Change In A1c Research Articles

Effectiveness of Continuous Glucose Monitoring in Older Adults with Type 2 Diabetes Treated with Basal Insulin.

Objective: To evaluate the effectiveness and safety of real-time continuous glucose monitoring (CGM) in adults 65 years old and older with type 2 diabetes (T2D) using basal without bolus insulin. Research Design and Methods: Using data from the MOBILE randomized trial comparing CGM versus blood glucose meter (BGM) monitoring for T2D treated with basal insulin, the treatment effect in participants ≥65 years (range: 65-79 years, N = 42) was compared with the treatment effect in participants <65 years (range: 33-64 years, N = 133). Results: For participants ≥65 years old, mean change in hemoglobin A1c (HbA1c) was -1.08% in the CGM group and -0.38% in the BGM group (adjusted mean difference = -0.65% [95% confidence interval (CI) -1.49 to 0.19]). In contrast, the adjusted mean difference in HbA1c between treatment groups was -0.35% [95% CI -0.77 to 0.07] in the <65 years age group. For time in range 70-180 mg/dL (TIR), mean adjusted treatment group difference was 19% (95% CI 4 to 35, P = 0.01) in ≥65 years old participants and 12% (95% CI 4 to 19, P = 0.003) in those <65 years old. Comparable treatment group differences favoring the CGM group were observed in both the ≥65 and <65 years age groups for mean glucose and less time >180, 250, and 300 mg/dL. Hypoglycemia was low in both groups with little difference between treatment groups in both age groups. Conclusions: In this study of adults with T2D treated with basal insulin without bolus insulin, participants ≥65 years old using CGM had a greater increase in TIR and a reduction in hyperglycemia than those using BGM and the benefit appeared to be at least as great as that observed in younger adults.

Four-year changes in central fatness, risk of diabetes, and metabolic control in older adults: a cohort study with mediation analysis.

Background/AimsOlder adults are vulnerable to central obesity, while the association of changes in central fatness with risk of diabetes and metabolic control has not been investigated among this particular population. This study was aimed to address these issues.MethodsA total of 1,815 adults aged ≥ 60 years without diabetes at baseline were followed for 4 years. Incident diabetes was ascertained based on plasma glucose, hemoglobin A1c, medical history, and/or the use of anti-diabetic drugs. Central fatness was assessed by waist circumference (WC), waist-height ratio (WHtR), and body roundness index (BRI). Logistic regression analyses were used to assess the association of changes in central fatness with risk of diabetes, along with dose-response and mediation analyses.ResultsDuring the 4-year follow-up, 177 participants developed diabetes. The risk of diabetes was increased by 42%, 41%, and 40% per 1 standard deviation increases in WC, WHtR, and BRI, respectively, in multivariable-adjusted models (all p < 0.01). Moreover, these relationships were all linearly-shaped (all pnonlinearity ≥ 0.11). Increases in WC, WHtR, and BRI correlated with increases in hemoglobin A1c, triglycerides-and-glucose index, triglycerides, white blood cell, and C-reactive protein (all p ≤ 0.04). Yet only changes in hemoglobin A1c and triglycerides-and-glucose index were identified as the possible mediators for risk of diabetes, with their mediating effect being about 35% and 21%, respectively.ConclusionsIncreases in central fatness were related to elevated risk of diabetes, and this association might be partly explained by the worsening of glycemic control and insulin resistance in older adults.

Clinical Impact of GLP-1 receptor agonists in veterans receiving basal-bolus insulin.

In 2017, an estimated 7.4million Americans used insulin to treat diabetes. Insulin is proven to lower A1c but can result in hypoglycemia and weight gain. Combining insulin with a glucagon-like peptide-1 receptor agonist (GLP-1-RA) may provide additional blood glucose control while limiting undesirable effects including weight gain. To characterize the clinical impact of adding a GLP-1-RA to a basal-bolus insulin regimen in patients with type 2 diabetes. This retrospective observational study used national Veteran's Health Administration data to identify patients with an existing basal-bolus insulin regimen who initiated a GLP-1-RA between January 1, 2005 and December 31, 2017. A1c, insulin total daily dose (TDD), and weight were collected at GLP-1-RA initiation (baseline), 3-, 6-, and 12-month time points and then analyzed using an intent-to-treat approach with the last observation carried forward. Decreases in A1c ≥ 0.5% and weight ≥2kg were deemed clinically significant. Among 7651 patients initiating GLP-1-RA therapy, mean A1c had a clinically significant decline at 3, 6, and 12months by -0.5%, -0.7%, and -0.7%, respectively, from a mean baseline of 9%. Patients with lower baseline A1c levels did not have clinically significant changes in A1c, whereas patients with baseline A1c ≥9% had more clinically significant declines. Insulin TDD decreased by -32, -38, and -42 units/day at 3, 6, and 12months, respectively, where the mean decrease in insulin TDD at 12months was 79 units/day among patients who discontinued bolus insulin (52.3%) compared with a mean decrease of 2 units/day among those who continued bolus insulin. Mean weight reductions at 3, 6, and 12months were -1.2, -2.3, and -2.9kg, respectively, from a mean baseline of 120.6kg. Combining a GLP-1-RA with basal-bolus insulin had a clinically significant improvement on blood glucose control, lowered insulin TDD, and reduced weight. These outcomes were achieved within 3 to 6months following GLP-1-RA initiation and were maintained through 1year.

Predicting changes in glycemic control among adults with prediabetes from activity patterns collected by wearable devices

The use of wearables is increasing and data from these devices could improve the prediction of changes in glycemic control. We conducted a randomized trial with adults with prediabetes who were given either a waist-worn or wrist-worn wearable to track activity patterns. We collected baseline information on demographics, medical history, and laboratory testing. We tested three models that predicted changes in hemoglobin A1c that were continuous, improved glycemic control by 5% or worsened glycemic control by 5%. Consistently in all three models, prediction improved when (a) machine learning was used vs. traditional regression, with ensemble methods performing the best; (b) baseline information with wearable data was used vs. baseline information alone; and (c) wrist-worn wearables were used vs. waist-worn wearables. These findings indicate that models can accurately identify changes in glycemic control among prediabetic adults, and this could be used to better allocate resources and target interventions to prevent progression to diabetes.

Efficacy and Safety of Metformin Versus the Other Oral Antidiabetic Drugs in Japanese Type 2 Diabetes Patients: A Network Meta-analysis.

IntroductionAlthough metformin is recommended as a first-line treatment for patients with type 2 diabetes (T2D) in Western countries, no specific treatment is recommended in Japan, and various agents are used. Metformin has long been used at low doses in Japan, and information regarding its effect at the maximum maintenance dose is lacking. Here, we compared the efficacy and safety of metformin at 1500 mg/day with those of the other oral anti-diabetic drugs (OADs) approved in Japan.MethodsRandomized controlled trials comparing a change in hemoglobin A1c (HbA1c) from baseline at 12 weeks or later (ΔHbA1c) among OADs (including placebo) as a first-line treatment in adult patients with T2D were selected by systematic review with comprehensive searching of CENTRAL, MEDLINE, Ichushi Web, and EMBASE and manual searching of clinical trial registries. The ΔHbA1c and incidence of hypoglycemia were compared among OAD treatments using Bayesian network meta-analysis (NMA). The relative risk (RR) of the incidence of hypoglycemia was determined relative to that of placebo.ResultsForty-six randomized controlled trials were identified in the systematic review, and 37 studies, comprising 38 different types of treatments, including placebos, were selected for the NMA of ΔHbA1c. Compared with metformin 1500 mg/day, 20 OAD treatments were significantly less effective in reducing HbA1c from baseline (differences from metformin 1500 mg/day: 0.40–0.96%). Two treatments (glimepiride 2 mg/day and pioglitazone 45 mg/day) showed greater mean reductions in HbA1c from baseline than metformin 1500 mg/day (− 0.38% and − 0.03%), although these differences were not significant. Regarding the incidence of hypoglycemia, only pioglitazone 30 mg/day among 31 treatments showed a lower RR (< − 0.01), whereas 23 treatments showed a significantly higher RR (1.02–66.71) than metformin 1500 mg/day.ConclusionThe NMA suggested a preferable efficacy and safety profile of metformin 1500 mg/day compared with the other OADs approved in Japan.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01979-1.

Neurogenic Orthostatic Hypotension: a Common Complication of Successful Pancreas Transplantation.

Background.Orthostatic hypotension (OH) is a poorly understood complication of simultaneous pancreas–kidney (SPK) transplantation. We sought to determine the incidence, timing, and relationship of OH to rapid glycemic control in the early posttransplant period.Methods.This was a nonrandomized retrospective single-center review of 75 SPK and 19 kidney-alone (KA) recipients with type 1 diabetes (DM).Results.OH occurred in 57 (76%) SPK versus 2 (10%) KA recipients (odds ratio [OR] 61.72, 95% confidence interval [CI], 9.69-393.01; P < 0.001). The median onset of OH was 12 (interquartile range [IQR] 9–18) days posttransplant and resolved in 85% of SPK recipients after a median of 2.5 (IQR 1.2–6.3) months. Among SPK recipients, independent risk factors for OH were a shorter duration of DM (OR 0.85, 95% CI, 0.73-0.98; P = 0.03) and rapid glycemic control in the early posttransplant period (OR 1.13, 95% CI, 1.01-1.27; P = 0.04), as evidenced by a larger percent change in hemoglobin A1c (HbA1c) from transplant to month 3. OH patients had a higher median baseline HbA1c [8.3% (IQR 7.2–10.0) versus 7.1% (IQR 6.8–8.3); P = 0.07], lower median 3-month HbA1c [4.8% (IQR 4.6–5.2) versus 5.2% (IQR 5.0–5.4); P = 0.02], and a larger reduction in HbA1c over time as compared to recipients without OH (P < 0.01).Conclusions.Our results show that OH is more likely to occur following SPK versus KA transplantation and is strongly associated with rapid glucose normalization within the early posttransplant period.

Abstract 12484: Weekday 16:8 Time-Restricted Eating in Breast Cancer Survivors: Feasibility, Safety, and Effects on Cardiometabolic Health

Introduction: Time-restricted eating (TRE) is a form of intermittent fasting involving ad libitum energy intake within a set time window, commonly 8 hours, followed by a water-only fast for 16 hours (i.e., 16:8 TRE). TRE is a practical approach to improve cardiometabolic health but has not been tested in cancer populations. Hypothesis: TRE is feasible (&gt;85% adherence), safe (no major adverse events), and will improve cardiometabolic health in breast cancer survivors. Methods: Women who completed chemotherapy for early-stage breast cancer 1-6 years earlier, are ≥60 years, have a BMI &gt;25 kg/m 2 , and not taking lipid or glucose-lowering medications were enrolled in a single-arm study of 16:8 TRE on weekdays for 8 weeks. Participants could eat ad libitum between 12-8 pm on weekdays and all weekend. No other dietary or physical activity instructions were given. Adherence was collected by twice daily text messages that asked participants to respond with the times that they started/stopped eating. The Framingham 10-year cardiovascular disease (CVD) risk score and heart age, and ectopic adipose tissue (3T magnetic resonance imaging) were assessed before and after 8 weeks of TRE. Results: Fifteen participants (66±4 years, 31±4 kg/m 2 ) have completed the study. Participants responded to 99% of text messages and adhered to the 16-hour fast a median of 98% of days (range 93-100%). Reported symptoms were minor and transient. At baseline, 73% of participants were at ‘intermediate’ (10-19%) CVD risk, and pharmacological treatment was indicated. Among those at intermediate risk, 8 weeks of TRE decreased the absolute CVD risk by a median of 2% and heart age by 6 years, and reversed the need for pharmacological treatment (i.e., reclassification to ‘low’ risk) or metabolic syndrome in 45%. In all participants, visceral adipose tissue decreased by a median of 6% (p=0.018) and triglycerides by 17% (p=0.008). There were no significant changes in hemoglobin A1c, or ectopic adipose tissue in the liver or thigh. Conclusions: Eight weeks of weekday 16:8 TRE is highly feasible, safe, and reduces CVD risk among older breast cancer survivors with overweight/obesity at moderate CVD risk. Improvements in glucose control and liver/thigh ectopic adipose tissue may require a longer intervention.

Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes.

Introduction:This trial assessed safety and effectiveness of an advanced hybrid closed-loop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D).Materials and Methods:This multicenter single-arm study involved an intent-to-treat population of 157 individuals (39 adolescents aged 14–21 years and 118 adults aged ≥22–75 years) with T1D. Study participants used the MiniMed™ AHCL system during a baseline run-in period in which sensor-augmented pump +/− predictive low glucose management or Auto Basal was enabled for ∼14 days. Thereafter, Auto Basal and Auto Correction were enabled for a study phase (∼90 days), with glucose target set to 100 or 120 mg/dL for ∼45 days, followed by the other target for ∼45 days. Study endpoints included safety events and change in mean A1C, time in range (TIR, 70–180 mg/dL) and time below range (TBR, <70 mg/dL). Run-in and study phase values were compared using Wilcoxon signed-rank test or paired t-test.Results:Overall group time spent in closed loop averaged 94.9% ± 5.4% and involved only 1.2 ± 0.8 exits per week. Compared with run-in, AHCL reduced A1C from 7.5% ± 0.8% to 7.0% ± 0.5% (<0.001, Wilcoxon signed-rank test, n = 155), TIR increased from 68.8% ± 10.5% to 74.5% ± 6.9% (<0.001, Wilcoxon signed-rank test), and TBR reduced from 3.3% ± 2.9% to 2.3% ± 1.7% (<0.001, Wilcoxon signed-rank test). Similar benefits to glycemia were observed for each age group and were more pronounced for the nighttime (12 AM–6 AM). The 100 mg/dL target increased TIR to 75.4% (n = 155), which was further optimized at a lower active insulin time (AIT) setting (i.e., 2 h), without increasing TBR. There were no severe hypoglycemic or diabetic ketoacidosis events during the study phase.Conclusions:These findings show that the MiniMed AHCL system is safe and allows for achievement of recommended glycemic targets in adolescents and adults with T1D. Adjustments in target and AIT settings may further optimize glycemia and improve user experience.Clinical Trial Registration number: NCT03959423.

A Nonrandomized Pilot of a Group, Video-Based Telehealth Intervention to Reduce Diabetes Distress in Parents of Youth With Type 1 Diabetes Mellitus

ObjectivesOur aim in this study was to refine and pilot a video-based telehealth intervention to reduce diabetes distress, depressive symptoms and hypoglycemia fear in parents of school-age children with type 1 diabetes and to assess for changes in child glycated hemoglobin (A1C). MethodsWe recruited 41 parents of children (5 to 12 years) to participate in a manualized, video-based telehealth intervention (Cognitive Adaptions to Reduce Emotional Stress [CARES]). Of these, 29 parents completed either a 12-week (n=13) or 8-week (n=16) version of CARES based on the timing of their recruitment. We assessed feasibility (i.e. attrition, attendance) and parent satisfaction with CARES. We used repeated-measures analysis of variance with parent group (8 vs 12 sessions) as a between-subject variable and time as a within-subject variable to measure change in our dependent variables. ResultsMostly mothers participated (97.3%). Parents’ mean age was 39.65±6.84 years and children’s mean age was 9.86±1.57 years at pretreatment. CARES had low attrition (20% to 25%) and good attendance (96% to 98%). Parents also reported high levels of treatment satisfaction (>85%). There were significant main effects for time for parent-reported diabetes distress and depressive symptoms at posttreatment and 3-month follow-up. There was a statistical trend suggesting a time × group interaction for parent depressive symptoms at posttreatment. There was a significant main effect for time for hypoglycemia fear at the 3-month follow-up but no change at posttreatment. There was no change in child A1C at posttreatment. ConclusionCARES showed high parent satisfaction, good feasibility and promising results for reducing diabetes distress in parents of school-age children with type 1 diabetes.

Farmers’ Market Voucher Initiative to Improve Diabetes Control in Older Adults

This pilot study investigated reported fruit and vegetable consumption and diabetic control for older patients with a diagnoses of diabetes and food insecurity at a rural Midwestern Federally Qualified Health Center. Vouchers ($40 per month for 3 months) were provided for fruits and vegetables at a local farmers’ market during a 12-week program (June 2020-August 2020). Data revealed a statistically significant increase in reported green vegetable consumption and farmers’ market visits postintervention. There was not a significant change in hemoglobin A1c, body mass index, or other reported produce consumption.

Intensification of Diabetes Medications at Hospital Discharge and Clinical Outcomes in Older Adults in the Veterans Administration Health System

Transient elevations of blood glucose levels are common in hospitalized older adults with diabetes and may lead clinicians to discharge patients with more intensive diabetes medications than they were using before hospitalization. To investigate outcomes associated with intensification of outpatient diabetes medications at discharge. This retrospective cohort study assessed patients 65 years and older with diabetes not taking insulin who were hospitalized in the Veterans Health Administration Health System between January 1, 2011, and September 28, 2016, for common medical conditions. Data analysis was performed from January 1, 2020, to March 31, 2021. Discharge with intensified diabetes medications, defined as filling a prescription at hospital discharge for a new or higher-dose medication than was being used before hospitalization. Propensity scores were used to construct a matched cohort of patients who did and did not receive diabetes medication intensifications. Coprimary outcomes of severe hypoglycemia and severe hyperglycemia were assessed at 30 and 365 days using competing risk regressions. Secondary outcomes included all-cause readmissions, mortality, change in hemoglobin A1c (HbA1c) level, and persistent use of intensified medications at 1 year after discharge. The propensity-matched cohort included 5296 older adults with diabetes (mean [SD] age, 73.7 [7.7] years; 5212 [98.4%] male; and 867 [16.4%] Black, 47 [0.9%] Hispanic, 4138 [78.1%] White), equally split between those who did and did not receive diabetes medication intensifications at hospital discharge. Within 30 days, patients who received medication intensifications had a higher risk of severe hypoglycemia (hazard ratio [HR], 2.17; 95% CI, 1.10-4.28), no difference in risk of severe hyperglycemia (HR, 1.00; 95% CI, 0.33-3.08), and a lower risk of death (HR, 0.55; 95% CI, 0.33-0.92). At 1 year, no differences were found in the risk of severe hypoglycemia events, severe hyperglycemia events, or death and no difference in change in HbA1c level was found among those who did vs did not receive intensifications (mean postdischarge HbA1c, 7.72% vs 7.70%; difference-in-differences, 0.02%; 95% CI, -0.12% to 0.16%). At 1 year, 48.0% (591 of 1231) of new oral diabetes medications and 38.5% (548 of 1423) of new insulin prescriptions filled at discharge were no longer being filled. In this national cohort study, among older adults hospitalized for common medical conditions, discharge with intensified diabetes medications was associated with an increased short-term risk of severe hypoglycemia events but was not associated with reduced severe hyperglycemia events or improve HbA1c control. These findings indicate that short-term hospitalization may not be an effective time to intervene in long-term diabetes management.

Mental Health History and DECIDE (Decision-Making Education for Choices in Diabetes Everyday) Diabetes Support Program Outcomes Among African Americans With Type 2 Diabetes.

The purpose of this study was to determine behavioral and clinical outcomes of the DECIDE (Decision-Making Education for Choices in Diabetes Everyday) diabetes support program trial participants with and without a mental health (MH) history by treatment arm. A secondary analysis was conducted of data from the DECIDE trial sample of urban African American adults with type 2 diabetes (T2DM; N = 137) who received the DECIDE diabetes support program in 1 of 3 delivery formats: self-study (n = 46), individual (n = 45), and group (n = 46). Positive screen on the Patient Health Questionnaire-2 and/or reported MH diagnosis were coded as MH history. Self-management, knowledge, problem-solving, and A1C data at baseline and 1 week and 6 months postintervention were analyzed for participants with and without MH history. Prevalence of MH history was 37% in the sample. Among those with no MH history, knowledge and problem-solving improved at 6 months postintervention in all intervention arms. For those with MH history, knowledge and problem-solving improved in the self-study and individual arms but not in the group arm. Clinically but not statistically significant changes in A1C were observed at 6 months. In an urban minority T2DM sample, those with an MH history benefited from the intervention, but delivery format mattered, with robust improvements when participants with an MH history received self-directed or one-on-one formats rather than group.

Diabetes outcomes before and during telehealth advancements surrounding COVID-19

BackgroundPharmacists can optimize outcomes related to type-2 diabetes (T2D) by taking advantage of telehealth opportunities despite the coronavirus 2019 (COVID-19) Public Health Emergency (PHE). ObjectiveIdentify and compare changes in T2D outcomes before (August 2019 through February 2020) and during (March 2020 through October 2020) the COVID-19 PHE. Secondary objectives were to identify and compare pay-for-performance metrics and additional fee-for-service submitted in these patients. MethodsThis study examined changes in T2D outcomes at one primary care office within a community health system. Pharmacists started regularly using Remote Patient Monitoring (RPM) services during the COVID-19 PHE to reduce in-person visits. Patients with an initial glycosylated hemoglobin (A1C) greater than or equal to 8% were included. Data collected included comorbidities, change in A1C, and diabetes and statin medication therapy adherence. Percentage of Healthcare Effectiveness Data and Information Set (HEDIS) and Merit-Based Incentive Payment System (MIPS) measures were met, and billing code frequencies were also assessed. ResultsIn the pre–COVID-19 PHE group (N = 30), the average 3- and 6-month A1C reductions were 1.3% and 1.2%, respectively, and the reductions were 2.0% and 2.2% in the during-COVID-19 PHE group (N = 61). The percentage of patients appropriately initiated or maintained on statins was 96.2% in the pre–COVID-19 PHE group versus 82.6% in the during-COVID-19 PHE group. Related to HEDIS, statin adherence was 95.2% in the pre–COVID-19 PHE group and 84.2% in the during-COVID-19 PHE group, and A1C control was 41.7% versus 54%, respectively. A1C control related to MIPS was 60% before COVID-19 PHE versus 73.8% during the COVID-19 PHE. Diabetes medication adherence related to HEDIS and medication reconciliation related to MIPS was 100% for both groups. ConclusionData demonstrate the opportunity for pharmacists to maintain and improve clinical outcomes related to T2D despite the ongoing COVID-19 PHE through implementation of telephonic monitoring.

Bariatric Surgery Improves Renal Function in Patients With Obesity.

BackgroundObesity affects 93.3 million adults in the United States and is a predisposing factor for the development and progression of chronic kidney disease (CKD). The objective of this study is to examine the association between weight loss and renal function in participants undergoing bariatric surgery following a 12-week multidisciplinary, community-based weight loss program.MethodologyThis is a retrospective chart review of participants who voluntarily enrolled in a 12-week multidisciplinary weight loss program prior to bariatric surgery from 2009 to 2018. The primary outcome was to assess the association between weight loss and renal function in participants undergoing bariatric surgery. Secondary outcomes included changes in hemoglobin A1c, lipids, fasting glucose, and blood pressure.ResultsAmong the 55 participants, baseline glomerular filtration rate (GFR) was 49 mL/min/m2, 80% were female, and the average baseline weight was 131 kg. At one-year post-intervention, 69% of patients improved in the CKD stage, with 45% of the participants improving from stage 3A to stage 2. GFR improved to 15 mL/min/1.73m2 (p = 0.025), and there was a negative correlation (rs = -0.3556) between weight and GFR (p = 0.013). Participants with hyperlipidemia had a 12 mL/min/1.73m2 rise in GFR, while participants without the diagnosis at one year had a 24 mL/min/1.73m2 rise in GFR (p = 0.007).ConclusionsThis study demonstrated improved renal function and reduced progression of CKD following a combined lifestyle and surgical intervention, indicating the importance of a comprehensive approach for the management of the chronic disease.

Increase in blood glucose level and incidence of diabetic ketoacidosis in children with type 1 diabetes mellitus in the Daegu-Gyeongbuk area during the coronavirus disease 2019 (COVID-19) pandemic: a retrospective cross-sectional study.

BackgroundThe coronavirus disease 2019 (COVID-19) outbreak in the Daegu-Gyeongbuk area in 2020 has caused difficulties in the daily life and hospital care of children with type 1 diabetes mellitus (T1DM). We detected an increase in blood sugar levels in these children and the number of patients hospitalized with more severe diabetic ketoacidosis (DKA) compared to those before COVID-19. MethodsThis single-center study was conducted at Kyungpook National University Children’s Hospital. The following patient groups were included; 45 returning patients diagnosed with T1DM and undergoing insulin treatment for more than 2 years and 20 patients newly diagnosed with T1DM before and after COVID-19 were selected by age matching. Returning patients before and after the outbreak were selected, and changes in hemoglobin A1c (HbA1c) levels were retrospectively reviewed. The HbA1c levels and severity of symptoms in newly diagnosed patients during hospitalization were examined. ResultsHbA1c levels in returning patients with T1DM were significantly increased after COVID-19 (before, 7.70%±1.38% vs. after, 8.30%±2.05%; p=0.012). There were 10 and 10 newly diagnosed patients before and after COVID-19, respectively. The proportion of patients with drowsiness and dyspnea at the time of admission was higher after COVID-19 than before (before, 2 of 10 vs. after, 4 of 10). The HbA1c levels were higher in newly diagnosed patients hospitalized after COVID-19 than before (before, 11.15% vs. after, 13.60%; p=0.036). ConclusionDue to COVID-19 in the Daegu-Gyeongbuk area, there was an increase in blood glucose levels in children with T1DM and in the incidence of severe DKA in newly diagnosed diabetes mellitus patients.

Effects of omarigliptin on glucose variability and oxidative stress in type 2 diabetes patients: A prospective study

AimsTo date, no clinical studies have compared once-weekly dipeptidyl peptidase 4 (DPP-4) inhibitors with once-daily DPP-4 inhibitors in terms of glucose variability (GV) and oxidative stress (OS). MethodsThirty-six patients with type 2 diabetes mellitus (T2DM) treated with once-daily DPP-4 inhibitors for at least 12 weeks were randomized to either continue once-daily DPP-4 inhibitors or receive omarigliptin, a once-weekly DPP-4 inhibitor, for 24 weeks. The primary end points were changes in the diacron-reactive oxygen metabolite (d-ROMs) test, a marker of OS, and GV using flash glucose monitoring. The secondary end point was changes in the diabetes treatment satisfaction questionnaire (DTSQ) scores. ResultsThere were no significant group differences in d-ROMs and DTSQ scores after 24 weeks of treatments. However, omarigliptin was superior to once-daily DPP-4 inhibitors in controlling fasting plasma glucose (FPG) and time in range (TIR). Although FPG and TIR were unchanged at 24 weeks after switching to omarigliptin, these parameters increased in the group receiving maintenance therapy with once-daily DPP-4 inhibitors. No statistically significant changes in hemoglobin A1c were observed between the two groups. ConclusionsOur findings suggest that switching from once-daily DPP-4 inhibitors to omarigliptin may be efficacious for maintaining FPG and TIR in T2DM patients.

COVID-19 Pandemic and Pediatric Type 1 Diabetes: No Significant Change in Glycemic Control During The Pandemic Lockdown of 2020

ImportanceThere is no consensus on the impact of the 2020 COVID-19 pandemic lockdown on glycemic control in children and adolescents with type 1 diabetes (T1D) in the US.AimTo determine the impact of the pandemic lockdown of March 15th through July 6th, 2020 on glycemic control after controlling for confounders.Subjects and MethodsAn observational study of 110 subjects of mean age 14.8 ± 4.9 years(y), [male 15.4 ± 4.0y, (n=57); female 14.1 ± 3.8y, (n=53), p=0.07] with T1D of 6.31 ± 4.3y (95% CI 1.0-19.7y). Data were collected at 1-4 months before the lockdown and 1-4 months following the lifting of the lockdown at their first post-lockdown clinic visit.ResultsThere was no significant change in A1c between the pre- and post-pandemic lockdown periods, 0.18 ± 1.2%, (95% CI -0.05 to 0.41), p=0.13. There were equally no significant differences in A1c between the male and female subjects, -0.16 ± 1.2 vs -0.19 ± 1.2%, p=0.8; insulin pump users and non-pump users, -0.25 ± 1.0 vs -0.12 ± 1.4%, p=0.5; and pubertal vs prepubertal subjects, 0.18 ± 1.3 vs -0.11 ± 0.3%, p=0.6. The significant predictors of decrease in A1c were pre-lockdown A1c (p<0.0001) and the use of CGM (p=0.019). The CGM users had significant reductions in point-of-care A1c (0.4 ± 0.6%, p=0.0012), the CGM-estimated A1c (p=0.0076), mean glucose concentration (p=0.022), a significant increase in sensor usage (p=0.012), with no change in total daily dose of insulin (TDDI). The non-CGM users had significantly increased TDDI (p<0.0001) but no change in HbA1c, 0.06 ± 1.8%, p=0.86.ConclusionsThere was no change in glycemic control during the pandemic lockdown of 2020 in US children.

A Pilot Study of Intervention With a Mobile Application Visualizing the Macronutrient Content for Type 2 Diabetes at a Japanese Center.

BackgroundEstimating the nutritional content of food is essential for self-management in people with type 2 diabetes mellitus, but it is a difficult skill to learn. The aim of this study was to investigate how diabetes management was impacted by the ability of patients to search for items they ate from a database of 26,300 different foods, and to visualize nutritional intake using the Japanese mobile application (app) “Calomeal.”MethodsThis was a single-arm, single-center, pilot study. Eighteen outpatients with type 2 diabetes mellitus used the “Calomeal” app for 3 months. The primary endpoint was change in hemoglobin A1c (HbA1c). Secondary endpoints were changes in body weight (BW), lipid parameters, and quality of life scores.ResultsThe baseline characteristics of the study subjects were as follows: age: 53.4 ± 7.8 years; male/female ratio: 11/7; HbA1c: 7.9 (7.58 - 8.23)%; and body mass index (BMI): 25.17 (21.63 - 28.59) kg/m2. Significant reductions in HbA1c and BMI were observed over 3 months (HbA1c: 7.9 (7.58 - 8.23)% to 7.6 (7.3 - 8.23)%, P = 0.0410; BMI: 25.17 (21.63 - 28.59) to 24.54 (21.57 - 27.81) kg/m2, P = 0.0057). Reductions in HbA1c and BMI both correlated with decreased carbohydrate intake estimated by the mobile app.ConclusionsJapanese patients who used their smartphones to visualize their nutritional intake using the “Calomeal” app demonstrated improved short-term glycemic control and BMI. Although the validity of the results should be tested in future randomized controlled trials, this approach may be a clinical option for improving self-management in Japanese patients with type 2 diabetes mellitus.

The relationship between the level of exercise and hemoglobin A1c in patients with type 2 diabetes mellitus: a systematic review and meta-analysis.

The aim of the study was to evaluate the relationship between changes in hemoglobin A1c (HbA1c) and exercise levels in type 2 diabetes mellitus (T2DM) patients when performing various types of exercise. The inclusion criteria were randomized controlled trials involving adults with T2DM, intervention involving exercise alone, the overall duration of intervention ≥12 weeks, and reporting HbA1c. Weighted mean difference (WMD) was defined as the mean difference between the intervention group and the control group weighted by the inverse of the squared standard error for each study, and all WMDs were pooled as overall effects. A meta-regression analysis was performed to evaluate the relationship between the exercise level and the WMD in HbA1c. Forty-eight studies (2395 subjects) were analyzed. The pooled WMD in HbA1c decreased significantly (-0.5% [95% confidence intervals: -0.6 to -0.4]) but contained significant heterogeneity (Q = 103.8, P < 0.01; I2 = 36.6%). A meta-regression analysis showed that the intensity (metabolic equivalents [METs]), time (min/session), or frequency (sessions/week) of the exercise was not associated with the HbA1c. However, the overall duration of exercise (weeks) was significantly associated with the WMD in HbA1c (meta-regression coefficient: 0.01 [95% confidence intervals: 0.002-0.016]; R2 = 70.0%), and that result did not contain significant heterogeneity (P > 0.05; I2 = 14.7%). The exercise intervention decreases HbA1c in T2DM patients. In addition, exercise for an extended duration was associated with an increase in HbA1c, so the effects of exercise may be evident early on, but results suggested that exercise for a prolonged period alone may increase HbA1c.

Clinical pharmacy specialists providing consistent comprehensive medication management with increased efficiency through telemedicine during the COVID19 pandemic.

IntroductionThe Veterans Affairs (VA) has been at the forefront of harnessing the skills of clinical pharmacy specialists (CPS) in patient‐aligned care teams (PACT) to improve patient care outcomes and create access for veterans. With the unfortunate arrival of Coronavirus disease 2019 (COVID19), PACT CPS were duty‐bound to expand telehealth services at an accelerated rate. The purpose of this quality improvement analysis is to compare CPS efficiency as well as some objective patient metrics to assess for a change in the quality of care. This is the first study to compare the efficiency and quality of care by CPS in the VA pre‐COVID19 and during the COVID19 pandemic.MethodsThis is a retrospective review of PACT CPS comprehensive medication management from 3/10/19 to 11/30/19 and 3/10/20 to 11/30/20. Data points focused on clinic encounters, patient accountability to appointments, disease state expansion, and markers of disease‐state management. Given diabetes and hypertension are the main disease states managed by most PACT CPS', the study evaluated changes in hemoglobin A1c (HbA1c) and blood pressure (BP) between the two cohorts as well. Data were analyzed using GraphPad Software or Microsoft Excel. A student T‐test was used for continuous data and Chi‐squared or Fishers Exact for nominal data.ResultsThe total number of PACT CPS encounters increased 32% in 2020, and the number of unique patients increased by 12%. There were a statistically significant increase in telephone and direct‐to‐consumer (DCT) video visits. The rates of no shows and cancellations significantly decreased between 2019 and 2020. There was no difference in the average change in HbA1c or average blood pressure between the two study groups.ConclusionsWhen PACT CPS services transitioned from primarily face‐to‐face visits to all virtual care, the consistency of care improved, and the quality of care was not compromised.