Change In A1c Research Articles

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

Influence of Framing: Recruitment to a Diabetes Disease Management Program From an Emergency Department Improves Enrollment and Outcomes

IntroductionDisease management programs (DMPs) provide education, self-management skills, care coordination, and frequent clinical assessment and medication adjustment. Our health system’s diabetes mellitus (DM) DMP recruited patients from an emergency department (ED) and outpatient settings (primary care physicians’ [PCP] and endocrinologists’ offices; cold calling patients with poorly-controlled diabetes). We investigated whether recruitment to a DMP from an ED is feasible and effective, hypothesizing such patients would have better enrollment rates, future A1c control, and ED utilization because their receptiveness to change was “framed” by their ED visit. “Framing” is the notion that the same problem presented using a different context impacts response to the information. Being told in an acute-care ED setting one has newly-diagnosed or poorly-controlled DM, or DM-related complications may influence desire/commitment to enroll in the DMP and make lifestyle/medication changes. That is, acute illness or acute setting may influence/”frame” willingness to enroll and improve glycemic control. MethodsWe captured all DMP recruitees’ demographic, medical, insurance, A1c, and recruitment venue characteristics and evaluated future enrollment rates, A1c, and ED utilization from any ED in our health system. We analyzed pre- vs. post-recruitment changes in A1c and ED visit rates, comparing patients recruited from the ED who enrolled, patients recruited from the ED who did not enroll, patients recruited from outpatient settings who enrolled, and patients recruited from outpatient settings who did not enroll. Continuous enrollment predictor and outcome variables were compared using the Mann-Whitney test; categorical outcome variables were compared using Fisher’s exact test.ResultsThere were no statistically significant differences in characteristics (including mean baseline A1c [~11.4%]) among patients recruited from the ED, clinics, or cold calling. Twenty-five percent of all ED-recruited patients enrolled vs. 35% from outpatient settings. When a recruiter familiar with the DMP was in the ED, 41% of ED patients enrolled vs. 12% at other times (p=0.0001). Nearly 84% of ED visits were for direct DM-related causes (eg, diabetic ketoacidosis, hyperosmolar hyperglycemic state) or complications with a well-established link to diabetes (eg, acute coronary syndrome, stroke, wound infection); there was no statistically-significant difference in enrollment rates between patients whose ED visit was vs. was not for a DM-related complaint (53.8% vs. 60.0%, p=0.8018). No other variables, including whether the patient had newly diagnosed DM, were associated with enrollment. Enrollees with worse baseline glycemic control (A1c ≥11%) had a greater median A1c decrease (3.5% vs. 1.9%) vs. those with less-poor baseline glycemic control (A1c <11%) or those declining the program (p=0.05). Post-recruitment ED visits-per-patient-per-month decreased among patients recruited from the ED (-0.08), but not among those recruited from outpatient settings. (+0.08), p<0.0001).ConclusionED recruitment to a diabetes DMP is feasible and effective. An ED-based diabetes DMP recruiter had enrollment rates substantially greater than a cold-calling DMP recruiter, comparable to enrollment rates from PCPs and endocrinologists, suggesting the importance of the recruitment framing/context. ED-recruited patients achieved substantial improvements in A1c and future ED visit rates.

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.

Factors associated with A1C reduction with GLP-1 agonist or SGLT-2 inhibitor use.

While use of glucagon-like peptide-1 (GLP-1) agonists and sodium-glucose cotransporter-2 (SGLT-2) inhibitors reduces the risk of atherosclerotic cardiovascular disease outcomes and lowers glycosylated haemoglobin (A1C), evidence on patient characteristics associated with clinically relevant A1C reduction is lacking. The objective of this retrospective cohort study was to identify patient characteristics associated with A1C reduction with initial GLP-1 or SGLT-2 use. Patients with type 2 diabetes and a baseline A1C ≥7% who were dispensed a GLP-1 or SGLT-2 between 01/01/10 and 12/31/17 were included. Patients were categorized as having a ≥1% or <1% A1C reduction during the 90-365 days after GLP-1/SGLT-2 initiation. Patient characteristics were collected during the 180 days prior to initiation. Multivariable logistic and linear regression modelling was performed to identify characteristics associated with a ≥1% A1C reduction and absolute change in A1C, respectively. Five hundred and seventy-two patients were included with 261 (46%) and 311 (54%) having and not having an ≥1% A1C reduction. Patients were primarily middle-aged, female, white, non-Hispanic and had a high burden of chronic disease. Characteristics associated with a ≥1% A1C reduction included: GLP-1/SGLT-2 persistence, congestive heart failure comorbidity, phentermine dispensing, care management team (CMT) enrollee and higher baseline A1C. Characteristics associated with absolute A1C reduction included: age, baseline A1C, CMT enrollee, GLP-1/SGLT-2 persistence and a phentermine dispensing. The results of this study provide practitioners with guidance on the patients who are most likely to have a clinically relevant A1C reduction with GLP-1 or SGLT-2 use.

Evaluation of the Addition of Pharmacist Management to a Medication Assistance Program in Patients with Hypertension and Diabetes Resistant to Usual Care

Objective: To evaluate the effect of a medication assistance program and the addition of pharmacist management on clinical outcomes in patients with hypertension and diabetes through an Advanced Pharmaceutical Care program. Methods: This was a prospective quality improvement study on patients with hypertension and/or diabetes resistant to usual care. The primary outcomes were change in A1C, blood glucose, and blood pressure between 3 phases: usual care, free medications, and free medications plus pharmacist management. Secondary outcomes included achievement of A1C, blood glucose, and blood pressure goals as well as pharmacist interventions. Results: Seven patients were included in the study. The mean A1C decreased from 11.3% to 8.3% with free medications (p = 0.28) and from 8.3% to 6.4% with pharmacist management (p = 0.119). Mean blood pressure during usual care, free medications, and pharmacist intervention was 150/87 mm Hg, 148/85 mm Hg, and 125/78 mm Hg, respectively. After pharmacist management, 75% of patients with type 2 diabetes were able to achieve A1C and blood glucose goals, and 71% of patients with hypertension achieved blood pressure <130/80 mm Hg. Conclusions: The Advanced Pharmaceutical Care program allowed pharmacists to identify and overcome patient-specific barriers to care, provide individualized disease state education, and optimize medication management. Medication assistance led to improvements in A1C and blood pressure, but did not affect achievement of disease state goals. Pharmacist involvement in hypertension and diabetes care led to clinically significant reductions in blood pressure and A1C and enabled patients to reach guideline-recommended blood pressure and glycemic goals.

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

Treatment of hyperglycemia not associated with NAFLD improvement in children with type 2 diabetes mellitus.

Background and objectivesNonalcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM) have become public health problems in the pediatric population. However, the relationship between these two conditions is not well understood. The primary objective of this study was to assess whether treatment of hyperglycemia in obese, treatment-naive children with type 2 diabetes (T2DM) was associated with an improvement of surrogate markers of NAFLD.Materials and methodsThis retrospective, longitudinal study included 151 obese children with a diagnosis of T2DM (Age: 14 ± 1 years, 72% female children, BMI: 98.6th percentile, and A1c: 10.3 ± 0.2%). Clinical/demographic information was collected before patients started any diabetes treatment and 1 and 3 years after starting metformin and/or insulin therapy.ResultsForty-eight patients (32%) had abnormal ALT/AST (i.e., >40 U/L), suggestive of NAFLD. After 1 year of therapy, there were no significant differences in plasma ALT among patients started on insulin, metformin, or combination: 5±4 vs. −10 ± 3 vs. −2±2 IU/L, respectively, P = .07. Of note, changes in plasma ALT were small, despite a significant reduction of A1c in patients prescribed insulin (alone or with metformin): -2.8 ± 1.0%, P = .01, and −2.7 ± 0.3%, P < .001, respectively. In line with this, no significant correlations were found between changes in A1c and plasma aminotransferases. In contrast, changes in plasma AST/ALT were more strongly associated with BMI changes (r = 0.32, P < .001, and r = 0.19, P = .04, respectively). Similar results were observed after 3 years of follow-up.ConclusionsNonalcoholic fatty liver disease is highly prevalent in obese children with T2DM. Treatment of hyperglycemia with metformin and/or insulin did not result in any significant improvement in surrogate markers of NAFLD (i.e., plasma aminotransferases). While changes in ALT and/or AST may not perfectly reflect histological changes in NAFLD, our findings suggest that the treatment of hyperglycemia per se may not be associated with NAFLD improvement.

Continuous glucose monitoring shared medical appointments improve diabetes self‐efficacy and hemoglobin A1C

AbstractIntroductionDiabetes self‐management education and support and professional continuous glucose monitoring (CGM) were combined into shared medical appointments (SMA) to provide care for people with diabetes. Although the individual components have evidence of efficacy, this combination has never been studied.ObjectivesThe purpose of this study is to assess the impact of CGM SMA on diabetes self‐efficacy and hemoglobin A1C (A1C) in persons with diabetes.MethodsAdults who attended a two‐part CGM SMA at a large academic medical center were included in this retrospective, pre‐post study. The CGM SMA incorporated diabetes education, peer support, and seven days of professional CGM. The primary outcome was change in diabetes self‐efficacy through a validated eight‐item Likert Scale instrument. Secondary objectives were changes in A1C, changes in diabetes medications, and type of planned lifestyle changes. Paired t tests were used to analyze change in A1C and diabetes self‐efficacy scores.ResultsA total of 171 participants were included in this analysis. Diabetes self‐efficacy scores increased by a mean of 1.63 ± 2.09 points (P &lt; .001) out of 10 points maximum after participation in the two‐part CGM SMA. The A1C decreased by a mean of 0.80 ± 1.52% (P &lt; .001), with a mean follow‐up A1C of 7.8 ± 1.60%. Those with an A1C &gt; 8% (n = 101) experienced a decrease of 1.20%. Participants utilizing the unblinded device (n = 133) experienced a decrease in A1C by 0.75% compared with 1.0% in those that utilized a blinded device (n = 38). Most medication changes made in the CGM SMA were dosage adjustments and changes in administration time.ConclusionsThe CGM SMA is a novel practice model incorporating diabetes education, peer support, professional CGM, and interprofessional care that demonstrated improvements in diabetes self‐efficacy and A1C.

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.

A1C Reduction in Patients Who Declined Pharmacist-Led Diabetes Management Services

Introduction: The purpose of this research is to assess the mean change in A1C associated with patients who declined a pharmacy-led diabetes management program and to evaluate effects of predictor variables on the odds of achieving improved A1C in these patients. Study design: Retrospective, single-center, single-group, cohort study. Methods: Patients 18 years or older with uncontrolled type 2 diabetes (defined as A1C ≥ 9%) who declined pharmacy-led diabetes management services were included in the study. The primary outcome of the study was to assess the mean change in A1C from time of phone call offering pharmacy management services (initial) to last observed A1C (final recorded A1C). Results: A total of 91 patients were included, 46 males and 45 females. The significant reduction in the mean change from baseline A1C to the final measured A1C was −0.59 (95% CI, −0.9327% to −0.2447%, P-value = 0.0010). This resulted in 8.79% of patients’ final A1C falling into the range of < 7%. Conclusion: Our study found a paradoxical reduction in A1C among patients who declined pharmacy-led diabetes management services, however, our study is limited by having no comparison group. Further research needs to be conducted to identify correlations between characteristics of patients declining diabetes management services in order to assist with identifying patient-specific methods for improving patient outcomes.

Use of Flash Continuous Glucose Monitoring Is Associated With A1C Reduction in People With Type 2 Diabetes Treated With Basal Insulin or Noninsulin Therapy.

BACKGROUNDGlycemic control is suboptimal in many individuals with type 2 diabetes. Although use of flash continuous glucose monitoring (CGM) has demonstrated A1C reductions in patients with type 2 diabetes treated with a multiple daily injection or insulin pump therapy regimen, the glycemic benefit of this technology in patients with type 2 diabetes using nonintensive treatment regimens has not been well studied.METHODSThis retrospective, observational study used the IBM Explorys database to assess changes in A1C after flash CGM prescription in a large population with suboptimally controlled type 2 diabetes treated with nonintensive therapy. Inclusion criteria were diagnosis of type 2 diabetes, age <65 years, treatment with basal insulin or noninsulin therapy, naive to any CGM, baseline A1C ≥8%, and a prescription for the FreeStyle Libre flash CGM system during the period between October 2017 and February 2020. Patients served as their own control subject.RESULTSA total of 1,034 adults with type 2 diabetes (mean age 51.6 ± 9.2 years, 50.9% male, baseline A1C 10.1 ± 1.7%) were assessed. More patients received noninsulin treatments (n = 728) than basal insulin therapy (n = 306). We observed a significant reduction in A1C within the full cohort: from 10.1 ± 1.7 to 8.6 ± 1.8%; Δ −1.5 ± 2.2% (P <0.001). The largest reductions were seen in patients with a baseline A1C ≥12.0% (n = 181, A1C reduction −3.7%, P <0.001). Significant reductions were seen in both treatment groups (basal insulin −1.1%, noninsulin −1.6%, both P <0.001).CONCLUSIONPrescription of the flash CGM system was associated with significant reductions in A1C in patients with type 2 diabetes treated with basal insulin or noninsulin therapy. These findings provide evidence for expanding access to flash CGM within the broader population of people with type 2 diabetes.

Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial

ObjectiveTo examine whether diabetes shared medical appointments (SMAs) implemented as part of usual clinical practice in diverse health systems are more effective than usual care in improving and sustaining A1c improvements.Research Design and MethodsA multi-site cluster randomized pragmatic trial examining implementation in clinical practice of diabetes SMAs in five Veterans Affairs (VA) health systems was conducted from 2016 to 2020 among 1537 adults with type 2 diabetes and elevated A1cs. Eligible patients were randomly assigned to either: (1) invitation to participate in a series of SMAs totaling 8–9 h; or (2) continuation of usual care. Relative change in A1c (primary outcome) and in systolic blood pressure, insulin starts, statin starts, and anti-hypertensive medication classes (secondary outcomes) were measured as part of usual clinical care at baseline, at 6 months and at 12 months (~7 months after conclusion of the final SMA in four of five sites). We examined outcomes in three samples of SMA participants: all those scheduled for a SMA, those attending at least one SMA, and those attending at least half of SMAs.ResultsBaseline mean A1c was 9.0%. Participants scheduled for an SMA achieved A1c reductions 0.35% points greater than the control group between baseline and 6-months follow up (p = .001). Those who attended at least one SMA achieved reductions 0.42 % points greater (p < .001), and those who attended at least half of scheduled SMAs achieved reductions 0.53 % points greater (p < .001) than the control group. At 12-month follow-up, the three SMA analysis samples achieved reductions from baseline ranging from 0.16 % points (p = 0.12) to 0.29 % points (p = .06) greater than the control group.ConclusionsDiabetes SMAs as implemented in real-life diverse clinical practices improve glycemic control more than usual care immediately after the SMAs, but relative gains are not maintained. Our findings suggest the need for further study of whether a longer term SMA model or other follow-up strategies would sustain relative clinical improvements associated with this intervention.Trial RegistrationClinicalTrials.gov ID NCT02132676

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)

Predictors of response to ambulatory pharmacist‐led diabetes care

AbstractPurposeAmbulatory care pharmacists have been shown to significantly improve health outcomes of patients with type 2 diabetes mellitus (T2DM); however, it is unclear which patients are most likely to benefit from these services. The primary objective of this study was to describe clinical response to pharmacist‐led diabetes care and identify baseline and interventional variables that are independently predictive of clinical response.MethodsThis was a retrospective cohort study of adult patients with T2DM referred for ambulatory care pharmacist diabetes management at one of two health systems in San Antonio, Texas from January 1, 2015 to December 31, 2018. Data were collected at baseline and during 6 months of follow‐up. Clinical response was defined as hemoglobin A1C (A1C) reduction from baseline ≥1% or meeting the documented A1C goal. Predictors of clinical response were identified using multivariable logistic regression, including 25 patient and clinical intervention covariates.ResultsA total of 180 patients were included. Patients were predominantly female (63%) and obese (58%) with a T2DM duration ≥10 years (67%). The median (interquartile range) change in A1C from baseline for responders and non‐responders was −2.2% (−3.7 to 1.3) and 0.4% (−0.4 to 1.05) (P &lt; .001), respectively. Significant predictors of response included baseline A1C (odds ratio [OR] 1.41; 95% confidence interval [CI] 1.08‐1.85), number of completed visits with the pharmacist (OR 1.65; 95% CI 1.03‐2.64), and medication frequency reduction (OR 10.7; 95% CI 1.04‐109.9). Number of primary care provider visits was a negative predictor of response (OR 0.69; 95% CI 0.49‐0.96).ConclusionPharmacist‐led diabetes management was associated with reduced A1C levels in patients with T2DM. Higher patient baseline A1C, more visits with the pharmacist, and medication frequency reduction were predictive of clinical response and should be considered in future patient referral and management protocols.

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.

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...