COVID-19 among Hospitalized Patients with Diabetes in Karachi: A Single Centre Study

Aim: To evaluate the clinical characteristics, severity, and outcomes of local COVID-19 patients with diabetes. Study Design: Case series Place and duration of study: Orthopedic Medical Institute Hospital, Karachi from 1st September 2020 to 28th February 2021. Method(s): One hundred and forty seven COVID-19 positive patients with diabetes and pre-diabetes were enrolled. The patients' demographic and clinical information specific to COVID-19 and diabetes was collected and analyzed. Result(s): The mean age of 64.03+/-11.56 years. The ischemic heart disease (39.9%) and hypertension (74.3%) were the two most prevalent comorbid conditions. The overall mortality rate of 20.3%. Between patients with diabetes receiving steroids and those receiving no steroids, the mean fasting (FBG) and random blood glucose (RBG) were relatively elevated. Glycemic control had no discernible impact on the severity, results, or length of the COVID-19 hospital stay (p>0.05). Conclusion(s): No significant effect of diabetes millitus control on COVID severity and outcomes, but the altered blood glucose levels suggest a need to define specific targeted intervention for COVID-19 patients with comorbidities, specifically diabetes mellitus.Copyright © 2023 Lahore Medical And Dental College. All rights reserved.

Outcomes of Continuous Remote Care in Pre-Diabetes and Type 2 Diabetes

Although telehealth existed and was widely implemented in the past, its potential and necessity was amplified in 2020 with the onset of the COVID pandemic. Many providers and patients shifted from periodic office visits to the use of episodic computer and telephone-based contacts. Although somewhat useful, these interactions cannot take the place of data and laboratory assessments, and always preclude direct patient examination. The true potential for telehealth requires data inputs from the patient to the provider, including anthropometrics and personal device data, with subsequent provider assessment, support, and follow-up therapeutic recommendations. Telehealth provides the opportunity to shift from an episodic encounter system (every 3-6 months) for chronic disease management to a continuous remote care paradigm in which data are continuously collected and reviewed, and patient support and education, together with therapeutic interventions may be instituted as rapidly and as often as needed. Diabetes serves as an ideal intervention to be managed by this continuous remote care telehealth model. This presentation will describe one model of diabetes care delivery using nutrition as the primary intervention through telehealth with data on sustainability, durability and patient outcomes, in a research setting over 5 years and in a real world setting over 2 years.

INSUFFICIENT VITAMIN D LEVELS IN PATIENTS WITH HEART FAILURE

Chronic heart failure despite the development of new treatment methods, remains the most common and prognostic adverse complication of all cardiovascular diseases. Studies conducted in different countries over the past decades have convincingly proved that vitamin D deficiency is one of the important factors in the development of CCC diseases. Vitamin D (VDR) receptors were detected in more than 40 target tissues, including cardiomyocytes, smooth muscle and endothelial vascular cells and have convincingly proved, that eliminating vitamin D deficiency improves blood pressure in hypertension and also reduces myocardial hypertrophy. The above studies also confirmed the effect of vitamin D on the development of prediabetes, diabetes, metabolic disorders. The effect of vitamin D on the prevention of atherosclerosis has also been confirmed. One of the mechanisms for the development of atherosclerosis is currently considered an inflammatory process. The effect of vitamin D on the course of inflammatory processes in the body was clearly manifested during the pandemic caused by the new coronavirus infection COVID-19. There was a clear correlation between vitamin D levels and the severity of infection. In severe COVID-19, as a rule, either a deficiency or a lack of vitamin D in the body was determined. In addition, low vitamin D levels increase the risk of developing severe forms of coronary heart disease. The study involved 30 patients <n = 30>diagnosed with heart failure(I-III NYHA) In 12 < 40%> patients out of 30, vitamin D levels were below 20.0 ng/mL, consistent with this vitamin deficiency. In 14 < 46,67%>the level of vitamin D in the blood was between 20.0 ng/mL and 30.0 ng/mL and this corresponded about the lack of vitamin D. Only 4 < 13,33%> patients has level of vitamin D in reference values and this was due to the use vitamin D due to comorbid pathology: thyroid disease, autoimmune diseases or previously identified vitamin D hypovitaminosis. Vitamin D partially enters the body with food mainly found in animal productsliver, milk, eggs, butter, etc and is formed in the skin under the influence of ultraviolet rays. However, patients with CHF often have concomitant diseases:kidney disease, diabetes, disorders and others, forcing them to adhere to a strict diet poor in vitamin D. Also, due to CHF, these patients mainly lead a sedentary lifestyle, and, as a result, receive little ultraviolet rays. This explains the frequently detected deficiency and deficiency of vitamin D in patients with CHF, if, they do not receive drugs that compensate for its deficiency.

Lifestyle Medicine: An Antidote to Cardiovascular Diseases

Despite numerous advances in basic understanding of cardiovascular disease pathophysiology, pharmacology, therapeutic procedures, and systems improvement, there hasn't been much decline in heart disease related morality in the US since 2010. Hypertension and diet induced risk continue to be the leading causes of cardiovascular morbidity. Even with the excessive mortality associated with the COVID-19 pandemic, in 2020, heart disease remained the leading cause of death. Given the degree of disease burden, morbidity, and mortality, there is an urgent need to redirect medical professionals' focus towards prevention through simple and cost effective lifestyle strategies. However, current practice paradigm and financial compensation systems are mainly centered disease management and not health promotion. For example, the financial value placed on 3-10 min smoking cessation counseling (.24RVUs) is 47-fold lower than an elective PCI (11.21 RVUs). The medical community seems to be enamored with the latest and greatest technology, new devices, and surgical procedures. What if the greatest technology of all was simply the way we live every day? Perhaps when this notion is known by enough, we will switch to this lifestyle medicine technology to prevent disease in the first place.

Maintenance of Health Benefits After an Exercise Intervention in Individuals With Prediabetes and Diabetes: Six-Month Follow-Up

Background: The Diabetes College Brazil Study (NCT03914924) is a pioneer randomized clinical trial designed to promote behavioral changes in adults living with prediabetes and diabetes. Method(s): A single-center randomized pilot study involving a 12-week exercise intervention aiming the participants accumulate at least 150 min of aerobic exercise and two sessions of resistance exercise per week with a 6-month follow-up after the intervention. The follow-up objective was to support the participants in maintaining the health benefits arising from the intervention through monthly structured phone calls. Physical activity (PA) level (seven days using a pedometer), exercise self-efficacy (Bandura's Exercise Self-Efficacy Scale), and quality of life (Medical Outcomes Study 36-Item Short-Form Health Survey) were assessed at pre, post-intervention (PI), and post-follow-up (PF). Variables measured in the PI and PF were compared by unpaired t-test. The aerobic exercise time in minutes/week was collected during monthly phone calls and compared by ANOVA. The weekly frequency of resistance exercise sessions was also collected and analyzed by absolute frequencies. The association between the interest variables was analyzed using the Pearson correlation test. Result(s): Of 21 participants who were assessed at PF, 12 answered all phone calls along with follow-up (75% male, 57.4 +/- 10.7 years, 8.3% prediabetes, 41.6% Type 1 diabetes, and 50% Type 2 diabetes) and were included in this study. There was no significant difference between the values obtained in the PI and PF for PA level (41947+/-28868 vs. 49915+/-33054 total steps/week, 5992+/-4124 vs. 7131+/-4722 average steps/day;P=0.09), exercise self-efficacy (65.6+/-13.1 vs. 71.8+/-22.3;P=0.31), physical health (82.7+/-22,84.1 vs. 81.4+/-20.5;P=0.64) and mental health (65.9+/-40.7 vs. 70,5+/-38,4;P=0.70) components of quality of life, revealing maintenance of the exercise intervention benefits after six months. Most participants aerobically exercised above 150 min/week in moderate-intensity during the follow-up, with no change in average exercise time over the six months (225.0+/-154.8, 197.0+/-133.9, 235.0+/-143.9, 142.0+/-102.6, 174.0+/-177.5 minutes/week;P=0.12). The proportion of participants who maintained resistance exercise were 41%, 58%, 66%, 50%, and 50%, and the average weekly frequency was more than three times a week during the follow-up. The average minutes of aerobic exercise/week during the follow-up was moderately correlated with total steps/week (r=0.59, P=0.06) and with mental (r=0.49, P=0.12) and physical (r=0.49, P=0.12) health components of quality of life, and strongly correlated with exercise self-efficacy (r=0.63, P=0.04). Conclusion(s): Participants maintained the health benefits of the intervention at the six-month follow-up, despite the social restrictions due to the COVID-19 pandemic.

The relationship Between Glycemic Control and Food Insecurity in People with Diabetes Mellitus and Comorbid Psychosis

Background/Significance: In the US, adults with psychosis have increased mortality mostly due to cardiovascular disease (CVD) (Olfson 2015). Diabetes mellitus (DM) is a potent CVD risk factor, which occurs in 28% of individuals with serious mental illnesses (Mangurian 2018). Little is understood of the contribution of social and environmental factors to diabetes health disparities experienced by people with psychosis. Food insecurity has been shown to be an independent risk factor for poor glycemic control (Seligman 2012). Methods: This IRB-approved cross-sectional survey aims to describe the prevalence and correlates of food insecurity among adults with DM and co-morbid psychosis who receive primary care through 12 clinics affiliated with a large academic healthcare system in Washington state. Administrative data was utilized to identify eligible patients: age 18-65;one inpatient or two outpatient diagnoses of schizophrenia (F20-29), bipolar disorder (F31), or major depressive disorder with psychotic features (F32.3;F33.3) and one inpatient or two outpatient diagnoses of DM (E08-E13.9). Patients with diagnoses of dementia or intellectual disability were excluded. All eligible patients were sent a letter with a unique link to a survey in Research Electronic Data Capture. The survey included questions related to diabetes clinical characteristics, self-care behaviors, and psychosis symptom severity in addition to demographics. Food insecurity was measured with the validated USDA’s Food Security Survey Module. Consistent with previous studies, participants will be considered food-insecure if two or more responses are affirmative. We compared food insecure and food secure particpants with level of social support and frequency of psychiatry symptoms. •Regression analysis was applied to examine the associations between food security status, social support, and mental health symptoms. Results: 624 patients with diabetes and psychosis were identified. 156 patients responded, giving a response rate of 26%. 25% of respondents were found to be food insecure. 16% of respondents demonstrated low social support while 43% showed moderate social support and 41% showed high social support. Mean CSI was 19.36, which suggests participants experienced symptoms several times per month (versus daily or weekly). Significantly lower social support was found in participants with food insecurity compared to those without (p=0.008). This relationship was driven by lower social support from family (p<0.001) compared to friends (p=0.61) or significant others (p=0.192). Additionally, greater psychiatric symptom severity was found in people with food insecurity (p <0.001). Regression analysis showed that social support did not significantly moderate the relationship between food security and frequency of psychiatric symptoms. Discussion: This study showed that food insecurity was significantly associated with both low perceived social support and more frequent psychiatric symptoms. However, no evidence of a moderating effect of social support on the relationship between food insecurity and psychiatric symptom severity was found. Rate of food insecurity was found to be lower than previous studies, which showed approximately 50% of individuals who used public mental health services faced food insecurity (Adams et al., 2021). The study sample was not limited to public mental health service users, which is the likely cause of this lower rate. Conclusion/Implications: Food insecurity is associated with poorer mental health outcomes, which have been associated with poorer health outcomes. The presence of perceived social support does not mitigate the need for addressing food insecurity. There is a need for both medical and mental health providers who care for people with co-morbid diabetes and psychosis to specifically address food insecurity. References: 1. Adams WE, Rogers ES, Edwards JP, Lord EM, McKnight L, Barbone M. Impact of COVID-19 on Peer Support Specialists in the United States: Findings From a Cross-Sectional Online Survey. Psychiatr c Services. 2021 Jun 23:appi-ps. 2. Coleman-Jensen AJ. US food insecurity status: toward a refined definition. Social Indicators Research. 2010 Jan 1;95(2):215-30. 3. Hammami N, Leatherdale ST, Elgar FJ. Does social support moderate the association between hunger and mental health in youth? A gender-specific investigation from the Canadian Health Behaviour in School-aged Children study. Nutrition journal. 2020 Dec;19(1):1-1. 4. Mangurian CV et al. Diabetes and prediabetes prevalence by race and ethnicity. Diabetes care. 2018 Jul 1;41(7):e119-20. 5. Na M, Miller M, Ballard T, Mitchell DC, Hung YW, Melgar-Quiñonez H. Does social support modify the relationship between food insecurity and poor mental health? Evidence from thirty-nine sub-Saharan African countries. Public health nutrition. 2019 Apr;22(5):874-81. 6. Olfson M et al. Premature mortality among adults with schizophrenia in the United States. JAMA psychiatry. 2015 Dec 1;72(12):1172-81. Seligman HK et al. Food insecurity and glycemic control among low-income patients with type 2 diabetes. Diabetes care. 2012 Feb 1;35(2):233-8. Stubbs B, Vancampfort D, De Hert M, Mitchell AJ.Acta Psychiatr Scand. 2015 Aug;132(2):144-57. Regression analysis showed that social support did not significantly moderate the relationship between food security and frequency of psychiatric symptoms.

Gestational Diabetes during the Pandemic: Screening Methods and Outcomes in First-time GDM

Objective: To study the impact of national recommendations on the method of screening used for GDM during the COVID-19 pandemic, and evaluate differences in maternal and fetal outcomes among women with first-time GDM (ftGDM). Design: A retrospective observational study in a single Tertiary London Hospital. During the pandemic, the RCOG recommended an amended GDM screening protocol to reduce hospital attendance and risk of virus transmission (fasting blood glucose level ≥5.3 and/or HbA1c ≥39 at 28 weeks of gestation). Our Trust did not adopt this due to concerns regarding its sensitivity. We adopt a 2-step approach to universal GDM screening using a 50g glucose challenge test, and refer those screening positive for a full oral glucose tolerance test. Method: Outcomes were reviewed for women with ftGDM delivering a singleton at ≥24 weeks gestation between 01/04/20 -28/ 5/21. Our primary aim was to determine the impact of the change in COVID-19 GDM screening policy, had it been implemented. Our secondary outcomes included GDM management method, maternal and perinatal complications. We excluded women with a booking HbA1c ≥42 (indicative of pre-diabetes) and those who had bariatric surgery. Demographic and outcome data were obtained from electronic databases. Results: 247 women were diagnosed with ftGDM using local screening methods. Only 23 of these women had a HbA1c ≥39 at time of diagnosis and a further 12 had FBG ≥5.3. There was no significant difference in age or ethnicity between the two groups. The locally diagnosed group had a statistically significantly lower booking BMI (P<0.001) and were less likely to require pharmacological management of GDM (P<0.001). There were no significant differences in rates of induction of labour, gestation at delivery, birth weight or any perinatal adverse outcome. However, the women in the Covid-19 GDM screening group were significantly more likely to be delivered by Emergency Caesarean Section (p = 0.03) and have gestational hypertensive disease (p = 0.025). Conclusions: If we had implemented RCOG HbA1c screening, we would have not diagnosed 207 women with GDM, 41% of whom required pharmacological treatment. It is not surprising that women with higher HbA1c values had higher rates of maternal complications, due to the well-established association between maternal hyperglycaemia and adverse obstetric outcomes. As such, it is imperative that more sensitive screening protocols such as the 50g screen are considered in any future pandemics, such that women with GDM can be identified and maternal hyperglycaemia treated to benefit in-utero fetal programming.

Unsuspecting Adult Case of Rhinovirus Pleuropericarditis

Rhinoviridae are the most common cause of upper respiratory tract infections, especially in children, and often referred to as “the common cold”. Symptoms are usually mild, nasopharyngeal in nature;they have, however, been implicated in cases of infantile viral pericarditis. Its role in the presentation of adult viral pericarditis remains unclear. We present the case of a 45-year-old male with a past medical history of pre-diabetes, hyperlipidemia and hypertension with complaints of severe left-sided chest pain that worsened with movement and coughing but improved when lying supine. Two weeks prior to presentation, he had developed an intermittent cough, treated with antibiotics and steroids. On presentation to the ED, the patient was afebrile but hypotensive to 80/52 mmHg, tachycardic to 116 BPM, hypoxic to 88% on room air, improving to 91% with 3L nasal cannula. Physical examination was notable for wheezing and egophony. Laboratory findings were concerning for WBC 19.97x10-3/uL, Hgb 13.4 g/dL, CRP 176 mg/L, Ferritin 772 ug/L, D-dimer 3.70 ug/mL FEU;procalcitonin 0.2 ng/mL and troponin <0.015 ng/mL. Respiratory viral panel revealed negative COVID-19 test but positive for rhinovirus/enterovirus. Electrocardiogram showed sinus tachycardia. Chest computed tomography demonstrated moderate pericardial effusion, ground glass attenuation of the lungs bilaterally with moderate left pleural effusion and reflux of contrast into the hepatic veins, suggestive of right heart failure. Echocardiogram demonstrated small to moderate pericardial effusion. The patient was admitted with the diagnosis of acute rhino/enteroviral-associated pleuropericarditis. Broad-spectrum antibiotics, prednisone, colchicine and indomethacin were commenced. Upon clinical stabilization of his condition, steroids were discontinued and he was discharged home with close follow-up. While rhinovirus has been associated with infantile viral pericarditis, it is implicated in pneumonia and COPD exacerbations in adults but rarely reported as a cause of adult pericarditis. A case-control study of adults diagnosed with acute idiopathic pericarditis had an independent association with an upper respiratory tract infection or gastroenteritis in the month preceding pericarditis diagnosis but did not delineate causative viruses. Therefore in cases of unknown causes of viral pericarditis, thorough history is vital. Steroids as part of the treatment algorithm for pleuropericarditis management has long been debated. Older literature has not favored the use of steroids due to high recurrence rate. However, Perrone et al refuted this point, noting that low-dose steroids with gradual tapers have equal efficacy and recurrence rates as compared with NSAIDs/colchicine. Therefore, steroids may be a reasonable option for patients with contraindications to NSAIDs/colchicine.

Demonstrating New-onset orWorsened Sudomotor Function post COVID-19

Objective: Identify if SARS-CoV-2 virus is triggering and/or worsening dysautonomia by reviewing the function of autonomic patients pre-COVID-19 and post-COVID-19 infection, as well as new onset autonomic patients post-COVID-19 infection. Background: Autonomic dysfunction may be part of acute and long COVID-19 infection. Design/Methods: Six participants were enrolled and divided into two groups. The first group of 4 volunteers reported worsened autonomic symptoms post-COVID-19 infection. These individuals had first autonomic test prior to COVID-19 pandemic outbreak (July 2019- December 2019). Autonomic function testing was repeated in these participants, 6 months to 1- year post-COVID-19 infection (June, 2021). The second group of 2 volunteers reported newonset autonomic symptoms post-COVID-19 infection and were tested March-May, 2021. All participants were screened for known causes of autonomic dysfunction and had normal neurophysiological studies (EMG/NCS), no hypertension/hyperlipidemia or thyroid dysfunction, no diabetes/prediabetes, no vitamin deficiencies, no history of HIV, hepatitis, or syphilis, no prior radiation or chemical exposure and no evidence of monoclonal gammopathy, or autoimmune condition. Participants were diagnosed with COVID-19 via PCR testing, and tested again via SARS-CoV-2 capsid-antibody test. Results: All volunteers were female (age: 21-37y) and endorsed orthostatic intolerance. Gastrointestinal symptoms (5/6), new-onset paresthesias, drier skin (3/6), and sexual dysfunction (2/6) were reported. Dysgeusia reported in 50%, but was not demonstrated on neurological examination. Parasympathetic autonomic function remained stable 6-months to 1- year post-COVID-19 infection and not demonstrated in participants with new-onset symptoms. Sympathetic-adrenergic dysfunction as new-onset orthostatic hypotension and abnormalities on blood-pressure response to Valsalva was found in 50% of participants. Sympathetic cholinergic (sudomotor) dysfunction was demonstrated in ALL participants. Worsened, or new-onset, sudomotor dysfunction was demonstrated in those with mild or normal sudomotor function on pre-COVID-19 autonomic testing Conclusions: Sudomotor dysfunction was demonstrated as worsened or new-sequelae to COVID-19 infection. COVID-19 may be responsible for new-onset or worsened small-fiber neuropathy in this sample.

Case Series: Post-COVID Small Fiber Neuropathy

Objective: To report a case series documenting biopsy-proven small fiber neuropathy (SFN) after COVID-19. Background: Patients recovering from COVID-19 who present with sensory as well as autonomic symptoms, including positional orthostatic tachycardia syndrome (POTS), frequently have negative electrodiagnostic testing. Skin biopsy may be required to reveal SFN. Design/Methods: This is a retrospective case series of patients seen in the Yale Neurology COVID-19 Clinic with positive SARS-CoV-2 PCR or antibody or a clinically consistent illness. After laboratory testing and a negative nerve conduction study, all patients underwent skin biopsy to test for intraepidermal SFN. Case 1: A 40F with pre-diabetes (HbA1c 6.2%) developed burning, numbness, and tingling in the hands and legs and POTS 6 weeks after acute COVID-19. Skin biopsy demonstrated non-length dependent SFN. Complete remission of neuropathy symptoms occurred within days of intravenous immunoglobulin (IVIG) therapy, which has been continued longitudinally. Case 2: A 65F with non-insulin dependent diabetes (HbA1c 8.0%) developed excruciating burning pain in her feet and orthostasis within weeks of acute COVID-19. Skin biopsy demonstrated non-length dependent SFN. She experienced partial relief of symptoms after IVIG and gabapentin. Case 3: A 43F with pre-diabetes (HbA1c 6.0%) developed orthostasis, numbness, paresthesias, and a “sunburned” feeling in her face, back, hands, and feet 2 weeks after acute COVID-19. Skin biopsy demonstrated length-dependent SFN. Symptoms improved over several months of pregabalin treatment, but have not resolved. The patient deferred immunotherapy. Case 4: A 40M developed POTS, numbness, and paresthesias in his face and left leg up to the knee within weeks of a clinical COVID-19 illness. Skin biopsy demonstrated non-length dependent SFN. IVIG therapy has resulted in significant improvement in symptoms. Conclusions: Sensory symptoms and POTS occur post-COVID, and SFN should be considered in the differential. Given the time of onset and response to immunotherapy, post-COVID SFN may have an underlying autoimmune etiology.

Exercise and lifestyle education program for people living with diabetes and prediabetes in Brazil: a pilot randomized trial

Background: Lifestyle changes are crucial to preventing diabetes and its cardiovascular complications, including maintaining a physically active lifestyle. Morever, patient education is essential to promote diabetes self-management and health condition control. However, programs that combine physical exercise and lifestyle education are still poorly implemented in low- and middle-income countries, such as Brazil. The Diabetes College Brazil Study is a pioneer randomized clinical trial (RCT) designed to promote behavioral changes in adults with diabetes and prediabetes. PURPOSE: To test the feasibility, acceptability, and preliminary effectiveness of Diabetes College Brazil Study interventions (Exercise (Ex) vs. Exercise and Lifestyle Education (ExLE)) as part of the preparation for the development of the RCT. Methods: This pilot randomized trial (NCT03914924) had two parallel arms: ExLE program (12 weeks of exercise and educational interventions) and Ex program (12 weeks of exercise intervention only) (Figure 1). Feasibility (eligibility, recruitment, retention, completeness of RCT variables measures and participation rates), acceptability (satisfaction with interventions), and preliminary effectiveness of interventions (comparison of RCT variables measured in pre-and post-assessments) were evaluated. The preliminary effectiveness of the interventions was analyzed from the values of the difference between post-and pre-intervention measures (Δ post-pre) using both per-protocol (PP) and intention to treat (ITT) analysis for the comparison between groups (Ex vs. ExLE). The value 0 was imputed to replace the missing data in the analysis that followed the ITT principle. The results were reported as estimates of effect (95% confidence interval (CI) of the difference) for variables with normal distribution. RESULTS: Thirty-seven individuals participated in the study (ExLE: n = 18, 56.9±9.5 years old, 55.6% female, 5.6% prediabetes;Ex: n = 19, 59.5±7.3 years old, 52.6% female, 21.1% prediabetes). Eligibility, recruitment and retention rates were 16%, 100% and 82% respectively. The completeness of RCT variables measures was higher in the pre-intervention assessment. Missing data in the post-intervention assessment were mainly related to modifications in research procedures due to the COVID-19 pandemic. Participation rates in supervised exercise sessions and education classes were 76% and 71%, respectively (total sample). Interventions were highly acceptable to participants. There was a trend towards better results in the ExLE than Ex for most variables, mainly for physical activity level and quality of life (Table 1). Conclusion: The interventions are feasible and acceptable to participants. The results of this trial indicate the potential clinical benefit of lifestyle educational intervention associated with exercise intervention for people with diabetes and prediabetes. (Figure Presented).

NEWER CONTINUOUS GLUCOSE MONITORING SYSTEMS

“Newer Continuous Glucose Monitoring Systems” Satish K. Garg, MD Professor of Medicine and Pediatrics, Director of adult Diabetes program, University of Colorado Denver and Barbara Davis Center for Diabetes, Aurora, Colorado. Over the past decade there have been many advances in diabetes technologies, such as Continuous Glucose Monitoring devices/systems (CGMs), insulin-delivery devices, and hybrid closed-loop systems. There have been significant advances in CGMs in the past decade. In fact, ten years ago very few people use to believe in the use of CGMs, even though they had been available for the past two decades. Many providers used to question who, why, and when will patients ever use CGMs similar to the questions asked about Self-Monitoring of Blood Glucose (SMBG) about four decades ago. At the time of this writing, more than five million people world-wide are using a CGM for their diabetes management, especially those who require insulin (all patients with Type 1 diabetes (T1D) and about 20% of patients with Type 2 diabetes (T2D)). Total sales of all CGMs now exceeds more than $7 billion and the use of SMBG is going down every day. Most of the CGMs have improved their accuracy significantly in the past two decades. I still remember doing studies on the GlucoWatch and earlier versions of Dexcom STS where mean absolute relative difference (MARD) used to be in the range of 15-26%. Now most of the CGMs (Guardian by Medtronic, G6 by Dexcom, and Libre 2 by Abbott) have single-digit MARD. In addition, the majority of the new CGMs do not require calibrations and the newer CGMs last for 10-14 days. An implantable CGM by Senseonics (Eversense®) is approved in the USA for 3 months and a different version is approved in Europe for 6 months. FDA has still not approved the 6-month version of Eversense® implantable sensor in the USA, which also has single-digit accuracy. The newer CGMs that are likely to be launched in the next 3-6 months;hopefully around the ATTD Conference, include 10.5-day Dexcom G7 (60% smaller than the existing G6), 7-day Medtronic Guardian 4, 14-day Libre 3, and 6-month Eversense®. Most of the newer CGM data can be viewed on Android or iOS/iPhone smart devices, and in many instances they have several features like predictive alarms and alerts, easy insertion, automatic initialization (in some instances down to 27 mins, Dexcom G7) with single-digit MARDs. It has also been noticed that arm insertion site might have better accuracy than abdomen or other sites like the buttock for kids. Lag time between YSI and different sensors have been reported differently, sometimes it's down to 2-3 mins;however, in many instances, it's still 15-20 mins. Diabetes effects communities of color disproportionately higher. For example, the highest prevalence of diabetes in the USA is amongst Native Americans (14.7%), which is nearly two times higher than Caucasians. African Americans and Hispanics also have higher prevalence of diabetes in the USA. It's also known that LatinX, African Americans, and Native Americans are much less likely to be offered new technologies like continuous subcutaneous insulin infusion (CSII/insulin pumps) and CGMs. Use of technology, especially CGMs, is expected to remove many of the social barriers and disparities in care for people with diabetes. A large database during the COVID-19 pandemic recently reported better Time-in-Range (TIR) in patients with diabetes irrespective of their ethnic background. However, the baseline TIR was significantly lower for minorities as compared to Caucasians. I believe the future will bring a larger increase in the use of CGMs for people with insulin-requiring diabetes (estimated at more than 100 million people globally) and those with T2D on non-insulin therapies (estimated at more than 400 million people globally). I also envision an increase in the number of pre-diabetes patients (estimated at more than 200 million people globally) using CGMs so that early medical intervention for diabetes management can be entertained. The intermittent or continuou use of CGM would depend upon the clinical needs. Needless to say, healthy individuals without diabetes (who can afford CGMs) might even use these technologies for self-evaluation of their glucose profiles after meals.

Dysglycemia in ICU Patients

Dysglycemia has emerged as a very common challenge in critically ill patients, especially with regard to current coronavirus disease 2019 pandemic. Prediabetes, poorly controlled diabetes, pharmaceutical intervention in intensive care unit (ICU) with glucocorticoids, catecholamines and other medicines, and stress response all contribute to dysglycemia in critically ill patients. Early identification and management are the key to prevent further complications. Patient prognosis in terms of clinical outcome, length of ICU stay, and in-hospital morbidity/mortality are adversely affected by patient's dysglycemic status. Apart from hyperglycemia, the other three important pillars of dysglycemia are discussed in this article. Synopsis of early intervention have been captured from India-specific practice guidelines. Important landmark trials have also been captured in this article to provide a clarity on certain aspects of managing dysglycemia in ICUs. Hence, this review article is an attempt to bring forth the salient aspects in diagnosing and managing dysglycemia in critical care settings.

Features of COVID-19 course in patients with obesity and dysglycemia

Aim. To study the features of coronavirus disease 2019 (COVID-19) in patients with different severity of carbohydrate metabolism disorders (CMDs), taking into account the possible role of obesity in the acceleration of clinical and laboratory disorders. Material and methods. There were 137 consecutive patients admitted to the infectious disease hospital for COVID-19 patients. Three 3 groups were formed: Group 1 — 42 patients with concomitant type 2 diabetes (T2D);group 2 — 13 patients with concomitant prediabetes;group 3 — 82 patients without concomitant CMDs. Results. Patients with T2D tended to have a more severe disease course according to the SMRT-CO algorithm (p=0,089), which was associated with the longest hospital stay (p=0,038), the most pronounced (p=0,011) and prolonged (p=0,0001) decrease in oxygen saturation, the maximum percentage of lung injury at the beginning (p=0,094) and at the end (p=0,007) of hospitalization, the greater need for intensive care unit (p=0,050), as well as the highest increase in C-reactive protein and fibrinogen (hypercoagulability and systemic inflammation were noted in all groups). Patients with prediabetes in terms of COVID-19 severity occupied an intermediate position between those with T2D and without CMDs;at the same time, they most often needed the prescription of biological preparations (p=0,001). In the first and second groups, there were larger, compared with the control, proportions of obese people (61,9%, 53,8% and 30,5%, respectively, p=0,003). Prediabetes group had a strong correlation between the severity of viral pneumonitis according to SMRT-CO and the presence of obesity (R=0,69, p=0,009). Conclusion. In patients with impaired carbohydrate metabolism of any severity, COVID-19 is more severe. At the same time, persons with overt T2D are prone to the most severe COVID-19 course, while patients with prediabetes in terms of disease severity occupy an intermediate position between them and those without CMDs. Obesity is a strong risk factor for severe COVID-19 among patients with initial CMDs (prediabetes), which is partly mediated by prior liver dysfunction associated with the metabolic syndrome. The increase in proinflammatory changes and hypercoagulability is associated with COVID-19 severity in patients with and without CMDs. These disorders had the greatest severity and persistence in patients with T2D.

QRISK3® stratification during the Coronavirus pandemic and the evolution of a health promotion opportunity in NHS hospital employees

Introduction: Healthcare workers (HCWs) from black and minority ethnic origin (BAME) worldwide paid a higher price in terms of mortality and morbidity during the pandemic. An association between cardiovascular (CVD) risk and COVID-19 complications was suspected as a cause for this disparity. A large NHS Trust developed its own COVID-19 risk stratification incorporating CVD risk of staff assessed by QRISK3® algorithm alongside other risk factors such as asthma/COPD, low immunity and cancer, long before UK wide guidance was published. High and increased-risk staff were offered additional COVID-19 protection. Material and Methods: All staff aged ≥45 years (8047 among total 18025 employees) were eligible to participate. Clinical information alongside blood pressure, BMI, renal and lipid profile and HbA1c was entered into the QRISK3 calculator. Staff with “increased” (Score >10;10% risk of a CVD event over 10 years) and “high” (>20) CVD risk were restricted at work. Results: A total of 1075 employees participated (75% white, 25% BAME). 5% and 7% were identified as increased and high-risk requiring restriction. Advice was provided to participants who were obese (36%);overweight (36%);hypertensive (25%);diabetic/ pre-diabetic (11%) and with unexpected results (BP≥140 systolic 17%, CKD 2%, HbA1c >48 1%). Hypertension was commoner among whites and Diabetes among BAME staff. Conclusions: The trust’s initiative of risk stratification by using QRISK3® may have provided an additional protection to staff with high CVD risk from COVID-19 complications. Its potentiality as a wellbeing tool for health promotion needs to be explored.

Covid-19 Induced Diabetes: Disclosing Truth behind the Potential Attention Seeker

Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2), the zoonotic virus answerable for the current global health crisis is ringing its dangerous bells on its post disease status. COVID-19 is causing multiple organ damage probably with its entry site. Insulin-Dependent Diabetes (IDDM) also known as Type I Diabetes is a multifactorial disease that typically occurs as a result of the interaction of genetic, environmental and immunologic factors.The mechanisms behind the development of Diabetes and associated consequences are complicated. The morphological mass of Insulin producing β-cells in the pancreatic islets of Langerhans and the functional status determine plasma Insulin levels. Insufficient Insulin levels may develop as a result of a lack of β-cell function resulting in hyperglycemia and Diabetes. Angiotensin-Converting Enzyme 2 (ACE2) receptor, the binding agent which allows Corona virus to enter and migrate to various organs such as lungs, heart, liver, pancreas, and kidneys is assumed to be responsible for this damage. The over expression of ACE2 receptor on pancreatic endocrine cells paves a way for extensive damage to Islets of Langerhans causing Insulin resistance and deficiency. Another common assumption among the researchers and health care professionals are the dreadful relationship shared by viruses and Diabetes which can exacerbate or provoke autoimmunity leading to β-cell auto-oxidation. The metabolic complications like Diabetic Ketoacidosis (DKA) and Hyper osmolar hyperglycemia are predominantly seen in various regions of the world in people with Pre-Diabetes and non-diabetics. However, this review explored the probable truth behind COVID-19 induced new-onset Diabetes mellitus and its complications.

Extended follow-up results from a prospective rct for transcatheter bariatric embolotherapy for weight loss in obese subjects

Introduction: Obesity is an important risk factor associated with poor cardiovascular outcomes. Lifestyle modification, pharmaceutical, and intragastric balloons weight loss therapy are often unsuccessful, unsustainable, or accompanied by risks. Transcatheter bariatric embolotherapy (TBE) is a promising therapy in which the left gastric artery is embolized to reduce the expression of “hunger” hormones from the gastric fundus. Despite several early clinical trials, long-term safety or efficacy has yet to be studied. We originally studied TBE in a double-blind, sham procedure, first in human RCT of 40 obese patients (pts) (NCT03185949). Complete details regarding the initial RCT were previously published, briefly the study demonstrated up to 9.3% TBWL at 1-year post-TBE. Following completion of the initial study at 1 year followup, we asked subjects to return for long-term evaluation. Methods: Subjects who previously completed the RCT with no major protocol deviations were asked to return for SOC follow-up visits at 2-, 2.5-, and 3-years post-embolization for further evaluation on weight loss, blood pressure, pre-diabetic clinical status, satiety, and Quality of Life (QoL). Given the evolving situation of the COVID-19 pandemic, the study site was unable to complete all planned study visits. Results: Between 2-3 years post-TBE subjects (n=11) demonstrated a mean 9% TBWL and 25% EBWL. This cohort of patients demonstrated a long-term weight loss maintenance, with previously reported weight loss of 8% TBWL at 1-year post-embolization. Overall QoL at 2 years postTBE increased by approximately 22%. The volume to achieve satiety was reduced by 33% in long-term follow-up. Oral Disposition Index increased from 1.89 mM at 6 months post-TBE to 4.41 mM 2 years postTBE. 1-hr Oral Glucose Tolerance Test (OGTT) C-Peptide levels decreased from 3.22 nmol/L at 6 months to 2.53 nmol/L at 2 years post-TBE. 2-hr OGTT C-Peptide levels also showed a decrease from 2.95 nmol/L at 6 months to 1.78 nmol/L at 2 years post-TBE, possibly indicating an improvement in pre-diabetic status. Conclusions: Bariatric embolization is safe and when used along with lifestyle therapy, results in clinically significant and sustained weight loss up to 2-3 years post-TBE.

Effect of a ketogenic diet vs mediterranean diet on hba1c: The keto-med randomized crossover trial

Background: Growing interest in very low carbohydrate diets, and in particular the ketogenic diet, has been met with some resistance. Important gaps exist regarding what diet to compare to the ketogenic diet. The objective of this study was to compare a Well Formulated Ketogenic Diet (WFKD) with a Mediterranean-Plus diet (Med-Plus;Mediterranean with emphasis on eliminating added sugars and refined grains), in a crossover study, stratified by diabetes status (T2D vs Prediabetes). Methods: The intervention involved having participants follow the WFKD and Med-Plus, for 12 weeks each, in random order. All meals were provided for the first 4 weeks of each diet phase (food delivery);then participants were responsible for purchasing and preparing their own foods (self-provided). The primary outcome was glycosylated hemoglobin (HbA1c). Secondary outcomes included weight, glucose as measured by continuous glucose monitor (CGM), and cardiometabolic risk factors, such as fasting insulin, glucose, and lipids. Results: Among participants randomized (n = 42), 33 had complete data at both diet phases (some missing data attributable to COVID disruptions). Participants were 60 ± 9 (mean ± sd) years of age, 61% men, with BMI 31 ± 5 kg/m2. Adherence for both diets was higher during the food delivery than the self-provided phase, but similar between diets for both phases. HbA1c concentrations were not significantly different between diets, but average CGM glucose levels were significantly lower during the WFKD compared to Med-Plus (p = 0.03). Additionally, WFKD induced a significantly greater decrease in triglycerides (-16% vs -5%, p = 0.02) and greater increase in LDL-C levels (10% vs -5%, p = 0.01), compared to Med-Plus. Weight change on WFKD vs Med-Plus was -8% vs -7% (p = 0.05). Sensitivity analyses largely confirmed the main findings. Conclusions: Participants improved in glucose control and weight management on both diets relative to baseline;however, glucose control was superior on the WFKD. Some caution is warranted when interpreting these results due to pandemic disruptions and a small sample size. A fair comparison of the two diets should also take into consideration non-glycemic effects.

Postpartum Diabetes Screening: Compliance in the COVID Era

Objective: Most women with gestational diabetes (GDM) will not undergo recommended postpartum screening, and it is unknown if COVID has impacted these low rates of follow-up. The objective of this study was to determine the rate at which patients completed their recommended postpartum diabetes screening and compare compliance prior to and during the COVID pandemic. Study Design: This was a retrospective review of patients diagnosed with GDM who delivered at a single institution from April 1, 2019 – March 31, 2021. The main outcome was difference in compliance with recommended 2-hour oral glucose tolerance test prior to and during the COVID pandemic. For the purpose of this study, compliance was defined as completion from 4 weeks to 6 months postpartum. Secondary outcomes were maternal and neonatal outcomes and the prevalence of impaired glucose tolerance postpartum among women who completed the screening. Univariate analysis was performed to compare the two populations. Results: During the study period, 220 patients met inclusion criteria. Among these patient, 104/220 (47.3%) were considered pre-COVID deliveries, defined as delivery prior to March 1, 2020. Baseline characteristics including age, parity, and ethnicity were similar between the two groups (p > 0.05). Diet-controlled diabetes was more prevalent during the COVID pandemic (74.1% versus 61.5%, p = 0.045). During the COVID pandemic, providers more frequently ordered postpartum screening (92.2% vs 81.7%, p = 0.020). Among the patients with screening tests ordered, approximately one third of patients completed recommended postpartum screening in both groups (p > 0.05) and similar rates of prediabetes and diabetes were observed (25.0% versus 37.5% during COVID and prior to the COVID pandemic, respectively, p > 0.05). Conclusion: Overall, the rate of postpartum diabetes screening is poor and remained stable prior to and during the COVID pandemic. Alternative strategies such as inpatient testing prior to hospital discharge may need to be considered.

Combined utility of Glucose and HbA1C testing for screening diabetes mellitus

Screening for diabetes mellitus is accomplished by measuring fasting blood glucose or HbA1C. The American Diabetes Association (ADA) guidelines recommend HbA1C for screening patients for diabetes or pre-diabetes, the U.S. Preventative Services Task Force (USPSTF) includes HbA1C only for monitoring and either glucose or HbA1C can be used for screening. This project sought to provide clinical laboratory evidence to support HbA1C as a diabetes screening test. De-identified electronic health record (EHR) patient data from individuals visiting a large medical center and its affiliated clinics that were tested for blood glucose (either alone, basic metabolic profile or comprehensive metabolic profile) and HbA1C ordered together on the same date of service were collected. 333,360 combined glucose and HbA1C requests were received in 2020. For further analysis, we included patients only with ICD-10 routine visit code Z00.00, excluding known diabetics, patients with elevated blood glucose and HbA1C below 5.7 % because this combination may indicate a non-fasting or inadequate fasting state. From the patients with diagnosis code Z00.00 and glucose within the reference interval, 73 % had HbA1C levels greater than 5.7 %. Among them, 65 % are of pre-diabetes [HbA1C between 5.7 and 6.4%] and 35% with HbA1C over 6.5%. Medical record review of patient charts with HbA1C over 6.5 % suggested a diagnosis of diabetes and were prescribed hypoglycemic medications. Elevated glucose and HbA1C complement each other in the initial diagnosis for diabetes and pre-diabetes;where as HbA1C alone is a good indicator in screening diabetes and pre-diabetes individuals that were previously not diagnosed with diabetes. We are currently collecting 2019 data to examine the differences and adjust for the sample volume due to effect of COVID-19 pandemic on patient visits in the early 2020. We are also evaluating if other variables such as insulin levels, insulin resistance status, and their correlation with HbA1C as a screening measure.