Change In Hemoglobin A1c Research Articles

Efficacy and Safety of the Novel Dipeptidyl Peptidase-4 Inhibitor Gemigliptin in the Management of Type 2 Diabetes: A Meta-Analysis.

BackgroundNo meta-analysis has holistically analysed and summarised the efficacy and safety of gemigliptin in type 2 diabetes. The meta-analysis addresses this knowledge gap.MethodsElectronic databases were searched for randomised controlled trials (RCTs) involving diabetes patients receiving gemigliptin in the intervention arm and placebo/active comparator in the control arm. The primary outcome was change in haemoglobin A1c (HbA1c). The secondary outcomes were alterations in glucose, glycaemic targets, lipids, insulin resistance, and adverse events.ResultsData from 10 RCTs involving 1,792 patients were analysed. Four had an active control group (ACG), with metformin/dapagliflozin/sitagliptin/glimepiride as the active comparator; six had a passive control group (PCG), with placebo/rosuvastatin as controls. HbA1c reduction by gemigliptin at 24 weeks was comparable to ACG (mean difference [MD], 0.09%; 95% confidence interval [CI], −0.06 to 0.23; P=0.24; I2=0%; moderate certainty of evidence [MCE]), but superior to PCG (MD, −0.91%; 95% CI, −1.18 to −0.63); P<0.01; I2=89%; high certainty of evidence [HCE]). Gemigliptin was superior to PCG regarding achieving HbA1c <7% (12 weeks: odds ratio [OR], 5.91; 95% CI, 1.34 to 26.08; P=0.02; I2=74%; 24 weeks: OR, 4.48; 95% CI, 2.09 to 9.60; P<0.01; I2=69%; HCE). Gemigliptin was comparable to ACG regarding achieving HbA1c <7% after 24 weeks (OR, 0.92; 95% CI, 0.52 to 1.63; P=0.77; I2=66%; MCE). Adverse events were similar between the gemigliptin and control groups (risk ratio [RR], 1.06; 95% CI, 0.82 to 1.36; P=0.66; I2=35%; HCE). The gemigliptin group did not have increased hypoglycaemia (RR, 1.19; 95% CI, 0.62 to 2.28; P=0.61; I2=19%; HCE).ConclusionGemigliptin has good glycaemic efficacy and is well-tolerated over 6 months of use.

Real-World Effectiveness of Once-Weekly Semaglutide From a US Commercially Insured and Medicare Advantage Population

PurposePatients managing type 2 diabetes mellitus (T2DM) often require combination therapy to meet their blood glucose control targets. With limited real-world evidence focused on the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) therapies, the objective of this study was to describe the association between semaglutide once weekly (OW) initiation and changes in hemoglobin A1c (A1c) levels. MethodsThis retrospective, descriptive cohort study used the HealthCore Integrated Research Environment (HIRE) to examine commercially insured and Medicare Advantage patients who had T2DM while taking semaglutide OW from December 1, 2017, to April 30, 2019. The first semaglutide OW prescription fill was defined as the study index date. Changes in mean A1c levels and A1c target attainment were evaluated among an intention-to-treat (ITT) population (overall group). Furthermore, a persistent population (PP) analysis on the same outcomes was performed that was limited to ITT patients who were observed to continue to use semaglutide OW at the time of the postindex A1c measurement. In addition, these outcomes were explored in patients stratified based on prior use of GLP-1RA therapy (experienced vs naive) and baseline A1c values >9% (75 mmol/mol). FindingsA total of 1888 patients were identified in the overall ITT group. The mean change in the overall ITT group between preindex and postindex A1c values was −0.9% percentage points (−9.8 mmol/mol) (mean preindex A1c, 8.2% [66.1 mmol/mol]) and −1.1 percentage points (−12.0 mmol/mol) (mean preindex A1c, 8.2% [66.1 mmol/mol]) in the PP subgroup (all P < 0.001). Among the subgroup of patients with a baseline A1c value >9% (75 mmol/mol), percentage point changes in A1c were −2.2 (−24.0 mmol/mol) and −2.4 (−26.2 mmol/mol) (all P < 0.001). When accounting for prior GLP-1RA use, the GLP-1RA–naive stratum had double the mean reduction in A1c compared with the GLP-1RA–experienced stratum (−1.2 [−13.1 mmol/mol] vs −0.6 [−6.6 mmol/mol] percentage points). ImplicationsSemaglutide OW is associated with clinically and statistically significant A1C reduction and increases in reaching A1 targets using real-world data, even in GLP-1RA–experienced patients, despite more frequent use of insulin or sodium glucose transport protein 2 inhibitors in this group. Target A1c attainment significantly increased overall and within all subgroups and strata, with approximately half of all patients attaining an A1c value <7% (53 mmol/mol) and three-quarters attaining an A1c value <8% (64 mmol/mol).

Association Between a Low Carbohydrate Diet, Quality of Life, and Glycemic Control in Australian Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Pilot Study.

BackgroundGlobally, the prevalence of type 1 diabetes mellitus (T1DM) is rising. In 2020, a total of 124,652 Australians had T1DM. Maintaining optimal glycemic control (hemoglobin A1c ≤7.0%, ≤53 mmol/mol) on a standard carbohydrate diet can be a challenge for people living with T1DM. The Diabetes Complications and Control Trial established that macrovascular and microvascular complications could be reduced by improving glycemic control. Recent studies have found that a very low or low carbohydrate diet can improve glycemic control. However, the overall evidence relating to an association between a very low or low carbohydrate diet and glycemic control in people living with T1DM is both limited and mixed. In addition, research has suggested that a reduced quality of life due to anxiety and depression adversely influences glycemic control. Despite a potential link between a very low or low carbohydrate diet and optimal glycemic control, to our knowledge, no research has examined an association between a low carbohydrate diet, quality of life, and glycemic control, making this study unique in its approach.ObjectiveThe study aims to develop a validated diabetes-specific quality of life questionnaire for use in Australian adults with T1DM and to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in Australian adults living with T1DM.MethodsThis cross-sectional study will be conducted in a tertiary hospital outpatient setting and will consist of 3 phases: phase 1, online Australian diabetes-specific quality of life questionnaire development and piloting (25-30 adults with T1DM); phase 2, questionnaire validation (364 adults with T1DM); and phase 3, a 12-week dietary intervention to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in adults with T1DM (16-23 adults with T1DM). The validation of the study-developed Australian diabetes-specific quality of life questionnaire, and changes in hemoglobin A1c and quality of life in adults with T1DM while undertaking a low carbohydrate diet over 12 weeks will be the primary outcomes of this study.ResultsPhase 1 of the study is currently open for recruitment and has recruited 12 participants to date. It is anticipated that the first results will be submitted for publication in November 2021. Presently, no results are available.ConclusionsThis study is the first of its kind in that it will be the first to generate a new validated instrument, which could be used in evidence-based practice and research to understand the quality of life of Australian adults with T1DM. Second, the low carbohydrate dietary intervention outcomes could be used to inform clinicians about an alternative approach to assist T1DM adults in improving their quality of life and glycemic control. Finally, this study could warrant the development of an evidence-based low carbohydrate dietary guideline for adults living with T1DM with the potential to have a profound impact on this population.Trial RegistrationClinicalTrials.gov NCT04213300; https://clinicaltrials.gov/ct2/show/NCT04213300International Registered Report Identifier (IRRID)PRR1-10.2196/25085

Professional continuous glucose monitoring: A retrospective cohort study comparing one vs two pharmacist‐driven encounters

AbstractIntroductionContinuous glucose monitoring (CGM) is a burgeoning approach to measuring glycemia, but the ideal implementation method to optimize outcomes while streamlining clinical procedures is unknown. Furthermore, literature on the impact of pharmacist‐driven professional CGM (proCGM) is lacking.ObjectivesThe primary objective was to compare the change in hemoglobin A1c from baseline to 6 months after pharmacist‐driven proCGM implementation with one vs two proCGM data interpretation encounters. A secondary objective was to describe changes in proCGM report metrics for participants with two encounters.MethodsIn this retrospective single‐center study, adults with diabetes identified via Current Procedural Terminology code 95250 or 95251 undergoing pharmacist‐driven proCGM implementation with A1c measured within 6 months were included. Patients with additional CGM during the follow‐up period were excluded. Patients were categorized as having one pharmacist‐driven (RPh1) or two pharmacist‐driven (RPh2) encounters for proCGM data analysis for a single sensor. A1c change was analyzed via paired and independent sample t tests and analysis of covariance. ProCGM report metrics were analyzed via paired t tests.ResultsSixty‐six RPh1 and 56 RPh2 patients were included. Demographics were similar between groups, except RPh1 patients were younger, had higher body mass index, used less bolus insulin, and had less baseline hypoglycemia (P = .003, P = .008, P = .002, and P = .001, respectively). Baseline A1c was 8.2% and 8.3% with a mean reduction by 6 months of 0.75% and 0.87% for RPh1 and RPh2, respectively, and a mean follow‐up A1c of 7.4% for both groups. Significant A1c improvement was seen in each group compared with baseline (P &lt; .001), with no significant difference between groups (P = .655). There was a significant rise in time in range from the first to second encounter without a significant increase in time below range (P &lt; .001 and P = .34, respectively).ConclusionPharmacist‐driven proCGM implementation can significantly improve glycemic control, but no difference was seen in A1c lowering between the two implementation methods.

Diabetes Knowledge and Metabolic Control in Type 1 Diabetes Starting With Continuous Glucose Monitoring: FUTURE-PEAK.

To investigate whether diabetes knowledge and health literacy impact glycemic control after 1 year of intermittently scanned continuous glucose monitoring (isCGM) in people with type 1 diabetes ≥ 16 years. In this prospective real-world cohort study, we assessed diabetes knowledge using a new 10-item questionnaire [Patient Education and Knowledge (PEAK)] and health literacy using the validated 6-item Newest-Vital Sign-D (NVS-D) questionnaire. Primary endpoint was association between PEAK score and change in hemoglobin A1c (HbA1c). Secondary endpoints were link between NVS-D score and change in HbA1c and that between time spent in/above/below range and PEAK/NVS-D scores. 851 subjects were consecutively recruited between July 2016 and July 2018. Median PEAK score was 8 (range: 0-10), and median NVS-D score was 6 (range 0-6). HbA1c evolved from 7.9% (7.8%-8.0%), 63 (62-64) mmol/mol, at start to 7.7% (7.6%-7.7%), 61 (60-61) mmol/mol (P < 0.001), at 6 months and to 7.8% (7.7%-7.9%), 62 (61-63) mmol/mol, at 12 months (P < 0.001). HbA1c only improved in subgroups with higher scores [PEAK subgroups with score 7-8 (P = 0.005) and 9-10 (P < 0.001) and NVS-D score 4-6 (P < 0.001)]. At 12 months, time spent below 70 mg/dL was reduced by 15% (P < 0.001), and time spent below 54 mg/dL was reduced by 14% (P < 0.001), irrespective of PEAK/NVS-D score. Multiple linear regression analysis demonstrated an association of PEAK score, scan frequency, and baseline HbA1c with evolutions in time in range and time in hyperglycemia. isCGM reduced time in hypoglycemia, and HbA1c evolved favorably. Our findings suggest that diabetes and health literacy affect glucometrics, emphasizing the importance of education.

Evaluation of a Diabetes Remote Monitoring Program Facilitated by Connected Glucose Meters for Patients With Poorly Controlled Type 2 Diabetes: Randomized Crossover Trial.

BackgroundPatients with poorly controlled type 2 diabetes (T2D) experience increased morbidity, increased mortality, and higher cost of care. Self-monitoring of blood glucose (SMBG) is a critical component of diabetes self-management with established diabetes outcome benefits. Technological advancements in blood glucose meters, including cellular-connected devices that automatically upload SMBG data to secure cloud-based databases, allow for improved sharing and monitoring of SMBG data. Real-time monitoring of SMBG data presents opportunities to provide timely support to patients that is responsive to abnormal SMBG recordings. Such diabetes remote monitoring programs can provide patients with poorly controlled T2D additional support needed to improve critical outcomes.ObjectiveTo evaluate 6 months of a diabetes remote monitoring program facilitated by cellular-connected glucose meter, access to a diabetes coach, and support responsive to abnormal blood glucose recordings greater than 400 mg/dL or below 50 mg/dL in adults with poorly controlled T2D.MethodsPatients (N=119) receiving care at a diabetes center of excellence participated in a two-arm, 12-month randomized crossover study. The intervention included a cellular-connected glucose meter and phone-based diabetes coaching provided by Livongo Health. The coach answered questions, assisted in goal setting, and provided support in response to abnormal glucose levels. One group received the intervention for 6 months before returning to usual care (IV/UC). The other group received usual care before enrolling in the intervention (UC/IV) for 6 months. Change in hemoglobin A1c (HbA1c) was the primary outcome, and change in treatment satisfaction was the secondary outcome.ResultsImprovements in mean HbA1c were seen in both groups during the first 6 months (IV/UC −1.1%, SD 1.5 vs UC/IV −0.8%, SD 1.5; P<.001). After crossover, there was no significant change in HbA1c in IV/UC (mean HbA1c change +0.2, SD 1.7, P=.41); however, those in UC/IV showed further improvement (mean HbA1c change −0.4%, SD 1.0, P=.008). A mixed-effects model showed no significant treatment effect (IV vs UC) over 12 months (P=.06). However, participants with higher baseline HbA1c and those in the first time period experienced greater improvements in HbA1c. Both groups reported similar improvements in treatment satisfaction throughout the study.ConclusionsPatients enrolled in the diabetes remote monitoring program intervention experienced improvements in HbA1c and treatment satisfaction similar to usual care at a specialty diabetes center. Future studies on diabetes remote monitoring programs should incorporate scheduled coaching components and involve family members and caregivers.Trial RegistrationClinicalTrials.gov NCT03124043; https://clinicaltrials.gov/ct2/show/NCT03124043

Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study.

Background: Initiating continuous glucose monitoring (CGM) can affect hemoglobin A1c (HbA1c) levels and patients' relationship with their diabetes. We used real-world HbA1c data to quantify short-term changes in glycemia and validated psychosocial questionnaires to assess changes in quality-of-life indicators in people during their first few months of CGM use.Methods: Eligibility was assessed during calls to Dexcom sales regarding its G6 CGM System. Eligibility criteria included ages 25–65 years, type 1 (T1D) or type 2 diabetes (T2D) on intensive insulin therapy (IIT), and no prior CGM use. Participants used a web-based portal to complete the 17-item Diabetes Distress Scale (DDS) and the 14-item Hypoglycemia Attitudes and Behavior Scale (HABS); provided validated HbA1c measurements; and shared their CGM data pre- and 3–5 months post-CGM initiation. Satisfaction and ease of use with the G6 System were also assessed.Results: Data were available from 248 patients (182 with T1D, 66 with T2D; 57% male, 88% non-Hispanic white). Mean (standard deviation) HbA1c fell significantly from 8.2% (1.9%) at baseline to 7.1% (1.1%) at the end of the study (P < 0.001); more than half (54.4%) of those with initial HbA1c values >7% experienced absolute HbA1c reductions of >1%. Significant reductions in diabetes distress (DDS) and hypoglycemic concerns (HABS) were observed (P < 0.001). Most (93%) participants were satisfied or very satisfied with the G6 System and 73% found it very easy to use.Conclusions: The first 3 months of CGM use was correlated with improvements in psychosocial outcomes and improved HbA1c levels for people with T1D or T2D who use IIT.

Efficacy and Safety of Luseogliflozin in Patients with Type2 Diabetes Complicated by Hepatic Dysfunction: A Single-Site, Single-Arm, Open-Label, Exploratory Trial.

IntroductionImprovements in glycemic control and hepatic function are clinically important goals in the treatment of patients with type 2 diabetes mellitus (T2DM) complicated by hepatic dysfunction. The favorable effects of the sodium–glucose co-transporter inhibitor luseogliflozin on hepatic dysfunction were anticipated for humans. Nevertheless, few clinical studies have confirmed its real-world efficacy on hepatic dysfunction. This trial assessed the efficacy and safety of luseogliflozin in patients with T2DM complicated by hepatic dysfunction.MethodsThis prospective, single-site, single-arm, open-label, exploratory trial included 55 subjects with T2DM complicated by hepatic dysfunction. Subjects were administered luseogliflozin and observed for 52 weeks. The primary endpoints were the change in aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (γ-GTP), and hemoglobin A1c (HbA1c) from baseline to week 52. The secondary endpoints included body weight, body mass index (BMI), waist circumference, blood pressure, fasting plasma glucose (FPG), homeostatic model assessment beta (HOMA-β), homeostatic model assessment of insulin resistance (HOMA-IR), ferritin, Mac-2 binding protein (M2-BP), fatty liver index (FLI), fibrosis-4 (FIB-4) index, type IV collagen 7S domain, nonalcoholic fatty liver disease (NAFLD) fibrosis score, high-sensitivity C-reactive protein (hs-CRP), and interleukin-6 (IL-6).ResultsAST, ALT, γ-GTP, and HbA1c significantly decreased from baseline to week 52. Body weight, BMI, waist circumference, and FPG also significantly decreased. HOMA-IR significantly decreased but HOMA-β was unchanged. FLI, ferritin, M2-BP, and NAFLD fibrosis scores significantly decreased whereas the FIB-4 index and type IV collagen 7S domain did not significantly change. The hs-CRP and IL-6 levels did not significantly change.ConclusionLuseogliflozin administration in patients with T2DM complicated by hepatic dysfunction was well tolerated, did not worsen the hepatic condition, and might even be beneficial to improve hepatic function, reduce liver fat, and attenuate liver injury and fibrosis.Trial RegistrationThis study was registered under the University Hospital Medical Information Network Clinical Trial Registry (UMIN-CTR) (No. UMIN000025808) and the Japan Registry of Clinical Trials (jRCT) (No. jRCTs021180017).

Efficacy and Safety of Glucagon-Like Peptide1 Receptor Agonists for the Treatment of Type2 Diabetes Mellitus: A Network Meta-analysis.

IntroductionThe present study aimed to evaluate the effects of glucagon-like peptide 1 receptor agonists (GLP-1RAs) on clinical and safety outcomes including glycemic control and cardiometabolic indicators using network meta-analysis.MethodsMEDLINE, Embase, and Cochrane Library Central Register of Controlled Trials were searched from inception through June 30, 2019. Randomized clinical trials comparing one or more of six eligible GLP-1RAs with placebo or another eligible GLP-1RA were identified. We further screened studies that had 24–30 week follow-up periods and target endpoints. The primary outcome was change in hemoglobin A1c (HbA1c). Secondary outcomes included additional glycemic control indicators, cardiometabolic measures, and adverse events. Frequentist random-effect network meta-analyses were conducted for effect comparison.ResultsThe NMA synthesized evidence from 54 studies covering 23,209 patients and 18 GLP-1RA regimens. All included GLP-1RA regimens except liraglutide 0.3 mg once weekly (QW) significantly lowered HbA1c after 24–30 weeks compared with placebo. The pairwise comparison of HbA1c-lowering effect showed that dulaglutide 0.75 mg QW, dulaglutide 1.5 mg QW, exenatide 2 mg QW, liraglutide 0.9 mg QW, liraglutide 1.2 mg QW, liraglutide 1.8 mg QW, loxenatide 100 µg QW, and loxenatide 200 µg QW were not significantly outperformed by any of the other regimens. The effects on blood pressure, weight, and lipids were relatively mixed. The GLP-1RA regimens had comparable safety profiles with regard to hypoglycemia and adverse events.ConclusionRegimens of GLP-1RAs had differential glycemic control and cardiometabolic effectiveness. Policymaking and patient-centric clinical decisions should take into consideration the comparative effectiveness profiles.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01637-6.

150 Management of diabetes in pregnancy during the COVID-19 pandemic at a New York City hospital

To compare diabetic control and maternal and neonatal outcomes in pregnant women during the Coronavirus 2019 (COVID-19) pandemic to women managed one year prior. This was a retrospective cohort study of pregnant women with diabetes managed either during the COVID-19 pandemic or one year earlier. Twenty-two gestational and pregestational diabetic subjects were identified in a city hospital clinic during the peak of the pandemic in New York City (NYC) from March 15, 2020 until May 31, 2020. Fifty-seven pregnant diabetic subjects were identified who were managed at this clinic during the same timeframe in 2019. Demographics and maternal and neonatal outcomes were collected and compared. Diabetic control was compared by measuring change in hemoglobin A1c and diabetic medication regimen at time of delivery. Outcomes documented included mode of delivery, gestational age at delivery, postpartum hemorrhage, maternal infection, birth weight, shoulder dystocia, APGAR score <7, fetal acidosis, NICU admission, neonatal glucose level and neonatal demise. Secondary outcomes included number of virtual or in person visits, COVID-19 status, and gestational age at time of the diabetes diagnosis. Patients managed during the COVID-19 pandemic had significantly more telehealth visits and fewer in person visits compared to the year prior (p<0.001). However, no significant differences in maternal or neonatal outcomes or diabetic control were noted. There was no significant change in mode of delivery (p>0.999), shoulder dystocia (p=0.075), macrosomia (p>0.999), APGARs (p=0.671) or change in hemoglobin A1c during pregnancy (p=0.342). There were no significant differences in maternal or neonatal outcomes or diabetic control for subjects managed during the COVID-19 pandemic in a NYC hospital. A decreased number of in person visits, substituted with telehealth visits, had no apparent negative effect on outcomes or diabetic control.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

The Effects of Vitamin E, Silymarin and Carnitine on the Metabolic Abnormalities Associated with Nonalcoholic Liver Disease

The obesity epidemic has resulted in an increase in the incidence of metabolic syndrome, and liver disease. Studies indicate that antioxidant supplementation may improve abnormal liver chemistries, glucose control, and hyperlipidemia, in patients with nonalcoholic fatty liver disease (NAFLD). The primary objective of the study was to determine the normalization of abnormalities in hepatic function testing in patients with NAFLD when treated with vitamin E 200 IU, Silymarin 750 mg, and l-carnitine 1 gram (VSC) for 18 weeks in comparison to a placebo-controlled group. Secondary objectives were to evaluate changes in blood glucose level, insulin, total cholesterol, triglycerides, high-density lipoproteins (HDL), low-density lipoproteins (LDL), C-reactive protein (CRP), hemoglobin A1C (HgA1c), and homeostatic models assessment (HOMA) in patients treated with VSC vs placebo. Findings showed that VSC caused a significant reduction in serum glucose, insulin, and HOMA levels. While there were downtrends in the other measured values these were not statistically significant. In this 18-week study, the ability of this supplement in reducing markers of liver inflammation, glucose, insulin, and triglycerides indicate that this supplement could play an important role in the treatment of nonalcoholic fatty liver disease, diabetes, and the metabolic syndrome

Impact of Longitudinal Virtual Primary Care on Diabetes Quality of Care.

BackgroundLack of healthcare access to due to physician shortages is a significant driver of telemedicine expansion in rural areas. Telemedicine is effective for management of chronic conditions such as diabetes but its effectiveness in primary care settings is unknown.ObjectiveTo evaluate differences in diabetes care before and after implementation of a longitudinal virtual primary care program.DesignPropensity score-matched cohort study utilizing difference-in-differences analysis.ParticipantsPatients with diabetes who received care at VA primary care clinics between January 2018 and December 2019 where the Virtual Integrated Multisite Patient Aligned Care Teams (V-IMPACT) program was implemented.ExposurePatient participation in at least one V-IMPACT visit while usual care patients did not participate in V-IMPACT.Main MeasuresThe primary outcome was change in hemoglobin A1C (HbA1C) and secondary outcomes included change in the proportion of patients meeting diabetes quality indicators: blood pressure control, statin use, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (ACEi/ARB) use, and annual microalbuminuria testing.Key ResultsOur propensity-matched cohort included 9010 patients split evenly between those who participated in V-IMPACT and those who remained in usual in-person care. Among individuals with diabetes who participated in V-IMPACT, the change in mean HbA1C was − 0.055% (95% CI − 0.088 to − 0.022%) while those in usual care had a − 0.047% (95% CI − 0.080 to − 0.014%) change before and after program implementation. We observed a 5.1% (95% CI 2.4 to 7.7%) absolute increase in the proportion prescribed statins in the V-IMPACT group, a 5.3% (95% CI 2.5 to 8.2%) increase prescribed ACE/ARBs, and a 4.6% (95% 1.7 to 7.5%) increase in completed yearly microalbuminuria testing. V-IMPACT was not associated with a significant difference in the proportion with controlled blood pressure at < 140/90 or < 130/90 mmHg thresholds.ConclusionsQuality of diabetes care delivered by a longitudinal virtual primary care model was similar if not better than traditional in-person care.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-020-06547-x.

Effects of catheter-based renal denervation on glycemic control and lipid levels: a systematic review and meta-analysis.

As an emerging interventional technique to treat resistant hypertension, renal denervation (RDN) has also attracted considerable attention due to its potential beneficial effects on glucose and lipid metabolism. Given that inconsistent results were documented among studies, we aimed to perform a systematic review and meta-analysis to elaborate on this issue. The PubMed, EMBASE, Web of Science (SCI) and ClinicalTrials.gov databases were comprehensively searched from their inception date to June 18, 2020, for relevant clinical studies evaluating the efficacy of RDN on glucose and lipid levels. The outcomes of interest were changes in fasting glucose, insulin, C-peptide, hemoglobin A1C (HbA1C), homeostatic model assessment-insulin resistance (HOMA-IR), cholesterol and triglyceride (TG) levels before versus after RDN and also RDN versus the control group. The mean differences (MDs) of the outcomes measured before versus after RDN and RDN versus the control group were pooled by a randomized effects model. Heterogeneity was quantified with Chi-square (χ2) and inconsistency index (I2). Assessment of publication bias was performed by the funnel plot and Egger's test. A total of 1600 studies were initially identified. Nineteen of the identified studies (six randomized controlled studies, one non-randomized controlled studies and 12 observational cohort studies) involving 2245 subjects were included in the final analysis. No significant change was observed after RDN in fasting glucose (weighted mean difference [WMD] - 0.19mmol/L; 95% CI - 0.37, 0.00mmol/L), insulin (standardized mean difference [SMD] - 0.01; 95% CI - 0.41, 0.39), C-peptide (SMD - 0.05; 95% CI - 0.30, 0.21), HbA1C (SMD - 0.05; 95% CI - 0.17, 0.07), HOMA-IR (SMD - 0.29; 95% CI - 0.72, 0.14), total cholesterol (TC) (WMD - 0.11mmol/L; 95% CI - 0.37, 0.15mmol/L), and low-density lipoprotein cholesterol (LDL-C) levels (WMD - 0.18mmol/L; 95% CI - 0.59, 0.24mmol/L) during follow-up. Changes in fasting glucose, insulin, HbA1C and TC levels in RDN groups were not significantly different from those in the control group. High-density lipoprotein cholesterol (HDL-C) and TG were slightly improved after RDN (WMD 0.07mmol/L, 95% CI 0.01, 0.14mmol/L; WMD - 0.26mmol/l, 95% CI - 0.51, - 0.01mmol/L, respectively). The funnel plot and Egger's test demonstrated the absence of potential publication bias. Catheter-based RDN appeared to have no impact on glucose metabolism. There was a statistically significant but clinically negligible improvement in HDL-C and TG levels based on the current evidence. Future research with more rigorous designs is warranted to draw definitive conclusions. The protocol of this meta-analysis was registered on PROSPERO (CRD42020192805). ( https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=192805 ).

Long-term safety and efficacy of alogliptin, a DPP-4 inhibitor, in patients with type 2 diabetes: a 3-year prospective, controlled, observational study (J-BRAND Registry)

IntroductionGiven an increasing use of dipeptidyl peptidase-4 (DPP-4) inhibitors to treat patients with type 2 diabetes mellitus in the real-world setting, we conducted a prospective observational study (Japan-based Clinical Research...

Feasibility and Acceptability of a Type 2 Diabetes Prevention Intervention for Mothers and Children at a Federally Qualified Healthcare Center.

Background:Maternal obesity and gestational diabetes mellitus (GDM) contribute to increased risk for type 2 diabetes mellitus (T2DM) among both mothers and their offspring. Randomized trials demonstrated T2DM risk reduction in adults following lifestyle behavior change and modest weight loss; the evidence base for at-risk children remains limited.Purpose:Evaluate the feasibility, acceptability, and preliminary efficacy of a T2DM prevention intervention for mother-child dyads delivered by Federally Qualified Health Center staff.Methods:A group randomized design tested the effects of a behavioral lifestyle intervention on T2DM risk factors in women with a history of GDM and their 8- to 12-year-old children. Mother-child dyads were recruited and randomized to intervention or wait-listed control conditions. Intervention participants completed the 13-week intervention; control participants received standard of care. Baseline and 13-week measures assessed program acceptability and feasibility, and explored effects on body weight, waist circumference, hemoglobin A1c, and lifestyle behaviors.Results:Forty-two dyads were randomized and 35 (83%) completed pre-/post-measurements. Participants and program leaders positively rated content and engagement. Nearly all strongly agreed that activities were enjoyable (97%), applicable (96%), useful (97%), and motivational (96%). Attendance averaged 65% across 2 cohorts; delivery costs were approximately $225/dyad. There were no significant differences in body weight, BMI (or BMI z-score), waist circumference, hemoglobin A1c, diet quality, physical activity, sleep, or home environment changes between intervention and control groups.Conclusions:A family T2DM prevention program was feasibly delivered by FQHC staff, and acceptable to mothers and children. Program efficacy will be evaluated in an adequately powered clinical trial.

Glycemic and cardiometabolic effects of exercise in South Asian Sri Lankans with type 2 diabetes mellitus: A randomized controlled trial Sri Lanka diabetes aerobic and resistance training study (SL-DARTS)

Background and aimsTo examine the effects of aerobic training (AT) and resistance training (RT) compared to standard care on glycemic control in South Asian Sri Lankan adults with Type 2 Diabetes Mellitus (T2DM). MethodsRandomized controlled trial (RCT) with parallel-group design recruited 86 sedentary Sri Lankans (aged 35–65 years) with T2DM into aerobic training (AT, n = 28), resistance training (RT, n = 28) and control (CN, n = 30) groups. Supervised progressive exercise training consisting of 75 min per session, 2 days per week for 12 weeks was conducted. The primary outcome was pre- and post-intervention absolute change in hemoglobin A1c (HBA1c). Secondary outcomes were serum lipids, liver enzymes, chronic inflammatory status, anthropometry, body composition and blood pressure. ResultsThe absolute change in HbA1c of RT vs. CN was −0.08% (95% CI, 0.8% to −0.7%, p = 0.8) and AT vs. CN was −0.22% (95% CI, 0.95% to −0.5%). Subgroup analysis (n = 49) with a high baseline HbA1c (>7.5%), absolute reduction in HbA1c in exercise groups were statistically significant (RT vs. CN was −0.37%; 95% CI 1.3% to −0.6%, p = 0.04 and AT vs. CN was −0.57%; 95% CI 1.7% to −0.6%, p = 0.03). The effect sizes (total and subgroup HbA1c >7.5%) ranged from 0.7 to 1.0 in AT, 0.4 to 1.1 in RT compared to 0.35 to 0.6 for the CN. Secondary outcomes did not significantly differ among groups. ConclusionsExercise training 2 days/week improved glycemic control in Sri Lankan adults with T2DM and the effects were significant in high baseline HbA1c (>7.5%) groups (RT > AT).

Pharmacists providing care in statewide physician organizations: findings from the Michigan Pharmacists Transforming Care and Quality Collaborative.

BACKGROUND: Clinical services provided by pharmacists embedded in practices can improve patient outcomes within the primary care setting. Little is known about whether physician organizations (POs) will retain the services of clinical pharmacists after outside funding for a statewide implementation program is ended. OBJECTIVE: To evaluate a statewide program, Michigan Pharmacists Transforming Care and Quality (MPTCQ), that incorporated pharmacists within 17 POs. METHODS: A descriptive study was conducted using data collected from June 2016 to September 2018 from primary care clinical pharmacist encounters in POs participating in MPTCQ. Process outcomes included the number of participating POs, patient encounters, and average visits per patient. Analyses at the encounter level were stratified by 2 encounter types: disease state management (DSM) or comprehensive medication review (CMR). Separately by encounter type, pharmacist effect was described by the number, type, and reasons for medication changes, as well as medication adherence and cost barriers found and addressed. Clinical outcomes included hemoglobin A1c and blood pressure change. Sustainability and patient satisfaction of pharmacists providing clinical services are reported. RESULTS: Across 17 POs, 27 pharmacists participated in the MPTCQ program. Pharmacists completed 24,523 patient encounters for DSM with 5,942 patients, with an average of 5 visits per patient with diabetes and 2 visits for hypertension. Pharmacists made 15,153 therapeutic medication changes during visits for diabetes and hypertension, with approximately 70% related to efficacy. Pharmacists completed 4,203 CMR visits for 3,092 patients. During CMR visits, 1,296 therapeutic medication changes were recommended. Problems with medication cost were identified in 13% of CMR visits. Blood pressure and A1c levels decreased in patients managed by pharmacists. In 157 patients surveyed, 87% rated their pharmacists' care as excellent. Sixteen POs retained their pharmacists at the end of funding. CONCLUSIONS: A statewide provider-payer partnership successfully integrated and retained primary care pharmacists within POs. Pharmacists in the MPTCQ program contributed to improvements in disease control by changing medications to improve patient clinical outcomes. DISCLOSURES: Support for MPTCQ was provided by Blue Cross and Blue Shield of Michigan (BCBSM) as part of the BCBSM Value Partnerships program. Coe was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number KL2TR002241. Although BCBSM and MPTCQ work collaboratively, the opinions, beliefs, and viewpoints expressed by the authors do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors have no conflicts of interest to report.

Study comparing the efficacy and renal safety for patients with diabetes switching from dapagliflozin to empagliflozin

Background Previously, dapagliflozin was limited to patients with an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2, while empagliflozin can be used for those with an eGFR ≥ 45 mL/min/1.73 m2. Therefore dapagliflozin was switched to empagliflozin in many patients when eGFR decreased. However, the clinical efficacy and safety of these switcfhes are not clear. Objective In this study, we compared the efficacy and renal safety between patients switching from dapagliflozin to empagliflozin in patients. Setting This is a retrospective study of adult patients (aged ≥ 20 years) who had attended the Kaohsiung Medical University Hospital. Method This retrospective observational study included patients who were switched from dapagliflozin to empagliflozin. To assess the effect of other hypoglycemic drugs on efficacy, the types and dose alterations of other hypoglycemic drugs were classified on the defined daily dose (DDD). Main outcome measure The primary outcome measure was the change in hemoglobin A1c (HbA1c) level after 6 months. Patients with HbA1c levels at or lower than the baseline value after 6 months were defined as effective and patients with levels higher than the baseline were defined as invalid. Safety was evaluated by comparing the difference of eGFR between the baseline value and 6 months after treatment. Results Overall, 111 patients were enrolled in the study. Six months after switching from dapagliflozin to empagliflozin, HbA1c significantly reduced, with no statistically significant difference observed in eGFR. In our study, 78 patients were assigned to the effective group (70.3%) and 33 patients were invalid (29.7%). When the other hypoglycemic drugs were grouped by total dosage, fasting plasma glucose and HbA1c only decreased significantly in the "DDD decrease" and "DDD increase" groups. Conclusion Our study showed that switching from dapagliflozin to empagliflozin in patients with type 2 diabetes was effective for blood glucose maintenance and caused no significant changes in renal function. In addition, compared to similar sodium-glucose co-transporter-2 inhibitors, other hypoglycemic drugs may be factors that influence the efficacy of sugar-lowering treatments.

Association of Sacubitril/Valsartan with Metabolic Parameters in Patients with Reduced Ejection Fraction Heart Failure at a Multidisciplinary Clinic.

Background: Sacubitril/valsartan was approved for New York Heart Association (NYHA) class II-IV heart failure with reduced ejection fraction (HFrEF) in 2015, based on the results of the PARADIGM-HF trial, which showed a reduction in cardiovascular (CV) death and heart failure hospitalization, compared with enalapril. A subsequent subgroup analysis of the trial showed glycemic improvement for patients on sacubitril/valsartan compared with those on enalapril. Methods: This was a retrospective observational study at the Loma Linda University (LLU) International Heart Institute (IHI). The aim was to evaluate the association of sacubitril/valsartan with glycemic index and other metabolic parameters, including change in hemoglobin A1C (HbA1C), blood pressure (BP), ejection fraction (EF), body weight, and lipid profile from baseline and at 3, 6, and 12 months. The rates of CV-related hospitalizations and total hospitalizations were also assessed. Results: The change in mean HbA1C from baseline was not significantly different at 1 year (P = 0.993). The mean EF was significantly higher and the mean diastolic BP was significantly lowered. Body weight and lipid parameters remained unchanged. Both the rates of CV-related hospitalizations and total hospitalizations were significantly lowered. For the prespecified subgroup analysis of diabetic HFrEF patients, the mean HbA1C was nonsignificant at 12 months (mean difference -0.48, P = 0.993). Conclusion: A non-significant reduction in HbA1C was associated in HFrEF patients with diabetes mellitus. Large randomized trials are needed to confirm our findings regarding the potential metabolic benefits of sacubitril/valsartan.

Building a Healthy Temple diabetes self-management education support program in Hispanic faith community settings: A cluster randomized controlled trial

Diabetes self-management is key to preventing diabetes complications disproportionately affecting Hispanics. Church appears a promising setting for delivering a diabetes self-management education support (DSMES) program. “Faith-placed” (FP) programing refers to health interventions implemented in the church setting; while “faith-based” (FB) signifies integrating spirituality with health interventions. The Building a Health Temple (BHT) DSMES program integrates spirituality with DSMES to improve diabetic outcomes.This cluster-randomized trial tests the effectiveness of BHT DSMES by adapting an existing DSMES program into faith-based context. A total of 360 participants will be recruited from 18 churches (~20 participants/church). Churches will be randomly assigned to either the FB or FP intervention arm. Intervention activities will be implemented over 14 consecutive weeks. Participants in the FB arm will participate in BHT DSMES including a Health Sermon, the Self-Management Resource Center (SMRC) Diabetes Self-Management Program (DSMP), and a 7-session Healthy Bible Study, delivered by two trained church lay health leaders. Participants in the FP arm will attend the same SMRC DSMP facilitated by outside health professional, followed by a 7-session community health and safety curriculum as a partial attention control intervention. The primary outcome will be a change in Hemoglobin A1c (HbA1c) level. Secondary outcomes include: changes in body mass index, waist circumference, diabetes distress score, diabetes self-care behaviors, eating behavior, and physical activity level. Data will be collected at baseline, 6, 9, and 12 months during the study period.The proposed study will lead to innovative DSMES program delivery through faith settings for Hispanic persons with diabetes.