Ramadan fasting in people with diabetes and chronic kidney disease (CKD) during the COVID-19 pandemic: The DaR global survey.

BACKGROUND AND AIMS: The DaR Global survey was conducted to observe the impact of the COVID-19 pandemic on the intentions to fast and the outcomes of fasting in people with diabetes and chronic kidney disease (CKD). METHODS: Muslim people with diabetes and CKD were surveyed in 13 countries shortly after the end of Ramadan 2020, using a simple Survey Monkey questionnaire. RESULTS: This survey recruited 6736 people with diabetes, of which 707 (10.49%) had CKD. There were 118 (16.69%) people with type1 diabetes (T1D), and 589 (83.31%) were with type2 diabetes (T2D). 62 (65.24%) people with T1D and 448 (76.06%) people with T2D had fasted with CKD. Episodes of hypoglycaemia and hyperglycaemia were more frequent among people with T1D compared to T2D, 64.52% and 43.54% vs 25.22% and 22.32% respectively. Visits to the emergency department and hospitalization were more frequent among people with CKD, however no significant difference was found between people with T1D and T2D. CONCLUSION: The COVID-19 pandemic had only a minor effect on the intention to fast during Ramadan in people with diabetes and CKD. However, hypoglycaemia and hyperglycaemia were found to be more frequent, as well as emergency visits and hospital admissions among people with diabetic kidney disease. Prospective studies are needed in future to evaluate the risk indicators of hypoglycaemia and hyperglycaemia among fasting people with CKD, especially in the context of different stages of kidney disease.

Dysglycemias in patients admitted to ICUs with severe acute respiratory syndrome due to COVID-19 versus other causes - a cohort study.

BACKGROUND: Dysglycemias have been associated with worse prognosis in critically ill patients with COVID-19, but data on the association of dysglycemia with COVID-19 in comparison with other forms of severe acute respiratory syndrome are lacking. This study aimed to compare the occurrence of different glycemic abnormalities in patients with severe acute respiratory syndrome and COVID-19 admitted to intensive care units versus glycemic abnormalities in patients with severe acute respiratory syndrome from other causes, to evaluate the adjusted attributable risk associated with COVID-19 and dysglycemia and to assess the influence of these dysglycemias on mortality. METHODS: We conducted a retrospective cohort of consecutive patients with severe acute respiratory syndrome and suspected COVID-19 hospitalized in intensive care units between March 11 and September 13, 2020, across eight hospitals in Curitiba-Brazil. The primary outcome was the influence of COVID-19 on the variation of the following parameters of dysglycemia: highest glucose level at admission, mean and highest glucose levels during ICU stay, mean glucose variability, percentage of days with hyperglycemia, and hypoglycemia during ICU stay. The secondary outcome was the influence of COVID-19 and each of the six parameters of dysglycemia on hospital mortality within 30 days from ICU admission. RESULTS: The sample consisted of 841 patients, of whom 703 with and 138 without COVID-19. Comparing patients with and without COVID-19, those with COVID-19 had significantly higher glucose peaks at admission (165 mg/dL vs. 146 mg/dL; p = 0.002) and during ICU stay (242 mg/dL vs. 187md/dL; p < 0.001); higher mean daily glucose (149.7 mg/dL vs. 132.6 mg/dL; p < 0.001); higher percentage of days with hyperglycemia during ICU stay (42.9% vs. 11.1%; p < 0.001); and greater mean glucose variability (28.1 mg/dL vs. 25.0 mg/dL; p = 0.013). However, these associations were no longer statistically significant after adjustment for Acute Physiology and Chronic Health Evaluation II scores, Sequential Organ Failure Assessment scores, and C-reactive protein level, corticosteroid use and nosocomial infection. Dysglycemia and COVID-19 were each independent risk factors for mortality. The occurrence of hypoglycemia (< 70 mg/dL) during ICU stay was not associated with COVID-19. CONCLUSION: Patients with severe acute respiratory syndrome due to COVID-19 had higher mortality and more frequent dysglycemia than patients with severe acute respiratory syndrome due to other causes. However, this association did not seem to be directly related to the SARS-CoV-2 infection.

The Effect of Tang Forte (Royal Jelly) Capsule on Hypoglycemia and Clinical Course in COVID-19 Patients Under Corticosteroid Therapy.

Corticosteroids improve the complications of Covid-19 but may cause some side effects such as hyperglycemia. Royal jelly is one of the bee products that exert anti-inflammatory, insulin-like, and hypoglycemic activities. The present study was conducted to investigate the effect of royal jelly capsules on blood sugar and the clinical course of Covid-19 in the patients receiving corticosteroid therapy. In this clinical trial, 72 Covid-19 patients with positive reverse transcription polymerase chain reaction (RT-PCR) test and pulmonary involvement hospitalized in Shahrekord Hajar Hospital were enrolled and randomized into two groups: treatment (receiving corticosteroids and Royal Jelly 1000 mg capsules daily for 7 days) and placebo (given corticosteroids and placebo). Laboratory tests, blood sugar, and clinical courses were determined and compared. Data was analyzed using SPSS version 16. On day 7 after the onset of the intervention, the dosage and frequency of insulin, FBS level, and required corticosteroid showed a decrease in both groups but the inter-group difference was not significant (P > .05). As well, the Spo2 level indicated a non-significant increase and hospital stay length indicated a non-significant decrease in the intervention group (P > .05). Among the symptoms, only headache, cough, and dyspnea indicated an improvement in the intervention group (P < .05). Overall, the results indicated the short-term consumption of royal jelly could not significantly improve blood sugar and the clinical course of Covid-19; however, it could significantly improve headache, cough, and dyspnea in the patients.

A Retrospective Cohort Analysis of Two Computerized Insulin Infusion Protocols.

OBJECTIVE: The primary objective of this analysis was to compare the safety and efficacy of a novel computerized insulin infusion protocol (CIIP), the Lalani Insulin Infusion Protocol (LIIP), with an established CIIP, Glucommander. METHODS: We conducted a 10-month retrospective analysis of 778 patients in whom LIIP was used (August 18, 2020 to June 25, 2021) at six HonorHealth Hospitals in the Phoenix metropolitan area. These data were compared with Glucommander that was used at those same hospitals from January 1, 2018 to August 17, 2020, n = 4700. Primary end points of the project included average time to euglycemia and average time in hyperglycemia (>180 mg/dL) and hypoglycemia (<70 mg/dL). Additional subgroup analysis was done to evaluate CIIP performance in patients in whom maintenance of euglycemia was more challenging. RESULTS: The LIIP had a faster time to euglycemia (191 vs 222 minutes, P < .001) and similar time in hypoglycemia (2.79 vs 2.76 minutes, P = .50) for all patients, when compared with Glucommander. Similar observations were made for the following subgroups: diabetic ketoacidosis/hyperosmolar hyperglycemic state (DKA/HHS) patients, COVID-19 patients, patients on steroids, patients with ≥60 glomerular filtration rate (GFR), patients with renal insufficiency, and patients with sepsis. CONCLUSIONS: The LIIP is a safe and effective CIIP in managing intravenous insulin infusion rates. Utilization of LIIP resulted in reduced time to euglycemia, P < .001, when compared with Glucommander and did not cause increased hypoglycemia during the project period. Contributing factors to the success of LIIP may include improved clinical workflow, learnability and ease of use, compatibility with the Epic electronic health record (EHR), and its unique, dynamic and adaptive algorithm.

Safety of sodium-glucose cotransporter 2 inhibitors (SGLT2i) during the month of Ramadan in patients with type 2 diabetes mellitus in Pakistani population-an observational study from a tertiary care center in Karachi.

BACKGROUND AND AIMS: Primary aim was to assess the safety of SGLT2-i in patients with Type 2 Diabetes Mellitus (T2D) in a real-life scenario during Ramadan by finding the frequency and severity of hypoglycemic/hyperglycemic events, dehydration, and Diabetic ketoacidosis (DKA). Secondary aim was to assess changes in glycated hemoglobin (HbA1c), weight and creatinine levels. METHODS: This prospective, observational, controlled cohort study was conducted at Aga Khan University Hospital, Karachi, Pakistan from March 15 to June 30, 2021. Participants were over 21 years of age, on stable doses of SGLT2-I, which was started at least 2 months before Ramadan. Endpoint assessments were done 1 month before and within 6 weeks after Ramadan. RESULTS: Of 102 participants enrolled, 82 completed the study. Most (52%) were males, with mean age 52.2 ± 9.5 years and average duration of T2D 11.2 ± 6.5 years. 63% were on Empagliflozin (mean dose; 14.8 ± 7.2 mg/day) whereas 37% were on Dapagliflozin (mean dose; 8.2 ± 2.7 mg/day). Six (7.3%) documented symptoms of hypoglycemia. However, no episode of severe hypoglycemia, hyperglycemia, dehydration, DKA, hospitalization or discontinuation of SGLT2i was reported. HbA1c changes were (7.7 ± 1.2% from 7.9 ± 2.3%, p 0.34), weight (78.4 ± 12.9 kgs from 78.9 ± 13.3, p 0.23) and eGFR (87.8 ± 27.9 from 94.3 ± 37.6, p < 0.001). The reasons of study participants drop outs were: six did not keep any fasts; four discontinued study participation for personal reasons; three were out of city and missed post Ramadan follow-up, two protocol violation and five could not be contacted for post-Ramadan follow up during the third wave of COVID-19. CONCLUSION: Results showed the safety of SGLT2i agents during Ramadan in the Pakistani population recommending it as a treatment option in adults with T2D, without any additional adverse events.

Real-world safety and effectiveness of iGlarLixi in people with type 2 diabetes who fast during Ramadan: The SoliRam observational study.

BACKGROUND AND AIMS: To evaluate the safety and effectiveness of iGlarLixi in adults with type 2 diabetes (T2D) fasting during Ramadan. METHODS: SoliRam was a multinational, prospective, single-arm, real-world observational study conducted during Ramadan 2020 and 2021 in adults with T2D treated with iGlarLixi ≥3 months at study entry. The primary endpoint was the percentage of participants experiencing ≥1 episode of severe and/or symptomatic documented hypoglycemia (<70 mg/dL [<3.9 mmol/L]). RESULTS: Among the 409 eligible participants followed during Ramadan, 96.8% fasted for ≥25 days and 92.4% did not break fasting during Ramadan. Four participants broke their fast due to hypoglycemia. Minimal adjustments were seen in antihyperglycemic therapies from pre to during Ramadan. Documented symptomatic hypoglycemia was experienced by 1.0%, 2.3%, and 0.3% of participants, respectively, during the last month of pre-Ramadan, Ramadan, and first month post-Ramadan. Mean change in HbA1c from pre-to post-Ramadan periods was -0.75% (-8.2 mmol/mol), and participants with HbA1c <7% (<53 mmol/mol) increased from 7.9% pre-Ramadan to 28.6% post-Ramadan. CONCLUSIONS: iGlarLixi is an effective and well-tolerated therapy for people with T2D, including those who intend to fast during Ramadan, and is associated with a low risk of hypoglycemia; benefits were observed both during and after Ramadan.

[Dysglycemia in COVID-19 and Type 2 Diabetes Mellitus: Peculiarities of the Glycemic Profile in Hospitalized Patients and the Role of Steroid-Induced Disorders].

BACKGROUND: There is a lack of data on the features of dysglycemia in hospitalized patients with COVID-19 and concomitant diabetes mellitus (DM) confirmed by continuous glucose monitoring (CGM). AIM: to study the glycemic profile in hospitalized patients with COVID-19 and type 2 diabetes mellitus by continuous glucose monitoring and the role of steroid therapy in dysglycemiadevelopment. MATERIALS AND METHODS: We examined 21 patients with COVID-19 and DM 2 and 21 patients with DM 2 without COVID-19 (control group) using a professional 4-7-day CGM. We also compared two subgroups of patients with COVID-19 and DM 2: 1) patients received systemic glucocorticosteroids (GCS) during CGM and 2) patients in whomCGMwas performed after discontinuation of GCS. RESULTS: Compared with controls, patients with COVID-19 and DM2 had lesser values of glycemic «time in range¼ (32.7 ± 20.40 vs 48.0 ± 15.60%, p = 0.026) andhigher parameters of mean glycemia (p <0.05) but similar proportion of patients with episodes of hypoglycemia (33.3% vs 38.1%, p = 0.75). Patients who received dexamethasone during CGM were characterized by higher hyperglycemia and the absence of episodes of hypoglycemia. In patients who hadCGM after dexamethasone discontinuation, hyperglycemia was less pronounced, but 60% of them had episodes of hypoglycemia, often nocturnal, clinically significant and not detected by routine methods. CONCLUSION: Patients with COVID-19 and DM 2had severe and persistent hyperglycemia but a third of them hadalso episodes of hypoglycemia. During therapy with dexamethasone, they had the most pronounced hyperglycemia without episodes of hypoglycemia. In patients who underwent CGM after discontinuation of dexamethasone, hyperglycemia was less pronounced but 60% of them have episodes of hypoglycemia, often nocturnal, clinically significant and not diagnosed by routine methods. It would be advisable to recommend at least a 5-6-fold study of the blood glucose level (with its obligatory assessment at night) even for stable patients with COVID-19 and DM 2after the end of GCS treatment.

Recurrent Hypoglycaemia In An Older Individual With Covid-19.

Coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged as a deadly pandemic overburdening healthcare system globally. While people of all ages were affected, the older population has faced disproportionately higher morbidity and mortality, likely due to altered immune responses and pre-existing comorbid conditions like cardiovascular disease, hypertension, diabetes mellitus, chronic pulmonary and kidney disease. Clinical manifestations in older patients may also be atypical with absence of fever, increased chances of acute confusion and longer recovery times. While other parameters of disease severity have been found, poor glycaemic control is another indicator of severity in COVID 19 infection. Moreover, older patients with diabetes mellitus are also at risk of hypoglycaemia which increases the risk of cardiovascular and cerebrovascular events, progression of dementia, falls, emergency department visits and hospitalization. Here we share a case of an older man with COVID-19 infection who presented primarily with recurrent hypoglycaemia and weakness. This case also highlights the social impact of an infection that has decimated support systems for vulnerable older adults.

Incidence of hypoglycemia with glimepiride/metformin fixed-dose combination in patients with type 2 diabetes inadequately controlled on metformin monotherapy in Peru: a prospective, active pharmacovigilance cohort study Short running title: Hypoglycemia with glimepiride plus metformin in Peru (preprint)

Purpose: — To evaluate hypoglycemia incidence rate during treatment with a fixed-dose combination of glimepiride and metformin in patients non-responders to metformin monotherapy. Data were collected during customary specialized practice in Peru where access to effective and safe, but low-cost medications, is needed. Methods— This was an observational, prospective, active pharmacovigilance, cohort study with in-person medical assessments. Medical assessments were conducted every 3-months, with monthly follow-up through phone calls. Data regarding use and administration of treatment were recorded by patients. Adverse events (AE) reported by patients and/or ascertained by attending physicians during the period of 18 months along with treatment-related events were identified. Cumulative incidence and hypoglycemia incidence rate were estimated. Poisson and logistic regression models were applied to study their relationship with risk factors and patterns of use. Results— 206 patients were enrolled in the study from 10 centers and were followed for a median duration of 12 months (range, 2-18 months). Forty treatment-related AEs were reported (cumulative incidence = 19.4%). No severe hypoglycemic events were observed. Most common AE found was non-severe hypoglycemia (cumulative incidence = 2.4%; incidence rate = 2.6/100 person/years). Self-administration of a higher dose than prescribed was associated with a higher probability of an AE (p=0.03). Conclusions— Administration of a fixed-dose combination of glimepiride plus metformin was associated with low incidence of non-severe hypoglycemia, and no incidence of severe hypoglycemia. These results advocate the use of fixed-dose combination of glimepiride plus metformin in low- and middle-income countries with limited resources, even more so in wake of COVID-19 pandemic.

Effectiveness of a flash glucose monitoring systems implementation program through a group and telematic educational intervention in adults with type 1 diabetes.

OBJECTIVES: Verifying the clinical effectiveness and the impact on quality-of-life parameters, fear of hypoglycaemia and satisfaction with the treatment obtained with a flash glucose monitoring (MFG) devices implantation program that includes a telematic and group educational intervention in adults with type 1 diabetes. PATIENTS AND METHODS: Prospective quasi-experimental study, carried out during the COVID-19 pandemic period with a 9-month follow-up at the Virgen Macarena University Hospital, Sevilla. RESULTS: Eighty-eight participants were included (men: 46.6%; mean age (years) 38.08, SD: 9.38); years of DM1 evolution: 18.4 (SD: 10.49); treatment with multiple doses insulin (MDI) 70.5% vs 29.5% subcutaneous insulin infusion therapy (CSII)). Baseline HbA1c was 7.74% (1.08). After the intervention, the global decrease in HbA1c was -0.45% (95% CI [-0.6, -0.25], P < 0.01), increasing to -1.08% in the group that started with HbA1c ≥ 8% (P < 0.01). A mean decrease in the Fear of Hypoglycemia 15 (FH15) test score of -6.5 points was observed (P < 0.01). In the global score of the Spanish version of Diabetes Quality Of Life (DQOL-s) test, the decrease was -8.44 points (P < 0.01). In Diabetes Treatment Satisfaction Questionnaire test (DTQ-s), global score increased in + 4 points (P < 0.01). CONCLUSIONS: The incorporation of an educational program in group and telematic format within the development of MFG devices implantation strategies is an effective option, with associated benefits in quality of life and fear of hypoglycemia in adult patients with DM1. This option can be implemented in usual clinical practice.

Clinical Spectrum and Outcome of Neonatal Multi-System Inflammatory Syndrome (MIS-N) - A Prospective Cohort Study. (preprint)

AIMS: To analyze the clinical spectrum in Neonates with MIS-N based on the time of presentation and also to assess the use of immunomodulator therapy in MIS-N. SUBJECTS AND METHODS: We studied 100 neonates, delivered at BLDE (DU) Shri B M Patil Medical College Hospital admitted to Level III-A NICU from JULY 2020 to MAY 2021. 98 neonates had high titers of Ig G antibodies and negative for COVID Antigen. We categorized the cohorts into EARLY MIS-N (<72 hrs) and LATE MIS-N (>72 hrs). RESULTS: 58 presented as EARLY MIS-N with Respiratory Distress in 40 (70%), cardiac dysfunction 34 (60%), PPHN 12(20%), Fever 12(20%), seizures 12(20%), encephalopathy in 6(10%), sepsis-like features 6(10%), had elevated inflammatory markers like CRP (30%), D-Dimer (70%), Ferritin (30%), cardiac biomarkers like BNP (60%), LDH (30%) and ECHO showing LV dysfunction in 50%. LATE MIS-N presented mostly with fever 28(70%), sepsis-like features 24(60%), Respiratory Distress in 16(40%), cardiac dysfunction 12 (30%), hypoglycemia 4(10%) parotitis 4(10%), had significantly elevated inflammatory markers like CRP (70%), D-Dimer (50%), Ferritin (70%), cardiac biomarkers like BNP (40%), LDH (20%) and ECHO showing LV dysfunction in 20%, dilated coronaries in 20 %, PPHN in 10%. Oxygen and respiratory support requirement was more in EARLY presenters and IVIG and steroid requirement was more in LATE presenters. CONCLUSION: We observed that maternal SARS COV2 antibodies transferred transplacentally and neonatal antibodies acquired after COVID 19 infection can cause MIS-N in neonates. The immunomodulator therapy is required in severe cases of MIS-N only.

VACtrac: Enhancing access immunization registry data for population outreach using Bulk Fast Interoperable Healthcare Resource (FHIR) protocol (preprint)

COVID-19 vaccination uptake has been suboptimal, even in high-risk populations. This paper describes work to extend the Bulk Fast Healthcare Interoperability Resource (FHIR) standard for use in querying state Immunization Information Systems (IIS). We also describe a population vaccination outreach tool that uses both Bulk FHIR and automated single queries to access IIS data. Bulk FHIR protocols needed to be extended to support IIS’s responses for care outside an institution resulting in the addition of Group and Master Data Management FHIR profile functionalities to Bulk FHIR queries to support more accurate and easier retrieval of data. While real-world testing of Bulk FHIR queries using the vaccination outreach system was not possible, we tested an automated-single-query tool in a focused effort to reach 1500 high-risk patients. Results confirmed the potential for performance problems during periods of high demand that could be resolved by Bulk FHIR’s asynchronous retrieval methods.

Impact of SARS-CoV-2 infection on disease trajectory in youth with T1D: An EHR-based cohort study from the RECOVER program (preprint)

Background: Post-acute sequelae of SARS-Co-V-2 infection (PASC) is associated with worsening diabetes trajectory. It is unknown whether PASC in children with type 1 diabetes (T1D) manifests as worsening diabetes trajectory. Objective: To explore the association between SARS-CoV-2 infection (COVID-19) and T1D-related healthcare utilization (for diabetic ketoacidosis [DKA] or severe hypoglycemia [SH]) or Hemoglobin (Hb) A1c trajectory. Methods: We included children <21 years with T1D and [≥]1 HbA1c prior to cohort entry, which was defined as COVID-19 (positive diagnostic test or diagnosis code for COVID-19, multisystem inflammatory syndrome in children, or PASC) or a randomly selected negative test for those who were negative throughout the study period (Broad Cohort). A subset with [≥]1 HbA1c value from 28-275 days after cohort entry (Narrow Cohort) was included in the trajectory analysis. Propensity score-based matched cohort design followed by weighted Cox regression was used to evaluate the association of COVID-19 with healthcare utilization >28 days after cohort entry. Generalized estimating equation models were used to measure change in HbA1c in the Narrow cohort. Results: From 03/01/2020-06/22/2022, 2,404 and 1,221 youth met entry criteria for the Broad and Narrow cohorts, respectively. The hazard ratio for utilization was (HR 1.45 [95%CI,0.97,2.16]). In the Narrow Cohort, the rate of change (slope) of HbA1c increased 91-180 days after cohort entry for those with COVID-19 (0.138 vs. -0.002, p=0.172). Beyond 180 days, greater declines in HbA1c were observed in the positive cohort (-0.104 vs. 0.008 per month, p=0.024). Conclusion: While a trend towards worse outcomes following COVID-19 in T1D patients was observed, these findings were not statistically significant. Continued clinical monitoring of youth with T1D following COVID-19 is warranted.

Early glycaemic variability increases 28-day mortality and prolongs intensive care unit stay in critically ill patients with pneumonia.

OBJECTIVE: This study aimed to evaluate the effect of early glycaemic variability (GV) on 28-day mortality in critically ill patients with pneumonia. PATIENTS AND METHODS: This single-centre retrospective study included patients admitted to the intensive care unit (ICU) due to pneumonia between 2018 and 2019. A total of 282 patients (mean age, 68.6 years) with blood sugar test (BST) results measured more than three times within 48 h after hospitalization and haemoglobin A1c (HbA1c) levels recorded within 2 months were enrolled. Coefficient of variation (CV) was calculated using the BST values. The effects of GV on 28-day mortality and prolonged ICU stay (>14 days) were also assessed. RESULTS: The mean age was 60.6 years (male to female ratio, 2.5:1). The 28-day mortality rate was 31.6% (n = 89) and was not different according to the presence of diabetes (DM vs. non-DM) or HbA1c levels (≥7.5 vs. <7.5%; both p > .05). However, the mortality rate was significantly higher in patients with high GV (CV ≥ 36%) than in those with low GV (CV < 36%; 37.5 vs. 25.4%, p = .028). The risk of mortality in patients with high GV was prominent in the subgroups with DM or low HbA1c levels. Among the surviving patients (n = 193), 44 remained in the ICU for more than 14 days. Compared to low GV, high GV was associated with a higher rate of prolonged ICU stay, although not statistically significant (27.8 vs. 18.5%, p = .171). After adjusting for the severity of illness and treatment strategy, CV was an independent risk factor for 28-day mortality (hazard ratio [HR], 1.01, p = .04) and prolonged ICU stay (odds ratio, 1.02; p = .04). CONCLUSIONS: High GV within 48 h of ICU admission was associated with an increased 28-day mortality risk and prolonged ICU stay. Early phase GV should be carefully managed in critically ill patients with pneumonia.KEY MESSAGESThe presence of diabetes or HbA1c alone is insufficient to predict 28-day mortality and prolonged ICU stay in critically ill patients with pneumonia.High glycaemic variability (GV) within 48 h of ICU admission increases 28-day mortality and prolongs ICU stay, which is consistent after adjusting for severity of illness and treatment strategy.Patients with high GV, especially those with DM or low HbA1c levels (<7.5%) should be more carefully treated to reduce mortality.

Hypoglycemia: A closer look at a community pharmacist's impact in optimizing diabetes care.

BACKGROUND: Hypoglycemia is a complication of diabetes and can have considerable clinical impact on mortality, morbidity, and quality of life. Certain patient populations with diabetes are at an increased risk of experiencing hypoglycemia, posing as a safety concern and may have possible negative affect(s) on diabetes if not appropriately managed. With community pharmacies often being an accessible means of health care, there is potential for widespread diabetes education in this setting. OBJECTIVES: Assess impact of pharmacist-initiated education on proper recognition/management of hypoglycemia in patients with type 1 and 2 diabetes. Secondary objectives aim to optimize diabetes care: (1) assessment of patient need for a glucagon kit prescription, (2) evaluation of adherence to highly recommended vaccinations for individuals with diabetes and acceptance of pharmacist vaccination recommendations, and (3) assessment of patient satisfaction with the study intervention. SETTING AND PRACTICE DESCRIPTION: A community pharmacy in the Suffolk County of Massachusetts serving middle- to lower-class and medically underserved patients. Most of the population includes an elderly, Hispanic, and Asian demographic. EVALUATION: Outcomes evaluated through change in hypoglycemia questionnaire scores from preintervention to postintervention, the percentage of patients who received a prescription for glucagon kit post pharmacist intervention, the percentage of patients that received a vaccination because of pharmacist intervention, and Likert scale-based survey for the assessment of patient satisfaction. RESULTS: Participant knowledge of hypoglycemia awareness/treatment improved significantly post pharmacist intervention (P < 0.001). Average gain in questionnaire scores from pre-edcation to posteducation was 6.4 points (maximum score = 9, P < 0.001). Glucagon prescriptions were facilitated/dispensed for 28.5% of eligible participants. Fifty-eight vaccinations were recommended, and 25.8% were administered. Patients' overall satisfaction score averaged 4.7 out of a maximum of 5 (higher scores more favorable). CONCLUSION: An educational service in a community pharmacy setting can provide effective education to recognize signs, symptoms, and proper treatment of hypoglycemia in patients on diabetes therapy that carries a high risk.

The 12-Item Hypoglycemia Impact Profile (HIP12): psychometric validation of a brief measure of the impact of hypoglycemia on quality of life among adults with type 1 or type 2 diabetes.

INTRODUCTION: The aim of this study was to determine the psychometric properties of the 12-Item Hypoglycemia Impact Profile (HIP12), a brief measure of the impact of hypoglycemia on quality of life (QoL) among adults with type 1 (T1D) or type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: Adults with T1D (n=1071) or T2D (n=194) participating in the multicountry, online study, 'Your SAY: Hypoglycemia', completed the HIP12. Psychometric analyses were undertaken to determine acceptability, structural validity, internal consistency, convergent/divergent validity, and known-groups validity. RESULTS: Most (98%) participants completed all items on the HIP12. The expected one-factor solution was supported for T1D, T2D, native English speaker, and non-native English speaker groups. Internal consistency was high across all groups (ω=0.91-0.93). Convergent and divergent validity were satisfactory. Known-groups validity was demonstrated for both diabetes types, by frequency of severe hypoglycemia (0 vs ≥1 episode in the past 12 months) and self-treated episodes (<2 vs 2-4 vs ≥5 per week). The measure also discriminated by awareness of hypoglycemia in those with T1D. CONCLUSIONS: The HIP12 is an acceptable, internally consistent, and valid tool for assessing the impact of hypoglycemia on QoL among adults with T1D. The findings in the relatively small sample with T2D are encouraging and warrant replication in a larger sample.

Metformin-associated Lactic Acidosis with Hypoglycemia during the COVID-19 Pandemic.

Metformin-associated lactic acidosis (MALA) is an extremely rare but life-threatening adverse effect of metformin treatment. The lifestyle changes associated with the coronavirus disease 2019 (COVID-19) pandemic may increase the potential risk of MALA development in patients with diabetes. We herein report a 64-year-old Japanese man taking a small dose of metformin who presented with MALA accompanied by hypoglycemia secondary to increased alcohol consumption triggered by lifestyle changes during the pandemic. Physicians should prescribe metformin judiciously to prevent MALA development and pay close attention to lifestyle changes in patients at risk for MALA during the COVID-19 pandemic.

Impact of COVID-19 lockdown on glucemic control in children and adolescents with type 1 diabetes mellitus.

BACKGROUND AND AIMS: To face the rapid spread of SARS-CoV2 coronavirus pandemic, home lockdown in Spain was decreed on 15th March 2020. The main objective of this study is to evaluate the impact of this constraint on glycemic control in children and adolescents with type 1 diabetes mellitus (T1D). PATIENTS AND METHODS: Observational, retrospective study in children and adolescents with T1D users of interstitial glucose monitoring systems. The following information corresponding to the last 2 weeks of lockdown was collected for subsequent comparison with data of 2 weeks prior to quarantine: daily insulin needs, mean interstitial glucose, estimated HbA1c, coefficient of variation (CV), time in range (70-180mg/dl), hypoglycemia (<70 and <54mg/dl) and hyperglycemia (>180 and> 250mg/dl), sensor use and number of blood glucose measurements. Data about meal routines, physical exercise, need for adjustments in therapy, acute complications and lockdown of caregivers were assessed via a survey. RESULTS: 80 patients were studied (mean age 12.61±3.32 years, mean time of evolution of the disease 5.85±3.92 years), 66.2% treated with an insulin pump, users of following glucose monitoring systems: Guardian 3 (65%), FreeStyle Libre (18.8%) and Dexcom G6 (16.2%). Time in range in the cohort increased significantly during confinement (72.1±10.5 vs 74.8±10.5%; P=0.011) with lower time in hypoglycemia both <70mg/dl (4.6±3.2 vs 3.2±2.7%; P<0.001) and <54mg/dl (1.2±1.6 vs 0.7±1.2%; P<0.001) and hyperglycemia >250mg/dl (4.6±3.9 vs 3.7±3.7%; P=0.038). CV also decreased (35.8±6.3 vs 33.1±6.1%; P<0.001). Patients treated with multiple doses of insulin and poorer baseline glycemic control experienced greatest improvement. Daily insulin requirements remained stable. Regular practice of physical exercise and caregivers' confinement did not have a significant impact. CONCLUSIONS: Glycemic control in children and adolescents with T1D improved during quarantine, particularly in those with worse baseline control.

Prospective cohort study of referred Malawian children and their survival by hypoxaemia and hypoglycaemia status.

Objective: To investigate survival in children referred from primary care in Malawi, with a focus on hypoglycaemia and hypoxaemia progression. Methods: The study involved a prospective cohort of children aged 12 years or under referred from primary health-care facilities in Mchinji district, Malawi in 2019 and 2020. Peripheral blood oxygen saturation (SpO2) and blood glucose were measured at recruitment and on arrival at a subsequent health-care facility (i.e. four hospitals and 14 primary health-care facilities). Children were followed up 2 weeks after discharge or their last clinical visit. The primary study outcome was the case fatality ratio at 2 weeks. Associations between SpO2 and blood glucose levels and death were evaluated using Cox proportional hazards models and the treatment effect of hospitalization was assessed using propensity score matching. Findings: Of 826 children recruited, 784 (94.9%) completed follow-up. At presentation, hypoxaemia was moderate (SpO2: 90-93%) in 13.1% (108/826) and severe (SpO2: < 90%) in 8.6% (71/826) and hypoglycaemia was moderate (blood glucose: 2.5-4.0 mmol/L) in 9.0% (74/826) and severe (blood glucose: < 2.5 mmol/L) in 2.3% (19/826). The case fatality ratio was 3.7% (29/784) overall but 26.3% (5/19) in severely hypoglycaemic children and 12.7% (9/71) in severely hypoxaemic children. Neither moderate hypoglycaemia nor moderate hypoxaemia was associated with mortality. Conclusion: Presumptive pre-referral glucose treatment and better management of hypoglycaemia could reduce the high case fatality ratio observed in children with severe hypoglycaemia. The morbidity and mortality burden of severe hypoxaemia was high; ways of improving hypoxaemia identification and management are needed.

Isolated ACTH deficiency following immunization with the BNT162b2 SARS-CoV-2 vaccine: a case report.

BACKGROUND: The global COVID-19 pandemic requires urgent development of new vaccines. Endocrinological adverse effects following the new mRNA vaccine against COVID-19 have been reported in several cases. Specific to the involvement of pituitary function; however, only a single case with hypophysis has been reported. This is the first case of isolated adrenocorticotropic hormone (ACTH) deficiency (IAD) following mRNA vaccination against COVID-19. CASE PRESENTATION: A healthy 31-year-old man received the BNT162b2 SARS-CoV-2 mRNA vaccine. The first injection was uneventful. One day after the second injection, he noticed general fatigue and fever. In the following several days, he additionally developed headaches, nausea, and diarrhea. Four days after the vaccine injection, he visited a hospital with worsening of these symptoms. Physical examination revealed slight disorientation but no other deficits. Laboratory tests revealed hyponatremia, hypoglycemia, and extremely low plasma ACTH and serum cortisol levels (ACTH < 1.5 pg/ml, cortisol 1.6 µg/dl). He was diagnosed with adrenal crisis and was emergently treated with hydrocortisone. The symptoms responded well and he recovered within a few days. Magnetic resonance images after the replacement with hydrocortisone revealed an atrophic pituitary gland. The patient was referred to our tertiary hospital for further endocrinological examination. Pituitary endocrine load tests revealed isolated adrenocortical response deficiency. After other clinical assessments, he was diagnosed as having isolated ACTH deficiency. After initiation of hydrocortisone replacement, there has been no recurrence of symptoms related to adrenocortical insufficiency nor involvement of other pituitary functions. CONCLUSION: This is the first reported case of IAD potentially associated with COVID-19 immunization. Recent reports have emphasized the importance of adjuvants in the mRNA vaccine that induce the endocrinological adverse effects through disturbance of the autoimmune system, but details are still unclear. Given the broad and rapid spread of vaccinations against COVID-19, it is clinically important to consider that there could be cases with a rare but emergent adrenal crisis even among those who present common symptoms of adverse effects following inactive SARS-CoV-2 mRNA vaccination.