Establishing the Saudi pediatric and youth diabetes registry: initial data and challenges.

The Saudi National Diabetes Registry focuses mainly on adult patients. In 2020, the National Guard Health Authority (NGHA) launched the Saudi Pediatric and Youth Diabetes Registry (SPYDR), for children and adolescents with diabetes. This report is about the first data and the challenges we faced during SPYDR initiation. Patients were identified from the electronic medical records of the Saudi NGHA hospitals using the International Classification of Disease (ICD-10). A trained coordinator verified the diagnosis and entered patients' details into the registry and a random sample was validated by experienced endocrinologists. The data were analyzed according to patients' demography, diabetes subtypes, duration, control, and complications. The challenges faced by the team were identified and addressed. At the time of manuscript submission, 2,344 individuals were enrolled. Their mean age at diagnosis was 9.08 (±4.27) years and 1,136 (48.46%) were females. Of these, 91.3% have type 1 (T1D), and 6.4% have type 2 diabetes (T2D). The mean HbA1c was 10.45% (±2.36) and duration of diabetes was 5.31 (±3.05) years. The main challenges included the COVID-19 pandemic, data validation, and centers' participation. However, within 12 months of initiation enrolled subjects matched the expected number. Despite the challenges, the first step of SPYDR was achieved. The initial data confirmed that T1D is the most common form of childhood diabetes, and the frequency of T2D is comparable to regional and international data. SPYDR provides the infrastructure for data sharing and collaborative research with the enrollment of patients from other Saudi healthcare institutes.

Optimizing Diabetes Management Using a Low-Calorie Diet in Saudi Arabia: A Cost-Benefit Analysis.

BACKGROUND: Low-calorie diets, high in protein and low in carbohydrates, are commonly recommended for patients with pre-diabetes and type 2 diabetes. The objective of this study was to carry out a cost-benefit analysis (CBA) of a low-calorie versus a standard diet from the perspective of the Saudi Arabian health system. METHODS: The CBA compares costs and benefits of the two diet strategies over a 1-year time horizon. Costs included diet and diabetes treatment-related resources while benefits were measured in terms of the costs of diabetes complications avoided. Data on costs and benefits were collected from published literature and subject matter experts. Incremental costs were estimated as the cost difference between low-calorie and standard diet. Incremental benefits were estimated as cost difference from medical complications when following a low-calorie or standard diet. The incremental absolute cost-benefit ratio was calculated to show the difference between the costs and benefits of the low-calorie diet. Incremental relative cost-benefit ratio was calculated to show the cost per dollar of benefit obtained. Monte Carlo simulation modeled variability in outcomes due to variation in costs and uncertainty of diabetes complications. RESULTS: The 1 year cost of standard diet was US$2515 ± 156 compared to US$2469 ± 107 per patient for a low-calorie diet. Incremental benefit is estimated at US$21,438 ± 7367 per patient. The estimated incremental absolute cost-benefit ratio was US$ - 21,360 establishing that benefits are greater than costs, while the estimated incremental relative cost-benefit ratio is 0.0037, establishing that benefits are 270 times greater than costs. CONCLUSION: The low-calorie diet was the dominant strategy compared to the standard diet in modeled scenarios. These findings highlight the importance of a low-calorie diet as part of diabetes management programs for outpatients with type 2 diabetes.

Evaluating the Clinical Effectiveness and Safety of Semaglutide in Individuals with Uncontrolled Type 2 Diabetes. Real-World Evidence from Saudi Arabia: The Observational, Multicenter, 15-Month EVOLUTION Study.

INTRODUCTION: This study aimed to assess the safety and effectiveness of semaglutide, administered either by weekly subcutaneous (SC) injection or orally, in real-life practice in Saudi Arabia in individuals with type 2 diabetes mellitus (T2DM). METHODS: A retrospective chart review study was conducted at 18 Saudi Arabia centers. An accredited centralized institutional review board approved the study. Medical records were included for individuals of any age ≥ 18 years with uncontrolled T2DM. The primary outcome measure was the laboratory glycated hemoglobin (HbA1c) level. Secondary measures included fasting blood glucose (FBG), weight, and hypoglycemia. All variables were checked after 6 and 12 months of semaglutide initiation. RESULTS: The analysis of this study included 1223 patients with uncontrolled T2DM (HbA1c > 7%). The mean (SD) baseline HbA1c was 10.02% (1.17). HbA1c was reduced by an average of 3.02% (0.84) and 3.17% (0.84) at 6 and 12 months, respectively. Results of a repeated measure analysis of variance (ANOVA) indicated significant differences in HbA1c (p value < 0.001). HbA1c levels at 6 and 12 months were significantly lower, 7.00% (0.70) and 6.85% (0.69), than at baseline, 10.02% (1.17). About 193 patients (56.4%) of the 295 patients having HbA1c < 9% achieved HbA1c of 5.7% or less. The frequency of hypoglycemia events was 4.60 (1.10) in the 3 months before semaglutide was initiated. The frequency of hypoglycemia events in the last 3 months was 2.30 (0.80) events and 0.80 (0.50) events at 6-month and 12-month follow-up visits, respectively. The percent reduction in body mass index (BMI) was an average of 13.07% (1.53) and 19.89% (4.07) at 6 and 12 months, respectively. Lipid profile and blood pressure were improved at 6 and 12 months. CONCLUSION: Semaglutide, administered either by SC injection or orally, provided substantial glycemic and weight-loss benefits in adults with T2DM.

Impact of sodium-glucose cotransporter-2 inhibitors on kidney outcomes in type 2 diabetes: A tertiary center experience.

BACKGROUND: Diabetic nephropathy (DN) is a complication of chronic hyperglycemia associated with diabetes mellitus (DM). Several studies have demonstrated the positive impact of sodium-glucose cotransporter-2 (SGLT2) inhibitors on kidney outcomes. The objective of the study was to evaluate the effects of dapagliflozin, an SGLT2 inhibitor, on kidney outcomes in Saudi patients with type 2 DM. MATERIALS AND METHODS: Study included all Saudi patients with type 2 DM who visited our center from August 1, 2021, to July 31, 2022, and had been on dapagliflozin for at least 3 months. Data was abstracted through chart review for all patients included in the study. Paired t-test or Wilcoxon signed-rank test were used to compare the results before and after treatment for continuous variables and the McNemar test was used to compare the results for categorical data. RESULTS: Study included 184 Saudi patients with type 2 diabetes with a mean age of 61.32 years (SD=9.37). Dapagliflozin 10 mg/day significantly reduced hemoglobin A1C (HbA1C) from a mean (SD) of 9.00 to 8.40 (P < 0.001). Among a subgroup of patients with significant proteinuria (n = 83), dapagliflozin significantly reduced ACR from a median of 93.1 to 64.9 mg/g (P = 0.001). Following treatment, the estimated glomerular filtration rate improved from a mean of 69.83 to 71.68 mL/min and the mean arterial pressure (MAP) fell from 90.03 to 89.06 mmHg, both were not statistically significant. Despite a statistically insignificant increase in the episodes of urinary tract infections (UTIs), the hospitalization rate declined. No episodes of amputations or ketoacidosis occurred during the study period. CONCLUSION: SGLT2 inhibitors had beneficial effects among Saudi patients with type 2 diabetes by improving diabetic control and lowering proteinuria. Dapagliflozin did not result in significant harm, including UTIs, amputations, and ketoacidosis.

Addressing the Continuum of Dysglycaemia and Vascular Complications in Prediabetes and Type 2 Diabetes: Need for Early and Intensive Treatment.

The onset of type 2 diabetes increases the risk of vascular complications and death. We know now that that this risk begins long before the diabetes diagnosis. Prediabetes and type 2 diabetes are not separate entities in practice and exist within a continuum of dysglycaemia and vascular risk that increases in severity over time. This excess risk requires early intervention with lifestyle therapy supported with pharmacologic antidiabetic therapy, intensified promptly where necessary throughout the duration of the diabetes continuum. Metformin is an evidence-based treatment for preventing prediabetes and improves cardiovascular outcomes in people with type 2 diabetes from diagnosis onwards. Newer agents (SGLT2 inhibitors and GLP-1 agonists) are appropriate for people presenting with type 2 diabetes and significant cardiovascular comorbidity. Additional therapies should be used without delay to achieve patients' individualised HbA1c goals and to minimise cardiovascular risk.

Psychological Wellbeing of Diabetic Individuals, Prediabetics, and Non-diabetics: A Population-Based Study in Saudi Arabia.

Background: The increased burden of diabetes affects the quality of life, including psychosocial problems. The study aims to compare the psychological well-being of individuals who are prediabetic, diabetic, or non-diabetic. Methods: A cross-sectional exploratory study was conducted from January to June 2016 (n = 1,019) in Al Kharj, Saudi Arabia. After consent and questionnaires were filled out, trained staff took blood samples followed by anthropometry. Chi-squared tests, one-way ANOVA, and multiple linear regression analyses were conducted to examine the association between diabetes classes defined by HbA1c cut-off levels set by the American Diabetes Association (three categories), individual items, and total score in general health questionnaire (GHQ). An ROC curve was plotted for the total GHQ-12 score against HbA1c. Findings: The mean GHQ score for psychological distress was significantly higher (F = 6.569, P = 0.038) in the diabetics (mean = 14.7) and the prediabetics (12.4) than in the non-diabetics (10.71). Four out of six positive GHQ items and three out of six negative GHQ items significantly differed among the three classes of diabetes. The adjusted multivariate analysis revealed that people with diabetes were most likely to report psychological distress compared to non-diabetics (unstandardized beta = 2.414; P = 0.037). The AUC examining the relationship between HBA1c and GHQ scores showed a moderate but statistically insignificant sensitivity/specificity of 0.643 (P = 0.23). Conclusion: This study demonstrates that psychological wellbeing is substantially poorer among diabetic or prediabetic individuals than non-diabetic individuals. Future longitudinal studies are required to examine a plausible causal relationship between diabetes/prediabetes and psychological distress.

Combined' Neck/Back Pain and Psychological Distress/Morbidity Among the Saudi Population: A Cross-Sectional Study.

Background: Psychological distress/morbidity is amongst the primary reason for the cause of pain at multiple sites, its progression, and recovery. Though still not very clear if physical pain in the neck or the back may predict psychological morbidities or not. Thus, we investigated the association between combined neck or back pain and psychological distress/morbidity. Methods: A cross-sectional study was conducted in Al-Kharj, Saudi Arabia, including 1,003 individuals. The questionnaire comprised of General Health Questionnaire-12 (GHQ-12) and some questions about neck and back pain. Data analysis was done using statistical software SPSS version 26.0. Results: The results of the multivariate analysis revealed a significant positive association between neck/back pain status and total GHQ score (unstandardized Beta = 2.442, P ≤ 0.0001). Having neck/back pain had almost a 2.5 times greater risk of psychological distress/morbidity. Further, females were more likely to have a higher risk of psychological distress/morbidity (unstandardized Beta = 1.334, P = 0.007) than males while adjusting for sociodemographic and clinical characteristics. Conclusion: The combination of neck and back pain was significantly associated with the Saudi population's psychological problems. Therefore, the Saudi government needs to devise high-risk strategies and allocate adequate resources to the cause so that at-risk people can be shielded from the adverse complications arising from this condition in the long run.

Rare Presentation of Hypoglycemia in a Patient with Anaplastic Large-Cell Lymphoma.

Anaplastic large-cell lymphoma is a rare type of aggressive non-Hodgkin's lymphoma, and arriving at a final diagnosis for this tumor is a challenge for the healthcare providers. Usually, it involves the lymph nodes and extranodal tissues such as the lungs, skin, and other soft tissues. Its presentation by extending into different organs such as the liver, lungs, bones, spleen, and thyroid is rare. Thus, involvement of other organs is very rare as we found in a 54-year-old male patient, a known case of hypertension and end-stage renal disease who was on hemodialysis, who presented to the emergency department with a history of generalized weakness and weight loss of about 20 kg for two months. The tumor cells are positive for CD45, CD30, CD15, MUMi, and Ki-67 (80%) and negative for CD20, PAX-5, CD79a, CD3, CD5, CD10, BCL6, BCL2, EMA, ALK-1, and CD138. The patient was hypoglycemic and hypercalcemic and was managed accordingly. The patient was evaluated, and the third assessment showed that hypoglycemia was resolved due to dexamethasone. The patient's glucose storage was depleted most likely due to liver involvement plus poor general condition. It was asserted that the patient's hypoglycemia could be related to his underlying malignancy. Also, the patient was advised to start tablet diazoxide 45 mg three times a day (3 mg/kg/day TID) in addition to levothyroxine tablet 50 mcg once a day. Tablet diazoxide was stopped, and nutritional support was recommended. This case reveals a rare systematic ALK-1-negative anaplastic large-cell lymphoma that involves multiple organs. The main learning point from this report is that these tumors can present atypically even in adults and can be ALK-1 negative, which is contrary to the typical systematic anaplastic large-cell lymphomas that are positive for ALK.

The Prevalence of Headache and Associated Factors in Al-Kharj, Saudi Arabia: A Cross-Sectional Study.

Background: Only few studies have investigated the prevalence and risk factors of headaches among the Saudi population. The study aimed to estimate the prevalence of headache and to explore its associated risk factors Al-Kharj, Saudi Arabia. Methods: The multistage sampling technique was used to enroll 1200 population-based participants who were asked to complete a self-administered questionnaire about headaches, demographics, and several other parameters such as smoking status and different chronic and psychological illnesses. The chi-square test and multivariate logistic regression analysis were used to test the association. Results: The overall prevalence of headaches in this study was 3%. The multiple logistic regression analysis showed that females were more likely to have headaches than males (odds ratio (OR) 0.735, 95% confidence interval (CI) = 0.612-1.341; P=0.024). Being a current smoker was also significantly associated with higher "odds" of having headache (OR = 1.319, 95% CI = 0.932-2.462; P=0.037). Participants who were overweight had a significantly higher risk of headache (OR = 1.631, 95% CI = 1.48-1.854; P=0.037). Nonmarried people were significantly more likely to have headache pain, compared to married individuals (OR = 0.875, 95% CI = 0.646-2.317; P=0.047). Conclusion: The prevalence of headaches was 3%, and four significant associated factors were identified: females, nonmarried, smoking, and overweight. The temporality of the relationship between these factors and headache cannot be confirmed in this cross-sectional study; so future longitudinal studies are needed to confirm these potential causal relationships.