The Diabetes Technology Society Error Grid and Trend Accuracy Matrix for Glucose Monitors.

INTRODUCTION: An error grid compares measured versus reference glucose concentrations to assign clinical risk values to observed errors. Widely used error grids for blood glucose monitors (BGMs) have limited value because they do not also reflect clinical accuracy of continuous glucose monitors (CGMs). METHODS: Diabetes Technology Society (DTS) convened 89 international experts in glucose monitoring to (1) smooth the borders of the Surveillance Error Grid (SEG) zones and create a user-friendly tool-the DTS Error Grid; (2) define five risk zones of clinical point accuracy (A-E) to be identical for BGMs and CGMs; (3) determine a relationship between DTS Error Grid percent in Zone A and mean absolute relative difference (MARD) from analyzing 22 BGM and nine CGM accuracy studies; and (4) create trend risk categories (1-5) for CGM trend accuracy. RESULTS: The DTS Error Grid for point accuracy contains five risk zones (A-E) with straight-line borders that can be applied to both BGM and CGM accuracy data. In a data set combining point accuracy data from 18 BGMs, 2.6% of total data pairs equally moved from Zones A to B and vice versa (SEG compared with DTS Error Grid). For every 1% increase in percent data in Zone A, the MARD decreased by approximately 0.33%. We also created a DTS Trend Accuracy Matrix with five trend risk categories (1-5) for CGM-reported trend indicators compared with reference trends calculated from reference glucose. CONCLUSION: The DTS Error Grid combines contemporary clinician input regarding clinical point accuracy for BGMs and CGMs. The DTS Trend Accuracy Matrix assesses accuracy of CGM trend indicators.

Time-in-range derived from self-measured blood glucose in people with type 2 diabetes advancing to iGlarLixi: A participant-level pooled analysis of three phase 3 LixiLan randomized controlled trials.

AIM: To evaluate the efficacy of a fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) in people with type 2 diabetes (T2D) using derived time-in-range (dTIR). METHODS: Participant-level data from LixiLan-L, LixiLan-O and LixiLan-G were pooled and dTIR (70-180 mg/dL), derived time-above-range (> 180 mg/dL) and derived time-below-range (dTBR; < 70 mg/dL) were calculated from participant seven-point self-monitored blood glucose profiles. RESULTS: This pooled analysis included data from 2420 participants receiving iGlarLixi (n = 1093), iGlar (n = 836), Lixi (n = 234) or a glucagon-like peptide-1 receptor agonist (GLP-1 RA) (n = 257). Numerically greater improvements in least square (LS) means dTIR were seen from baseline to end of treatment (EOT) with iGlarLixi (25.7%) versus iGlar (15.8%), Lixi (11.7%) or GLP-1 RA (16.2%). At EOT, the mean (standard deviation) dTBR was 0.71% ± 3.4%, 0.61% ± 3.2%, 0.08% ± 1.0% and 0.0% ± 0.0% for iGlarLixi, iGlar, Lixi and GLP-1 RA, respectively. In a subgroup analysis, participants aged younger than 65 years (n = 1690) and 65 years or older (n = 713) showed numerically greater improvements in LS means dTIR from baseline to EOT with iGlarLixi versus iGlar, Lixi or GLP-1 RA. CONCLUSIONS: iGlarLixi achieved improvements in dTIR, with low dTBR values, providing further evidence to inform clinical outcomes with the use of iGlarLixi.

A post-hoc pooled analysis to evaluate efficacy and safety of insulin glargine 300 U/mL in insulin-naïve people with type 2 diabetes with/without prior use of glucagon-like peptide-1 receptor agonist therapy.

AIMS: To evaluate treatment advancement with insulin glargine 300 U/mL (Gla-300), with or without prior glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy in type 2 diabetes (T2D). METHODS: Efficacy and safety outcomes of insulin-naïve patients intensifying with Gla-300, with/without prior GLP-1 RA therapy, were evaluated in three analyses (N = 3562): a pooled analysis of seven interventional studies, a subanalysis comparing participants who stopped GLP-1 RA therapy and initiated Gla-300 with those who received add-on Gla-300, and an expanded analysis including two observational studies. RESULTS: Glycaemic outcomes, including HbA1c improvement and fasting plasma glucose, were similar between groups with/without prior GLP-1 RA use. HbA1c least squares mean change from baseline was - 1.7 % and - 1.6 % with and without prior GLP-1 RA, respectively. Glycaemic outcomes were similar between participants who stopped GLP-1 RA therapy when initiating Gla-300 and those who received add-on Gla-300, although more participants receiving add-on Gla-300 achieved HbA1c targets. The expanded analysis yielded similar results. Incidence of hypoglycaemia was low with no clinically relevant weight changes in all analyses. CONCLUSIONS: Treatment advancement with Gla-300 in patients with T2D, with/without prior GLP-1 RA therapy, improved glycaemic outcomes with no relevant impact on weight, while maintaining a low hypoglycaemia risk.

Medication Adherence and Treatment Satisfaction With Lipid-Lowering Drugs Among Patients With Diabetes and Dyslipidemia.

BACKGROUND: Poor adherence to lipid-lowering drugs in diabetic patients with dyslipidemia increases has been linked with an increased cardiovascular risk. A better understanding of the determinants of adherence to lipid-lowering drugs and treatment satisfaction among people with diabetes and dyslipidemia is crucial. OBJECTIVE: We aimed to assess the prevalence of adherence to lipid-lowering drugs, identify its determinant factors, and evaluate treatment satisfaction among users of lipid-lowering drugs who have diabetes and dyslipidemia. METHODS: We surveyed 398 adult patients with diabetes and dyslipidemia, using a validated medication adherence survey (Adherence to Refills and Medications Scale) and a validated treatment satisfaction survey (Treatment Satisfaction Questionnaire for Medication, TSQM). Sociodemographic and medical history data were collected through questionnaires. RESULTS: The prevalence of poor medication adherence was 36%. Factors associated with poor adherence included adverse reactions to medications, lack of medication availability, and lack of family support. Adherent patients reported lower low-density lipoprotein-cholesterol (LDL-C) and total cholesterol levels, higher treatment satisfaction, and a higher prevalence of cardiovascular disease and comorbidities. Having a family history of dyslipidemia was negatively associated with adherence, while the number of comorbidities positively influenced it. The scores of TSQM components such as effectiveness, global satisfaction, and convenience were significantly higher in people who were adherent or achieved the LDL-C target. CONCLUSION AND RELEVANCE: Our findings highlight the need for interventions targeting several factors impacting adherence to lipid-lowering drugs in patients with diabetes and dyslipidemia. Managing adverse effects, leveraging family support, and ensuring medication access represent crucial aspects of improving adherence and potentially mitigating cardiovascular risks in this high-risk population.

MiniMed 780G System Use in Type 1 Diabetes During Ramadan Intermittent Fasting: A Systematic Literature Review and Expert Recommendations.

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.

A Real-World Prospective Study of the Effectiveness and Safety of Automated Insulin Delivery Compared With Other Modalities of Type 1 Diabetes Treatment During Ramadan Intermittent Fasting.

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.

The MiniMed 780G automated insulin delivery system adapts to substantial changes in daily routine: Lessons from real world users during Ramadan.

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.

The American Thyroid Association risk stratification and long-term outcomes of differentiated thyroid cancer: a 20-year follow-up of patients in Saudi Arabia.

Background: Studies have reported differing factors associated with poor outcomes in patients with differentiated thyroid cancer (DTC). We aimed to describe our 20 years of experience in the management of thyroid cancer (TC) and identify predictors of treatment outcomes. Methods: We conducted a retrospective review of medical records of patients with TC seen in the Thyroid Center at King Saud University Medical City (KSUMC) in Riyadh, Saudi Arabia, between the years 2000 and 2020. Demographic and clinical data including pathological characteristics were collected. The American Thyroid Association (ATA) risk stratification was determined for all patients at the postoperative period as well as the response to therapy at the final follow-up visit. Results: A total of 674 patients (mean age: 47.21 years) with TC, 571 (84.7%) of which were women, were included. There were 404 (60.0%) patients with ATA low risk, 127 (18.8%) with intermediate risk, and 143 (21.2%) with high-risk histology. Overall, 461 patients (68.4%) had an excellent response to treatment, 65 (9.6%) had an indeterminate response, 83 (12.3%) had a biochemical incomplete response, and 65 (9.6%) had a structural incomplete response. Patients who had an excellent response were mostly ATA low risk (n = 318 of 431, 68.1%), whereas 40 of 65 patients (61.5%) of those with ATA high-risk histology had a structural incomplete response to treatment. There were significantly more women who had an excellent response compared with men. Obesity, lymphovascular invasion, and size of the tumor were significant predictors of worse outcomes to therapy. Conclusion: Tumor size, lymphovascular invasion, and obesity are strong predictors of a worse response to therapy among patients with TC. Patients with obesity should be carefully followed up regardless of their risk stratification in light of the recent compelling evidence associating obesity with thyroid cancer and its higher risk of a worse disease outcome. ATA risk stratification is well correlated with patient long-term outcomes.

Lipohypertrophy and Insulin: An Old Dog That Needs New Tricks.

OBJECTIVE: To review the current status of practical knowledge related to insulin-associated lipohypertrophy (LH) - an accumulation of fatty subcutaneous nodules commonly caused by repeated injections and/or infusions of insulin into the same site. METHODS: Review of published literature with additional contributions from leading multidisciplinary experts with the emphasis on clinical aspects including pathophysiology, clinical and economic consequences, diagnosis, prevention and treatment. RESULTS: LH is the most common dermatologic complication of insulin therapy. Risk factors for the development of lipohypertrophy include repeated delivery of large amounts of insulin into the same location over time, repeated injection trauma to the skin and subcutaneous tissue, and multiple injections using the same needle. Subcutaneous insulin injection in skin areas with lipohypertrophy is associated with reduced pain; however, this problem can interfere with insulin absorption, thereby increasing the likelihood of glucose variability, hypo- and hyperglycemia when a site is changed. Modern visualization technology of the subcutaneous space with ultrasound can demonstrate lipohypertrophy early in the course of its development. CONCLUSIONS: The physiological and psychological consequences of developing insulin lipohypertrophy can be prevented and treated with education focusing on insulin injection techniques.

Perspectives on Prediabetes and Aging.

Diabetes prevention programs (DPPs) have been shown to effectively delay, and sometimes prevent, the progression from prediabetes to diabetes; however, labeling someone with prediabetes comes with potential negative psychological, financial, and self-perception consequences. Many older adults with prediabetes nowadays have a relatively "low-risk" form of prediabetes that rarely progresses to diabetes and may regress to normoglycemia. In this article, we review the impact of aging on glucose metabolism and provide a holistic approach to cases of prediabetes in older adults that maximizes the benefit-risk balance of interventions aimed at addressing prediabetes.

A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings.

BACKGROUND: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. METHODS: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. RESULTS: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. CONCLUSION: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

"Pre-Ramadan" telemedicine: Effect on fasting experience and glycemic control during ramadan in people with type 1 diabetes.

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.

The impact of a prolonged lockdown and utilization of diabetes telemedicine on cardiometabolic health in people with diabetes during the COVID-19 outbreak in Saudi Arabia.

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.

Predictors of use and improvement in glycemic indices after initiating continuous glucose monitoring in real world: Data from Saudi Arabia.

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.

Assessment of the Effectiveness of a Protocol to Manage Dexamethasone-Induced Hyperglycemia Among Hospitalized Patients With COVID-19.

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.

COVID-19 Precautionary Measures and Type 1 Diabetes Patients in Saudi Arabia.

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.

Use of Preventive Aspirin Among Older US Adults With and Without Diabetes.

Importance: The net benefit of aspirin for prevention of cardiovascular disease (CVD), particularly primary prevention, remains debated in people with and without diabetes. Recent studies suggest that the benefits of preventive aspirin may be outweighed by the potential for harm in older adults; therefore, it is important to monitor current aspirin use in order to minimize risk for future harm in the oldest segment of the population. Objective: To determine the prevalence of preventive aspirin use in older US adults with and without diabetes for both primary and secondary prevention by age, sex, and CVD risk category. Design, Setting, and Participants: This cross-sectional analysis used nationally representative data from the National Health and Nutrition Examination Survey from 2011 to 2018. A total of 7103 individuals 60 years or older with and without diabetes completed a questionnaire on preventive aspirin use. Statistical analyses were performed from July 1, 2019, to April 1, 2021. Main Outcomes and Measures: Preventive aspirin use was defined as participants' self-reported use of low-dose aspirin therapy based on their physician's advice or their own decision. Results: A total of 7103 individuals (mean [SD] age, 69.6 [0.1] years; 45.2% men; 75.8% White participants) were evaluated. Overall, 61.7% of older US adults with diabetes vs 42.2% without diabetes used aspirin. Among people with diabetes, in multivariable logistic models adjusting for race, sex, education, CVD risk category, and body mass index, the likelihood of aspirin use in older vs younger age categories (reference: 60-69 years) did not differ. Among people without diabetes, aspirin use was significantly greater in older age categories vs the reference (model 3, 70-79 years, odds ratio [OR], 1.50; 95% CI, 1.23-1.83; model 3, ≥80 years, OR, 1.59; 95% CI, 1.24-2.04). An estimated 9.9 million US adults 70 years or older with or without diabetes reported taking aspirin for primary prevention. The likelihood of aspirin use for primary prevention in those at high vs low risk for CVD did not differ among older adults with diabetes (model 3, OR, 1.69; 95% CI, 0.65-4.39) but was significantly higher in those without diabetes (model 3, OR, 2.46; 95% CI, 1.63-3.71). Women vs men with diabetes were less likely to be using aspirin for primary prevention (model 3, OR, 0.63; 95% CI, 0.48-0.83). Conclusions and Relevance: This cross-sectional study found that preventive aspirin use was higher among older adults with diabetes than in those without diabetes. Results suggest that 9.9 million older US adults who previously took aspirin for primary prevention would not be recommended for its continued use, particularly among those with diabetes.

Pharmacological treatment of type 2 diabetes in Saudi Arabia: A consensus statement from the Saudi Society of Endocrinology and Metabolism (SSEM).

BACKGROUND AND AIMS: The list of available treatment options for managing blood glucose in patients with type 2 diabetes (T2D) has grown over recent years making the task of choosing between traditional and newer glucose-lowering agents a difficult one for healthcare providers. METHODS: We summarize treatment algorithms developed by popular professional societies and propose a patient-centered and culture-driven recommendations for selecting diabetes medications for people with T2D in Saudi Arabia. RESULTS: Though most professional societies recognize patient's adherence to medications as an important factor in achieving glycemic targets, published algorithms schemes do not formally enlist adherence to medication as a deciding factor in the choice of glucose-lowering agents. Medication appeal to patients, an important determinant of medication adherence, is influenced by several factors including lifestyle, common beliefs, customs and traditions, health literacy, perception of health and disease, socioeconomic and cultural backgrounds, and religious commitments and obligations. In Saudi Arabia, poor adherence to therapy is a major obstacle to effective management of local people with T2D. CONCLUSIONS: The Saudi population has a unique socioeconomic and cultural background that widely respect adherence to religion and culture; and the applicability of international guidelines for the management of T2D to the Saudi population has been called into question. In this consensus statement, we propose patient-centered and culture-driven recommendations that integrate medication-adherence and medication-cost into overall selection of diabetes medications for people with T2D in Saudi Arabia.

Severe vitamin D deficiency is not related to SARS-CoV-2 infection but may increase mortality risk in hospitalized adults: a retrospective case-control study in an Arab Gulf country.

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.

The impact of a prolonged lockdown and use of telemedicine on glycemic control in people with type 1 diabetes during the COVID-19 outbreak in Saudi Arabia.

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.