BACKGROUND:The use of Continuous Glucose Monitoring (CGM) devices has significantly improved diabetes management. However, several limitations persist, including the great variation in accuracy, inconsistent study designs, and variations in regulatory approval standards. Therefore, the need for regulatory harmonization, robust validation, and transparent data reporting is crucial. METHODS:The current consensus report was developed through a structured, multi-phase process to comprehensively assess these challenges. A literature review of databases such as PubMed, Scopus, and the Saudi Digital Library, focusing on publications from 2016 to 2024, evaluated evidence on CGM devices in terms of performance and clinical outcome, with priority given to regional data, randomized controlled trials (RCTs), and systematic reviews. A multidisciplinary panel reviewed the literature, engaging in structured discussions. Recommendations were formulated using the Delphi method, ensuring consensus and alignment with global standards while addressing regional challenges. RESULTS AND RECOMMENDATIONS:The resulting recommendations advocate for aligning Saudi regulatory standards with international frameworks like Food and Drug Administration iCGM criteria, Medical Device Regulation (MDR)-aligned criteria, establishing and enforcing minimum performance criteria, including dynamic testing for glucose fluctuations, strengthening local post-market surveillance capacity, mandating transparent data reporting by manufacturers, and facilitating comprehensive clinical education and cross-sector collaboration.
Background: Adults with diabetes mellitus (DM) are at increased risk of herpes zoster (HZ) and its complications because of impaired cell-mediated immunity, chronic hyperglycemia, and multiple comorbidities. Despite the availability of highly effective recombinant zoster vaccine (RZV), vaccine uptake remains suboptimal among patients with diabetes in Saudi Arabia. This consensus statement was developed to provide evidence-based recommendations for HZ vaccination in adults with DM within the Saudi healthcare setting. Methods: A multidisciplinary expert panel convened under the auspices of the Saudi Society of Diabetes conducted structured evidence review and consensus process. A comprehensive literature search of PubMed/MEDLINE, Embase, Scopus, Web of Science, and the Cochrane Library was performed to identify studies published during the previous 10 years on HZ epidemiology, vaccine efficacy and safety, and vaccination strategies in adults with diabetes. Evidence was critically appraised and integrated with expert opinion using a modified Delphi-informed consensus approach. Recommendations were categorized according to evidence strength (Level A–C) and aligned with national immunization policies. Results: Available evidence consistently demonstrates that diabetes is associated with an increased risk of HZ, postherpetic neuralgia, hospitalization, and other complications. Saudi epidemiological data identified 1,019 HZ cases over a 6-year period, with 31.3% developing complications, 12.5% requiring hospitalization, and 1.2% requiring intensive care. Randomized trials and real-world studies demonstrate that RZV provides approximately 94% efficacy against HZ with durable protection and an acceptable safety profile. The expert panel developed 10 evidence-based recommendations addressing patient selection, vaccination timing, immunocompromised populations, co-administration with other vaccines, risk stratification, healthcare provider education, patient awareness, electronic reminder systems, equitable vaccine access, and pharmacovigilance. The panel emphasized routine assessment of vaccination status during diabetes care and strong physician recommendation as key strategies to improve vaccine uptake. Conclusion: Adults with diabetes represent a high-risk population for herpes zoster and should be prioritized for recombinant zoster vaccination according to current national recommendations. Integrating vaccination assessment into routine diabetes care, strengthening healthcare provider engagement, and implementing system-level interventions may substantially improve vaccination coverage and reduce the burden of HZ among adults with diabetes in Saudi Arabia.
Diabetes mellitus (DM) is a major health problem and a leading cause of death in the Kingdom of Saudi Arabia (KSA). The World Health Organization (WHO) ranks KSA as the seventh country with the highest diabetes prevalence in the world. The healthcare and treatment costs for diabetes have risen by more than 500% in the last two decades. Obesity is the main risk factor for type 2 diabetes mellitus (T2DM), which involves insulin resistance and β-cell dysfunction. Genetic and environmental factors also influence the development of T2DM. There are various options for controlling blood glucose in T2DM patients, including a new class of oral drugs called sodium-glucose transport protein 2 inhibitors (SGLT2i). These drugs reduce glucose reabsorption and increase glucose excretion in the kidney. They can be used at any stage of diabetes and have benefits such as lowering blood pressure, A1C levels, and body weight. Dapagliflozin is one of the SGLT2 inhibitors that T2DM patients well tolerate. This review examines the impact of T2DM in KSA, its risk factors and complications, and the role of Dapagliflozin in its management. It also provides expert opinions on the current situation of T2DM in KSA.
Diabetes mellitus (DM) is a significant public health and economic concern in Saudi Arabia, affecting more than 20% of adults. Insulin remains a cornerstone in DM management, but the country relies significantly on imported products. Hence, this results in high healthcare expenditures and variable availability. In line with Vision 2030, Saudi Arabia has prioritized the localization of insulin manufacturing to ensure sustainable access, reduce import dependency, and enhance national health security. This paper explores the clinical, economic, and policy implications of localizing insulin production in the Kingdom. The current work used a case study methodology to assess the feasibility, challenges, and strategic opportunities for the domestic production of innovative insulins, such as Degludec and IDegAsp. The study supports the development of public-private partnerships, investment in biotechnology infrastructure, and regulatory reform to foster a robust local biopharmaceutical ecosystem. By 2027, Saudi Arabia aims to meet 50% of its insulin demand through local production, making it the first country in the GCC region to produce innovative insulin. This initiative is expected to promote affordability and position the Kingdom as a leader in insulin innovation.
Cardiorenal metabolic disease (CRMD) encompasses a cluster of interrelated conditions-including obesity, type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD), chronic kidney disease (CKD), and metabolic dysfunction-associated steatotic liver disease (MASLD)-that share common pathophysiologic pathways and amplify morbidity and mortality risks. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has demonstrated robust evidence across randomized controlled trials and real-world studies in improving glycemic control (mean glycated hemoglobin [HbA1c] reduction of 1.0-1.5%), inducing sustained weight loss (average 10-15%), and reducing major adverse cardiovascular events (by 26% in SUSTAIN-6 and 20% in SELECT). Its potential renal and hepatic benefits, including slower estimated glomerular filtration rate (eGFR) decline and reduction in liver fat content, highlight its suitability for integrated CRMD management. This consensus report was developed through a structured, multiphase Delphi process involving endocrinologists, cardiologists, nephrologists, hepatologists, and public health experts from across Saudi Arabia. A comprehensive literature search (PubMed, Scopus, and Saudi Digital Library [2016-2024]) prioritized high-quality evidence from randomized controlled trials (RCTs), systematic reviews, and regional data. The panel reached consensus on key recommendations: (1) early identification and holistic management are critical for effective CRMD control; (2) adults at risk should undergo systematic screening for metabolic, cardiovascular, renal, hepatic, and cognitive complications; and (3) semaglutide should be positioned as a cornerstone therapy given its multiorgan benefits and favorable safety profile. Implementation strategies emphasize the careful selection of patients, individualized dosing, patient education, and integration into national pathways. In alignment with Saudi Vision 2030, incorporating semaglutide into CRMD management, supported by provider training, multidisciplinary care models, and cost-effectiveness analyses, can significantly reduce the national burden of metabolic disease and CVD.
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). 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. The analysis of this study included 1223 patients with uncontrolled T2DM (HbA1c > 7
Therapeutic inertia in type 2 diabetes, defined as a failure to intensify treatment despite poor glycemic control, can arise due to a variety of factors, despite evidence linking improved glycemic control with reductions in diabetes-related complications. The present study aimed to evaluate the health and economic burden of therapeutic inertia in people with type 2 diabetes in Saudi Arabia. The IQVIA Core Diabetes Model (v.9.0) was used to evaluate outcomes. Baseline cohort characteristics were sourced from Saudi-specific data, with baseline glycated hemoglobin (HbA1c) tested at 8.0
AimsThis study seeks to provide insights into the practical application and effects of oral semaglutide in Saudi T2DM patients under routine medical supervision.MethodsThe primary outcome measure was the laboratory HbA1c. Secondary measures included fasting blood glucose (FBG), weight, and hypoglycemia. All variables were checked after six months and 12 months of initiation.ResultsThe analysis of this study included 245 uncontrolled (HbA1c > 7%) T2DM patients. The mean baseline HbA1c was 10.1 % (1.2). HbA1c was reduced by an average of 3.1% (0.8) and 3.2% (0.8) at 6 and 12 months, respectively. The frequency of hypoglycemia events in the last three months before semaglutide was initiated was 4.4 (1.1). The frequency of hypoglycemia events in the last three months was 2.2 (0.8) and 0.7 (0.4) at 6-month and 12-month follow-up visits, respectively. The percent reduction in body mass index (BMI) was an average of 13.0 % (1.4) and 19.7 % (3.4) at six months and 12 months, respectively. Lipid profile and blood pressure were improved at six months and 12 months.ConclusionsOral semaglutide provided substantial glycemic and weight-loss benefits in adult individuals with T2DM.
Backgrounds and Objectives:The preferences of patients for oral GLP-1 RA treatments, particularly in KSA, have not yet been sufficiently studied.In order to add to the body of knowledge already available in this field, the current study sought to determine the acceptance and preference of various GLP-1 RA formulations (weekly injectable vs. daily oral) among T2DM patients in KSA as well as to investigate how doctors who treat T2DM patients there felt about GLP-1RAs. Methods:The current cross-sectional two-arm (patients-arm and physicians-arm) study was carried out all over KSA using an online survey.Two online surveys were used, one for each arm.The analyses were carried out on 700 T2DM cases and 400 physicians (150 diabetes specialists and 250 general practitioners) who completed the surveys.The primary outcome measure in the patients-arm was the preference for oral GLP-1RA or injectable GLP-1RA.For the physicians-arm, the primary outcome measure was the right time of GLP-1RA prescription or delay.Results: Out of the 700 patient respondents, 588 (84.0%) prefer the daily oral formula of GLP-1RA, while 112 (16.0%) prefer the once-weekly subcutaneous formula.About 40.2% of those who prefer the injectable formula perceive that the injectable formula is more effective, 30.3% reported that it is more convenient for them, and 28.6% stated that they take too many oral medications.On the other hand, reasons for preference for oral formula were perception of injections as a 'last resort' treatment (23.0%), fear of injection (20.2%), fear of hypoglycemia (19.2%), convenience (19.0%), and poor communication with physicians (18.5%).Out of the 400 physicians, 340 (85.0%) were delayed in the prescription of GLP-1RAs for their patients, and only 60 (15.0%) prescribed GLP-1RAs at the right time.Among different criteria of respondents, only specialty affects this delay (Table 2).Interestingly, the delay is only among the general physician group (73.%) of those who delay.Reasons behind hesitance differ among groups (p-value < 0.0001), among those who delay prescription of GLP-1RAs, were injectable (72.6%, followed by time constraints (20.3%), and unavailability (7.1%).However, in those who did not delay, they perceived that the reasons behind hesitance were time constraints (45.0%), followed by unavailability (33.3%), and being injectable (21.7%). Conclusions:In conclusion, the preference for the oral form of GLP-1RAs is self-evident in this two-arm study among patients and physicians.That can help to tackle the problem of underutilization of this group when they are indicated.
Glucagon-like peptide-1 receptor agonists (GLP-1RAs) provide adequate glycemic control, weight reduction, low risk of hypoglycemia, and CV risk reduction.Their usage for type 2 DM (T2DM) is recommended mainly when hypoglycemia or weight gain should be considered, also, whenever initial therapy is failed.There are many recent updates in the treatment paradigm of T2DM.There are many types of GLP-1RAs, with a knowledge gap regarding switching between the different types.A Saudi task force gathered to develop an explicit, evidence-based consensus for switching between GLP-1RAs, when, why, and how?This article contains the expert panel's recommendations as a contribution to complement the knowledge gap in this area from the national perspective.As an alternative to intensifying therapy, switching from one GLP-1RA to another has various advantages.Improvements in glycemic control, weight loss, adherence, and medications with established cardiovascular benefits are among them.Also, switching needs to be individualized upon many discussed factors like the dose of the previous GLP1-RA and gastrointestinal adverse effects.Discussion with patients about the why and how to switch is critical.
Hypothyroidism is a common disorder, potentially severe, often clinically ignored, easily diagnosed by laboratory tests, and highly treatable.It may cause chronic illnesses if left untreated.Saudi Society of Endocrinology and Metabolism (SSEM) assembled a panel of twelve endocrinologists with experience in thyroid diseases in adults and children and made up a task force.An initial concept proposal that included types of hypothyroidism, population, scope, and prevalence in Saudi Arabia was obtained.The proposal was divided into several topics discussed in February 2022.The panel approved that the consensus will include all types of hypothyroidism in Saudi Arabia, screening, diagnosis, management, and special population.A literature review was carried out.Most of the latest international guidelines were screened in Europe and USA.The literature search was completed in March 2022.They drafted a report that was distributed to the entire panel.Approval of the recommendations required consensus, defined as a majority approval.The recommendations were revised to accommodate any differences of opinion until a consensus was reached.Recommendations were finally formulated on April 2022.Subsequently, the panel reviewed and discussed the supporting rationale of
Purpose: This research was intended to explore the effects of new-generation basal insulin (degludec U100 And glargine U300) versus long-acting basal insulin (glargine U100, detemir) on the incidence of diabetic ketoacidosis episodes and diabetes treatment measures. Patients and methods: This is a cross-sectional, retrospective medical record analysis. The study population included adults with type 1 diabetes mellitus (DM) who were on the hospital records in 2020. Data were collected from 221 eligible participants through review of electronic medical records. Each record was scanned for basal insulin type, total daily insulin dose, diabetic ketoacidosis (DKA) occurrences, and glycated hemoglobin A1C (HbA1c) levels. Data were collected from 6 months before to 6 months after the initiation of ultra-long-acting insulin. Statistical analysis was conducted using R version 3.5.2. The normality of distribution for each independent variable was verified using Shapiro-Wilk tests. The independent paired t-test was used to compare insulin therapy measures between the two insulin regimens. The main outcome measures were the incidence of DKA episodes and clinical outcomes associated with diabetes. Results: The HbA1c did not change significantly before and after ultra-long-acting insulin therapy was initiated (9.9 vs 9.8, respectively; P >0.05). Insulin total daily doses were significantly higher after shifting to ultra-long-acting insulin. Sub-analysis showed higher total daily insulin doses in glargine U300 users compared with degludec U100 users (P =0.0021). However, basal insulin doses did not change after treatment with ultra-long-acting insulin. No statistically significant difference in DKA occurrences was found before and after the start of ultra-long-acting insulin treatment. Conclusion: The frequency of DKA episodes was not affected by changing the treatment to ultra-long-acting insulin. Moreover, the results suggest that insulin dosage and types are not the only cause of uncontrolled diabetes. Additional efforts should be made to cover all factors affecting diabetes complication control.
Dear Dr. Martin Hovland, We learned from the literature that premixed insulins are short-acting insulin or rapid-acting insulin analogue mixed with intermediate-acting insulin in a fixed ratio, addressing FBG and PPBG in one injection. There are two categories; high-mix and low-mix premixed insulins. We, a Saudi task force, gathered to develop an explicit, evidence-based consensus for the use of the low-mix premixed insulin for better glycemic control. The treatment with premixed aspart 30 was non-inferior to treatment with premixed insulin lispro 25. In addition, Self-monitored blood glucose levels were comparable. Safety profiles were similar between both treatments, as was the incidence of hypoglycemic episodes. The switch between both products of the low-mix family can be carried out without any problem. Both products of the low-mix premixed insulin analogues aspart 30/70 and premixed insulin lispro 25/75 have comparable efficacy and safety as shown from the medical literature. Therefore, we can change from one to another safely as demonstrated by the US FDA statement. In addition, the ergonomic features of KwikPen’s design and function may offer important advantages for the user during insulin administration.
Introduction: Impairment in kidney function leads to disturbed thyroid physiology. All levels of the hypothalamic-pituitary-thyroid axis may be involved, including alterations in hormone production, distribution, and excretion, and even CKD progress with hypothyroidism. Aim of Work: To assess the prevalence of hypothyroidism among chronic kidney disease patients. Materials and Methods: A cross-sectional analysis was conducted in the nephrology department of security forces hospital from January 2015 to February 2018. Biochemical tests (includes blood urea, serum creatinine, PTH, total T4, TSH) were carried out to all participants. Results: Out of 255 CKD patients in the present study, 166 patients had no hypothyroidism, 43 had subclinical hypothyroidism, and 46 had hypothyroidism. The percentage of hypothyroidism among CKD patients was 34.9%, including dialysis patients and 17.66% after exclusion. Out of 24 peritoneal dialysis patients in the current study (P = 0.03), 7 had subclinical hypothyroidism and another 7 had hypothyroidism. In addition, out of 139 hemodialysis patients (P = 0.02), 20 patients had subclinical hypothyroidism and 18 had hypothyroidism. The majority (67.36%) of CKD patients were in CKD stage 5 and had no hypothyroidism (45.10%). Only 29 (11.37%) patients in CKD stage 5 had hypothyroidism and 28 (10.89%) patients had subclinical hypothyroidism. T4 was higher in nondialysis patients, whereas TSH and PTH were higher in dialysis patients. Conclusion: The prevalence of hypothyroidism among chronic kidney disease patients was high and increased with the decrease in estimated GFR.