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AIM: To report on the effectiveness and safety of the MiniMed 780G automated insulin delivery system in real-world users during the month of Ramadan. MATERIALS AND METHODS: CareLink Personal data were extracted from MiniMed 780G system users from the Gulf region. Users were included if they had ≥10 days of sensor glucose data during the month of Ramadan 2022 as well as in the month before and after. For the main analysis, continuous glucose monitoring endpoints were aggregated per month and were reported by time of day (daytime: 05.31-18.00 h, and night-time). Additional analyses were performed to study the pace at which the algorithm adapts. RESULTS: Glycaemic control was well kept in the 449 included users (mean sensor glucose = 152.6 ± 18.7 mg/dl, glucose management indicator = 7.0 ± 0.4%, time in range = 70.7 ± 11.0%, time below 70 mg/dl = 2.3 ± 2.3%). Albeit some metrics differed from the month before (p < .0001 for all), absolute differences were very small and considered clinically irrelevant. During Ramadan, there was no increased risk of hypoglycaemia during daytime (time below 70 mg/dl = 2.3 ± 2.4%), time in range was highest during daytime (80.0 ± 10.7%, night: 60.4 ± 15.3%), while time above 180 mg/dl was highest during night-time (37.3 ± 16.3%, day: 17.7 ± 10.7%). The algorithm adapted immediately upon lifestyle change. CONCLUSION: The MiniMed 780G automated insulin delivery system is effective, safe and fast in adapting to the substantial changes that occur in the lifestyle of people with type 1 diabetes during Ramadan.
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Diabetes Mellitus Tipo 1 , Hipoglicemia , Humanos , Insulina/efeitos adversos , Glicemia/análise , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemia/prevenção & controle , Insulina Regular Humana/uso terapêutico , Sistemas de Infusão de Insulina/efeitos adversos , Hipoglicemiantes/efeitos adversosRESUMO
BACKGROUND: There is a paucity of global data on cardiovascular disease (CVD) prevalence in people with type 2 diabetes (T2D). The primary objective of the CAPTURE study was to estimate the prevalence of established CVD and its management in adults with T2D across 13 countries from five continents. Additional objectives were to further characterize the study sample regarding demographics, clinical parameters and medication usage, with particular reference to blood glucose-lowering agents (GLAs: glucagon-like peptide-1 receptor agonists and sodium-glucose co-transporter-2 inhibitors) with demonstrated cardiovascular benefit in randomized intervention trials. METHODS: Data were collected from adults with T2D managed in primary or specialist care in Australia, China, Japan, Czech Republic, France, Hungary, Italy, Argentina, Brazil, Mexico, Israel, Kingdom of Saudi Arabia, and Turkey in 2019, using standardized methodology. CVD prevalence, weighted by diabetes prevalence in each country, was estimated for the overall CAPTURE sample and participating countries. Country-specific odds ratios for CVD prevalence were further adjusted for relevant demographic and clinical parameters. RESULTS: The overall CAPTURE sample included 9823 adults with T2D (n = 4502 from primary care; n = 5321 from specialist care). The overall CAPTURE sample had median (interquartile range) diabetes duration 10.7 years (5.6-17.9 years) and glycated hemoglobin 7.3% (6.6-8.4%) [56 mmol/mol (49-68 mmol/mol)]. Overall weighted CVD and atherosclerotic CVD prevalence estimates were 34.8% (95% confidence interval [CI] 32.7-36.8) and 31.8% (95% CI 29.7-33.8%), respectively. Age, gender, and clinical parameters accounted for some of the between-country variation in CVD prevalence. GLAs with demonstrated cardiovascular benefit were used by 21.9% of participants, which was similar in participants with and without CVD: 21.5% and 22.2%, respectively. CONCLUSIONS: In 2019, approximately one in three adults with T2D in CAPTURE had diagnosed CVD. The low use of GLAs with demonstrated cardiovascular benefit even in participants with established CVD suggested that most were not managed according to contemporary diabetes and cardiology guidelines. Study registration NCT03786406 (registered on December 20, 2018), NCT03811288 (registered on January 18, 2019).
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Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus Tipo 2/epidemiologia , Idoso , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/prevenção & controle , Estudos Transversais , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Masculino , Pessoa de Meia-Idade , Prevalência , Prognóstico , Fatores de Proteção , Medição de Risco , Fatores de Risco , Fatores de TempoRESUMO
OBJECTIVE: Well-controlled glucose levels (ie, 70-180 mg/dL) have been associated with lower mortality from COVID-19. The addition of dexamethasone to COVID-19 treatment protocols has raised concerns about the potential negative consequences of dexamethasone-induced hyperglycemia. METHODS: We developed a protocol to guide the management of dexamethasone-induced hyperglycemia in hospitalized patients with COVID-19. Two of the 4 medical teams managing patients with COVID-19 at a tertiary center in Saudi Arabia used the protocol and the other 2 teams continued to manage hyperglycemia at the discretion of the treating physicians (protocol and control groups, respectively). The glycemic control and clinical outcomes in 163 patients hospitalized with COVID-19 and dexamethasone-induced hyperglycemia between July 5th and September 30th, 2020, were retrospectively compared between the 2 groups. RESULTS: Compared to the control group, the protocol group had higher proportions of patients with well-controlled glucose across all premeals and bedtime glucose readings throughout the hospital stay. The differences in glycemic control between the 2 groups were statistically significant for fasting glucose on days 4, 5, and the discharge day; prelunch glucose on the discharge day; predinner glucose on days 3, 5, and the discharge day; and bedtime glucose on day 1 (all P < .05). After adjusting for age, sex, nationality, body mass index, Charlson score, and diabetes status, patients in the protocol group were more likely to have well-controlled glucose levels compared with those in the control group. Moreover, the in-hospital mortality was significantly lower in the protocol group (12.93%) compared to the control group (29.93%) (P < .01). CONCLUSION: The implementation of a protocol to manage dexamethasone-induced hyperglycemia in hospitalized patients with COVID-19 resulted in more patients achieving well-controlled glucose levels and was associated with lower mortality from COVID-19.
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Tratamento Farmacológico da COVID-19 , Hiperglicemia , Glicemia , Dexametasona , Humanos , Hiperglicemia/induzido quimicamente , Hiperglicemia/tratamento farmacológico , Estudos Retrospectivos , SARS-CoV-2RESUMO
PURPOSE: As the world continues to cautiously navigate its way through the coronavirus disease 2019 (COVID-19) pandemic, several breakthroughs in therapies and vaccines are currently being developed and scrutinized. Consequently, alternative therapies for severe acute respiratory coronavirus 2 (SARS-CoV-2) prevention, such as vitamin D supplementation, while hypothetically promising, require substantial evidence from countries affected by COVID-19. The present retrospective case-control study aims to identify differences in vitamin D status and clinical characteristics of hospitalized patients screened for SARS-CoV-2, and determine associations of vitamin D levels with increased COVID-19 risk and mortality. METHODS: A total of 222 [SARS-CoV-2 (+) N = 150 (97 males; 53 females); SARS-CoV-2 (-) N = 72 (38 males, 34 females)] out of 550 hospitalized adult patients screened for SARS-CoV-2 and admitted at King Saud University Medical City-King Khalid University Hospital (KSUMC-KKUH) in Riyadh, Saudi Arabia from May-July 2020 were included. Clinical, radiologic and serologic data, including 25(OH)D levels were analyzed. RESULTS: Vitamin D deficiency (25(OH)D < 50 nmol/l) was present in 75% of all patients. Serum 25(OH)D levels were significantly lower among SARS-CoV-2 (+) than SARS-CoV-2 (-) patients after adjusting for age, sex and body mass index (BMI) (35.8 ± 1.5 nmol/l vs. 42.5 ± 3.0 nmol/l; p = 0.037). Multivariate regression analysis revealed that significant predictors for SARS-CoV-2 include age > 60 years and pre-existing conditions (p < 0.05). Statistically significant predictors for mortality adjusted for covariates include male sex [Odds ratio, OR 3.3 (95% confidence interval, CI 1.2-9.2); p = 0.02], chronic kidney disease [OR 3.5 (95% CI 1.4-8.7); p = 0.008] and severe 25(OH)D deficiency (< 12.5 nmol/l), but at borderline significance [OR 4.9 (95% CI (0.9-25.8); p = 0.06]. CONCLUSION: In hospital settings, 25(OH)D deficiency is not associated with SARS-CoV-2 infection, but may increase risk for mortality in severely deficient cases. Clinical trials are warranted to determine whether vitamin D status correction provides protective effects against worse COVID-19 outcomes.
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COVID-19 , Deficiência de Vitamina D , Árabes , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Estudos Retrospectivos , SARS-CoV-2 , Arábia Saudita , Vitamina DRESUMO
BACKGROUND: Information on the clinical characteristics and outcomes of hospitalized Covid-19 patients with or without diabetes mellitus (DM) is limited in the Arab region. This study aims to fill this gap. METHODS: In this single-center retrospective study, medical records of hospitalized adults with confirmed Covid-19 [RT-PCR positive for SARS-CoV2] at King Saud University Medical City (KSUMC)-King Khaled University Hospital (KKUH), Riyadh, Saudi Arabia from May to July 2020 were analyzed. Clinical, radiological and serological information, as well as outcomes were recorded and analyzed. RESULTS: A total of 439 patients were included (median age 55 years; 68.3% men). The most prevalent comorbidities were vitamin D deficiency (74.7%), DM (68.3%), hypertension (42.6%) and obesity (42.2%). During hospitalization, 77 out of the 439 patients (17.5%) died. DM patients have a significantly higher death rate (20.5% versus 12.3%; p = 0.04) and lower survival time (p = 0.016) than non-DM. Multivariate cox proportional hazards regression model revealed that age [Hazards ratio, HR 3.0 (95% confidence interval, CI 1.7-5.3); p < 0.001], congestive heart failure [adjusted HR 3.5 (CI 1.4-8.3); p = 0.006], smoking [adjusted HR 5.8 (CI 2.0-17.2); p < 0.001], ß-blocker use [adjusted HR 1.7 (CI 1.0-2.9); p = 0.04], bilateral lung infiltrates [adjusted HR 1.9 (CI 1.1-3.3); p = 0.02], creatinine > 90 µmol/l [adjusted HR 2.1 (CI 1.3-3.5); p = 0.004] and 25(OH)D < 12.5 nmol/l [adjusted HR 7.0 (CI 1.7-28.2); p = 0.007] were significant predictors of mortality among hospitalized Covid-19 patients. Random blood glucose ≥ 11.1 mmol/l was significantly associated with intensive care admission [adjusted HR 1.5 (CI 1.0-2.2); p = 0.04], as well as smoking, ß-blocker use, neutrophil > 7.5, creatinine > 90 µmol/l and alanine aminotransferase > 65U/l. CONCLUSION: The prevalence of DM is high among hospitalized Covid-19 patients in Riyadh, Saudi Arabia. While DM patients have a higher mortality rate than their non-DM counterparts, other factors such as old age, congestive heart failure, smoking, ß-blocker use, presence of bilateral lung infiltrates, elevated creatinine and severe vitamin D deficiency, appear to be more significant predictors of fatal outcome. Patients with acute metabolic dysfunctions, including hyperglycemia on admission are more likely to receive intensive care.
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COVID-19/epidemiologia , Diabetes Mellitus/epidemiologia , Admissão do Paciente , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19/diagnóstico , COVID-19/mortalidade , Comorbidade , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/mortalidade , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Arábia Saudita/epidemiologia , Adulto JovemRESUMO
OBJECTIVE: To compare the fasting experience and glycemic control during Ramadan among people with type 1 diabetes (PWT1D) who use automated insulin delivery (AID) versus other modalities of treatment. RESEARCH DESIGN AND METHODS: A total of 294 PWT1D who attempted fasting during Ramadan in 2022 were categorized on the basis of treatment modality into one of five groups: 1) AID (n = 62); 2) conventional pump + continuous glucose monitoring (CGM; n = 37); 3) pump + self-monitoring of blood glucose (SMBG; n = 8); 4) multiple daily injections (MDI) + CGM (n = 155); and 5) MDI + SMBG (n = 32). Predictors of fasting most days of Ramadan (i.e., breaking fast ≤2 days because of diabetes) were analyzed using uni- and multivariable logistic regression. RESULTS: The median numbers of days when fasting was broken because of diabetes were 2, 5, 3, 3.5, and 2.5 for AID, conventional pump + CGM, MDI + CGM, pump + SMBG, and MDI + SMBG users, respectively (P = 0.047). Users of AID had a significantly greater time in range (TIR) and lower glycemia risk index, time below range, and time above range compared with users of conventional pumps and MDI (both P < 0.05). Likewise, 53% of AID users attained the double target of 1) breaking fast ≤2 days because of diabetes and 2) maintaining TIR ≥70% during Ramadan compared with only 3% of the conventional pump users and 44% of the MDI + CGM users (both P < 0.05). Compared with MDI + CGM users, AID users were twice as likely to complete fasting most days of Ramadan. CONCLUSIONS: Use of AID is associated with the highest rates of fasting and best glycemic control during Ramadan fasting.
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Diabetes Mellitus Tipo 1 , Humanos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Insulina/uso terapêutico , Glicemia , Estudos Prospectivos , Jejum Intermitente , Automonitorização da Glicemia , Insulina Regular Humana , Hipoglicemiantes/uso terapêuticoRESUMO
This article offers a systematic literature review (SLR) on the use of the MiniMed 780G automated insulin delivery system (MM780G) in people with type 1 diabetes (PwT1D) during Ramadan intermittent fasting. It also presents consensus recommendations on the use of MM780G during the Ramadan period. The SLR was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology. The recommendations resulted from a consensus-forming process involving a panel of experts. The process considered evidence found in the SLR as well as the expert opinions. In total, six studies were included in the SLR. The evidence and expert opinions led to recommendations related to (a) pre-Ramadan counseling of MM780G users who plan to fast; (b) suggested MM780G settings, meal announcement strategy, and safety aspects during Ramadan (including a contingency plan); and (c) post-Ramadan transition into and out of Eid-al-Fitr festivities. The SLR findings showed that the MM780G maintains glycemic control at target in PwT1D during Ramadan (meeting continuous glucose monitoring-based clinical targets proposed by the International Consensus on Time-in-Range) while ensuring low rates of hypoglycemia and diabetic ketoacidosis. Automated insulin delivery also helps PwT1D fast more days of Ramadan compared with users of other less advanced modalities of treatment. Pre-Ramadan guidance on specific aspects of the MM780G along with the International Diabetes Federation and Diabetes and Ramadan International Alliance counseling guidelines is recommended. There is still a challenge with post-Iftar hyperglycemia, which could potentially be mitigated by following the recommendations outlined in this article.
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The Global Leadership Initiative on Malnutrition (GLIM) is a new approach established for the assessment of malnutrition. This study aimed to validate the GLIM for the diagnosis of malnutrition in patients with type 2 diabetes mellitus (T2DM) in Saudi Arabia, using the Subjective Global Assessment (SGA) as a reference. In addition, the association between the GLIM criteria and vascular complications in those patients was examined. A cross-sectional study was conducted on 101 patients with T2DM. The level of agreement between the GLIM and SGA tools was calculated using the kappa coefficient (κ). A receiver operating characteristic curve was used to determine the sensitivity and specificity of the GLIM. In addition, binary logistic regression was performed to investigate the association between each GLIM criterion and T2DM vascular complications. According to both the GLIM and the SGA, malnutrition was found in 15.8% and 17.8% of patients, respectively. The GLIM criteria achieved a very good level of accuracy (AUC = 0.877). The agreement between the tools was substantial (κ = 0.778). The 'disease/inflammation' criterion of the GLIM was significantly associated with macrovascular complications. To conclude, the GLIM criteria for diagnosis of malnutrition presented satisfactory levels of validity, and as such are acceptable for assessing the nutritional status of patients with T2DM.
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Diabetes Mellitus Tipo 2 , Desnutrição , Humanos , Estudos Transversais , Liderança , Arábia Saudita , Estado Nutricional , Avaliação NutricionalRESUMO
OBJECTIVES: To investigate cardiovascular disease (CVD) prevalence in adult patients with type 2 diabetes mellitus (T2DM) in Saudi Arabia using data from the CAPTURE cross-sectional study. METHODS: CAPTURE was a non-interventional, multinational study carried out between December 2018 and September 2019. In Saudi Arabia, clinical (including medication) and demographic data were collected across 7 sites (Alhada Armed Forces Hospital, Taif; King Saud University Medical City, King Saud University, Riyadh; Specialized Medical Centre Hospital, Riyadh; King Abdulaziz University Hospital, Jeddah; King Abdulaziz Hospital for National Guard, Al Ahsa; Diabetes and Endocrinology Center, Buraidah; and Dallah Hospital, Riyadh, Saudi Arabia) from adults aged ≥18 years. The prevalence of CVD was estimated and weighted according to care setting, with data between groups not statistically compared. RESULTS: Among the 883 adults enrolled in this study (566 from primary care, 317 from secondary care), 158 had established CVD, making the weighted prevalence of 18% (95% CI: [15.5-20.5]). The weighted prevalence of atherosclerotic CVD was 15.1% (95% CI: [12.8-17.5]), accounting for 82.4% of the CVD cases. Coronary heart disease was the most common subtype of CVD (13.4%), followed by cerebrovascular disease (1.7%). A total of 23.6% of patients were treated with glucose-lowering agents with proven cardiovascular benefit. CONCLUSION: In Saudi Arabia, approximately one in 5 adults with T2DM had established CVD, lower than the global prevalence, possibly because of disparities in patient characteristics, potential genetic predispositions, or a lack of accurate documentation due to poor coordination between care settings.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Humanos , Adulto , Adolescente , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/epidemiologia , Doenças Cardiovasculares/epidemiologia , Arábia Saudita/epidemiologia , Prevalência , Estudos Transversais , Hospitais UniversitáriosRESUMO
OBJECTIVE: People with type 1 diabetes (T1D) are advised to have a "pre-Ramadan" visit to receive the assessment and education needed to safely fast during the holy month of Ramadan. The COVID-19 lockdown has interrupted this standard of care in Muslim-majority countries where telemedicine is not well-established. Here, we examined the impact of virtual"pre-Ramadan" visits, as an alternative option to the traditional (in-person) visits, on fasting experience and glycemic control during Ramadan in people with T1D. METHOD: 151 individuals with T1D were categorized into 3 groups according to the type of"pre-Ramadan" visit that they attended in 2020: virtual (n = 50), in-person (n = 56), and no visit (n = 45). Number of days fast was broken and CGM metrics were retrospectively compared across the groups. RESULT: Patients who had a virtual"pre-Ramadan" visit were more likely to use continuous glucose monitors (CGM) than those who had no visit (61.7% and 38.6%, respectively, p < 0.05). Attending a virtual"pre-Ramadan" visit was associated with the least number of days fast was broken compared to those who had no visit (p < 0.01) or in-person visit (p = 0.02). CGM time in range (TIR) during Ramadan was the highest in those who had virtual "Pre-Ramadan" visits compared to those who had no visit or in-person visits (59%, 44%, and 47%,respectively). After adjusting for age, gender, pre-Ramadan A1c, and CGM use, the odds of fasting most days of Ramadan were highest in the virtual group [OR (CI): 9.13 (1.43, 58.22)] followed by the in-person group [3.02 (0.54,16.68)] compared to the no visit group. CONCLUSION: Virtual"pre-Ramadan" visits are effective alternative to in-person visits when managing people with T1D who plan to fast during Ramadan.
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COVID-19 , Diabetes Mellitus Tipo 1 , Telemedicina , Glicemia , Controle de Doenças Transmissíveis , Jejum , Controle Glicêmico , Humanos , Islamismo , Estudos RetrospectivosRESUMO
OBJECTIVE: To mitigate the spread of COVID-19, Saudi Arabia implemented a nationwide lockdown that lasted for approximately five months. Due to the limited availability of telemedicine in Saudi Arabia, many people with diabetes (PWD) lost access to diabetes care services during the lockdown period. Here, we examined the impact of lockdown on cardiometabolic health in PWD and how this may have differed between those who utilized diabetes telemedicine during lockdown versus those who did not. METHODS: Hemoglobin A1C (A1C), body weight, lipid, and other cardiometabolic parameters were retrospectively reviewed in 384 PWD who attended routine clinic visits in the pre-lockdown (September 2019 to March 2020) and post-lockdown (Aug to Dec 2020) periods. Changes in cardiometabolic parameters from pre- to post-lockdown were compared across 3 groups according to the type of visit that they had during lockdown (April to July 2020): "no visit" (n = 215), "in-person" visit (n = 44), or "virtual" visit (n = 125). The virtual visits in our institution followed a simplified protocol that utilized technological tools readily available to most PWD and clinicians. RESULTS: PWD who attended "virtual" visits during lockdown were the youngest and most likely to have type 1 diabetes; followed by those who attended "in-person" visits and those who had "no visit". A significant reduction in A1C from pre- to post-lockdown periods was noted in PWD who attended a "virtual visit" (9.02 to 8.27%, respectively, p < 0.01) and those who attended an "in-person" visit (9.18 to 8.43%, respectively, p < 0.05) but not in those who had "no visit" (8.75 to 8.57%, p > 0.05). No significant changes were noted in serum glucose, blood pressure, or lipid parameters during the lockdown in any of the groups. CONCLUSION: Simplified telemedicine visits, including real-time audio calls, were as effective as in-person visits in improving glycemic control in PWD during the lockdown period in a country where telemedicine infrastructure was not well-established. Older adults and those with type 2 diabetes were less likely to utilize telemedicine; suggesting a potential risk of digital divide that warrants greater attention in the future.
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COVID-19 , Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Telemedicina , Idoso , COVID-19/epidemiologia , COVID-19/prevenção & controle , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Controle de Doenças Transmissíveis , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/terapia , Surtos de Doenças , Glucose , Hemoglobinas Glicadas , Humanos , Lipídeos , Estudos Retrospectivos , Arábia Saudita/epidemiologia , Telemedicina/métodosRESUMO
BACKGROUND AND AIMS: To identify predictors of use and benefit from continuous glucose monitoring (CGM) in people with type 1 diabetes (T1D). METHODS: Predictors of CGM use and changes in glycemic indices and other clinical parameters after initiating intermittently-scanned CGMs were examined in 116 individuals with T1D living in Saudi Arabia. Participants were categorized based on frequency of CGM sensor scanning at month 6 into: Frequent users (≥10 scans/day) and infrequent users (<10 scans/day). RESULTS: Frequent CGM users had an improvement in time in range (TIR) and time above range (TAR) at months 6 and 12; whereas infrequent users had comparable improvements but only at month 12. Individuals with baseline TIR <50% had a significant improvement in TIR and TAR; whereas those with baseline TIR ≥50% had a significant improvement only in time below range (TBR). Baseline TIR <50% and higher frequency of scans were predictive of improvement in TIR at month 6 (OR: 4.84, p <0.01, 1.05, p= 0.04; respectively); whereas baseline TBR was the only predictor of improvement in TBR (OR:1.24,p < 0.01). Being a woman, higher number of scans/day during the first 2 weeks of CGM use, and having a lower A1C at baseline predict being a frequent scanner at month 6 (OR: 2.81, p=0.04; 1.12, p <0.01; and 0.73, p <0.01; respectively). CONCLUSIONS: Improvement in glycemic control with CGM use can be predicted by: number of scans per day and baseline TIR and TBR in people with T1D.
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Automonitorização da Glicemia , Diabetes Mellitus Tipo 1 , Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Hemoglobinas Glicadas/análise , Índice Glicêmico , Humanos , Arábia Saudita/epidemiologiaRESUMO
INTRODUCTION: Sodium-glucose co-transporter-2 (SGLT2) inhibitors moderately reduce glucose levels in type-2 diabetes mellitus (T2DM). Some cases of diabetic ketoacidosis (DKA) were reported with SGLT2 inhibitors. However, data on the long-term safety of dapagliflozin in Saudi Arabia are lacking. The present study aimed to monitor the safety of dapagliflozin in patients with T2DM and evaluate the change in HbA1c during the observation period compared to baseline. METHODS: This was a local, prospective, single-arm, non-interventional, regulatory post-marketing study. The study was conducted in Saudi Arabia from May 2017 to September 2019. Patients received either 5 or 10 mg dapagliflozin in conjunction with diet and exercise modifications to treat T2DM. The occurrence of adverse events was observed over the treatment duration and for 3 days after administering the last dose of dapagliflozin. RESULTS: A total of 527 patients were recruited in the study, 524 of which were eligible for the statistical analysis. About 62% were males. The median (IQR) age was 52.3 (14.8) years, while the median (IQR) body mass index was 31.6 (7.7) kg/m2. The median (IQR) duration since the patients were first diagnosed with T2DM was 8.78 (6.73) years. The most common comorbidities were hyperlipidemia (51.1%) and hypertension (41.1%). Almost three-quarters of the study population (73.7%) received other antidiabetic medications in addition to dapagliflozin. Over a period of 12 months, a total of 106 adverse events were experienced by 65 (12.33%) patients. Vulvovaginal pruritus (3.1%), dysuria (2.7%), polyuria (1.3%), urinary tract infections (1%), fatigue (0.8%), and hypoglycemia (0.8%) were among the reported adverse events. One case of DKA (0.2%) was reported. The mean (SD) HbA1c% level significantly decreased from 8.6 (1.6) % at baseline to reach 7.2 (1.2) % after 12 months of treatment (p < 0.0001). CONCLUSION: Dapagliflozin was found to be a well tolerated and effective treatment option for T2DM patients in Saudi Arabia. Vulvovaginal pruritus and dysuria were the most common adverse events.
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BACKGROUND: To minimize the spread of Coronavirus Disease-2019, Saudi Arabia imposed a nationwide lockdown for over 6 weeks. We examined the impact of lockdown on glycemic control in individuals with type 1 diabetes (T1D) using continuous glucose monitoring (CGM); and assessed whether changes in glycemic control differ between those who attended a telemedicine visit during lockdown versus those who did not. MATERIALS AND METHODS: Flash CGM data from 101 individuals with T1D were retrospectively evaluated. Participants were categorized into two groups: Attended a telemedicine visit during lockdown (n = 61) or did not attend (n = 40). Changes in CGM metrics from the last 2 weeks pre-lockdown period (Feb 25 - March 9, 2020) to the last 2 weeks of complete lockdown period (April 7-20, 2020) were examined in the two groups. RESULTS: Those who attended a telemedicine visit during the lockdown period had a significant improvement in the following CGM metrics by the end of lockdown: Average glucose (from 180 to 159 mg/dl, p < 0.01), glycemic management indicator (from 7.7 to 7.2%, p = 0.03), time in range (from 46 to 55%, p < 0.01), and time above range (from 48 to 35%, p < 0.01) without significant changes in time below range, number of daily scans or hypoglycemic events, and other indices. In contrast, there were no significant changes in any of the CGM metrics during lockdown in those who did not attend telemedicine. CONCLUSIONS: A six-week lockdown did not worsen, nor improve, glycemic control in individuals with T1D who did not attend a telemedicine visit. Whereas those who attended a telemedicine visit had a significant improvement in glycemic metrics; supporting the clinical effectiveness of telemedicine in diabetes care.
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Glicemia/metabolismo , COVID-19/epidemiologia , Controle de Doenças Transmissíveis , Diabetes Mellitus Tipo 1/sangue , Controle Glicêmico , Telemedicina , Adolescente , Adulto , Automonitorização da Glicemia/métodos , Controle de Doenças Transmissíveis/métodos , Controle de Doenças Transmissíveis/estatística & dados numéricos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/epidemiologia , Surtos de Doenças , Feminino , Controle Glicêmico/métodos , Controle Glicêmico/normas , Humanos , Hipoglicemiantes/uso terapêutico , Masculino , Avaliação de Programas e Projetos de Saúde , Quarentena/métodos , Quarentena/estatística & dados numéricos , Estudos Retrospectivos , SARS-CoV-2 , Arábia Saudita/epidemiologia , Telemedicina/organização & administração , Telemedicina/estatística & dados numéricos , Adulto JovemRESUMO
AIM: To minimize the spread of COVID-19, the Kingdom of Saudi Arabia (KSA) enforced a nationwide lockdown. We aimed to explore whether the manner in which Saudi patients with type 1 diabetes (T1D) manage their disease has changed during this unparalleled lockdown. METHODS: An online survey exploring the effect of lockdown on T1D outcomes was distributed among T1D patients residing in KSA during lockdown. RESULTS: A total of 1010 patients responded to the survey. Around 40% reported communicating with their physicians during lockdown. Age, level of education, residence, previous visits to diabetes education clinics, last HbA1c value, and average monthly income were all significantly associated with communication with the treating physician (p = 0.008, p < 0.001, p < 0.001, p = 0.002, p < 0.001, and p < 0.001, respectively). Age, level of education, and average monthly income were significantly associated with experiencing severe hypoglycemia (p = 0.036, p = 0.03, and p < 0.001, respectively), while average monthly income and level of education were significantly associated with experiencing diabetic ketoacidosis (DKA) (p < 0.001 and p = 0.0039, respectively); during lockdown. Patients who communicated with their physicians reported lower rates of severe hypoglycemia compared to those who did not (25.2% vs 30.7%, respectively). CONCLUSION: Age and level of education were significantly associated with communication with the treating physician, and experiencing severe hypoglycemia and DKA; in patients with T1D during the lockdown period in Saudi Arabia. Keeping two-way virtual communication channels between physicians and their T1D patients should be encouraged.
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COVID-19 , Diabetes Mellitus Tipo 1 , Controle de Doenças Transmissíveis , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/epidemiologia , Humanos , SARS-CoV-2 , Arábia Saudita/epidemiologiaRESUMO
AIMS: To determine the prevalence and factors associated with depression and anxiety among people with and without diabetes during the coronavirus disease 2019 (COVID-19) outbreak. METHODS: A cross-sectional questionnaire-based study collecting demographic and mental health data from 2166 participants living in the Arab Gulf region (568 with diabetes, 1598 without diabetes). Depression and anxiety were assessed using the 9-item Patient Health Questionnaire and the 7-item Generalized Anxiety Disorder scale, respectively. RESULTS: The prevalence of depression and anxiety symptoms were 61% and 45%, in people with diabetes (PWD) and 62% and 44%, respectively, in people without diabetes. PWD who have had their diabetes visit canceled by the clinic were more likely to report depression and anxiety symptoms than those without diabetes (odds ratio [95% confidence interval]: 1.37 [1.02, 1.84] and 1.37 [1.04, 1.80], for depression and anxiety; respectively). PWD who had no method of telecommunication with their health care providers (HCP) during the pandemic, PWD with A1C of ≥ 10%, women, employees (particularly HCPs), students, unmarried individuals, and those with lower income were more likely to report depression and/or anxiety symptoms (all P < 0.01). Fear of acquiring the coronavirus infection; running out of diabetes medications; or requiring hospitalization for hypoglycemia, hyperglycemia, or diabetic ketoacidosis; and lack of telecommunication with HCPs were all associated with significantly higher odds of having depression and anxiety symptoms among PWD. CONCLUSIONS: The remarkably high prevalence of depression and anxiety symptoms during the COVID-19 pandemic, particularly among subgroups of PWD, calls for urgent public health policies to address mental health during the pandemic and reestablish health care access for PWD.
Assuntos
COVID-19 , Diabetes Mellitus/psicologia , Saúde Mental , Pandemias , Adulto , Idoso , Ansiedade/epidemiologia , Ansiedade/psicologia , Arábia/epidemiologia , Estudos Transversais , Depressão/epidemiologia , Depressão/psicologia , Feminino , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores Sexuais , Inquéritos e Questionários , TelecomunicaçõesRESUMO
BACKGROUND: The importance of telemedicine in diabetes care became more evident during the coronavirus disease 2019 (COVID-19) pandemic as many people with diabetes, especially those in areas without well-established telemedicine, lost access to their health care providers (HCPs) during this pandemic. SUBJECTS AND METHODS: We describe a simplified protocol of a Diabetes Telemedicine Clinic that utilizes technological tools readily available to most people with diabetes and clinics around the world. We report the satisfaction of 145 patients and 14 HCPs who participated in the virtual clinic and 210 patients who attended the virtual educational sessions about "Diabetes and Ramadan." RESULTS: The majority of patients agreed or strongly agreed that the use of telemedicine was essential in maintaining a good glucose control during the pandemic (97%) and they would use the clinic again in the future (86%). A similar high satisfaction was reported by patients who attended the "Diabetes and Ramadan" virtual educational session and 88% of them recommended continuing this activity as a virtual session every year. Majority of the HCPs (93%) thought the clinic protocol was simple and did not require a dedicated orientation session prior to implementing. CONCLUSIONS: The simplicity of our Diabetes Telemedicine Clinic protocol and the high satisfaction reported by patients and HCPs make it a suitable model to be adopted by clinics, especially during pandemics or disasters in resource-limited settings. This clinic model can be quickly implemented and does not require technological tools other than those widely available to most people with diabetes, nowadays. We were able to successfully reduce the number of patients, HCPs, and staff physically present in the clinics during the COVID-19 pandemic without negatively impacting the patients' nor the HCPs' satisfaction with the visits.
Assuntos
Instituições de Assistência Ambulatorial/organização & administração , COVID-19/epidemiologia , Diabetes Mellitus/terapia , Endocrinologia/organização & administração , Telemedicina/organização & administração , Agendamento de Consultas , Registros Eletrônicos de Saúde , Humanos , Satisfação no Emprego , Pandemias , Satisfação do Paciente , Arábia Saudita/epidemiologiaRESUMO
BACKGROUND AND AIM: Diabetes mellitus (DM) of both types is a genetically determined disorder and is prevalent in the Saudi population. Furthermore, the rate of consanguineous marriages is also high among Saudis. Therefore, we aimed to determine the prevalence of consanguinity among people with DM and investigate the effect of consanguinity on the occurrence of diabetes at different levels. METHODS: A descriptive cross-sectional study was carried out at the Obesity, Metabolism and Endocrine Center of King Fahad Medical City in Riyadh, Saudi Arabia in January 2021. Information on patients' demographics (age, gender), family history of DM, and presence of consanguinity, and degree of consanguineous marriage were collected. RESULTS: We included 324 people with DM, 143 (44.1%) with type 1 diabetes (T1DM), and 181 (55.9%) with type 2 diabetes (T2DM). We included 201 people without DM for T1DM control and 300 people for T2DM control. The mean age was 26.6 ± 11.1 years for the T1DM group and 57.8 ± 11.6 years for the T2DM group. Consanguinity was noted among 73 (51.4%) T1DM patients, but T1DM was not significantly related to consanguinity. T2DM was significantly correlated with consanguinity (r=0.132, p=0.004) particularly among patients with a degree of consanguinity as first-cousins for both paternal and maternal sides (odds ratio [OR]=1.151 and 1.476). Gender and positive family history for DM and consanguineous marriage between cousins were significant factors for T2DM. After controlling for gender and a positive family history of DM, consanguineous marriage between cousins from both the paternal and maternal sides remained significant. CONCLUSION: T2DM occurrence increases in presence of consanguinity in the Saudi population. This relationship might contribute to the higher risk of DM prevalence. Further studies are needed to elucidate this relationship deeply. It's unclear whether lowering consanguineous marriages would decrease the prevalence of diabetes or not. However, a clear message about this correlation has to be delivered to the public.
RESUMO
The infectiousness of COVID-19 is high among the susceptible population, making the calculation of the reproduction number (R) an essential step to implement preventive measures. We aim to estimate COVID-19 transmission to determine if the disease is successfully controlled or extra measured should be adopted to attain this goal. The daily incidence data of COVID-19 in Saudi Arabia from March 2nd, 2020, to April 4th, 2021, were obtained from the continuously updated Saudi Ministry of Health COVID-19 repository. To get accurate estimation of the situation over the last 4 months (from December 1st, 2020, to April 4th, 2021), we calculated the weekly (every 7 days) R starting from March 2nd, 2020, and till the last week of the available data. The calculated values of R were represented as median, first quantile (Q1), and third quantile (Q3). As early as the first week of December 2020, the median R was 0.81 (0.80-0.83) which means that each existing infected case would transmit infection to only one person. This was followed by fluctuations over the next few weeks around R value of 1, reaching its highest level of 1.45 (1.42-1.47) between December 31st, 2020, and January 6th, 2021. This was followed by a relatively steady decline over the following weeks, with some till mid-March where the R values started to slightly rise again. Social distancing, protective precautions, avoiding abuse of the partial lifting, expanding the screening process, and other Saudi measures sound to be successful and should be replicated in similar communities. This measure should be continued till the vaccination process is completed, to reduce the number of contacts and to avoid uncontrolled transmission of the disease.
Assuntos
COVID-19 , Humanos , Reprodução , SARS-CoV-2 , Arábia SauditaRESUMO
Context: Following total thyroidectomy and radioactive iodine (RAI) ablation, serum thyroglobulin levels should be undetectable to assure that patients are excellent responders and at very low risk of recurrence. Objective: To assess the utility of stimulated (sTg) and non-stimulated (nsTg) thyroglobulin levels in prediction of patients outcomes with differentiated thyroid cancer (DTC) following total thyroidectomy and RAI ablation. Method: A prospective observational study conducted at a University Hospital in Saudi Arabia. Patients diagnosed with differentiated thyroid cancer and were post total thyroidectomy and RAI ablation. Thyroglobulin levels (nsTg and sTg) were estimated 3-6 months post-RAI. Patients with nsTg <2 ng/ml were stratified based on their levels and were followed-up for 5 years and clinical responses were measured. Results: Of 196 patients, nsTg levels were <0.1 ng/ml in 122 (62%) patients and 0.1-2.0 ng/ml in 74 (38%). Of 122 patients with nsTg <0.1 ng/ml, 120 (98%) had sTg levels <1 ng/ml, with no structural or functional disease. sTg levels >1 occurred in 26 (35%) of patients with nsTg 0.1-2.0 ng/ml, 11 (15%) had structural incomplete response. None of the patients with sTg levels <1 ng/ml developed structural or functional disease over the follow-up period. Conclusion: Suppressed thyroglobulin (nsTg < 0.1 ng/ml) indicates a very low risk of recurrence that does not require stimulation. Stimulated thyroglobulin is beneficial with nsTg 0.1-2 ng/ml for re-classifying patients and estimating their risk for incomplete responses over a 7 years follow-up period.