A1C Reduction Research Articles

A scoping review of the use and impact of telehealth medication reviews.

Telehealth has been proposed as a mechanism to overcome the practical difficulties associated with conducting timely and efficient medication reviews particularly in rural and remote settings. The aim was to examine the literature on the use and impact of telehealth-facilitated medication reviews. A scoping review of the literature was conducted. Articles that reported medication reviews performed by telehealth were identified by searching the Pubmed, Embase, Cochrane Library and CINAHL databases to January 2019 and screened using predefined inclusion criteria. Data were extracted from included articles and synthesised narratively. Findings are reported using the PRISMA-ScR guidelines. Twenty-nine studies, including 15 descriptive and 14 quasi-experimental studies, met the inclusion criteria. Twenty studies were reports of the implementation and/or evaluation of a service and others were proof of concept, feasibility or pilot studies. Telehealth medication reviews, conducted as standalone interventions or as a part of team-based care, included medication order reviews, medication management, antimicrobial stewardship programs and geriatric services and were delivered to patients in outpatient (n=15) or hospital (n=12) settings, with one study conducted in residential care and one study across settings. Outcomes reported included process evaluation (n=23), medication use (n=8), costs (n=6), clinical outcomes (n=5), and healthcare use (n=1). Positive impact was observed on clinical outcomes (e.g. reduction in haemoglobin A1c), medication use (e.g. reduction in antimicrobial medications) and costs (e.g. savings due to travel avoided). Good overall satisfaction with the interventions was seen in all studies that reported patient satisfaction. The current evidence suggests that telehealth medication review may be a feasible model for delivering these services and potentially can save costs and improve care. However, the level of evidence may not be sufficient to reliably inform practice and policy on telehealth-facilitated medication-reviews.

Health literacy and exercise-focused interventions on clinical measurements in Chinese diabetes patients: A cluster randomized controlled trial

BackgroundThe diabetes patients in China have low health literacy and low levels of physical activities which may result in the poor glycemic control and other clinical outcomes. This study is designed to evaluate the effectiveness of health literacy and exercise-focused interventions on clinical outcomes among Chinese patients with type 2 diabetes (T2DM). MethodsIn this cluster randomized controlled trial, 799 T2DM patients with the most recent A1c ≥ 7·5% (58 mmol/mol, or fasting glucose level ≥10 mmol/L) were recruited from 35 clinics in 8 communities in Shanghai, China, and randomized into one standard care (control) arm and three intervention arms receiving interventions focused on health literacy, exercise or both. A1c (primary outcome), blood pressure and lipids (secondary outcomes) were measured at baseline, 3-, 6-, 12-months of intervention period and 12-months after completion of the interventions. This trial is registered with the International Standard RCT Number Register, number ISRCTN76130594. FindingsThe three intervention groups had more reductions in A1c than the control group, with 0·90% reduction in the health literacy, 0·83% in the exercise and 0·54% in the comprehensive group at 12-months (p<0·001) and these improvements remained even after a 1-year follow-up period post intervention. The risk of suboptimal A1c (≥7·0% or 53 mmol/mol) was also significantly lower in three intervention groups than control group at each follow-up visit, with adjusted risk ratios (RR) ranging from 0.06 to 0.16. However, the control group has greater reductions in low-density lipoprotein (LDL) than the health literacy group from baseline to 12-months (β=0·55, p<0·0001) and from baseline to 24-months (β=0·62, p<0·0001). A higher risk of abnormal LDL was also observed for the health literacy group at 12-months [adjusted risk ratio (RR): 2·22, 95%CI: 1·11-4·44] and 24-months [adjusted risk ratio (RR): 2·37, 95%CI: 1·16-4·87] compared to the control group. No significant benefits in systolic blood pressure (SBP), diastolic blood pressure (DBP) and low-density lipoprotein (HDL) were observed from the interventions compared to the usual care. InterpretationThe health literacy and exercise interventions result in significant improvements in A1c. However, no significant benefits in blood pressure and lipids control were observed. These effective interventions may have potential of scaling up in China and other countries to help diabetes patients manage their blood glucose levels. FundingThis Study was supported by the China Medical Board (CMB) Open Competition Project (No.13-159) and the Social Science Fund of China National Ministry of Education (No.14YJAZH092).

Oral Semaglutide: First-in-Class Oral GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes Mellitus.

Objective:The purpose of this article is to review the pharmacological characteristics and clinical evidence of oral semaglutide for the treatment of type 2 diabetes mellitus (T2DM). Data Sources: A MEDLINE/PubMed search was conducted between January 1, 2005, and September 30, 2019. Search terms included semaglutide, glucagon-like peptide 1 receptor agonist, GLP-1 receptor agonist, and type 2 diabetes. Study Selection and Data Extraction Quantification: The following study designs were included in the analysis: systematic review and/or meta-analyses, clinical trial, or observational study design. Narrative reviews were excluded. Articles were included only if they were published in the English language or evaluated oral semaglutide with regard to pharmacology, pharmacokinetics, safety, and efficacy in humans. Data Synthesis: Oral semaglutide has been Food and Drug Administration approved for the treatment of T2DM as an adjunct to diet and exercise. Oral semaglutide has been shown to result in an absolute hemoglobin A1C reduction between -0.5% and -1.5% and weight reductions between -1 and -4.7 kg. Oral semaglutide has been shown to be noninferior to placebo for cardiovascular (CV) safety although additional CV outcomes trials are ongoing. Adverse effects appear to be similar to those of other glucagon-like peptide-1 receptor agonists and are gastrointestinal in nature. Relevance to Patient Care and Clinical Practice: Oral semaglutide may be appropriate as second- or third-line add-on therapy for patients with T2DM who are not meeting treatment goals on metformin and are overweight and reluctant to use an injectable drug. Conclusions: Oral semaglutide appears safe and effective as monotherapy and add-on pharmacological therapy for the treatment of T2DM.

Effectiveness of Insulin Degludec in Thai Patients with Diabetes Mellitus: Real-World Evidence From a Specialized Diabetes Center.

Background Insulin degludec, an ultra-long-acting insulin analogue, has been available in Thailand since October 2016. Although clinical trial results revealed less hypoglycemia, data from real-world settings is limited especially in Asian patients. This study aimed to evaluate prospectively the real-world effectiveness, safety, quality of life (QOL) and patient satisfaction with insulin degludec among Thai patients with diabetes mellitus (DM). Methods From October 2016 to September 2017, all patients who had started insulin degludec for at least 3 months were observed and evaluated at baseline, 3, 6, and 12 months. QOL was assessed using WHOQOL-BREF-THAI and level of satisfaction was measured by 7-point Likert scale. Glycemic fluctuation from paired iPro2 continuous glucose monitoring (CGM) obtained 4–6 weeks apart were also evaluated from a subset of patients with T1DM who switched from insulin glargine to insulin degludec. Results A total of 55 patients (T2DM 76.4%, females 54.5%, mean age 57.1±16.1 years, duration of diabetes 16.7±8.8 years, BMI 27.3±5.5 kg/m 2 , baseline A1C 9.3±2.3%, median duration of treatment 8 months) were included in the study. In T1DM patients (n=13), the overall mean A1C reduction at 12 months was 0.5% with minimal weight gain of 0.9 kgs at 12 months. In T2DM patients (n=42), the overall mean A1C reduction at 12 months was 0.8% with minimal weight loss of 0.4 kgs at 12 months. The proportion of T1DM patients who could achieve optimal glycemic control increased slightly from 14.3 to 18.2% but the proportion of T2DM patients who could achieve optimal glycemic control increased from 30.8 to 53.8%. Patient satisfaction showed a sustained improvement throughout the duration of study. In four T1DM patients who had paired CGM data, insulin degludec provided greater reductions in glycemic variability endpoints with increased time-in-range when compared with previous insulin glargine. Discussion Our data suggested that the effectiveness of insulin degludec was consistent with the results seen in clinical trials with lower risk of patients-reported hypoglycemia, and a significant improvement in glycemic control. Patients also reported higher treatment satisfaction. More long-term and cost-effectiveness data are needed to establish the role of this ultra-long-acting insulin in real-world settings.

A604 Improvement in Hemoglobin A1c after Laparoscopic Roux-en-Y Gastric Bypass and Sleeve Gastrectomy in an Ethnically Diverse Population

Abstract Background Obesity is a well-known risk factor for the development of type 2 diabetes mellitus (T2D). The efficacy of bariatric surgery in reducing weight with resulting improvement in T2D has been reliably demonstrated. Objectives We investigated and compared the effects of laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) on hemoglobin A1c (A1C) levels in a predominantly Hispanic and African–American population. Settings Community Hospital in New York, New York, United States Methods This is a retrospective review of a 5-year data from a single center where patients with diabetes who underwent LRYGB or LSG were included. A1C levels and body mass index (BMI) were analyzed preoperatively and then annually postoperatively for up to 5 years. Improvements in A1C were compared between the two groups after adjusting for age, sex, race, and hypertension with linear mixed-effects or logistic regression models. Results Of the 676 included patients, 84.8% were females and the mean age was 47 years. A1C levels decreased significantly (p 0.05): 24% vs. 17% (2 years), 22% vs. 16% (3 years), 22% vs. 13% (4 years), and 17% vs. 10% (5 years). Changes in BMI were not correlated to changes in A1C at various study points. Conclusion Both LRYGB and LSG resulted in significant decreases in A1C levels and are correlated with changes in BMI. LRYGB had the greatest effect at 1-year postoperatively. There was no significant difference in A1C reduction for LRYGB and LSG after 1-year postoperatively in this predominantly Hispanic and African American cohort.

Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors: A Clinician's Guide.

This comprehensive review covers the historical background, physiology, application in type 2 diabetes, novel uses, cardiovascular benefits, side effects and contraindications of sodium-glucose cotransporter-2 (SGLT2) inhibitors. SGLT2 inhibitors are an insulin-independent class of oral antihyperglycemic medication that clinicians use in the treatment of type 2 diabetes. Multiple landmark clinical trials support the effectiveness of SGLT2 inhibitors in reducing blood glucose levels, but it is important to understand when to properly utilize them. SGLT2 inhibitors are the most beneficial as an adjunct medication in addition to metformin in patients with a history of cardiovascular or renal disease who need further hemoglobin A1c reduction. The novel mechanism of action also demands clinicians be aware of the side effects not typically experienced with other oral antihyperglycemic drugs, such as genital tract infections, lower leg amputations, electrolyte disturbances and bone fractures. On top of their benefits in type 2 diabetes, novel uses for SGLT2 inhibitors are being uncovered. Diabetic patients with non-alcoholic fatty liver disease, who are at an increased risk of cirrhosis and hepatocellular carcinoma, experience a clinically significant reduction in serum alanine aminotransferase levels. SGLT2 inhibitors are also effective at lowering body weight in obese individuals and decreasing systolic blood pressure. Dual SGLT1/SGLT2 inhibitors are currently being investigated as possibly the first oral medication for type 1 diabetes.

Ipragliflozin as an add-on therapy in type 2 diabetes mellitus patients: An evidence-based pharmacoeconomics evaluation

AimTo evaluate the efficacy, safety and cost-effectiveness of ipragliflozin as an add-on therapy in patients with type 2 diabetes mellitus (T2DM). MethodsPubMed, EMBASE, the Cochrane Library, Web of Science and four Chinese databases, as well as the ClinicalTrials.gov website were searched from their inception through Jan 2019. Methodological quality was assessed using the Cochrane risk of bias, and meta-analysis was performed using RevMan5.3. ResultsA total of 11 randomized controlled trials with 1766 patients were included. Ipragliflozin administered (50 mg) once daily as an add-on therapy to other glucose-lowering medications (metformin, pioglitazone, sulfonylurea, α-glucosidase inhibitor, sitagliptin, insulin) was associated with reductions in hemoglobin A1c (HbA1c) of −0.74% (95% confidence interval (CI) −1.00 to −0.48), fasting plasma glucose (WMD −25.03 mg/dL; 95% CI −32.89 to −17.16), weight, waist circumference, blood pressure, and triglycerides levels. Neither the incidence of treatment-emergent adverse events (TEAEs) (RR 1.08; 95% CI 1.00 to 1.16) nor drug-related TEAEs (RR 1.19; 95% CI 0.93 to 1.54) was significantly increased. However, it was associated with an increased risk of hypoglycemia when added to insulin (RR 1.71; 95% CI 1.13 to 2.61). Compared with the pioglitazone group and the sitagliptin + metformin group, the incremental cost-effectiveness ratio of ipragliflozin add-on therapy group was $4976.89, $2089.76 per percentage of qualified HbA1c, respectively. ConclusionIpragliflozin as an add-on therapy is well tolerated and effective. Ipragliflozin as an add-on therapy do not appear cost-effective compared with metformin alone, but may be competitive against pioglitazone group and the sitagliptin + metformin group.

Persistence with Basal-Bolus Insulin Therapy in Patients with Type 2 Diabetes Mellitus and Effect on Clinical and Economic Outcomes: A Retrospective Claims Database Study.

Persistence with multiple daily insulin injections (MDI) may be challenging for patients with type 2 diabetes (T2DM). However, limited information is available regarding the effect of persistence with MDI on outcomes. To evaluate persistence with basal and bolus insulin therapy and assess its relationship with clinical and economic outcomes in a real-world setting. This retrospective matched cohort study used 2012-2015 data from multiple U.S. commercial health plans (IBM MarketScan). Patients with T2DM aged 18-64 years with ≥ 2 basal and ≥ 2 bolus insulin claims during a 12-month period were eligible for inclusion if they had 18 months of continuous health plan enrollment (6-month baseline and 12-month post-index). Persistence during 12 months post-index was defined using 2 methods: (a) method 1, ≤ 90-day gaps in both basal and bolus insulin claims and (b) method 2, ≥ 1 basal and ≥ 1 bolus insulin claim every quarter (every 90 days) for 4 consecutive quarters after index bolus claim. Propensity score matching was used to match persistent and nonpersistent method 2 cohorts. Mean per-patient all-cause and diabetes-related medical costs (2015 U.S. dollars, excluding outpatient drugs) and health care resource use (HCRU) were calculated. For patients with hemoglobin A1c (A1c) values during baseline and post-index months 10-12, treatment success was defined as (a) A1c decrease from baseline of ≥ 1% and/or (b) baseline A1c ≥ 7% with post-index A1c < 7%. Baseline characteristics of matched cohorts were compared using standardized mean differences (SMDs). Outcome variables were compared using t-tests, chi-square tests, and generalized linear models. Characteristics of 12,882 eligible patients and 12-month persistence rates were similar as defined by method 1 (22.4%) and method 2 (21.1%). After matching, the method 2 cohorts included 2,723 and 8,169 persistent and nonpersistent patients, respectively, with well-balanced baseline characteristics (mean age 53 years; 58% men; all SMDs < 0.1). All-cause annual medical costs were lower for the persistent cohort (mean $13,499 vs. $17,362; P < 0.0001), as were annual diabetes-related costs (mean $6,392 vs. $8,376; P < 0.0001). In persistent versus nonpersistent cohorts, 11% versus 15% of patients, respectively, experienced ≥ 1 hospitalization; 21% versus 24%, respectively, had ≥ 1 ED visit; 9% versus 12%, respectively, experienced ≥ 1 diabetes-related hospitalization; and 13% versus 15%, respectively, had ≥ 1 diabetes-related ED visit (P ≤ 0.005 for all). Mean baseline A1c was similar in persistent and nonpersistent cohorts (9.7% vs. 9.6%, respectively; P = 0.63). Persistence with MDI was associated with greater mean reduction in A1c (-1.3% vs. -0.8%, respectively; P = 0.006) and greater percentages of patients achieving treatment success (55% vs. 39%, respectively, for nonpersistent; P = 0.009). Poor persistence with basal-bolus insulin therapy over 12 months of follow-up was prevalent and was associated with greater medical costs, greater HCRU, and poorer glycemic control than for patients who were persistent. Interventions are needed to improve persistence with insulin therapy and aid patients with T2DM to achieve glycemic control. Funding for this study was provided by Becton, Dickinson and Company (BD). All authors except Edelman are employees and stockholders of BD. Edelman reports board membership at Senseonics and participation in advisory board/speakers bureau at Lilly USA, MannKind, Novo Nordisk, Sanofi-Aventis U.S., Merck, and AstraZeneca, all unrelated to this study. A poster for this study was presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2018; April 23-26, 2018; Boston MA.

Patient Reported Outcomes following initiation of Glucagon-like peptide-1 Receptor agonists in patients with type 2 Diabetes in a specialist endocrinology practice of the LMC diabetes registry: The PROGRESS-Diabetes study

AimsTo compare patient-reported outcomes and clinical outcomes in patients who initiated dulaglutide or liraglutide as part of usual clinical therapy. MethodsThis observational study enrolled adults with type 2 diabetes who initiated dulaglutide or liraglutide between April 2017 and January 2018. A prospective patient cohort completed questionnaires at baseline and at their usual follow-up visit three to six months later. Clinical outcomes were assessed in a post-hoc retrospective analysis using propensity score matching. ResultsIn the per-protocol analysis, 146 dulaglutide and 79 liraglutide patients had similar significant improvements in diabetes treatment satisfaction scores (dulaglutide 9.6 ± 1.1, p < 0.001; liraglutide 10.6 ± 1.4, p < 0.001) and follow-up scores for diabetes device satisfaction. Only dulaglutide had significant improvements in medication adherence scores. In the overall cohort, 754 matched patients showed similar reductions in A1C (dulaglutide −0.8% [9 mmol/mol]; liraglutide −0.7% [8 mmol/mol]). Liraglutide patients had a greater reduction in weight than those initiating dulaglutide (−2.8 kg vs. −1.8 kg; p < 0.001). ConclusionsPatients who initiated dulaglutide or liraglutide in a real-world specialist practice had similar improvements in diabetes medication satisfaction and diabetes device satisfaction. Only dulaglutide patients had significant improvements in medication adherence scores. Both treatment cohorts had similar patterns of A1C change, and liraglutide had significantly greater weight loss, which are similar to findings from clinical trials.

The Effects of Dual GLP-1/GIP Receptor Agonism on Glucagon Secretion-A Review.

The gut-derived incretin hormones glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are secreted after meal ingestion and work in concert to promote postprandial insulin secretion. Furthermore, GLP-1 inhibits glucagon secretion when plasma glucose concentrations are above normal fasting concentrations while GIP acts glucagonotropically at low glucose levels. A dual incretin receptor agonist designed to co-activate GLP-1 and GIP receptors was recently shown to elicit robust improvements of glycemic control (mean haemoglobin A1c reduction of 1.94%) and massive body weight loss (mean weight loss of 11.3 kg) after 26 weeks of treatment with the highest dose (15 mg once weekly) in a clinical trial including overweight/obese patients with type 2 diabetes. Here, we describe the mechanisms by which the two incretins modulate alpha cell secretion of glucagon, review the effects of co-administration of GLP-1 and GIP on glucagon secretion, and discuss the potential role of glucagon in the therapeutic effects observed with novel unimolecular dual GLP-1/GIP receptor agonists. For clinicians and researchers, this manuscript offers an understanding of incretin physiology and pharmacology, and provides mechanistic insight into future antidiabetic and obesity treatments.

A Mixed-Methods, Randomized Clinical Trial to Examine Feasibility of a Mindfulness-Based Stress Management and Diabetes Risk Reduction Intervention for African Americans with Prediabetes.

African Americans have disproportionately high rates of stress-related conditions, including diabetes and diabetes-related morbidity. Psychological stress may negatively influence engagement in risk-reducing lifestyle changes (physical activity and healthy eating) and stress-related physiology that increase diabetes risk. This study examined the feasibility of conducting a randomized trial comparing a novel mindfulness-based stress management program combined with diabetes risk-reduction education versus a conventional diabetes risk-reduction education program among African American adults with prediabetes and self-reported life stress. Participants were recruited in collaboration with community partners and randomized to the mindfulness-based diabetes risk-reduction education program for prediabetes (MPD; n = 38) or the conventional diabetes risk-reduction education program for prediabetes (CPD; n = 30). The mindfulness components were adapted from the Mindfulness-based Stress Reduction Program. The diabetes risk-reduction components were adapted from the Power to Prevent Program and the Diabetes Prevention Program. Groups met for eight weeks for 2.5 hours, with a half-day retreat and six-monthly boosters. Mixed-methods strategies were used to assess feasibility. Psychological, behavioral, and metabolic data were collected before the intervention and at three and six months postintervention to examine within-group change and feasibility of collecting such data in future clinical efficacy research. Participants reported acceptability, credibility, and cultural relevance of the intervention components. Enrollment of eligible participants (79%), intervention session attendance (76.5%), retention (90%), and postintervention data collection attendance (83%, 82%, and 78%, respectively) demonstrated feasibility, and qualitative data provided information to further enhance feasibility in future studies. Both groups exhibited an A1C reduction. MPD participants had reductions in perceived stress, BMI, calorie, carbohydrate and fat intake, and increases in spiritual well-being. Considering the high prevalence of diabetes and diabetes-related complications in African Americans, these novel findings provide promising guidance to develop a larger trial powered to examine efficacy of a mindfulness-based stress management and diabetes risk-reduction education program for African Americans with prediabetes.

A Randomized Trial of the Close Reading and Creative Writing Program: An Alternative Educational Method for Adult Group Care Intervention in Type 2 Diabetes Management

ObjectivesGroup care for individuals with diabetes is a recognized educational practice, but techniques from narrative medicine using of literary works have never been incorporated in these programs. We designed a new educational model (i.e. the Close Reading and Creative Writing program) of group care for individuals with diabetes incorporating close reading and creative writing in group education. A randomized trial was designed to evaluate this intervention. MethodsA total of 49 individuals with type 2 diabetes, aged <85 years and with >6 years of school education, were randomized to 2 different group care dynamics: (a) a “control group,” with a classical structured educational approach currently used at our institution; and (b) an “intervention group,” with introduction of literary texts, narrative skills, close reading and creative writing. Evaluation included anthropometric measures, glycated hemoglobin (A1C) and questionnaires for psychological evaluation. Individual A1C levels in the 6-year period before the trial were collected from clinical records. ResultsA significant reduction of A1C was observed in the intervention group, showing noninferiority in relation to the classical approach. A significant decrease in A1C was observed in relation to the 6 previous years. A significant increase in satisfaction with the therapist and group process was observed. ConclusionsThis is the first randomized trial designed to evaluate a group care intervention to manage type 2 diabetes using narrative techniques. The results suggest that this may be a useful model for more highly schooled individuals, and may represent an alternative for the educational process.

Sodium-Glucose Cotransporters as Potential Therapeutic Targets in Patients With Type 1 Diabetes Mellitus: An Update on Phase 3 Clinical Trial Data.

Objective: To review phase 3 trials of sodium-glucose cotransporter (SGLT) inhibitors in type 1 diabetes mellitus (T1DM) patients. Data Sources: A literature search of Ovid MEDLINE databases (1946 through May 17, 2019) limited to English-language human clinical trials was conducted using the following terms: sodium-glucose transporter 2 inhibitors, canagliflozin, dapagliflozin, empagliflozin, sotagliflozin, ertugliflozin, ipragliflozin, or remogliflozin combined with type 1 diabetes mellitus. Results were verified via Google Scholar and clinicaltrials.gov. Study Selection and Data Extraction: Articles were included if they were phase 3 trials in adults with T1DM. Data Synthesis: Phase 3 trials are available for dapagliflozin, empagliflozin, and sotagliflozin. All 3 drugs demonstrated statistically significant reductions in hemoglobin A1C, weight, and total daily insulin dose without an increased risk of hypoglycemia in up to 52 weeks of therapy. The incidence of diabetic ketoacidosis (DKA) was higher in patients on a SGLT inhibitor at all doses, with the exception of empagliflozin 2.5 mg (0.8% vs 1.2% with placebo). Relevance to Patient Care and Clinical Practice: SGLT inhibitors are potential adjuncts to insulin in T1DM patients, providing clinically meaningful benefits. Regulatory bodies have either approved or are reviewing these agents for use in T1DM. Clinicians should be familiar with the DKA risk associated with SGLT inhibitors and utilize DKA risk-mitigation strategies. Empagliflozin 2.5 mg warrants additional investigation given its efficacy without an increased incidence of DKA. Conclusions: Phase 3 trial data of SGLT inhibitors provide evidence for sustained efficacy in T1DM patients. Appropriate patient selection for therapy and routine monitoring are essential to minimize associated risks.

The Effect of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter-2 Inhibitors in Patients Prescribed Regular U-500 Insulin.

Background: Only 2 small studies have examined the use of glucagon-like peptide-1 (GLP-1) receptor agonists with U-500 insulin, with mixed results. Moreover, there are no studies to our knowledge that have investigated use of sodium-glucose cotransporter-2 (SGLT-2) inhibitors with U-500 insulin therapy. Objective: This research was designed to determine the effectiveness of GLP-1 agonists and SGLT-2 inhibitors in patients already taking U-500 insulin. Methods: A retrospective chart review was conducted on patients using U-500 insulin to which a GLP-1 agonist or SGLT-2 inhibitor was added as their treatment protocol. The primary outcome measure was change in glycosylated hemoglobin (A1C) after 3 to 6 months on the additional therapy. Secondary outcomes included A1C change at 12 months, changes in total daily dose (TDD) of U-500 insulin, body mass index (BMI) and body weight from baseline, and episodes of hypoglycemia. Results: A total of 17 patients were included in the review. The combination of a GLP-1 agonist and/or SGLT-2 inhibitor with U-500 insulin resulted in significant reductions in A1C (0.84%, P = 0.004) and TDD of U-500 insulin (33.5 units, P = 0.031) at the 3- to 6-month interval. Furthermore, statistically significant decreases in mean BMI and body weight were observed 12 months postbaseline. Hypoglycemia occurred in the majority of patients (64.7%). Conclusion and Relevance: This is the first study to examine SGLT-2 inhibitors in combination with U-500 insulin therapy. Clinically, the addition of a GLP-1 agonist and/or SGLT-2 inhibitor can improve A1C and decrease TDD, BMI, and body weight.

Evaluation of the economic and clinical impact of community pharmacist-driven pharmacy benefit management services

ObjectiveTo evaluate the economic and clinical impact of community pharmacist–led pharmacy benefit management (PBM) services. SettingIndependent community pharmacy in western North Carolina. Practice descriptionSona Benefits is a PBM partner to self-funded plans in western North Carolina. The services provided by Sona Benefits are led by pharmacists at its affiliate company, Sona Pharmacy + Clinic. Practice innovationIn October 2016, Sona Benefits began providing PBM services to members employed by a local continuing care retirement community. EvaluationEconomic outcome measures included change in total medical and prescription costs per member per year (PMPY) and change in cost per prescription from baseline. Change in clinical outcome measures (hemoglobin A1C, weight, blood pressure) was assessed for members who participated in 2 or more quarterly health coaching sessions. ResultsPrescription costs were reduced from $1219.72 to $858.57 PMPY and medical health care costs were reduced from $5910.76 to $4290.30 PMPY from baseline. This represented a total decrease of $1981.61 PMPY in health care costs. A reduction in the average cost per prescription from $95.10 to $61.88 was observed. For patients enrolled and active in health coaching, we observed reductions in weight, hemoglobin A1C, and blood pressure. Between the initial and final health coaching visits, average weight decreased from 204.6 lb (92.8 kg) to 203.6 lb (92.4 kg), the percentage of patients at hemoglobin A1C goal increased from 47% to 53%, and percentage of patients at goal for blood pressure increased from 58% to 78%. ConclusionInclusion of community pharmacists in PBM service delivery produced economic benefits for plan sponsors. Preliminary clinical data suggested benefits of pharmacist-led health coaching services, but further evaluation is needed to determine the long-term impact.

2363-PUB: The Efficacy of Low vs. High FDA-Approved SGLT2 Inhibitor Dose Compared with DPP-4 Inhibitors: A Meta-analysis

All FDA-approved SGLT2 inhibitors (SGLT2i) are currently available in two doses. While most SGLT2i have demonstrated CV benefit, there may be a difference in hemoglobin A1c (A1c) reduction between both doses. We performed a meta-analysis to evaluate the efficacy of both SGLT2i doses compared to maximum DPP-4 inhibitor (DPP-4i) dose. We searched MEDLINE, EMBASE, CENTRAL, and CINAHL for randomized trials comparing at least one FDA-approved SGLT2i dose to maximum DPP-4i dose in type 2 diabetes and reporting a change in A1c. We performed two separate analyses according to dose (low SGLT2i dose vs. DPP-4i and high SGLT2i dose vs. DPP-4i). We included 12 trials. There was a significantly greater A1c reduction favoring lower SGLT2i dose compared to DPP-4i at ≥52 weeks (w) but not at ≤26 w (MD [95% CI] = -0.12% [-0.23, -0.02] and 0.00% [-0.06, 0.07] respectively) with an absolute A1c reduction of -0.76% vs. -0.75% at ≤26 w and -0.71% vs. -0.58% at ≥52 w respectively. When comparing higher SGLT2i dose vs. DPP-4i, there was a significantly greater A1c reduction for SGLT2i at ≤26 and ≥52 w (MD [95% CI] = -0.13% [-0.20, -0.05] and -0.26% [-0.36, -0.16] respectively) with an absolute A1c reduction of -0.91% vs. -0.77% at ≤26 w and -0.83% vs. -0.55% at ≥52 w respectively. We conclude that low SGLT2i dose had similar A1c reduction as DPP-4i in early treatment but became significant as treatment was prolonged. Higher SGLT2i dose is favored over DPP-4i. Disclosure J. Uhrig: None. B.M. Mishriky: None. S.O. Page: None. K. Sewell: None. J.R. Powell: None. S.P. Patil: Research Support; Self; Novo Nordisk Inc. D.M. Cummings: None.

838-P: Financial Incentives to Improve Glycemic Control in Adults with Diabetes: A Pilot Randomized Controlled Trial

Background: Behavioral economics research has identified several decision-making patterns that contribute to poor adherence to medical regimens, however, few studies have investigated the possible influence of financial incentives on diabetes outcomes. Methods: We randomized 60 African Americans with type 2 diabetes to one of three financial incentive structures: 1) single incentive at 3 months for A1c reduction, 2) two-part incentive for home testing of glucose and A1c reduction at 3 months, and 3) multiple component incentive for home testing, attendance of weekly telephone education classes and A1c reduction at 3 months. The primary outcome was A1c reduction within each arm at 3 months. As a pilot, this study was not powered to test between group differences. Results: The mean age for individuals was 57.9, with 71.9% women. Each incentive structure led to significant reductions in A1c at 3 months with the greatest magnitude of change from baseline in the group with incentives for multiple components: group 1 mean reduction = 1.25, group 2 mean reduction = 1.73, group 3 mean reduction = 1.74. Conclusion: Financial incentives across three separate structures led to significant decrease in A1c over 3 months. The magnitude of this effect was large and, in the range, found with diabetes medication trials, rather than smaller effects often seen in behavioral interventions. Therefore, this pilot randomized controlled trial suggests that structured incentives has significant impact on A1c reduction beyond what is typically seen with behavioral interventions and may be an important focus of future interventional studies to improve metabolic control and hence reduce diabetes complication and mortality rates in African Americans with type 2 diabetes. Disclosure L.E. Egede: Consultant; Self; Novo Nordisk Inc. Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases. R.J. Walker: None. H.L. Prigmore: None. J.S. Williams: None. J.A. Campbell: None. A. Dawson: None. Funding National Institutes of Health

1208-P: Empagliflozin and HbA1c Reduction in a National Cohort

Empagliflozin, a sodium-glucose cotransport 2 inhibitor, provides A1c reduction by .6-1.0% in large randomized control trials. These trials included adults with type 2 diabetes (T2D) who had baseline A1c 7-10%. The use of empagliflozin in reducing A1c in clinical practice has not been investigated. We constructed a longitudinal cohort of 16391 adults with T2D who initiated empagliflozin from 11/1/2014 to 3/1/2018 in the Veterans Health Administration and followed them until 10/1/2018. We studied 7792 adults (96% men, 73% non-Hispanic white (NHW), 14% black) who had A1c measures at baseline and during follow-up and who did not change their antidiabetic medication regimens (58% with insulin, 36% without insulin). Linear regression estimated absolute A1c change at 6 months, adjusted for age, sex, race/ethnicity, baseline A1c, categorical BMI, kidney function, and concurrent insulin. At baseline, median A1c was 8.5% (12% with A1c ≥10%), median BMI was 33 kg/m2 (25% of adults with BMI 35-40 kg/m2, 18% BMI &amp;gt;40 kg/m2), and 19% with reduced kidney function. Baseline A1c was 8.9% for black adults and 8.5% for NHW adults. The average reduction in A1c was .74% for black adults and .70% for NHW adults. Overall, average adjusted A1c reduction was .71%. Adults with baseline A1c ≥10% had a greater adjusted reduction compared to adults with baseline A1c 7-10% (1.76% vs. .46%, p&amp;lt;.001). Adults with BMI 35-40 kg/m2 and &amp;gt;40 kg/m2 had a greater adjusted reduction compared to normal and overweight adults (.71% and .75%, vs. .46% and .59%, respectively, p &amp;lt;.001). Adults on a concurrent insulin regimen had a smaller adjusted reduction compared to those with a non-insulin regimen (.50% vs. .72%, p&amp;lt;.001). Empagliflozin decreased A1c in T2D adults across a range of ages, races/ethnicities, BMIs and concurrent insulin prescription. Empagliflozin seems to offer the greatest A1c reduction for T2D adults with A1c ≥10% or BMI &amp;gt;35. This study provides real-world evidence of empagliflozin use and A1c reduction in a large integrated healthcare system. Disclosure P. Chang: None. K. Heberer: None. J. Lee: None. Funding National Institute on Drug Abuse (T32DK007217); U.S. Department of Veterans Affairs

174-LB: Impact of Quality Improvement (QI) Program on 5-Year Risk of Diabetes-Related Complications

We have successfully implemented the ADA’s Diabetes INSIDE® QI program at a University hospital and safety-net health system (Tulane and Parkland), focused on system-wide improvement in poorly controlled type 2 diabetes (A1c&amp;gt;8.0%). We extrapolated clinical outcomes of the QI program on a 5-year risk of complications, utilizing a validated risk prediction model: Building, Relating, Assessing, Validating of Outcomes (BRAVO) simulation model. We measured the differences between the baseline and post-intervention values of risk factors in 2,429 individuals with A1c &amp;gt;8% at baseline and used the BRAVO model to project the 5-year risk reduction of diabetes-related complications under the assumption that intervention benefits diminished with time. The intervention period was defined as one year and the post-intervention period as the subsequent six months. The QI program was associated with reductions in A1c (-0.84%) and LDL-C (-5.94 mg/dl) among individuals with A1c level &amp;gt;8.0%, with greater reduction in A1c (-1.67%) and LDL-C (-6.81 mg/dl) among those with A1c level &amp;gt; 9.5% at baseline (all p&amp;lt;0.05). The potential outcome of the QI program on 5-year risk of complications are presented in Fig 1. Our outcomes model suggests that the observed risk factor reduction is projected to lead to clinically significant 5-year risk of events - benefiting patients and population health as it relates to future complications burden." Disclosure H. Shao: None. L. Shi: None. R.E. Furman: None. L. Meneghini: Advisory Panel; Self; AstraZeneca, Novo Nordisk Inc., Sanofi-Aventis. Consultant; Self; Sanofi-Aventis. Other Relationship; Self; American Diabetes Association. T.S. Harlan: None. V. Fonseca: Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Abbott, Asahi Kasei Corporation, Novo Nordisk Inc., Sanofi US, Takeda Pharmaceutical Company Limited. Research Support; Self; Bayer US. Stock/Shareholder; Self; Amgen Inc., Bravo4health, Mellitus Health. Funding Lilly USA, LLC; Novo Nordisk; Sanofi

2381-PUB: Shared Medical Appointments: An Academic-Community Partnership to Improve Metabolic Outcomes among People with Type 2 Diabetes in the Central Valley of California

Diabetes has reached epidemic proportions in the United States. Shared medical appointments are an increasingly popular model to provide access to DSMES and primary care services. The purpose of the study was to evaluate the effectiveness of a Shared Medical Appointment (SMA) intervention, compared to usual primary care (UPC), for the treatment of adults with type 2 diabetes over a 6-month period in two rural Federally Qualified Health Centers (FQHC) in the central valley of California. This study was a quasi-experimental design with a non-randomized matched control group that followed participants prospectively for 6 months. All adults living with type 2 diabetes receiving primary care at 2 FQHC clinics were eligible for inclusion. Participants in the control group were matched retrospectively on baseline A1C and age. To test the effect of group membership on A1C change, differences in change scores were compared between the ALDEA SMA intervention group and the UPC control group. Linear regression analysis was computed to assess if mean A1C change at 6 months post-intervention was greater among SMA intervention group participants compared to the UPC control group participants. The reductions in A1C were greater in the intervention group relative to the control group at 6 months. Results of the linear regression analysis revealed a net reduction A1C difference of -1.12% from baseline to 6 months (p≤0.05) in FQHC #1, and -1.06% from baseline to 6 months (p≤0.05) in FQHC #2. This study demonstrated that patients in the ALDEA program were able to achieve a significant reduction in A1C compared to those who received UPC. Despite its limitations, the ALDEA SMA program was successful in empowering patients and improving glycemic control. Disclosure C.E. Noya: None. E. Gatewood: None. A. Alkon: None. E. Castillo: None. A.C. Kuo: None. Funding Health Resources and Services Administration