearly outline how ethical considerations influenced the study design, particularly in a sensitive context like pediatric diabetes.This highlights the researchers' commitment to ethical rigour.

Results
There is evidence of selective outcome reporting in the results section.Specifically, not all results from the logistic regression analysis are displayed.This selective reporting could undermine the study's credibility and the robustness of its conclusions.

Suggestions:
Comprehensive Reporting: Ensure that all results from the logistic regression analysis are presented, including both significant and non-significant findings.This transparency strengthens the study's validity.
○ Data Visualization: Incorporate more visual elements such as graphs or tables to summarize key findings, particularly from the logistic regression analysis.Visual aids help readers quickly grasp complex data and understand the relationships between variables.

○ Discussion
The discussion section inappropriately includes results that should be confined to the results section.The discussion should focus on interpreting the findings, explaining the implications of the results, and discussing them in the context of existing literature.Moreover, there is a need to explain why certain variables were significant in the logistic regression analysis, supported by relevant evidence.

Suggestions:
Restructure Content: Avoid presenting new results in the discussion.Focus on interpreting the results already presented and discussing their implications.

○
Justify Findings: Explain why certain variables were significant in the logistic regression analysis, supported by relevant literature.
○ Highlight Study's Limitations: Include a detailed discussion of the study's limitations, such as potential biases (e.g., selection bias or confounding factors), and how these were addressed or could be addressed in future research.This transparency strengthens the study's credibility.

○
Future Research Directions: Expand on the implications of the findings for future research.For example, suggest exploring significant variables further in longitudinal studies or different populations to validate the findings.

○
Impact on Clinical Practice and Policy: Discuss how the findings could influence clinical practice or public health policy, especially in the context of pediatric diabetes management.Explore how regular monitoring and family education could be better integrated into public health initiatives.

Conclusion
The conclusion currently makes statements not fully supported by the results presented.The conclusion must be directly backed by the study's findings, without overgeneralizing or making unsupported claims.

Suggestions:
Align with Results: Ensure the conclusion accurately reflects the study's results.Avoid introducing new information or making extrapolations beyond the data presented.
Clear and Concise: Summarize the key findings and their implications succinctly, reinforcing the study's contributions without overstating them.

Consistency in Terminology:
Ensure that the terminology is consistent throughout the manuscript.To avoid confusion, terms like "glycemic control," "blood sugar control," and "HbA1c levels" should be used uniformly.

Highlighting the Study's Limitations:
Acknowledge potential biases, such as selection bias or confounding factors, and discuss how these were addressed or could be mitigated in future research.This enhances the study's credibility.

Future Research Directions:
Encourage the authors to outline specific areas for future research based on their findings, such as conducting longitudinal studies or expanding the research to different populations to validate and extend the results.

Impact on Clinical Practice and Policy:
Suggest ways the findings could inform clinical guidelines or public health policies, particularly in improving pediatric diabetes management through regular monitoring and education initiatives.

Data Visualization:
I recommend using additional visual elements like graphs, charts, or tables to effectively present complex data and highlight key relationships identified in the logistic regression analysis.

Clarity and Consistency:
Ensure that all manuscript sections use consistent terminology and maintain a clear, logical flow to enhance readability and comprehension.

Kalyani Pathak
Dibrugarh University, Dibrugarh, Assam, India This paper provides valuable insights into the prevalence and epidemiological characteristics of Type 1 Diabetes Mellitus in children in Karbala.However, it would benefit from more clarity regarding the methodology.The use of a structured questionnaire, biochemical, and anthropometric measurements are mentioned, but specific details are missing.For example, it would be helpful to know the exact questions asked in the questionnaire and the nature of the biochemical measurements.Also, it would be interesting to understand how the authors controlled for potential confounding factors.
The manuscript is well-structured and provides important information on Type 1 Diabetes Mellitus in children.However, it would be beneficial to provide more context on the implications of the findings.The authors mention that only 31.6% of patients had HbA1c < 7%, but the significance of this finding for the patient population or the health care system is not discussed.It would be useful to elaborate on what these results mean for future research, public health policies, or clinical practices in Karbala.

Is the work clearly and accurately presented and does it cite the current literature? Yes
Is the study design appropriate and is the work technically sound?Yes

Are sufficient details of methods and analysis provided to allow replication by others? Yes
If applicable, is the statistical analysis and its interpretation appropriate?I cannot comment.A qualified statistician is required.
Are all the source data underlying the results available to ensure full reproducibility?Yes

Are the conclusions drawn adequately supported by the results? Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Diabetes, Traditional medicine I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.
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○ 6 .
Overall Structure and PresentationConsistency and Clarity: Maintain consistent terminology and ensure each section transitions smoothly to the next.

Table 1 .
Distribution of T1DM patients by clinical characteristics. 11

Table 2 .
Distribution of the study participants by blood glucose control status.

Table 3 .
Distribution of T1DM patients by certain clinical and behavioral factors.

Table 4 .
Logistic regression analysis (OR with 95% CI) for factors related to the glycemic state of children in Karbala city, Iraq.

the work clearly and accurately presented and does it cite the current literature? No Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Partly Competing Interests:
Focus on interpreting results, addressing limitations, and outlining future research directions without introducing new data.No competing interests were disclosed.My research is dedicated to advancing the safety and effectiveness of medication management within community and clinical settings.It emphasizes reducing prescribing errors through pharmacist-led interventions and other systematic approaches.A significant aspect of this research involves exploring the side effects of widely used medications, such as metformin in Type 2 Diabetes Mellitus, by conducting comprehensive reviews of existing studies.Collaborating with healthcare professionals aims to translate research findings into practical applications that improve patient care.Research interests extend to international collaborations, particularly between Malaysia and Thailand, focusing on drug security, medicines policy, and primary care pharmacy.The ultimate goal is to enhance patient outcomes by ensuring safer and more effective use of medications.
○ Detailed Reporting: Provide sufficient detail in the methods and results sections to allow replication and full understanding by readers.○ Transparent Reporting: To enhance the study's transparency and reliability, present all findings comprehensively, including non-significant results.○ Comprehensive Discussion: ○ Is I confirm that I

have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
Reviewer Report 30 June 2023 https://doi.org/10.5256/f1000research.138985.r180900© 2023 Pathak K.This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.