Outcomes of Health Care Services Provided to Egyptian Patients with Type 1 Diabetes Mellitus: A Single Centre Experience from a Developing Country

doi:10.21203/rs.3.rs-2011231/v1

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Outcomes of Health Care Services Provided to Egyptian Patients with Type 1 Diabetes Mellitus: A Single Centre Experience from a Developing Country

https://doi.org/10.21203/rs.3.rs-2011231/v1

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Background

Despite the existence of evidence-based guidelines for the care of children with diabetes, widespread gaps in knowledge, attitude, and practice remain.

Aim of the work:

To evaluate the current health care services provided to patients with type 1 diabetes registered in Pediatric and Adolescent Diabetology Unit (PADU), Children's hospital of Ain-Shams University, in terms of metabolic control and complications encountered.

Methods

This retrospective cross-sectional study was conducted on 672 patients attending PADU. Patients' data was extracted from their records including baseline and follow up examination and investigations.

Results

Mean age of studied patients is 12.63 ± 3.41 years, mean BMI is 20.11 ± 4.03 (kg/m²) with a median diabetes duration of 5.54 ± 3.07 years. Mean HbA1c of all patients was 8.75 ± 1.94%, with 86.9% of patients having HbA1c > 7%. The mean number of blood glucose monitoring is 2.43 ± 0.64 times/day and mean insulin dose is 1.17 ± 0.27 u/kg/day. Regarding microvascular complications 6.7% had nephropathy ,4.9% had peripheral neuropathy, no retinopathy and 10.85% had hyperlipidemia. Patients with more than 5-year-diabetes duration have significantly higher cholesterol level (167.58 ± 38.02 versus 163.23 ± 35.54 mg/dl), higher LDL (100.23 ± 29.49 versus 95.70 ± 28.11 mg/dl), and lower number of SMBG (2.24 ± 0.66 versus 2.58 ± 0.57 times/day, p < 0.05 for all).

Conclusion

These results are a testimony of the reality managing diabetes by dynamic teams striving to achieve recommended standards of care for pediatric diabetes in an environment with limited resources.

Type 1 Diabetes

Health Care

glycemic control

microvascular complications

Type 1 diabetes (T1D) is a chronic autoimmune disease that affects mainly young people. In the last 50 years, a steady increase of the T1D incidence in the young is reported worldwide, with an average 4% increase annually. In addition, the mean age at the diagnosis is decreasing ^[1].

Daily comprehensive care and periodic surveillance can minimize the risk of long-term multisystem organ complications associated with poor metabolic control, including retinopathy, nephropathy, neuropathy, cardiovascular disease, and acute complications like diabetic ketoacidosis and severe hypoglycemia ^[2].

The American Diabetes Association (ADA) recommends that “efforts to assess the quality of diabetes care and create quality improvement (QI) strategies should incorporate reliable data metrics, to promote improved processes of care and health outcomes.” by using current clinical practice recommendations to optimize diabetes care and achieve treatment goals ^[3]. QI approaches using metrics such as clinical care scores been reported in pediatric diabetes using process measures and shown to improve care delivery ^[4].

Therapeutic education for T1D involves the process of transmitting knowledge and developing the skills and behavior required to treat the disease. Guidelines agree on stressing the importance of therapeutic educational intervention in teaching self-management skills to children and adolescents with T1D ^[5].

Despite the availability of evidence-based guidelines for the care of children with diabetes mellitus, there remain large and widespread gaps between expert recommendations and the actual delivery of care. There is also marked variability in practice between centers. Therefore, it is important to standardize the collection of valid data to allow meaningful comparison of clinical practices and outcomes across centers and over time ^[6].

We aimed to evaluate the current health care services provided to patients with T1D registered in terms of metabolic control, presence of complications, and degree of patients’ knowledge.

This descriptive retrospective cross-sectional study included 672 children and adolescents with T1D attending the Pediatric and Adolescent Diabetology Unit (PADU). An informed consent in addition to an assent in adolescents were obtained from all patients and their legal guardians before enrollment in the study. This study was reviewed and approved by the local ethical committee in the Declaration of Helsinki (as revised in Brazil 2013).^[7]

Patients' data were extracted from outpatient records to fulfill the following:

I. Demographic data: age, gender, and age at onset of diabetes to calculate diabetes duration.

II. Diabetes history: insulin therapy [including insulin dose, type and mode of insulin and number of injections], frequency of SMBG, manifestations of acute complication and their frequency, manifestation of chronic complications.

III. Anthropometric assessment: Height and weight were obtained in a standardized manner using a stadiometer and electronic scale that were appropriately calibrated.

IV. Assessment of glycemic control during last year prior enrollment including a) number of hypoglycemia and/or diabetic ketoacidosis episodes; b) presence and type (s) of micro-vascular complications routinely checked periodically according to ISPAD guidelines ^[8]; c) average Hemoglobin A1c (HbA1c) [D-10 (BioRad, France)].

V. Assessment of patients’ knowledge score (0-24) using DKQ "Diabetes Knowledge Questionnaire^[9] which is a 24-item version with a reliability coefficient of 0.78, indicating internal consistency, and it also showed sensitivity to the intervention, suggesting construct validation.

VI. Laboratory Investigations:

Hemoglobin A1c (HbA1c) [D-10 (BioRad, France)]: assessment of the mean HbA1c% during the 12 months prior to enrollment in the study
Urinary albumin excretion was measured in an early morning urine sample (at 8 am) as urinary albumin-to-creatinine ratio (UACR) by an immuno-nephelometric method. Microalbuminuria as defined by UACR 30–299 mg/g creatinine was confirmed by finding of two or all of three samples abnormal over a 3- to 6-months period.^[10]
Fundus examination for retinopathy assessment was done by professional ophthalmologist through direct and indirect ophthalmoscopy.
Lipid profile including fasting serum triglycerides, total cholesterol, LDL and HDL measured by absorbance photometry on Cobas Integra 800 (Roche Diagnostics GmbH, 68298 Mannheim, Germany) using reagents supplied by the company.

VII. Associations:

Thyroid profile including free T4 and TSH
Screening of celiac disease using anti-tissue transglutaminase IgA and IgG

Statistical analysis:

Data were collected, revised, coded and entered to the Statistical Package for Social Science (IBM SPSS) version 20. The qualitative data were presented as number and percentages while quantitative data were presented as mean, standard deviations and ranges when their distribution found parametric. The comparison between two groups with qualitative data were done by using Chi-square test and/or Fisher exact test was used instead of Chi-square test when the expected count in any cell was found less than 5. The comparison between two independent groups with quantitative data and parametric distribution was done by using Independent t-test. P value was considered significant if less than 0.05.

The current study included 395 (58.8%) females and 277 (41.2%) males with mean age of 12.63 ± 3.41 years (range 4–18). Mean height is 144.38 ± 17.09 cm and mean weight is 43.34 ± 15.29 kg, and mean duration of diabetes was 5.54 ± 3.07 years. The mean HbA1c was 8.75 ± 1.94% (range 5.5–16%), mean cholesterol was 165.09 ± 36.66 (range 65–336 mg/dl), mean HDL was 52.81 ± 16.46 (range 18–134 mg/dl), mean LDL 97.63 ± 28.77 mg/dl (range 5–244 ) and median TSH (IQR) was 2.1 (1.4–2.93(µU/ml)) (range 0.01–18.7); 13 (1.9%) patients had hypothyroidism while 9 patients (1.3%) had celiac disease. The frequency of severe hypoglycemia was 16.7% and DKA with hospitalization was 30.5% with median (IQR) 1 (1–2) range 1–6 attacks / year.

Only nine (1.3%) patients used insulin pump while the rest of the patients were on insulin injection with mean number of injections per day 4.37 ± 0.53. Majority of patients; 340 (50.6%) were using basal bolus insulin analogues while 323 (48.1%) were using NPH. The mean number of SMBG per day was 2.43 ± 0.64 times. Microalbuminuria was detected in 45 (6.7%) of the patients and sensory neuropathy symptoms (numbness, burning pain) was positive in 33 (4.9%) patients while none of the patients had retinopathy.

The parents of children and adolescents with T1D demonstrated a satisfactory level of theoretical knowledge of therapeutic conduct and self-monitoring principles with a mean 17.17 ± 2.63. Yet, knowledge is poor in some items related to basic knowledge about etiology of diabetes.

Patients with longer duration of diabetes (> 5 years) had significantly higher cholesterol level, LDL, higher blood pressure and lower attacks of DKA. (p < 0.05) [Table 1].

Patients older than 11 years are significantly shorter and thinner than younger colleagues with less frequent attacks of DKA. They have higher blood pressure, higher insulin dose and higher lipid profile than those less than 11 years old [Table 1].

Patients with microvascular complications are older in age with longer duration of diabetes, higher blood pressure, more attacks of hypoglycemia and DKA, higher lipid profile [Table 2].

Patients achieving standards of care are found to be 88(13%) with good glycemic control (HbA1c < 7%), 566 patients (84.2%) with desirable cholesterol level (less than 200 mg/dl), 408 (60.7%) with targeted LDL level(less than 100 mg/dl), 630 patients (93.8%) with triglycerides level less than 150 mg/dl[Table 3].

The current study was planned to evaluate current health care services in terms of metabolic control and complications encountered in patients with T1D registered at PADU, Children's hospital, Ain-Shams University. All eligible patients were included with a total of 672 T1D children and adolescents

Glycemic control

Results of present study showed that the glycemic control was poor among patients with a mean HbA1c of 8.75 ± 1.94%, a median of 10.3% and only 88 (13.1%) of patients achieved glycemic targets with HbA1c < 7%. In our region, mean HbA1c was 8.8% in 228 T1D with a mean age of 10.99 years in a study carried out in Saudi Arabia ^[11]. Poor glycemic control found was similar to the published data from another cross-sectional study in China, which showed that mean HbA1c value was > 75 mmol/mol (9.0%). Also, it was found that the mean HbA1c values were in a high level in all age interval and showed a downward trend with age ^[12]. In Jordan, the percentage of children who achieved target HbA1c of < 7.5% was 20.5% ^[13].

In developed countries figures were not very far as in Italy, 28.1% of T1D reached target HbA1c values of < 7.5% ^[14]. A figure of 18% of T1D achieved HbA1c < 7.5% in a cohort of 240 patients aged 13 to18 years, with diabetes duration more than 5 years at Barbara Davis Center for Childhood Diabetes ^[15]. In Tanzania, only 4 out of 150 patients achieved target HbA1c < 7.5% ^[16].

It is noteworthy mentioning that in our study, pubertal and adolescents above the age of 11 years constituted 65.8% (442/672) of enrolled patients whose mean HbA1c was 8.85%. It does not explain why mean of the whole group was high. Those younger than 11 years, displayed also high mean HbA1c of 8.55%. All patients are receiving basal-bolus insulin, a minority were on insulin pump and the mean SMBG was 2.43 times /day. However, poor adherence to nutrition therapy, longtime spent watching T.V or using mobile games, and poor regular exercise may explain high HbA1c in young T1D patients.

As expected, adolescents are poorly controlled due to psychiatric problems, eating problems, and poor adherence to therapy ^[17]. Despite the availability of more advanced insulin analogs, glucose monitoring, and insulin delivery devices nowadays, adolescents remain unable to achieve optimal glycemic control ^[18]. T1D Exchange Clinic Registry revealed that 83% of adolescents have HbA1c levels above 7.5% (58 mmol/mol) ^[19]. The DCCT has found a mean HbA1c of intensively treated adolescents with T1D of 8.1% (65 mmol/mol) which is higher than the corresponding adult cohort of 7.1% (65 mmol/mol) ^[20]. This important difference between developed and developing countries mostly reflects the impact of economic level on diabetes management since diabetes represent a huge economic burden for the families ^[21].

It is known that puberty can affect metabolic control, leading to higher HbA1c levels. We conducted this investigation by splitting participants into two groups based on their age (Group 1 ≤ 11 years, Group 2 > 11 years). Those in Group 2 had higher levels HbA1c, and we noticed a correlation between higher age and higher HbA1c levels on a group level which we believe can at least partly be explained by a rapid growth and increase of hormones in puberty that affect insulin sensitivity ^[22].

The differences of level of HbA1c values between different studies may be due to ethnicity, clinical characteristics, parental education, and income level, but the most important factor could be overall quality of care ^[23].

Gender in the current study was not associated with metabolic control, which was also reported by others ^[11],[13]. Evidence from other studies concerning gender was conflicting; female gender was associated with poor HbA1c by Rosenbauer et al., 2012 ^[23]. There was also a gender difference as female patients have higher HbA1c than males at diagnosis as well as at follow up of 13 034 patients under 18 years ^[24]. A constant HbA1c sex differences from 2004 to 2018 with lower HbA1c level in females was also reported ^[25]

In the present study, contrary to many researchers ^[26],[13] mean diabetes duration was comparable in patients who achieved target HbA1c (≤ 7%) and those who did not. Results support the poor control of the whole groups as only 13.1% achieved target HbA1c. Meanwhile patients with longer diabetes duration (≥ 5 years) have poor metabolic control reflected by higher lipid profile and poor growth parameters.

Self-monitoring blood glucose (SMBG) provides a “snapshot” of the glucose values, and it is used both to titrate prandial insulin doses and to define correction bolus. The relationship between HbA1c and complications may not be the same as the relationship between mean blood glucose and complications. HbA1c does not distinguish individuals with similar average glycemia but with pronounced differences in hypoglycemic events and/or hyperglycemic excursions. Although HbA1c is important for monitoring diabetic patients to ensure good glycemic control, glucose variability and time in range glucose monitoring is as important as HbA1c to avoid long term complications ^[27].

A poor glycemic control among children probably reflects the existing limitations of diabetes care, including lack of insulin supply, but also lack of knowledge and motivation with inappropriate dosing of insulin, poor monitoring practices, or missing insulin doses, and sometimes due to school-based stigma. In contrast to developed countries where intensive diabetes treatment is offered, children in low-income countries often receive conventional insulin treatment in an inconsistent manner ^[28].

Growth parameters

The current study showed that the frequency of being overweight, or obesity was 11.4% and mean BMI was significantly higher in girls, in patients older than 11 years and with longer diabetic duration. Obesity affects large amounts of patients with T1D across their lifetime, with a prevalence that has increased during recent decades, and with rates ranging between 2.8% and 37.1% ^[29].

The dramatic increase in the prevalence of overweight and obesity worldwide affects patients with T1D which are especially vulnerable to excess weight. In this regard, increased BMI in T1D is associated with a greater cardiometabolic risk and enhanced development of chronic complications compared to lean patients with T1D. On the other hand, insulin resistance leads to high insulin requirements and hinders glycemic control and weight management ^[30]. Weight change in TID is complex. Factors that may affect weight gain in patients with T1DM include the level of glycemic control, intensive insulin treatment, pattern of treatment, pubertal status, the presence of eating disorders and appearance of complications (such as thyroid disease or gastric disease) ^[31].

Additionally, growth parameters were compromised in diabetic children compared to the controls. Despite advances in medical care of children with T1DM, growth remains sub-optimal and likely reflects ongoing metabolic derangement ^[32].

Knowledge

Therapeutic education for T1D involves the process of transmitting knowledge and developing the skills and behavior required to treat the disease. ^[5] We used "Diabetes Knowledge Questionnaire (DKQ) which is a 24-item version. The parents of children and adolescents with type 1 diabetes demonstrated a satisfactory level of theoretical knowledge of therapeutic conduct and self-monitoring principles with a mean 17.17 ± 2.63. Poorer metabolic control in some patients suggests that metabolic control in type 1 diabetes depends on factors other than education ^[33]. Yet, knowledge is poor in some items related to basic knowledge about etiology of diabetes. Knowledge about hypoglycemia symptoms and blood glucose level of hyperglycemia is scoring good. Effective health education improves knowledge, attitude, and practices, particularly with regard to lifestyle modifications and dietary management, culminating into better glycemic control ^[34].

Acute complications

The frequency of severe hypoglycemia was 16.7% and DKA with hospitalization was 30.5% in the current study, both were more frequently reported by female patients, those more than 11 years old, and in those with microvascular complications. In addition, hypoglycemia was associated with poor glycemic control and DKA with longer diabetes duration more than 5 years.

In an earlier study, the incidence of ketoacidosis was 8 per 100 person-years and increased with age in girls, with higher HbA1c, and insulin dose. The incidence of severe hypoglycemia was 19 per 100 person-years. In younger children, the risk of severe hypoglycemia increased with diabetes duration and underinsurance. In older children, the risk of severe hypoglycemia increased with duration, underinsurance, lower HbA1c, and presence of psychiatric disorders ^[35]. In Tanzania, a study enrolled 150 young with T1D with mean age was 16 years (SD 5.9 years) and average duration of 1 year and 3 months (IQR 1 to 2 years). The most frequently reported complications in the preceding three months were hyperglycemia (n = 25) followed by DKA (n = 18) and hypoglycemia (n = 4). Hyperglycemia and hypoglycemia were more prevalent in adolescents and young adults, whilst DKA was more commonly reported in children ^[16].

Microvascular complications

Overall, microvascular complications (MVC) of T1D, occurred with frequency of 6.7% and 4.9%, nephropathy and peripheral neuropathy respectively. The same cohort were assessed earlier, and results were more or less close as peripheral neuropathy, retinopathy, and persistent microalbuminuria were present in 6.3%, 1.8%, and 6.8%, respectively ^[36].

This frequency is low as compared to another study on Egyptian T1D children and adolescents. In Egypt, Assiut governorate, a study was conducted on 180 T1D aged between 6 and 21 years, and results revealed that the prevalence of microalbuminuria was higher accounting for 20.5%, and macroalbuminuria was found in 7.8%. Diabetic retinopathy was detected in 1.1%, and diabetic neuropathy in 5.5%. They were more frequent among poor glycemic and dys-lipidemic patients ^[37].

in the Waikato region, children and youth with T1D with a duration of diabetes of ≥ 10 years, microvascular disease prevalence improved from 2003 where the prevalence of diabetic retinopathy and nephropathy of 26.4% and 25.4%, respectively. In 2017, the corresponding figures were 6% for non-proliferative retinopathy, 6% for microalbuminuria. Symptomatic diabetic neuropathy was the same accounting for 3%. The mean HbA1c in Waikato youth with T1D has not changed over the past 14 years. Furthermore, less than one in six children and youth in the 2017 cohort were meeting their recommended glycemic targets ^[38].

In Norway, retinopathy was found in 16% and nephropathy in 13% of the population (874 T1D half of them aged 14–17 years, a median diabetes duration of 9 years). Patients transferring from the pediatric department to adult care between the ages of 14 and 17 years had higher median HbA1c and prevalence of late complications than those transferring at ages 18–22 year ^[39].

In Congo, retinopathy prevalence was 6.4% (n = 4), the four patients with diabetic retinopathy had disease duration more than 5 years. Microalbuminuria was detected in 21% (n = 13) and 14.5% (n = 9) were at risk of developing microalbuminuria (A/C ratio between 20 mg/g and 29 mg/g). The prevalence of diabetic neuropathy was 1.6% (n = 1). There was a statistically significant association between the HbA1c level and the presence of microalbuminuria. Glycemic control was poor with 12.9–14.5% of patients met the optimal control target as set by the ISPAD (HbA1c < 7.5% or < 58 mmol/mol). All the patients were on either premixed insulin alone or premixed plus regular insulin ^[40].

Our results showed lower frequency of MVC without improved HbA1c. Similar findings were reported in others who have also shown a marked decline in the incidence of diabetic retinopathy and nephropathy without significant temporal improvements in HbA1c levels ^[41],[42].

Presence of microvascular complications in the present study was associated with older age, longer diabetes duration, and dyslipidemia (higher mean total cholesterol, LDL and triglycerides). Also, acute complications in terms of severe hypoglycemia and DKA episodes occurred more frequently in those with MVC. Although mean HbA1c was higher (9.05% versus 8.72%), but the difference was not significant.

In a meta-analysis involving 758 youth with T1D, the key risk factors for diabetic polyneuropathy and cardiac autonomic neuropathy were hyperglycemia/HbA1c, age, diabetes duration, the presence of other microvascular complications, waist/height ratio, lipid profile and blood pressure. For cardiac autonomic neuropathy, additional risk factors were cigarette smoking, BMI and total daily insulin ^[43] Diabetes duration, A1C, dyslipidemia, blood pressure, and male sex were identified as risk factors for nephropathy ^[41].

Thus, preventing acute complications such as hypoglycemia and chronic complications that may develop over time, improving self-efficacy for disease management, and developing a deeper understanding of the disease will help people come to terms with their diagnosis and improve the quality of life of people living with T1D ^[44].

Dyslipidemia

Our study represents retrospective data from a single large diabetes care center in which we found borderline and high levels of total cholesterol in 15.8%, LDL-C in 13%, and Triglycerides (TG) in 6.2% of children and adolescents with T1DM. An exceedingly higher figure were reported by others; 64% ^[45] and 65% in a previous Egyptian study done on 60 children and adolescents ^[46].

In the retrospective study of Soliman and Ibrahim on 806 children and adolescents with T1DM, dyslipidemia was represented 70.47%. As regards the pattern of dyslipidemia, high LDL and low HDL were the most frequent abnormalities in the study group; 62.16%, 60.21%, respectively ^[47].

Diabetic dyslipidemia involves a triad of elevation in the level of TG, with decrease in HDL-C, and formation of small dense LDL particles, and diabetic are at either very high, high, or at least moderate risk of cardiovascular disease ^[48] Researchers demonstrated that 37% of the Egyptian population has elevated blood cholesterol levels ^[49].

In the present study, lipid profile was assessed among variables, and it was found that female patients displayed higher mean total cholesterol and HDL-C. Patients 11 years and older, and those with microvascular complications have got higher mean total cholesterol, LDL-cholesterol and triglycerides. LDL-cholesterol only was higher in patients more than 5 years diabetes duration. Patients with poor glycemic control have got lower HDL-cholesterol. As regards the pattern of dyslipidemia, high LDL and low HDL were the most frequent abnormalities in the study group. This is in line with many previous studies. One study documented that increased TC and LDL were the main abnormalities ^[46]. Dyslipidemia was reported in T1D in the form of high LDL-cholesterol and was related to longer diabetes duration ^[50] The primary target for prevention of cardiovascular disease in patients with DM remains LDL-cholesterol ^[51].

In the current study, it was found that hyperlipidemia was accompanied by higher diastolic blood pressure in patients older than 11 years old, but in patients with more than 5 years duration, although both mean systolic and diastolic BP were higher, the difference did not reach statistical significance. High lipid profile and blood pressure put patients at risk of chronic complications. Atherosclerosis starts early in life and relates to dyslipidemia which is potentially modifiable risk factor for cardiovascular disease in youth with T1D ^[52].

In another study conducted on 576 T1D aged 10–18 years, patients with dyslipidemia had significantly lower mean body mass index significantly higher median fasting blood sugar higher median glycosylated hemoglobin and also hypertension was significantly higher in dyslipidemic patients ^[45] Another study reported that age, BMI, HbA1c, and poor metabolic control were significantly higher in cases with dyslipidemia ^[53].

The wide range of prevalence and patterns of dyslipidemia in different studies may be due to multiple genetic factors in different ethnicities ^[3].

Despite a low frequency of microvascular complications, our results demonstrated that management of children and adolescents with type 1 diabetes in our center is not optimal in terms of glycemic control. The latter is correlated with many modifiable variables, namely, lipids, insulin dose, and hypoglycemic episodes. Dissemination of results and prospective projects serve as further motivation to improve outcome and more uniform care for patients with diabetes.

ADA

American Diabetes Association

BMI

body mass index

DKA

diabetic ketoacidosis

DKQ

Diabetes Knowledge Questionnaire

HbA1c

Glycated hemoglobin

ISPAD

International Society for Pediatric and Adolescent Diabetes

MCV

microvascular complications

PADU

Pediatric and Adolescent Diabetology Unit

Quality improvement

SMBG

self -monitoring blood glucose

T1D

Type 1 diabetes

UACR

urinary albumin-to-creatinine ratio

Funding: “The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.”

Conflicts of interest/Competing interests: “The authors have no relevant financial or non-financial interests to disclose.”

Availability of data and material: Data are available on request

Authors' contributions: “All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Safinaz Adel Elhabashy, Nancy Samir Elbarbary, Ahmed Abdelhameed Hassan, and Rasha Adel Thabet. The first draft of the manuscript was written by Nancy Elbarbary and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.”

Ethics approval: “This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Ain Shams University, Cairo, Egypt on 13 June 2020.

Consent to participate: “Informed consent was obtained from all individual participants included in the study.”

Consent for publication: consent to publish has been received from all participants should appear in the manuscript.

Acknowledgment: We wish to express our sincere appreciation to all the patients and their families following in the Pediatric Diabetes Clinic, Children’s Hospital, Ain Shams University for their cooperation during the study period.

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Table 1

Descriptive and comparative analysis of patients with type 1 diabetes
Variables	All patients N = 672	Boys N = 277	Girls N = 395	p	< 5 years duration N = 385	≥ 5 years duration N = 287	p	Age < 11 years N = 230	Age ≥ 11 years N = 442	P
Age (years)				0.064			0.000			0.000
Mean ± SD	12.63 ± 3.41	12.92 ± 3.14	12.43 ± 3.58	0.064	11.70 ± 3.47	13.88 ± 2.91	0.000	7.61 ± 1.88	14.00 ± 2.12	0.000
Social class				0.451			0.911			0.615
Low	475 (70.8%)	214(77.2%)	261(66%)		277(71.9%)	198(68.9%)		157(68.2%)	319 (72.1%)
Middle	91 (13.5%)	28(10%)	63 (15.9%)		51(13.2%)	40(13.9%)		36 (15.6%)	54 (12.2%)
Very Low	106 (15.7%)	35(12.8%)	71 (18.1%)		57(14.9%)	49(17.2%)		37 (16.2%)	69 (15.7%)
Diabetes Duration (year)				0.788			0.000			0.000
Mean ± SD	5.54 ± 3.07	5.50 ± 2.94	5.57 ± 3.16	0.788	2.28 ± 1.16	7.45 ± 2.43	0.000	3.15 ± 2.11	5.78 ± 3.36	0.000
Insulin dose U/kg/day				0.402			0.000			0.002
Mean ± SD	1.17 ± 0.27	1.16 ± 0.26	1.18 ± 0.28	0.402	1.14 ± 0.26	1.22 ± 0.28	0.000	1.13 ± 0.28	1.20 ± 0.27	0.002
Severe hypoglycemia in last year Median (IQR)	112 (16.7%) 2 (1–4)	33 (11.9%) 3 (1–4)	79 (20.0%) 2 (1–3)	0.006	62 (16.1%) 2 (1–3)	50 (17.4%) 2 (1–4)	0.050	14 (6.1%) 1 (1–2)	98 (22.2%) 3 (1–4)	0.000
DKA in last year Median (IQR)	205 (30.5%) 1 (1–2)	65 (23.5%) 1 (1–2)	140 (35.4%) 1 (1–2)	0.001	130 (33.8%) 1 (1–2)	75 (26.1%) 1 (1–2)	0.000	38 (16.5%) 1 (1–1)	167 (37.8%) 1 (1–2)	0.000
Nephropathy positive Negative	45 (6.7%) 627 (93.3%)	15(5.4%) 262(94.6%)	30(7.6%) 365(92.4%)	0.266	13(3.4%) 372(96.6%)	32(11.1%) 255(88.9%)	0.000	8(3.5%) 222(96.5%)	37(8.4%) 405(91.6%)	0.016
Neuropathy positive Negative	33 (4.9%) 693(95.1%)	7(2.5%) 270(97.5%)	26(6.6%) 369(93.4%)	0.017	9(2.4%) 376(97.6%)	24(8.4%) 263(91.6%)	0.000	5(2.2%) 225(97.8%)	28(6.3%) 414(93.7%)	0.018
Retinopathy positive Negative	0(0%) 672 (100.0%)	0(0%) 262 (100.0%)	0(0%) 358 (100.0%)	NA	0(0%) 385 (100.0%)	0(0%) 287 (100.0%)	NA	0(0%) 230 (100.0%)	0(0%) 442 (100.0%)	NA
Combined	26(3.8%)	6(2.6%)	20(5%)	0.000	6(1.6%)	20(7%)	0.000	5(2.2%)	21(4.7%)	0.000
Weight PC percentiles				0.760			0.000			0.000
Mean ± SD	43.46 ± 26.54	43.55 ± 14.52	43.18 ± 15.83	0.760	39.94 ± 15.10	47.89 ± 14.36	0.000	51.30 ± 23.79	37.91 ± 27.01	0.000
Weight < 3rd percentile Between 3rd and 97th > 97th PC	44 (6.5%) 600 (89.2%) 28 (4.3%)	26 (9.3%) 232 (83.7%) 19 (7%)	18 (4.5%) 368 (93.1%) 9 (2.4%)	0.000	20 (5.1%) 364 (94.6%) 1 (0.3%)	24 (8.3%) 236 (82.2%) 27(9.5%)	0.111	5 (2.1%) 215 (93.5%) 10 (4.4%)	39 (8.8%) 385 (87.1%) 18 (4.1%)	0.000
Height percentiles				0.642			0.131			0.000
Mean ± SD	38.63 ± 29.32	39.27 ± 30.54	38.16 ± 28.44	0.642	40.29 ± 28.97	36.73 ± 29.66	0.131	45.51 ± 29.93	33.76 ± 27.92	0.000
Height < 3rd percentile Between 3rd and 97th > 97th PC	67 (10.0%) 595 (88.5%) 10 (1.5%)	32 (11.5%) 236 (85.1%) 9 (3.4%)	35 (8.8%) 359 (90.8%) 1 (0.4%)	0.097	31 (8%) 345 (89.6%) 9 (2.4%)	36 (12.5%) 250 (87.1%) 1 (0.4%)	0.543	21 (9.1%) 208 (90.5%) 1 (0.4%)	46 (10.4%) 387 (87.5%) 9 (2.1%)	0.006
BMI (kg/M²)				0.001			0.000			0.000
Mean ± SD	20.11 ± 4.03	19.48 ± 3.60	20.55 ± 4.25	0.001	19.48 ± 3.91	20.95 ± 4.03	0.000	17.64 ± 2.95	21.39 ± 3.91	0.000
Blood pressure systolic (mmHg)				0.480			0.000			0.000
Mean ± SD	109.52 ± 7.37	109.28 ± 7.48	109.69 ± 7.30	0.480	108.64 ± 7.74	110.70 ± 6.67	0.000	107.64 ± 7.94	110.49 ± 6.87	0.000
Blood pressure diastolic (mmHg)				0.896			0.000			0.000
Mean ± SD	69.34 ± 5.89	69.31 ± 5.64	69.37 ± 6.06	0.896	68.56 ± 5.98	70.39 ± 5.61	0.000	67.87 ± 5.74	70.11 ± 5.83	0.000
HbA1c (%) Mean ± SD ≥ 7 < 7	8.75 ± 1.94 584(87%) 88(13%)	8.69 ± 1.90 245 (88.4%) 32 (11.6%)	8.83 ± 1.89 339 (85.8%) 56 (14.2%)	0.838 0.321	8.85 ± 2.03 339 (88.1%) 46 (11.9%)	8.61 ± 1.81 245 (85.4%) 42 (14.6%)	0.109 0.307	8.55 ± 1.56 206 (89.6%) 24 (10.4%)	8.85 ± 2.10 378 (85.5%) 64 (14.5%)	0.261 0.140
Serum Lipids: Total cholesterol (mg/dl) LDL (mg/dl) HDL (mg/dl) Triglycerides (mg/dl)	165.09 ± 36.66 97.63 ± 28.77 52.81 ± 16.46 86.60 ± 41.31	160.95 ± 32.51 96.43 ± 27.42 51.49 ± 14.88 81.17 ± 33.88	167.99 ± 39.08 98.47 ± 29.69 53.74 ± 17.44 90.41 ± 45.47	0.001 0.239 0.020 0.084	163.23 ± 35.54 95.70 ± 28.11 52.70 ± 16.40 84.33 ± 44.08	167.58 ± 38.02 100.23 ± 29.49 52.95 ± 16.56 89.65 ± 37.14	0.129 0.043 0.845 0.099	154.50 ± 31.06 88.19 ± 21.52 54.40 ± 18.84 75.16 ± 26.50	170.60 ± 38.14 102.54 ± 30.80 51.98 ± 15.03 92.56 ± 46.13	0.000 0.000 0.071 0.000
TSH (µU/ml) Median (IQR)	2.1 (1.4–2.93)	2.03 (1.4–2.85)	2.17 (1.4–2.98)	0.192	2.18 (1.55–2.99)	2.08 (1.4–2.93)	0.689	2.02 (1.4–2.82)	2.15 (1.4–2.98)	0.391
Free T4 (ng/dL) Mean ± SD	3.15 ± 3.37	3.10 ± 3.26	3.18 ± 3.44	0.768	3.06 ± 3.38	3.27 ± 3.36	0.419	3.21 ± 3.21	3.12 ± 3.45	0.740
DKA: Diabetic Ketoacidosis, BMI: body mass index, HA1c: glycated hemoglobin, LDL: low density lipoprotein, HDL: high density lipoprotein, TSH: thyroid stimulating hormone
*: Chi-square test, •: Independent t-test

Table (2): Disease outcomes of type 1 diabetes regarding microvascular complications (MVC).

		Microvascular complications(MVC)		P-value
		Without MVC	With MVC
		No. = 620	No. = 52
Sex	Female	359 (57.9%)	36 (69.2%)	0.111
	Male	261 (42.1%)	16 (30.8%)
Age in years	Mean ± SD	12.48 ± 3.44	14.44 ± 2.45	0.000
	Range	4 – 18	10 – 18
Age groups	Age <=11	222 (35.8%)	8 (15.4%)	0.003
	Age>11	398 (64.2%)	44 (84.6%)
Social class	Low Middle Very low	454 (73.2%) 81 (13.0%) 85 (13.8%)	21 (40.0%) 10 (20.0%) 21 (40.0%)	0.402
duration of diabetes(years)	Mean ± SD	5.39 ± 3.01	7.33 ± 3.23	0.000
duration of diabetes groups	Duration <=5	369 (59.5%)	16 (30.8%)	0.000
	Duration >5	251 (40.5%)	36 (69.2%)
daily insulin dose (unit per kg)	Mean ± SD	1.17 ± 0.27	1.21 ± 0.33	0.332
Insulin type	NPH Basal-bolus Analog Insulin pump	299 (48.2%) 312 (50.3%) 9 (1.5%)	24 (46.2%) 28 (53.8%) 0 (0.0%)	0.633
Severe hypoglycemia in the last year	Yes Median (IQR)	93 (15.0%) 2 (1 – 4)	19 (36.5%) 2 (2 – 4)	0.000
DKA leading to hospitalization	Yes Median (IQR)	176 (28.4%) 1 (1 – 2)	29 (55.8%) 1 (1 – 2)	0.001
Height (cm)	Mean ± SD	143.72 ± 17.28	152.17 ± 12.25	0.001
height percentile	Median (IQR)	25 (10 – 50)	25 (17.5 – 75)	0.723
Weight (kilogram)	Mean ± SD	42.79 ± 15.30	49.88 ± 13.64	0.001
weight percentile	Median (IQR)	50 (25 – 50)	25 (10 – 50)	0.158
BMI	Mean ± SD	20.02 ± 3.99	21.18 ± 4.33	0.045
Blood pressure systolic (mmHg)	Mean ± SD	109.31 ± 7.43	112.02 ± 6.12	0.011
Blood pressure systolic (mmHg)	Range	80 – 130	100 – 130	0.011
Blood pressure diastolic (mmHg)	Mean ± SD	69.25 ± 5.93	70.38 ± 5.32	0.184
Blood pressure diastolic (mmHg)	Range	50 – 90	60 – 80	0.184
HbA1c (%))	Mean ± SD	8.72 ± 1.89	9.05 ± 2.47	0.247
HbA1c groups	Good glycemic control	78 (12.6%)	10 (19.2%)	0.172
HbA1c groups	Poor glycemic control	542 (87.4%)	42 (80.8%)	0.172
Cholesterol(mg/dl)	Mean ± SD	163.48 ± 35.32	184.33 ± 46.16	0.000
HDL(mg/dl)	Mean ± SD	52.47 ± 16.43	56.88 ± 16.40	0.063
LDL(mg/dl)	Mean ± SD	96.68 ± 27.63	109.02 ± 38.52	0.003
Triglyceride(mg/dl)	Mean ± SD	85.57 ± 40.48	98.94 ± 49.03	0.025
TSH (µU/ml)	Median (IQR)	2.1 (1.41 – 2.94)	1.69 (1.21 – 2.77)	0.122
Free T4 (ng/dL)	Mean ± SD	3.11 ± 3.25	3.61 ± 4.52	0.304

DKA: Diabetic Ketoacidosis, NPH: Neutral Protamine Hagedorn, BMI: body mass index, HA1c: glycated hemoglobin, LDL: low density lipoprotein, HDL: high density lipoprotein, TSH: thyroid stimulating hormone. *: Chi-square test, •: Independent t-test

Table (3): Patients achieving standards of care

Variables

Number (%)

HbA1c <7%

88 (13%)

Lipids

Total cholesterol (< 200) (mg/dl)

LDL (<100) (mg/dl)

Triglycerides (<150) (mg/dl)

566 (84.2%)

408 (60.7%)

630 (93.8%)

No microvascular complications

In patients > 11 years old

398 (90.0%)

No microvascular complications

In patients > 5 years duration

251 (87.5%)

HA1c: glycated hemoglobin, LDL: low density lipoprotein, HDL: high density lipoprotein

No competing interests reported.

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Outcomes of Health Care Services Provided to Egyptian Patients with Type 1 Diabetes Mellitus: A Single Centre Experience from a Developing Country

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