Greater Reduction In A1C Research Articles

Impact of Risk Stratification in Patients With Diabetes Mellitus in a Health System Specialty Pharmacy Setting

Background: Integrated pharmacist care into health systems results in significant A1c reduction and improved outcomes in patients with diabetes. However, little is known about the adoption of Health System Specialty Pharmacy (HSSP) chronic disease management (CDM) services within diabetes clinics. Risk stratification is proven to enhance care in various patient populations. Objective: The objective of this study is to describe how the implementation of risk stratification in the HSSP setting results in optimized patient outcomes in diabetes. Method: This is a retrospective descriptive study reporting the results of expanding the HSSP care model to implement risk stratified CDM services for patients with diabetes. A total of 285 patients were enrolled in the HSSP CDM pharmacy services and were stratified into high- or low-risk groups. Results: Eighty-eight patients were stratified as high-risk with an average baseline A1c of 11.47% and a most recent average of 8.84%. The remaining 285 patients were stratified into the low-risk group. Their average baseline A1c was 7.48% and the last recorded average A1c was 7.15%. Patients not enrolled in HSSP CDM services (N = 100) had a lower reduction in average A1c compared to patients enrolled in the program. Conclusion: Patients stratified into high- and low-risk groups had greater reductions in A1c compared to patients who did not use HSSP CDM services. These results showcase the success of risk stratification and demonstrate the impact HSSP has on patients needing CDM services and outlines a strategy to provide the greatest impact in a high-volume patient population.

Association Between Adherence, A1C Improvement, and Type of Continuous Glucose Monitoring System in People with Type1 Diabetes or Type2 Diabetes Treated with Intensive Insulin Therapy.

Use of continuous glucose monitoring (CGM) systems by people with diabetes is associated with improved glycemic outcomes, including lower glycated hemoglobin (A1C). Less is known about adherence to CGM systems, whether glycemic outcomes are impacted by levels of adherence, or whether adherence rates differ between types of CGM systems-intermittently scanned CGM (isCGM) or real-time CGM (rtCGM). A retrospective analysis of de-identified US administrative health claims and linked laboratory data was conducted using the Merative™ MarketScan® Research Database. The cohort included CGM-naïve people with type1 diabetes (T1D) or type2 diabetes treated with intensive insulin therapy (T2D-IIT) who initiated rtCGM or isCGM between August1, 2019 and March31, 2021 (defined as the index date). Adherence was calculated over a 12-month period using the proportion of days covered (PDC) with PDC ≥ 0.8 defined as adherent. A1C values were obtained within 6months of the index date. A total of 7669 individuals were identified. Subgroups included T1D using isCGM (n = 1578), T1D using rtCGM (n = 1244), T2D-IIT using isCGM (n = 3567), and T2D-IIT using rtCGM (n = 1280). After 12months, PDC was 0.71 (0.30)-0.72 (0.31) (mean(SD)) for T1D and T2D-IIT rtCGM users and 0.55 (0.34)-0.56 (0.34) for T1D and T2D-IIT isCGM users. The proportion of adherent users (PDC ≥ 0.8) was 56.8-59.7% for rtCGM users and 36.3-37.6% for isCGM users. Overall, regardless of diabetes type, the odds of adherence were over two times higher for rtCGM users compared to isCGM users. For those with available A1C information (T1D n = 213; T2D-IIT n = 346), independent of CGM type, adherence to CGM was associated with a greater reduction in A1C and more people reaching A1C targets of < 7.0% or < 8.0%. For people with T1D or T2D-IIT, higher adherence to CGM is associated with greater reductions in A1C, and higher adherence rates were observed with rtCGM systems than with isCGM systems.

Endocrinology/Primary Care Pharmacy Collaboration vs Endocrinology Care Alone in Patients With Type 2 Diabetes and A1c >9.

Background: Type 2 diabetes (T2D) requires close collaboration between patients and their care management team, often including endocrinology. Primary care pharmacist impact on diabetes management in collaboration with endocrinology is not well established. Objective: To assess if pharmacy and endocrinology collaboration results in a greater A1c reduction in patients with T2D vs endocrinology alone. Methods: This retrospective, observational cohort study was conducted in adult outpatients with T2D and baseline A1c >9% who saw endocrinology within 1 year preceding the study period (January 1, 2021 to January 1, 2022). Patients were included if they had a follow-up A1c 6 months (±90 days) from index date and completed at least 1 endocrinology visit during the study period. Patients managed by endocrinology/primary care pharmacist collaboration (Endo/PharmD) were compared with those who received endocrinology care alone (Endo). Primary outcome was change in A1c from baseline to 6 months. Secondary outcomes included total number of completed visits and percentage of patients achieving A1c <6.5%, <7%, <8%, and <9% between groups at 6 months. Results: A total of 418 patients were included (22 Endo/PharmD, 396 Endo). The change in follow-up A1c was not significantly different between groups, -0.481% (standard error [SE] = 0.396); P = 0.6179. Endo/PharmD patients had significantly more provider visits during the study period (5.3 ± 2.3 vs 2.3 ± 1.2; P < 0.001). No significant difference was observed in odds of A1c goal attainment between groups at 6 months. Conclusion and Relevance: Endocrinology/primary care pharmacist collaboration occurred infrequently but was associated with a trend toward greater A1c reduction in patients with T2D and A1c >9%.

1121-P: Association between Self-Monitored Blood Glucose and Continuous Glucose Monitor in Youth with Type 1 Diabetes and Medicaid

Background: In many states, patients with type 1 diabetes (T1D) and public insurance must demonstrate self-monitored blood glucose (SMBG) 3 times per day for continuous glucose monitor (CGM) approval. On January 2022, a policy change in California led to less stringent criteria for CGM approval, allowing for the evaluation of whether lower baseline SMBG leads to poor compliance and outcomes with CGM use. Method: We used electronical health record data of pediatric patients with T1D, Medicaid at UCLA who started CGM after January 2019. Patients were stratified by SMBG frequency (&amp;lt; 3 times per day vs ≥ 3 times per day). We used descriptive statistics to report baseline demographics, and chi-squared test, t-test and logistic regression to evaluate differences in compliance and change in A1c. Results: We found 52 patients who met the criteria - 52% with SMBG &amp;lt; 3 vs. 48% with SMBG ≥ 3. The patients were mostly male in both groups (63% vs. 60%). Patients with SMBG &amp;lt; 3 were older at time of T1D diagnosis (10 vs 6.2 years old), started CGM at older age (16.1 vs 11.7 years old), more likely to start CGM after January 2022 (82% vs 40%), and had higher baseline A1c (10.9% vs 9.0%). At 3 and 6 months after starting CGM, there was significantly greater reduction in A1c in those with SMBG &amp;lt;3 (1.6% vs 0.3%, p = 0.021, and 1.5% vs 0.23%, p = 0.01). There was no significant difference in CGM compliance (60% vs 72%, p = 0.21, and 69% vs 80%, p = 0.24, respectively) between the two groups. In adjusted models for 3 and 6 months, there were no significant association between CGM compliance (OR 1.04, 95%CI 0.68-1.60, and OR 1.06, 95%CI 0.76-1.28, respectively) and change in A1c. Conclusion: Patients with lower baseline SMBG had similar CGM compliance and greater improvement in A1c than patients with higher baseline SMBG. This suggests that restricting CGM approval to those who are adherent to SMBG ≥3 may exclude use in patients who would benefit the most from CGM technology. Larger studies are needed to confirm these findings. Disclosure J.Chan: None. J.K.Yee: None. T.Moin: None. E.M.Everett: None. Funding University of California, Los Angeles Children's Discovery and Innovation Institute (CDI-FRSA-07012022); National Center for Advancing Translational Sciences (UL1TR001881)

Magnitude of A1C improvement in relation to baseline A1C and amount of weight loss in response to intensive lifestyle intervention in real-world diabetes practice: 13 years of observation.

Effect of intensive lifestyle intervention (ILI) on A1C in participants with diabetes is underestimated. A1C improvement is presumed to be dependent on the amount of weight loss. Here, we evaluate the magnitude of A1C change in relation to baseline A1C and the amount of weight loss in participants with diabetes who underwent ILI over 13 years in real-world clinical practice. A total of 590 participants with diabetes were enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program, a 12-week multidisciplinary ILI program designed for real-world clinical practice between September 2005 and May 2018. We stratified participants based on baseline A1C into three groups: group A: A1C ≥ 9%, group B: A1C 8 to <9%, and group C: A1C ≥6.5% to <8%. After 12-weeks of intervention, body weight decreased in all groups, and pairwise comparisons of A1C changes showed that: group A had 1.3% greater A1C reduction than group B (p = 0.0001) and 2% greater than group C (p = 0.0001), while group B had 0.7% greater A1C reduction than group C (p = 0.0001). We conclude that ILI may decrease A1C by up to 2.5% in participants with diabetes. At similar magnitude of weight loss, A1C reduction was more prominent in participants with higher baseline A1C. This may be valuable for clinicians to set a realistic expectation of A1C change in response to ILI.

Short-term cost-effectiveness analysis of tirzepatide for the treatment of type 2 diabetes in the United States.

BACKGROUND: Tirzepatide is a novel once-a-week dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist that is used as an addition to diet and exercise to improve blood glucose in adults with type 2 diabetes. It is the first dual glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor agonist that has been approved by the US Food and Drug Administration. The SURPASS-2 clinical trial demonstrated superiority of tirzepatide 10 mg and 15 mg over semaglutide 1 mg in glycated hemoglobin A1c reduction and weight loss from baseline to week 40. Economic analyses to support coverage and access decision-making for tirzepatide are limited. OBJECTIVES: To evaluate the cost-effectiveness of tirzepatide 10 mg vs semaglutide 1 mg injection over 52 weeks of treatment regarding A1c reduction and weight loss from the perspective of the US health care payer. METHODS: A decision tree model over a 52-week time horizon was developed to identify incremental treatment-related costs of once-weekly tirzepatide 10 mg vs semaglutide 1 mg injection. Costs were divided by mean reduction in A1c and change in body weight from baseline to week 52 observed in the SURPASS-2 clinical trial. In addition to efficacy, probabilities of adverse events, discontinuation, and need for rescue therapy were derived from the SURPASS-2 study. Drug costs in 2022 US dollars were based on wholesale acquisition cost. Costs associated with adverse events were sourced from the published literature. One-way sensitivity analyses were conducted. RESULTS: Treatment with once-weekly tirzepatide 10 mg injection was associated with a higher cost and larger reduction in A1c and body weight after 52 weeks, compared with once-weekly semaglutide 1 mg injection. The incremental cost-effectiveness ratio for tirzepatide vs semaglutide was $2,247 per 1% reduction in A1c and $237 per 1 kg weight loss. One-way sensitivity analysis suggested that incremental cost-effectiveness ratios were most sensitive to the drug costs and treatment effect on A1c and weight. CONCLUSIONS: Once-weekly tirzepatide 10 mg was associated with higher cost and greater reduction in A1c and weight vs semaglutide. Tirzepatide 10 mg is cost-effective compared with semaglutide 1 mg if payers' willingness-to-pay threshold exceeds $2,247 for 1% reduction in A1c level and $237 for 1 kg weight loss.

Comparison of A1c Reduction, Weight Loss, and Changes in Insulin Requirements With Addition of GLP-1 Agonists vs SGLT-2 Inhibitors in Patients Using Multiple Daily Insulin Injections

Objective: To determine whether Glucagon-Like Peptide 1 (GLP-1) agonists or Sodium Glucose Transporter 2 (SGLT-2) inhibitors result in greater A1c reduction, weight loss, and reduction of insulin requirements in veterans using multiple daily doses of insulin. Methods: This retrospective, single-site, cohort study included patients of VA Eastern Kansas Health Care System with a diagnosis of Type II Diabetes utilizing multiple daily dose insulin and an SGLT-2 inhibitor or GLP-1 agonist. SAS Enterprise Guide was utilized to complete a multivariate analysis of variance to evaluate all outcomes. Key Findings: 150 patients met selection criteria. The GLP-1 group averaged a .65% reduction in A1c compared to a 1.05% reduction in the SGLT-2 group (P = .1397). The Basal insulin dose was reduced by 5.5 units in the GLP-1 group vs 2.45 units in the SGLT-2 group (P = .3132), and 7.12 units vs 8.14 units respectively for short-acting insulin (P = .8170). The resulting weight reduction was 4.1 Kg in the GLP-1 group compared to 3.6 Kg in the SGLT-2 group (P = .6993). Conclusion: The results suggest there is not a statistically significant difference in changes to A1c, insulin requirements, or weight after 1 year of treatment with an SGLT-2 vs GLP-1 in patients using multiple daily insulin injections.

82-LB: Improvement of Glycemic Control in People with Type 2 Diabetes Using Basal Insulin (PwT2D-BI) and Continuous Glucose Monitoring (CGM) —U.S. Study Using Machine Learning (ML)

Background: CGM provide real-time glucose data that allows users to manage their diabetes holistically. This study aimed to assess the association between glycemic control and CGM use in PwT2D-BI. Methods: This retrospective study used IBM MarketScan® 2015 - 2019 Databases to identify PwT2D-BI with (CGM) and without (control) use of CGM. CGM users were followed from first BI until CGM initiation, defined as index date (ID) . The ID of non-CGM controls were randomly assigned based on time between first BI and ID of CGM. . Comparison CGM use for 6 and 12 months were performed using Frequentist Model Averaging (FMA) in a ML framework adjusting for baseline characteristics. Model strategies were applied including matching, weighting, stratification and regression. Results: A total of 5,934 PwT2D-BI (251 CGM; 5,683 control) were included in the study (Table 1) . Observed A1c reduction from baseline to 12 months was 0.87%, 0.95% for 6 and 12 months of CGM use, respectively vs. 0.32% for controls. FMA analyses found CGM users had a statistically significantly greater reduction in A1c both at 6 months (treatment difference 0.30 [0.13,0.48]) and 12 months (0.50 [0.37, 0.72]) . Conclusion: Findings suggest that CGM use for at least 6 months in PwT2D-BI has clinical benefit as demonstrated by A1c reduction in the real-world setting. Disclosure C. Chinthammit: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A. J. M. Brnabic: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. M. Perez-nieves: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

Implications of remote monitoring Technology in Optimizing Traditional Self-Monitoring of blood glucose in adults with T2DM in primary care

BackgroundSelf-monitoring of blood glucose (SMBG) has been shown to reduce hemoglobin A1C (HbA1C). Accordingly, guidelines recommend SMBG up to 4–10 times daily for adults with type 2 diabetes (T2DM) on insulin. For persons not on insulin, recommendations are equivocal. Newer technology-enabled blood glucose monitoring (BGM) devices can facilitate remote monitoring of glycemic data. New evidence generated by remote BGM may help to guide best practices for frequency and timing of finger-stick blood glucose (FSBG) monitoring in uncontrolled T2DM patients managed in primary care settings. This study aims to evaluate the impact of SMBG utility and frequency on glycemic outcomes using a novel BGM system which auto-transfers near real-time FSBG data to a cloud-based dashboard using cellular networks.MethodsSecondary analysis of the intervention arm of a comparative non-randomized trial with propensity-matched chart controls. Adults with T2DM and HbA1C > 9% receiving care in five primary care practices in a healthcare system participated in a 3-month diabetes boot camp (DBC) using telemedicine and a novel BGM to support comprehensive diabetes care management. The primary independent variable was frequency of FSBG. Secondary outcomes included frequency of FSBG by insulin status, distribution of FSBG checks by time of day, and hypoglycemia rates.Results48,111 FSBGs were transmitted by 359 DBC completers. Participants performed 1.5 FSBG checks/day; with 1.6 checks/day for those on basal/bolus insulin. Higher FSBG frequency was associated with greater improvement in HbA1C independent of insulin treatment status (p = 0.0003). FSBG frequency was higher in patients treated with insulin (p = 0.003). FSBG checks were most common pre-breakfast and post-dinner. Hypoglycemia was rare (1.2% < 70 mg/dL).ConclusionsAdults with uncontrolled T2DM achieved significant HbA1C improvement performing just 1.5 FSBGs daily during a technology-enabled diabetes care intervention. Among the 40% taking insulin, this improvement was achieved with a lower FSBG frequency than guidelines recommend. For those not on insulin, despite a lower frequency of FSBG, they achieved a greater reduction in A1C compared to patients on insulin. Low frequency FSBG monitoring pre-breakfast and post-dinner can potentially support optimization of glycemic control regardless of insulin status in the primary care setting.Trial registrationTrial registration number:NCT02925312 (10/19/2016).

61-OR: Glycemic Control and Depressive Symptoms among Minority Women with Type 2 Diabetes Enrolled in the Women In Control (WIC2) Diabetes Medical Group Visit (DMGV) Study

Background: Comorbid depression is associated with poor diabetes control. DMGVs improve glycemic control and depressive symptoms among patients with type 2 diabetes (T2DM). The WIC2 study compared the effectiveness of an eight-week DGMV conducted in a virtual world platform vs. an in-person format to improve diabetes outcomes for 288 minority women with uncontrolled T2DM (HbA1c ≥8.0%). Objective: We conducted a secondary data analysis of the WIC2 clinical trial data to examine the association between improvements in depressive symptom burden (PHQ-8) and improvements in HbA1c among participants enrolled in the WIC2 study. Methods: We measured mean changes in PHQ-8 and HbA1c at baseline, 9-weeks, and 6-months post-enrollment among 288 WIC2 participants. We performed logistic regression to examine the association between a reduction in depressive symptoms per PHQ-8 (-5 points) and reduction in HbA1c (-0.4%) at 9-weeks and 6-months. We used multivariable logistic regression to adjust for potential confounders, including age, education, and study arm. Results: At baseline, nearly half of WIC enrollees reported mild (29.5%), moderate (17.4), or severe (1.7%) depressive symptoms. Their mean PHQ-8 score was 5.5 (SD 5.0) and mean A1c was 9.93% (SD 1.74). From baseline to 6-months, 17.4% (n=41) achieved a 5-point decrease in PHQ-8; among this subset, the mean PHQ-8 score was 10.49 (SD 4.69), indicative of moderate depression at baseline. Of these 41 participants, 68.3% (n=28) also achieved the threshold A1c improvement at 6-months. After controlling for study arm, education, and age, participants with 5-pt or greater reduction in PHQ-8 score from baseline to 6-months had 2.45 times the odds (CI: 1.16, 5.18) of achieving 0.4% or greater reduction in A1c. Conclusion: Improvements in depressive symptom burden correlate with improvements in diabetes management among women with uncontrolled T2DM. Disclosure P. Gardiner: None. B. M. Cruz: None. A. Bragg: None. M. Winter: None. K. Melo: None. J. M. Howard: None. S. Mitchell: Other Relationship; Self; See Yourself Health LLC, Speaker’s Bureau; Self; Merck Sharp &amp; Dohme Corp. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R01DK10653)

829-P: Improving Diabetes Self-Management with a Peer-to-Peer Mentoring Program: Final Results of a Pilot Program at a Safety Net Health Care System

New York City Health + Hospitals (NYC H+H) is the largest safety net healthcare system in the nation, serving more than one million patients each year. Most of NYC H+H’s patients are low-income and people of color, who, in NYC as in the rest of the nation, bear a disproportionate burden of chronic diseases. At NYC H+H, 18% of patients have diagnosed diabetes, and nearly 23,000 (39%) of the 59,000 patients monitored in NYC H+H’s diabetes registry have poorly controlled diabetes (A1c ≥ 8). In an effort to support these patients’ diabetes management between their regular visits, NYC H+H launched a pilot program of InquisitHealth, a one-on-one peer mentoring service that matches patients with mentors who have controlled their own diabetes and received training to become peer coaches. Several small, randomized, controlled trials have demonstrated the program’s effectiveness in reducing A1c, but there is limited evidence of its effectiveness in a real-word setting. The key aims of this pilot program were to: 1) bridge the gap between patients and providers outside of clinic visits, 2) increase patient education on and support for diabetes self-management, and 3) improve patients’ diabetes outcomes as evidenced by reductions in A1c. The pilot program enrolled 336 patients at two NYC H+H facilities for a twelve-month intervention. Among the first 180 patients enrolled at one large acute care hospital, the mean reduction in A1c from baseline to six months following enrollment was 1.08. As compared to propensity score-matched control patients at a similar non-participating hospital in the NYC H+H network, participants experienced a greater reduction in A1c of 0.61 (-1.08 vs. -0.47, p&amp;lt;0.01). Results from the 12-month final analysis of all participants will be presented. Disclosure R. Kalyanaraman marcello: None. J. Dolle: None. S. Kaur: None. S. R. Patterson: None. N. Davis: None. Funding National Institutes of Health (UL1TR001445)

649-P: Impact of Early Initiation of Dulaglutide on A1C in Patients with Type 2 Diabetes

This retrospective, observational study assessed glycemic control over a 6-month follow-up among patient cohorts with T2D who initiated dulaglutide (DU) 0.75 mg or 1.5 mg following use of either 1, 2 or 3+ oral antihyperglycemic drugs (OAD) during the 24-month pre-index period. This analysis used US claims data from the HealthCore Integrated Research Database (HIRD®) between November 2012 and February 2020 (index date=earliest DU fill between November 2014 and August 2019). Patients ≥18 years old with T2D, ≥1 pharmacy claim for OAD during the pre-index period, continuous enrollment from 24 months pre-index to 6 months post-index date, and ≥1 A1C result within both 6 months pre- and 6 months post-index were included. There were differences in patient characteristics between the cohorts with significant trends (*see figure) of increasing age, comorbidity index scores and pre-index A1C seen with increasing number of prior OADs. Early initiation of DU, proxied by initiation after 1 OAD, resulted in an A1C reduction of 1.39%, and reductions of 1.30% and 1.01% in the 2 OAD and 3+ OAD cohorts, respectively (figure). Greater A1C reductions were observed across subgroups with higher pre-index A1C in each OAD cohort. In this real-world study, a clinically relevant reduction in A1C was seen within 6 months across all cohorts defined by the timing of initiation of DU, with increasing trend of A1C reduction seen with fewer number of prior OADs.View largeDownload slideView largeDownload slide DisclosureM. Hoog: Employee; Self; Eli Lilly and Company, Lilly Diabetes, Stock/Shareholder; Self; Abbott, Eli Lilly and Company, PPD. J. L. Smith: Employee; Self; HealthCore, Other Relationship; Self; Eli Lilly and Company. M. Yu: Employee; Self; Lilly Diabetes, Employee; Spouse/Partner; LifeLabs, Stock/Shareholder; Self; Lilly Diabetes, Stock/Shareholder; Spouse/Partner; Lilly Diabetes. J. Peleshok: Employee; Self; Eli Lilly and Company. R. Mody: Employee; Self; Eli Lilly and Company. M. Grabner: Other Relationship; Self; Eli Lilly and Company.

799-P: Gender Differences in Diabetes Distress Comparing Dapagliflozin plus Saxagliptin to Glimepiride When Added to Metformin in Poorly Controlled Type 2 Diabetes

Distress due to diabetes symptoms and medication side effects is distinct from psychological disorders and can interfere with A1C control and quality of life (QOL). We analyzed patient-reported outcomes (PRO) during a double-blind, 156-wk randomized clinical trial to evaluate effects of gender and treatment on diabetes distress in T2D patients (A1C, 7.5-10.5%) receiving stable metformin (M) ≥1500 mg/d and assigned to either dual add-on therapy with dapagliflozin (D) 10 mg/d + saxagliptin (S) 5 mg/d (n = 227) or single add-on glimepiride (G) titrated 1-6 mg/d (n = 216). A1C, weight and PRO (353 items) were assessed at baseline and wks 12, 28, 52, 104 and 156, and analyzed using linear mixed-effects models. At wk 52, D+S+M resulted in greater reductions in A1C (-1.4±0.1 vs. -1.0±0.1%) and weight (-3.1±0.3 vs. 1.0±0.3 kg) vs. G+M (p&amp;lt;0.001) that remained lower through wk 156. Men had lower A1C at each visit vs. women (all p&amp;lt;0.05). Distress scores (0-100) due to weight gain for D+S+M vs. G+M (83.0±0.8 vs. 75.4±0.9), weight concern (59.9±1.3 vs. 52.5±1.4) and being overweight (40.6±1.2 vs. 44.8±1.2) all favored D+S+M (p&amp;lt;0.01). Model interactions showed that women vs. men experienced greater distress (p = 0.01) that interfered with work, role and daily activities (p&amp;lt;0.001) on G+M compared to D+S+M. Mental health (p = 0.11) and health perceptions (p = 0.59) did not show treatment differences. QOL ratings for women favored D+S+M (p&amp;lt;0.01). Overall satisfaction (78.4±0.3 vs. 76.7±0.3, p&amp;lt;0.001) favored D+S+M, as did subscales of work/role, effectiveness, side effects, burden, preference, net benefit, and regimen acceptance (all p&amp;lt;0.05). Women showed greater improvements in treatment satisfaction compared to men. While addressing diabetes distress to improve a patient’s well-being is important, ameliorating diabetes distress related to medication side effects such as weight gain may also lead to improved adherence, self-care and glycemic control. Disclosure M.A. Testa: Stock/Shareholder; Spouse/Partner; GI Windows. Stock/Shareholder; Self; Phase V Technologies, Inc. D.C. Simonson: Stock/Shareholder; Self; GI Windows. Stock/Shareholder; Spouse/Partner; Phase V Technologies, Inc.

1195-P: Improving Diabetes Self-Management with a Mobile App: Results of a Pilot Program at a Safety Net Hospital System

For patients with type 2 diabetes, self-management remains a significant challenge. In recent years, the use of digital health technologies (DHTs) for chronic disease management has increased, with some facilitating improvements in diabetes outcomes. Historically, safety net systems have been slow to adopt DHTs, in part due to assumptions about literacy and the use of technology among low-income or non-English speaking patients. Additionally, the use of DHTs among diverse, low-income patient populations has not been well studied. NYC Health + Hospitals (H+H) is the largest safety net healthcare system in the nation. H+H launched a pilot program of BlueStar, an FDA-approved mobile app for diabetes self-management, among patients with poorly controlled type 2 diabetes at two of its acute care hospitals. The app was provided to patients in English and Spanish. Participants were able to record and receive feedback on their medications, blood glucose, blood pressure, and meals. Key aims of this pilot program were to: 1) increase patient education and support for diabetes self-management; 2) test the use of technology adaptation in a vulnerable patient population; and 3) improve diabetes outcomes as measured by reductions in A1c. Two hundred ninety-nine patients received the app, and 137 (46%) used the app at least once. Of these 137 patients, 52% used the app at least once per week; recording blood glucose and medication were the most frequently used features (82% and 62%, respectively). Among the first 196 patients enrolled, the mean reduction in A1c from baseline to six months post enrollment was 0.7 at hospital A (n=97) and 1.6 at hospital B (n=97). As compared to matched control patients at non-participating facilities, participants experienced a greater reduction in A1c of 0.1 (p=0.61) at hospital A and 0.7 (p=0.02) at hospital B. Results from the final analysis of all 299 participants as well as key themes from semi-structured interviews with patients will be presented. Disclosure R. Kalyanaraman Marcello: None. J. Dolle: None. S. Kaur: None. S.R. Patterson: None. N. Davis: None. Funding National Institutes of Health (UL1TR001445)

Effect of Pharmacist-Driven Professional Continuous Glucose Monitoring in Adults with Uncontrolled Diabetes.

Diabetes requires close monitoring to achieve optimal outcomes and avoid adverse effects. Continuous glucose monitoring (CGM) is one approach to measuring glycemia and has become more widespread with recent advances in technology; however, ideal implementation of CGM into clinical practice is unknown. CGM can be categorized as personal CGM, which can be for at-home use to replace self-monitoring of blood glucose, or professional CGM (proCGM), which is used intermittently under the direction of a health care professional. The expanding role of the clinical pharmacist allows pharmacists to be at the forefront of implementing proCGM technology, but literature on the effect of pharmacist-driven proCGM is lacking. Pharmacists and physicians within 1 physician-owned clinic used proCGM technology differently. Pharmacists conducted 1 or 2 office visits to interpret data and make interventions, while physicians interpreted data 1 time and relayed interventions via phone. To (a) compare the change in hemoglobin A1c from baseline to 6 months between the different methods of proCGM implementation, and (b) describe and compare the clinical interventions made as a result of the different methods of proCGM implementation. In this retrospective cohort study, adults identified in the electronic medical record via Current Procedural Terminology code 95250 or 95251 undergoing proCGM with CGM data interpreted and baseline A1c ≥ 7% were included. Patients with additional CGM use within the 6-month follow-up period were excluded. Data collection included demographics, A1c at baseline and during the 6-month follow-up period, and CGM-associated interventions. Patients were categorized as undergoing 1 pharmacist-driven encounter (RPh1), 2 pharmacist-driven encounters (RPh2), or 1 physician-driven encounter (MD1) for proCGM implementation. Combined RPh1 and RPh2 (cRPh) data were also used for analysis. The primary outcome was change in A1c from baseline to 6 months, which was evaluated by analysis of covariance. Of 378 patient charts reviewed, 315 instances of proCGM implementation met inclusion criteria (58 RPh1, 35 RPh2, 222 MD1), and 253 had post-implementation A1c data for analysis of the primary outcome (52 RPh1, 30 RPh2, 171 MD1). Baseline A1c was 8.4%, 8.8%, and 9.1% with mean reduction from baseline to 6 months of 1.0%, 1.3%, and 0.6%, respectively. cRPh patients experienced a greater mean reduction in A1c compared with MD1 (P = 0.002). RPh2 patients had a statistically significant reduction compared with MD1 (P = 0.005), but RPh1 patients did not (P = 0.054). The number of CGM-associated pharmacological interventions was 1.33 for RPh1 patients, 1.63 for RPh2 at the first encounter and 1.34 at the second, and 1.17 for MD1. Pharmacist-driven implementation of proCGM was associated with greater A1c reductions and more pharmacological interventions versus physician-driven implementation. This study demonstrated improved clinical outcomes with pharmacists providing direct patient care through implementation of new diabetes technology. No outside funding supported this study. The authors have nothing to disclose. Preliminary results of this work were presented at the American College of Clinical Pharmacy Virtual Poster Symposium, May 28-29, 2019. The abstract was not peer-reviewed because of enrollment in the Mentored Research Investigator Training (MeRIT) program. Final peer-reviewed results were presented at the American College of Clinical Pharmacy Annual Meeting; October 26-29, 2019; New York, NY.

Effects of the low carbohydrate, high fat diet on glycemic control and body weight in patients with type 2 diabetes: experience from a community-based cohort

ObjectiveThe optimal diet to improve glycemia in patients with type 2 diabetes remains unclear. Low carbohydrate, high fat (LCHF) diets can improve glycemic control, but have not been investigated in...

742-P: Magnitude of A1C Improvement in Relation to Weight Loss after Intensive Lifestyle Intervention in Real-World Diabetes Practice: Thirteen Years of Observation

The effect of intensive lifestyle intervention (ILI) on A1C in real-world clinical practice is inconsistent and is frequently underestimated. It is also presumed that the magnitude of A1C improvement is solely dependent on the amount of weight loss. In this study we report the magnitude of A1C change in a large cohort of patients with diabetes who underwent ILI over 13 years in relation to their baseline A1C and the amount of weight loss. We evaluated 590 diabetic patients (age 52.5±11 years, 58.6% females, A1C 7.7±1.4%, weight 105.54±18.6 Kg, BMI 36.7±5.1 Kg/m2, diabetes duration 10.9±9.8 years, 83.7% with type 2 diabetes), who enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program, a 12-week multidisciplinary ILI designed for real-world clinical practice between September 2005 and May 2018. We stratified patients based on baseline A1C into three groups: group A with A1C 9% (16.95% of participants), group B with A1C from 8 to &amp;lt;9% (19.15% of participants), and group C with A1C &amp;lt;8% (63.9% of participants). After 12 weeks of intervention, body weight decreased by 8.5±4.6 Kg in group A, 8.0±4.6 Kg in group B, and 7.6±5.8 Kg in group C (p=0.22 between groups). A1C decreased by 2.5±1.3% in group A, 1.2±0.8% in group B and 0.5±0.6% in group C (p&amp;lt;0.001 between groups). Pairwise comparisons of A1C changes between groups showed that: group A had 1.3% greater A1C reduction than group B (p=0.0001) and 2% greater A1C reduction than group C (p=0.0001), while group B had 0.7% greater A1C reduction than group C (p=0.0001). Conclusion: ILI may decrease A1C by up to 2.5% in patients with diabetes. In patients with a similar magnitude of weight loss, A1C reduction was more prominent in those with higher baseline A1C levels. This may be valuable for clinicians to set realistic expectations of A1C reduction for their patients in response to ILI, which is usually the primary step in diabetes management. Disclosure A.H. Eldib: None. S. Tomah: Stock/Shareholder; Self; Amarin Corporation. A. Mottalib: None. S. Ashrafzadeh: None. O. Hamdy: Advisory Panel; Self; AstraZeneca, Sanofi-Aventis. Consultant; Self; Abbott, Merck &amp; Co., Inc. Research Support; Self; National Dairy Council. Stock/Shareholder; Self; Healthimation, LLC.

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

256-OR: Costarting Sitagliptin with Metformin Is Associated with a Lower Likelihood of Disease Progression in Newly Treated Patients with Type 2 Diabetes

Aim: Sitagliptin can potentially preserve beta cell function by promoting local action of GLP-1 in the pancreas. This study examined if early addition of sitagliptin to metformin is associated with a delay in the progression of type 2 diabetes. Methods: Administrative health records from Alberta, Canada between April 1, 2008 and March 31, 2015 were used to conduct a retrospective cohort study. New metformin users were identified and included if they added sitagliptin during follow-up. Patients costarting therapy with sitagliptin and metformin were compared to those who added sitagliptin after initial metformin therapy. Potential confounding variables included age, sex, comorbidities, and cardiovascular medications at baseline. A multivariable logistic regression model was used to evaluate the association between sitagliptin addition (costart versus delayed) and insulin initiation. Change in A1c 1 year after adding sitagliptin was evaluated using a multivariable linear regression model. Results: Mean (SD) age of the 8,746 included patients was 52.1 (11.1) years, 5,655 (64.7%) were men, and 1,149 (13.1%) costarted treatment with metformin and sitagliptin. Insulin was added to the therapy of 192 (16.7%) costarters and 1,640 (21.6%) of delayed sitagliptin users (adjusted odds ratio 0.73; 95% CI: 0.62 to 0.86). The A1c change 1 year after starting sitagliptin was greater in the costarters (-2.1%; SD 2.8%) compared to delayed sitagliptin users (-1.0%; SD 1.9%). After adjusting for baseline A1c and other covariables, costarters had a greater reduction in A1c -0.56% (95% CI: -0.74% to -0.38%). Conclusions: Costarting sitagliptin with metformin is associated with a lower likelihood of disease progression in newly treated patients with type 2 diabetes compared with adding sitagliptin later in therapy. Disclosure S.A. Campbell: None. P.E. Light: None. S.H. Simpson: None. Funding Canadian Institutes of Health Research

172-LB: Phone-Based Management by a PharmD May Improve Glycemic Control More Than Endocrinology Care Alone

Clinical inertia is a widespread reason for suboptimal control of patients with diabetes (DM). One approach to addressing clinical inertia is to include non-physician providers in DM management. Evidence suggests that intervention by pharmacists improves glycemic control more than usual care. There is little data, however, on the effect of pharmacist care delivered by phone as an adjunct to DM care provided by an Endocrinologist. We conducted a retrospective analysis to assess the effect of phone-based DM management by a Doctor of Pharmacy (PharmD) on glycemic control among patients seen by an Endocrinologist. Between 02/2018-12/2018, 65 adult DM patients were referred by their Endocrinologists to a PharmD for phone intervention at an urban academic medical center. The intervention included medication reconciliation, education on medication self-administration, coordination with pharmacies to dispense medications, and adjustment of DM medications. A total of 41 patients (INT) received 1+ intervention phone call (median [iQR] 3 [2-5] calls), and 24 patients (NoINT) were referred but could not be contacted (n=20) or required no intervention (n=4). At baseline, all INT patients and 96% of NoINT patients were on insulin, 41% and 21% were on a GLP-1RA, and 56% and 46% were on oral medication(s). In the INT group, mean A1C decreased significantly 1.9 ± 2.2% from 10.2 ± 2.4% before the first call to 8.3 ± 1.7% (p&amp;lt;0.0001) after the first call (mean 90.5 ± 50.8 days). In the NoINT group, mean A1C decreased nonsignificantly 0.7 ± 2.1% from 9.2 ± 2.4% to 8.5 ± 2.3% (p=0.123) after the first call attempt (mean 82.3 ± 42.7 days). The INT group had a significantly greater reduction in A1C than the NoINT group (1.2%, p=0.031, 2-sample t-test). Phone-based DM management of Endocrinology patients by a PharmD may lead to better glycemic control than management by an Endocrinologist alone. These data should encourage the conduct of an RCT to test this promising strategy for addressing clinical inertia in DM patients. Disclosure D.J. Rubin: Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. J. Wu: None. D. Patel: None. U. Hajari: None. M. Barros: None.