bluuebunny/crossref_metadata_2025 huggingface dataset:
IMG-1 Reduces Blood Glucose Levels in Type 1 Diabetic Animal Models
Authors: POLLETT JONATHAN B. , NOH HYE LIM , KIM JASON K. , THAI NGOC
Published: June 2018

IMG-1 is a novel compound that has been shown to successfully treat type 2 diabetes in ZDF rats and decrease insulin resistance by suppressing HGP and increasing hepatic insulin action in DIO mice. To test the efficacy of IMG-1 to treat type I diabetes Streptozotocin (STZ)-induced diabetic models were employed. In the first study C57BL/6J mice were treated with STZ (50mg/kg) for 5 days to induce diabetes. The animals were either administered IMG-1 or PBS via oral gavage daily for 29 days. Blood glucose (BG) levels were evaluated three times weekly and insulin was measured twice weekly. After 17 days of treatment, IMG-1 treated animals displayed a significant decrease in BG levels (200-300 mg/dl) that persisted for the remainder of the study, while the control animals had continuously high BG levels (400-600 mg/dl). Insulin levels were low in these animals and unaffected by IMG-1. This finding was mimicked in a second experiment where a STZ rat model was used where Sprague-Dawley rats were given a single injection of STZ (60mg/kg) to induce diabetes. In the rat model, the IMG-1 treated animals had significantly lower BG levels by day 9 and remained low for the entire study (200-300 mg/dl). Total bilirubin, ALP, ALT, AST, BUN and creatinine levels were assessed following the 29-day study to determine liver and kidney toxicity. Bilirubin, BUN and creatinine levels were within the normal range, while the ALP, ALT and AST levels were elevated with the STZ treatment (common in this model). IMG-1 did not have any effect on the liver enzymes compared to control. IMG-1 can regulate BG levels in type I diabetic animal models and does not affect kidney or liver function.

Disclosure

J.B. Pollett: Employee; Self; Imagine Pharma. H. Noh: None. J.K. Kim: None. N. Thai: Board Member; Self; Imagine Pharma.
Durable HbA1c Reduction with Initial Combination Therapy with Metformin/Pioglitazone/Exenatide in Subjects with New-Onset Diabetes—Six-Year Follow-Up of the EDICT Study
Authors: ABDUL-GHANI MUHAMMAD , PUCKETT CURTISS L. , TRIPLITT CURTIS L. , MAGGS DAVID , ADAMS JOHN M. , CERSOSIMO EUGENIO , DEFRONZO RALPH A.
Published: June 2018

Background: We previously have shown that initial combination therapy with metformin/pioglitazone/exenatide (Triple Therapy) produced greater reduction in A1c than sequential add-on therapy in subjects with new onset of type 2 diabetes (T2D).

Research Design and Methods: The EDICT study is a randomized open-label study in which newly diagnosed drug-naïve T2D subjects with new onset diabetes were randomized to receive Triple Therapy (n=132) or escalating dose of metformin followed by sequential addition of glipizide and then glargine insulin (Conventional Therapy) (n=146) to maintain A1c< 6.5. Here, we report the 6-year follow-up results.

Results: Subjects receiving Triple Therapy experienced a significantly greater reduction in A1c after a mean follow-up of 6 years vs. Conventional Therapy (5.8% vs. 6.7%, p<0.001) (Figure 1). Further, more subjects maintained HbA1c <6.5% in the Triple Therapy group (25%) than in the Conventional Therapy (52%). Progression of carotid IMT (read blindly) was reduced by >50% (P<0.001) in Triple Therapy vs. Insulin Therapy.

Conclusion: The results of this study demonstrate that combination therapy with metformin/pioglitazone/ exenatide in newly diagnosed T2DM patients produces greater and more reduction in A1c than sequential add-on therapy with metformin, sulfonylurea, and basal insulin.

Disclosure

M. Abdul-Ghani: None. C.L. Puckett: None. C.L. Triplitt: Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Eli Lilly and Company. Consultant; Self; Sanofi, Novo Nordisk Inc. D. Maggs: Stock/Shareholder; Self; Fractyl Laboratories, Inc.. Employee; Self; Fractyl Laboratories, Inc.. Stock/Shareholder; Spouse/Partner; Gelesis. Employee; Spouse/Partner; Gelesis. J.M. Adams: None. E. Cersosimo: Research Support; Self; AstraZeneca, VeroScience, LLC.. Speaker's Bureau; Self; AstraZeneca, Sanofi, Janssen Pharmaceuticals, Inc., Eli Lilly and Company. R.A. DeFronzo: Speaker's Bureau; Self; AstraZeneca, Novo Nordisk Inc.. Advisory Panel; Self; AstraZeneca, Novo Nordisk Inc., Janssen Pharmaceuticals, Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Elcelyx Therapeutics, Inc., Intarcia Therapeutics, Inc.. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Takeda Pharmaceuticals U.S.A., Inc..
FOXO1 Inhibition Potentiates Endothelial Function and Ischemic Angiogenesis in Diabetes via Suppression of ROCK1/Drp1-Mediated Mitochondrial Fission
Authors: TIE LU , SHI YUNDI , WANG DI
Published: June 2018

Diabetes-induced endothelial cell (EC) dysfunction and neovascularization impairment constitute vascular complications with limited treatment regimens. Transcription factor FOXO1 is a key angiogenic regulator and plays a pathologic role in progression of diabetes. The present study was designed to determine the involvement of FOXO1 in impaired EC function and post-ischemic neovascularization in diabetes and investigate underlying mechanisms. We found that FOXO1-selective inhibitor AS1842856 improved blood flow recovery and capillary density in ischemic hindlimb, and rescued the delay of wound closure with a concomitant augmentation of mean perfusion rate in diabetic mice. In vitro, treatment with AS1842856 or FOXO1 siRNA abrogated high glucose-induced apoptosis and ameliorated capillary tube formation in human umbilical vein endothelial cells (HUVECs). FOXO1 inhibition relieved alterations in mitochondrial networks and significantly suppressed the overproduction of mitochondrial reactive oxygen species (mtROS) induced by high glucose in ECs. Expression of dynamin-relatedprotein-1 (Drp1) and phosphorylation at Ser616, a protein required for mitochondrial fission, were enhanced by hyperglycemia, which could be neutralized by FOXO1 inhibition. Moreover, the transcription of Rho-associated coiled-coil containing protein kinase 1 (ROCK1), which phosphorylates Drp1 at Ser616, was shown by luciferase assay to be directly regulated by FOXO1. These findings suggested that FOXO1 is critical to preserve mitochondrial quantity and function in ECs, and FOXO1 may serve as a therapeutic target for microvascular complications of diabetes.

Disclosure

L. Tie: None. Y. Shi: None. D. Wang: None.
Cost-Effectiveness of Interventions to Prevent and Manage Diabetes—A Systematic Review and Update
Authors: SIEGEL KAREN R. , ZHOU XILIN , NG BOON PENG , JAWANDA SHAWN , PROIA KRISTA , ZHANG XUANPING , ZHANG PING
Published: June 2018

Many interventions are available for preventing type 2 diabetes (DM) and managing DM, but their cost-effectiveness (CE) varies greatly. Previously, we conducted a systematic cost-effectiveness (CE) review of all DM interventions covering studies between 1985 and 2007. Here, we update the study for Jan 20to July 2017. We used the same search strategies (databases, MeSH terms and keywords, exclusion criteria and study quality assessment tool) to select studies. We grouped interventions by CE ratios (CER) in cost per quality-adjusted life years (QALY) or life year gained (LYG)—cost saving (CER ≤ 0); very cost-effective (0 < CER ≤ $25,000); cost-effective ($25,000 < CER ≤ $50,000); marginally cost-effective ($50,000 < ICER ≤ $100,000); or not cost-effective (>$100,000)—and whether evidence was strong, supportive, or uncertain. We used the median CER to represent the CE of an intervention if multiple evaluations exist. Costs and CER were expressed as 2015 U.S. dollars. The initial search yielded 18,195 titles; 46 prevention and 110 management papers were included in the review. Interventions that were cost-saving or very cost-effective with strong evidence included: for preventing type 2 DM, 1) imposing taxes on sweetened beverages and 2) structured lifestyle intervention and metformin in people at high risk; for management of DM and its complications, 1) ACE inhibitor therapy for intensive hypertension (HTN) control, 2) self-monitoring of blood glucose, 3) comprehensive foot care to prevent ulcers, 4) multi-component coordinated care with peer support for managing HTN, hyperglycemia, hyperlipidemia, and chronic kidney disease, and early detection of DM complications. The CERs of other interventions ranged from $30,000 to $4,817,000 per QALY or <$25,000 per QALY with a high degree of uncertainty. Our results provide critical information for making evidence-based clinical and public health policy decisions.

Disclosure

K.R. Siegel: None. X. Zhou: None. B. Ng: None. S. Jawanda: None. K. Proia: None. X. Zhang: None. P. Zhang: None.
Improving Multidisciplinary Care in Pediatric Diabetes Clinic
Authors: DESALVO DANIEL J. , BARTZ SARA K. , YEE CURTIS , SONABEND RONA
Published: June 2018

Background: A team-based approach facilitates comprehensive assessment and individualized care plan for diabetes patients. The ADA recommends diabetes patients see a Certified Diabetes Educator (CDE), Registered Dietician (RD) and Social Worker (SW) at least once yearly. Prior to this QI project there was no structured process in our pediatric diabetes clinic for these visits, leading to low rates of multidisciplinary patient care.

Objectives: Our goal was to improve the proportion of diabetes patients receiving evidenced-based multidisciplinary care for enhanced education and social support. Specifically, we aimed to improve the percentage of diabetes patients (<21yo) with CDE visits from baseline of 59% in FY2014 to ≥75% in FY2017, RD visits from baseline of 33% in FY2014 to ≥75% in FY2017, and SW visits from baseline of 24% in FY2014 to ≥75% in FY2017.

Methods: Fish bone and key driver diagrams were deployed to identify strategies for improvement. Our intervention established a policy of Annual Visits for multidisciplinary care with a model to ensure optimal communication. PDSA1: Use birthdays as a mechanism to trigger Annual Visit with CDE, RD, SW; PDSA2: Develop and utilize sustainable pre-visit planning document; PDSA3: Staff call patients scheduled for Annual Visit the day prior; PDSA4: Multidisciplinary pre-clinic huddle to discuss daily clinic procedure; PDSA5: Utilization of EMR diabetes patient registry to identify gaps in care; PDSA6: Utilize a Nurse Coordinator to ensure patients receive required services

Results: The rates of patients seen by multidisciplinary staff increased from baseline for all 3 groups in FY2017: CDE-79.4%, RD-64.3% and SW-83.9%. Thus, the goal of ≥75% was achieved for CDE and SW, but not RD visits (primarily due to staffing).

Conclusions: This QI project resulted in improved transparency, organization and accountability within the clinic. Increasing CDE, RD, and SW support for diabetes patients could impact quality of care delivery, value to the patient, and clinical outcomes.

Disclosure

D.J. DeSalvo: Consultant; Self; Dexcom, Inc.. Speaker's Bureau; Self; Insulet Corporation. S.K. Bartz: None. C. Yee: None. R. Sonabend: None.
Drug Copay and Hospitalizations in Elderly Patients with Type 2 Diabetes
Authors: XU LIOU , PAWASKAR MANJIRI , TANG YUEXIN , PUCKREIN GARY , RAJPATHAK SWAPNIL , STUART BRUCE C.
Published: June 2018

Prior studies have shown that higher drug copay may be associated with a lower medication adherence and higher healthcare resource utilization in type 2 diabetes (T2D) patients but mostly in younger commercially insured population. Hence the current study examined this association in elderly T2D patients. This retrospective database study using Medicare claims database included T2D patients on branded non-insulin anti-hyperglycemic agent (AHA) monotherapy during index period (1/1/2013-2/28/2013). Drug copay was calculated for a 30-day supply of the index AHA. Hospitalization was assessed during 10-month follow-up period. Poisson regression model was used to control for baseline characteristics to evaluate the association between copay and hospitalization. A total of 28,656 T2D elderly patients met the inclusion criteria (mean age 78 years, 53% female, and 90% white). Mean branded drug copay was of $40. Higher drug copay was associated with increase in the risk of hospitalization [(e.g., Compared to patients with <$10 drug copay, those with $60+ drug copay had 17% higher risk of hospitalization (p= 0.02)] (Table). This study suggests that higher drug copays for branded AHAs have significant impact on the risk of hospitalization in elderly patients covered under Medicare. Payers need to take into account drug copays while making formulary decisions.

Disclosure

L. Xu: None. M. Pawaskar: Employee; Self; Merck & Co., Inc. Y. Tang: Employee; Self; Merck & Co., Inc.. Stock/Shareholder; Self; Merck & Co., Inc.. Employee; Spouse/Partner; GlaxoSmithKline plc.. Stock/Shareholder; Spouse/Partner; GlaxoSmithKline plc.. G. Puckrein: None. S. Rajpathak: Employee; Self; Merck & Co., Inc. B.C. Stuart: Consultant; Self; Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation.
Factors Associated with Secondary Nonadherence to Oral Antihyperglycemic Agents among Patients with T2DM
Authors: LARSON SHARON , TANG YUEXIN , LESTER KIRCHNER H.
Published: June 2018

Glycemic control in patients with T2DM remains sub-optimal. A major contributor to poor goal achievement is medication nonadherence. This study aimed to examine secondary nonadherence to oral anti-hyperglycemic agents (AHA) among T2DM patients and to assess its association with community- and individual-level characteristics.

Using claims and electronic medical records in Geisinger Health System during 2003-2015, this retrospective cohort study included adults with newly diagnosed T2DM who filled their 1st order of oral AHA. Secondary nonadherence was determined when patients did not fill the 2nd oral AHA prescription within 30 days after the 1st fill supply ended.

Among 2,413 patients who filled the 1st order, 764 (31.7%) were not adherent to the 2nd prescription. Younger age, non-white (vs. white) and chronic kidney disease was associated with higher odds of nonadherence. Patients with higher baseline HbA1c when ≤ 10% was associated with lower odds of nonadherence, while those with higher baseline HbA1c when >10% were more likely to be non-adherent. Community-level characteristics were not found to be associated with nonadherence.

Nearly one-third of patients did not complete a 2nd fill of their oral AHA. This study identified patient characteristics associated with secondary nonadherence that may provide intervention points for improving medication adherence in diabetes management.

Disclosure

S. Larson: None. Y. Tang: Employee; Self; Merck & Co., Inc.. Stock/Shareholder; Self; Merck & Co., Inc.. Employee; Spouse/Partner; GlaxoSmithKline plc.. Stock/Shareholder; Spouse/Partner; GlaxoSmithKline plc.. H. Kirchner: None.
Severe Hypoglycemia (SH) and Diabetic Ketoacidosis (DKA) Hospitalization Rates—Twenty-Five Years in the Epidemiology of Diabetes Complications (EDC) Study
Authors: PAMBIANCO GEORGIA , ORCHARD TREVOR J.
Published: June 2018

SH and DKA are common serious acute complications of type 1 diabetes (T1D), but whether rates have changed with recent improvements in diabetes management is not clear. We, thus examined data from the Pittsburgh Epidemiology of Diabetes Complications (EDC) study of childhood onset T1D (mean age 28 and duration 19 years, n=658) to determine if the hospitalized rates of SH and DKA have changed over 25 years of follow-up. Participants reported hospitalizations at each biennial survey for the prior 5 years (1986-1988, 2012-2014) or prior 3 years (1996-1998, 2004-2006). Rates per 100 person years for SH and DKA were then calculated by dividing the total number of self-reported SH or DKA admissions by the total appropriate accumulated person years of reporting at each follow-up. Hospitalization rates for SH declined after 1996-1998 with a fall in HbA1c suggesting better overall management. The DKA hospitalization rate was consistent throughout the follow-up. The factors underlying these encouraging trends require further investigation and survival bias cannot be excluded.

Disclosure

G. Pambianco: None. T.J. Orchard: None.
Cost Effectiveness of DPP-4i and SGLT2i Combination Therapy for the Treatment of Type 2 Diabetes in the U.S.
Authors: PAWASKAR MANJIRI , PINAR BILIR S. , GRABER-NAIDICH ANNA , GONZALEZ CLAUDIO D. , RAJPATHAK SWAPNIL , DAVIES GLENN M.
Published: June 2018

Management of type 2 diabetes (T2D) needs different treatment strategies to achieve the individualized glycemic goal. This study evaluated the long-term cost effectiveness of strategies involving pathway 1: metformin followed by intensification with dipeptidyl peptidase-4 inhibitors (DPP-4i), sodium-glucose co-transporter 2 inhibitors (SGLT2i) and insulin vs. pathway 2: metformin followed by intensification with sulfonylurea (SU) and insulin in the U.S. Cost-effectiveness analysis was performed using the validated QuintilesIMS CORE Diabetes Model from a U.S. payer perspective. Clinical and economic outcomes were modeled over a lifetime for a cohort of T2D patients who fail to achieve glycemic goal on metformin monotherapy. Clinical data were obtained from clinical trials. Direct medical costs [e.g., medications (whole sale acquisition costs), diabetes management, adverse events, and complications] were obtained from published sources. Despite higher direct medical costs for pathway 1 compared to pathway 2 ($117,779 vs. $93,196 respectively); pathway 1 improved total quality-adjusted life years (QALY) by 0.28 vs. pathway 2. Pathway 1 also led to cost offsets from fewer diabetes-related complications and delayed initiation of insulin. The incremental cost-effectiveness ratio (ICER) was favorable for pathway 1 at $89,038/QALY. Most of the scenario analysis (changes in treatment effect, hypoglycemia, and cardiovascular protective effects of SGLT2is) resulted in ICERs under $100,000/QALY except for the population with baseline HbA1c of 7%, and older age (65+ years). Negotiated discounts on branded medications resulted in significant improvement in ICERs (ICER of $69,554/QALY for 15% discount and $0/QALY for 75% discount). Among patients failing metformin monotherapy in the U.S, additional intensification with DPP-4i followed by SGLT2i may be considered more cost effective compared to intensification with SU followed by insulin.

Disclosure

M. Pawaskar: Employee; Self; Merck & Co., Inc. S. Bilir: Consultant; Self; Merck & Co., Inc.. A. Graber-Naidich: None. C.D. Gonzalez: Employee; Self; Merck & Co., Inc. S. Rajpathak: Employee; Self; Merck & Co., Inc. G.M. Davies: Employee; Self; Merck & Co., Inc..
Impact of a Structured Patient-Support Program on Adherence and Persistence with Basal Insulin Therapy at 12 Months
Authors: ZHOU FANG L. , YEAW JASON , KARKARE SWAPNA , DEKOVEN MITCH , REID TIMOTHY S.
Published: June 2018

The COACH patient-support program was launched in 2015 to support and educate patients prescribed insulin glargine 300 U/mL (Gla-300). The study objective was to assess program impact on adherence and persistence among patients with T2D on Gla-300 therapy.

A retrospective cohort study was conducted, linking data from COACH to patient data in the IQVIA Integrated Data Warehouse. Overall inclusion criteria for patients identified from 2/1/2016-7/31/2016 were: ≥1 T2D diagnosis code, aged ≥18 years, ≥1 pharmacy claim for Gla-300 (first claim as index date), continuous database activity for ≥180 days preceding the 6-month pre-index, and pharmacy stability in the 6-month pre-index. Exclusion criteria were: ≥1 pharmacy claim for another basal insulin ≤14 days preceding index, and data-quality issues. Patients from the COACH Participant cohort (active participants of the program) were directly matched to a Non-COACH cohort of patients not enrolled in COACH. Patients who were insulin naive, switched from any other basal insulin to Gla-300, and with high levels of engagement to COACH were analyzed as subcohorts. Treatment persistence and adherence were measured over a 12-month follow-up.

The matched cohorts included 544 patients each. Over 12 months, a significantly greater proportion of COACH Participants were persistent (48.5% vs. 42.1%; p=0.0309) and adherent (68.0% vs. 61.4%; p=0.0201) to Gla-300 compared with patients in the Non-COACH cohort. In multivariate adjusted analyses, the odds of being adherent to index medication were 1.81 times higher (OR 1.81; p=0.0002) and the risk of discontinuation was 40% lower (HR 0.60; p<0.0001) for COACH Participants. Similar results were found among naive and switching subcohorts. A higher level of engagement with COACH was associated with a lower risk of discontinuation.

Active participation in the COACH patient-support program was associated with improved adherence and persistence to Gla-300.

Disclosure

F.L. Zhou: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. Employee; Spouse/Partner; Lexicon Pharmaceuticals, Inc.. Stock/Shareholder; Spouse/Partner; Lexicon Pharmaceuticals, Inc. J. Yeaw: Other Relationship; Self; Sanofi US. S. Karkare: None. M. DeKoven: None. T.S. Reid: Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Sanofi. Advisory Panel; Self; Sanofi, Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Consultant; Self; AstraZeneca, Intarcia Therapeutics, Inc.. Speaker's Bureau; Self; Lilly.
Preserving Vision by Empowering Patients
Authors: YANG ALMIRA J. , LA VAN T. , EKE CHIBUZO U. , FIREK ANTHONY
Published: June 2018

Diabetic retinopathy (DR) is a preventable complication of diabetes with early detection and intervention. Prior studies have shown patient engagement and empowerment improve patient knowledge and self-care resulting in better outcomes. Yet, screening and treatment of DR remain a major challenge especially in our underserved, indigent patient populations. Graphic education material is often used to improve detection of DR but its effectiveness is rarely assessed, especially in the underserved. To improve DR screening in our population, we developed a quality improvement project using in-clinic graphic material to empower patients to screen for DR, followed by post clinic surveys to evaluate the impacts on screening rates and patient engagement.

Posters in English and Spanish were placed in primary care clinics directly viewed by patients for 3 months. We surveyed 100 patients and 12 providers to evaluate the effectiveness of the intervention. We reviewed 84 and 200 charts to determine both pre- and post-intervention DR screening rates.

No difference was seen in the DR screening rate between the pre- and post-intervention periods (51.0% vs. 50.0%, p = 0.86). There were improvements in the referral rate and the retinal exam visit rate between pre- and post-intervention periods (76.2% vs. 82.2%, p = 0.142; 63.9% vs. 73.3%, p = 0.046, respectively). Among the 49 patients who saw educational posters, 69.4% reported the posters prompted them to discuss with the providers about retinal screening exams.

Our study demonstrated that posters can improve patients’ awareness of DR leading to positive engagement with their providers, and eventually improve DR screening efforts. However, multiple factors such as patient literacy, limited encounter time, and understanding may limit the effectiveness of education interventions particularly in our underserved patients. As DR particularly impacts this population, more innovative and direct interactions may need to be implemented to improve self knowledge and patient empowerment to improve DR screening.

Disclosure

A.J. Yang: None. V.T. La: None. C.U. Eke: None. A. Firek: None.
Racial Disparities in the Burden of End-Stage Renal Disease due to Diabetes among Medicare Beneficiaries
Authors: GLANTZ NAMINO M. , DUNCAN IAN , AHMED TAMIM , KERR DAVID
Published: June 2018

Diabetes disproportionately impacts minority populations in the United States. In particular, Hispanics are almost twice as likely as non-Hispanic whites to be diagnosed with diabetes and have higher rates of end-stage renal disease (ESRD) due to diabetes. We analyzed data from the Medicare 5% sample file by race/ethnicity for type 1 (T1D) and type 2 diabetes (T2D) to determine the economic burden of ESRD.

For the years 2012-13 we identified 1,397,933 enrollees from the publicly-available Medicare 5% sample > 65 years without Medicare Advantage coverage (HMO).

The prevalence of T1D was 2.0% and 21.9% for T2D. ESRD affected 5.4% of the T1D and 1.9% of T2D populations. Rates of ESRD were significantly higher for other races for both T1D and T2D compared to whites.

Comparing costs, allowed amount (claims less discounts/ineligible charges) for treating ESRD was higher for T1D Hispanics than T1D whites ($8,946 vs. $8,332 per member/month, P<0.001). In contrast to other races, T2D Hispanics with ESRD were not more costly than whites ($6,634 vs. $6,542). Similar results were seen for net paid costs taking into account cost-sharing. Average cost-sharing for all patients with ESRD was $730 (no diabetes), $1,177 (T1D) and $939 (T2D) per member/month respectively.

In conclusion, the burden of ESRD due to T1D and T2D and the associated cost for T1D with ESRD were higher for Hispanics than for white Medicare enrollees.

Disclosure

N.M. Glantz: Research Support; Self; Eli Lilly and Company. I. Duncan: Consultant; Self; Eli Lilly and Company. T. Ahmed: None. D. Kerr: Advisory Panel; Self; Glooko, Inc.. Research Support; Self; Eli Lilly and Company. Speaker's Bureau; Self; Sanofi-Aventis. Stock/Shareholder; Self; Cellnovo. Advisory Panel; Self; Novo Nordisk Inc..
Quality of Diabetes Care—Comparisons between Rzeszow, Podkarpacie, Poland and Waukesha, Wisconsin, U.S.
Authors: IDSO JOHN , TELEGA GRZEGORZ , DąBROWSKI MARIUSZ , KIDAMBI SRIVIDYA
Published: June 2018

Introduction: Poland spent 6.4% of its GDP on healthcare in 2013, while the United States (U.S.) spent 16.9%, despite similar life expectancies. Type 2 diabetes mellitus (DM) was estimated to have cost the U.S. $176 billion in 2012. This study compares the quality of DM care between Waukesha in Wisconsin, U.S. and Rzeszow in Podkarpacie region of Poland—cities comparable in population size, age, race, and income levels.

Methods: DM quality data for the Polish cohort was abstracted from the charts of 144 DM patients attending a regional diabetes clinic in Rzeszow, Podkarpacie from 2013-2014. Podkarpacie DM cost data was attained from the Polish National Health Fund. One hundred and forty-four DM patients, matched for age, BMI, and sex, from a diabetes clinic in Waukesha, WI were chosen as comparators. DM quality data was obtained through the Clinical Research Data Warehouse at the Medical College of Wisconsin. Cost data for WI was inferred from a previously published cost estimate for WI.

Results: The mean (SD) for glycosylated hemoglobin (HbA1C, %) in the Polish and U.S. cohorts was 7.4 (1.3) and 7.8 (1.9) respectively (p=0.04). Mean systolic/diastolic blood pressures (BP, mm Hg) in the Polish and U.S. cohorts were 148 (20)/81 (0.3) and 132 (16)/74 (11) (p <0.001, p<0.001) respectively. Insulin was prescribed in 38% of patients in Poland and 58% in U.S. The cost of hospitalizations, outpatient care, and medications per Polish patient with DM was $781 or 3.2% of the gross national income (GNI) per capita. In 2012, the direct medical cost was estimated at $8,926 per adult with DM in Wisconsin, or 15.9% GNI income per capita.

Discussion: Based on our results, Polish cohort had a slightly better HbA1C. The U.S. cohort had much better BP control compared to the Polish cohort. The cost of care at Podkarpacie was ∼10-fold lower compared to Waukesha. While both countries operate under different political and economic conditions, each could benefit from a deeper understanding of the other’s quality practices and cost structures.

Disclosure

J. Idso: None. G. Telega: Research Support; Self; Kadmon Corporation. M. Dąbrowski: Other Relationship; Self; Ascensia Diabetes Care, AstraZeneca, Berlin-Chemie AG, Eli Lilly and Company, MSD K.K., Sanofi-Aventis, Servier. S. Kidambi: None.
Body Weight (BW) Outcomes with Canagliflozin 300 mg (CANA) vs. Glucagon-Like Peptide-1 Receptor Agonists (GLP-1s) in a Real-World (RW) Setting
Authors: COLEMAN CRAIG I. , HERMAN WILLIAM H. , PANDYA SHIVANI , WANG LI , BASER ONUR , CAI JENNIFER , BOOKHART BRAHIM
Published: June 2018

CANA and GLP-1s have demonstrated weight loss (WL) in patients with type 2 diabetes mellitus (T2DM) in clinical trials. We compared the effects of CANA vs. GLP-1s on BW outcomes in routine practice using claims and electronic health record data from the U.S. Optum integrated database for adults with T2DM and ≥1 prescription claim for CANA or any GLP-1 from 1/1/13-3/31/15. BW outcomes and achievement of clinically significant WL ≥5% were assessed in matched patients with both ≥1 BW measurement during baseline (BL) and >31 days post-index. Inverse probability of treatment weighting (IPTW) accounted for differences in BL covariates. Weighted Cox regression was used to examine the hazard ratio (HR) and 95% confidence interval (CI) of WL ≥5%. After IPTW, covariates were balanced between cohorts except for BL BMI (CANA: n = 213; GLP-1: n = 235). Significant differences in BW were seen in the CANA vs. GLP-1 cohort over 9 months of follow-up (Figure). CANA cohort patients were more likely to achieve WL ≥5% (HR 1.93; 95% CI: 1.40-2.66) with a significantly longer duration at WL ≥5% (133 vs. 103 days; P = 0.01) than GLP-1 cohort patients.

In summary, superior WL of >9 kg at 9 months, >17% more patients achieving WL ≥5%, and longer duration of WL ≥5% as seen in the CANA vs. GLP-1 cohort may have important clinical implications due to links between BW reduction and other clinical/economic outcomes.

Disclosure

C.I. Coleman: Research Support; Self; Janssen Pharmaceuticals, Inc., Boehringer Ingelheim Pharmaceuticals, Inc. W.H. Herman: Other Relationship; Self; Merck Sharp & Dohme Corp., Lexicon Pharmaceuticals, Inc.. Consultant; Self; Janssen Scientific Affairs, LLC.. Research Support; Spouse/Partner; Nestlé. Other Relationship; Self; American Diabetes Association. Advisory Panel; Self; National Committee for Quality Assurance (NCQA). S. Pandya: Other Relationship; Self; Janssen Scientific Affairs, LLC. L. Wang: Other Relationship; Self; Janssen Scientific Affairs, LLC.. O. Baser: None. J. Cai: Employee; Self; Janssen Scientific Affairs, LLC. B. Bookhart: Employee; Self; Janssen Scientific Affairs, LLC..
Cost-Effectiveness Analysis of Empagliflozin Compared with Canagliflozin or Standard of Care (SoC) in Patients with T2DM and Established Cardiovascular (CV) Disease
Authors: KANSAL ANURAAG , REIFSNIDER ODETTE , LEE JOSEPH , FAHRBACH KYLE , GANDHI PRANAV , PFARR EGON , USTYUGOVA ANASTASIA V.
Published: June 2018

Empagliflozin, a sodium-glucose cotransporter 2 inhibitor, is FDA approved to reduce the risk of CV death in adults with T2DM and established CV disease. EMPA-REG OUTCOME showed a significant reduction in major adverse CV event (MACE), CV death, and hospitalization for heart failure (HHF) for empagliflozin vs. placebo in addition to SoC. Recently, CANVAS showed significant reduction in MACE and HHF with canagliflozin vs. placebo in addition to SoC. The objective of this study was to assess the cost-effectiveness of empagliflozin vs. canagliflozin or SoC in patients with T2DM and established CV disease in the U.S. A discrete event simulation model was used to simulate CV, renal, and select adverse events from EMPA-REG OUTCOME. Occurrence of each event was modeled using event-free survival curves with time-dependent covariates. A hazard ratio for canagliflozin vs. empagliflozin on each modeled event was estimated from published CANVAS data and EMPA-REG OUTCOME using an indirect treatment comparison. U.S. costs and utilities were taken from public sources. Patients receiving empagliflozin were predicted to live longer by 0.93 years vs. canagliflozin and 1.86 years vs. SoC due to lower CV death rates. When compared to SoC, empagliflozin had fewer or similar events per 100 patients-years, except for nonfatal stroke (NFST) and genital mycotic infection (GMI). For empagliflozin vs. canagliflozin, there were less amputation (0.58 vs. 1.08), kidney injury (0.33 vs. 0.47), and bone fracture (1.12 vs. 1.45); similar nonfatal myocardial infarction (1.93 vs. 1.85), HHF (1.74 vs. 1.65), albuminuria progression (5.96 vs. 6.14), composite renal outcome (1.16 vs. 1.20), and GMI (1.80 vs. 1.79); but more NFST (1.20 vs. 0.85). Based on a $100,000/QALY threshold, empagliflozin was cost-effective compared with canagliflozin or SoC at $2,932/QALY or $55,489/QALY, respectively.

Disclosure

A. Kansal: None. O. Reifsnider: Consultant; Self; Evidera. J. Lee: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. K. Fahrbach: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. P. Gandhi: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. E. Pfarr: None. A.V. Ustyugova: Employee; Self; Boehringer Ingelheim GmbH.
The Association of Glucose Values at Hospital Discharge with 30-Day Readmission and Post-discharge Mortality Rates in Patients with Diabetes
Authors: SPANAKIS ELIAS , UMPIERREZ GUILLERMO E. , SIDDIQUI TARIQ , ZHAN MIN , SNITKER SOREN , FINK JEFFREY C. , SORKIN JOHN D.
Published: June 2018

Objective: Thirty-day readmission and post-discharge mortality rates reflect quality of care. Little is known about the association of glucose values of the last day of the inpatient stay with the risk of readmission and mortality after discharge.

Design: Nationwide cohort of 836,189 admissions of DM patients admitted to non ICU setting in 110 Veteran Affairs hospitals, between 2000-2014. Demographic, social economic variables and several comorbidities were collected. General estimating equations were used to determine if the minimum glucose values of the last 24 hours of hospital stay were associated with 30-day readmission rate, 30, 90 and 180-day mortality rates, and combined 30-day readmission/mortality.

Results: The 30-day readmission rate was 17.2% and the 30, 90 and 180-day mortality rates were 2.3%, 6.1% and 10% respectively, with a combined 18.8% for 30-day mortality/readmission rates. There was a sharp increase of the 30-day readmission rate with glucose values below 98 mg/dl. The post-discharge mortality rates increased with glucose values below 68.3 mg/dl, and the combined 30-day readmission/mortality rate increased with glucose values below 86.4 mg/dl (Figure).

Conclusions: DM patients with glucose values below 98 mg/dl and 68.3 mg/dl at the last day of hospitalization in the non ICU setting are at a higher risk for 30-day readmission and 180-day mortality.

Disclosure

E. Spanakis: Research Support; Self; Dexcom, Inc. G.E. Umpierrez: Research Support; Self; Sanofi US, Merck & Co., Inc., Novo Nordisk Inc., AstraZeneca. Advisory Panel; Self; Sanofi, Intarcia Therapeutics, Inc.. T. Siddiqui: None. M. Zhan: None. S. Snitker: Employee; Self; Novo Nordisk Inc.. J.C. Fink: None. J.D. Sorkin: None.
Economic Evaluation of Dapagliflozin as Add-On to Metformin in T2DM in the Israeli Health Care Setting
Authors: MOSHEL SHAI , VEXBERG MICHAL HIRSCH , SHAVIT OREN , TOLEDANO YOEL
Published: June 2018

Background: Dapagliflozin is a potential for combination therapy with metformin in T2DM. However, its cost-effectiveness relative to other alternatives in the Israeli healthcare setup remains unknown.

Objective: To evaluate the cost-effectiveness of dapagliflozin 10mg as add-on to metformin, compared to common alternatives (sitagliptin 100mg, glimepiride 2mg, liraglutide 1.2mg) based on Meuhedet health services database.

Methods: A cost-effectiveness evaluation was performed using the Cardiff diabetes model. A cohort of 1000 T2DM patients (ages 21 and older) who had received additional medication to metformin was randomly chosen from Meuhedet’s database. Baseline values for demographic and clinical variables prior to the add-on therapy, along with data from clinical trials served as inputs to the model. Simulation was performed for each drug, calculating its total costs and benefits (QALYs). The model’s time horizon was set to 40 years, annual discount rate for both costs and benefits was 3.5% and incremental cost effectiveness ratio (iCER) threshold was £20,000/QALY. Finally, single-variable and multivariable sensitivity analyses were performed.

Results: In the base-case scenario, dapagliflozin was found cost-effective compared to sitagliptin, liraglutide and glimepiride (iCER values of £1,232, £-16,517 and £13,476, respectively). For all comparisons, iCER was driven by differences in costs, while differences in QALYs were minimal. Dapagliflozin remained cost-effective even after performing sensitivity analyses. However, when performing the simulation under comparators’ generic competition scenario, dapagliflozin was no longer cost-effective compared to liraglutide (iCER =£24,900/QALY).

Conclusion: Dapagliflozin as add-on treatment to metformin was cost-effective compared to several alternatives in T2DM patients in Israel’s healthcare system. Additional research is needed in order to evaluate the effects of evolving new clinical data.

Disclosure

S. Moshel: Research Support; Self; AstraZeneca. M. Hirsch Vexberg: None. O. Shavit: None. Y. Toledano: None.
Lifestyle Interventions Lower Cardiovascular Disease in Chinese Adults with IGT—Thirty-Year Follow-Up of Da Qing Diabetes Prevention Study
Authors: GONG QIUHONG , ZHANG PING , MA JIXIANG , WANG JINPING , AN YALI , CHENG YILING J. , ZHANG BO , LI HUI , CHEN YANYAN , HU YINGHUA , GREGG EDWARD W. , BENNETT PETER H. , LI GUANGWEI
Published: June 2018

Lifestyle interventions can prevent or delay type 2 diabetes (T2DM) but their long-term effect on cardiovascular disease (CVD) remains unclear. We assessed the effect of lifestyle interventions on the incidence of CVD events among Chinese adults with impaired glucose tolerance (IGT) who participated in the Da Qing Diabetes Prevention Study (DQDPS) and who were followed for up to 30 years after randomization. DQDPS was a 6-year clinical trial conducted in Da Qing, China from 1986 to 1992 in which 576 adults with IGT were randomized by clinic to a control group (138) or one of three lifestyle intervention groups (438) (diet or exercise or both). After the 6-year active intervention, participants were followed to assess their first CVD events until December 31st 2016. CVD was defined as fatal or nonfatal CVD, which included myocardial infarction, congestive heart failure, stroke, and amputation. The intervention effect on CVD was assessed using Cox proportional hazards analysis. 542 (94.1%) of the original participants had data for CVD events. 192 in the combined intervention group and 79 in the control group had a first CVD event during the follow-up. The 30-year cumulative incidence of CVD was 51.8% (95% CI 47.1-56.5) in the intervention group and 65.7% (95% CI 57.8-73.6) in the control group. CVD incidence per 1000 person-years was 21.8 (95% CI 18.8-25.1) in the intervention group compared to 29.0 (95% CI 23.0-36.2) in the control. After accounting for clinic cluster, the intervention reduced the risk of the first CVD event by 27% (HR 0.73, 95% CI 0.55-0.96; p=0.024).Our study is the first to show that a lifestyle intervention program in persons with IGT significantly reduces the incidence of CVD. Our results provide further justification to adopt lifestyle interventions as public health measures to prevent T2DM.

Disclosure

Q. Gong: None. P. Zhang: None. J. Ma: None. J. Wang: None. Y. An: None. Y.J. Cheng: None. B. Zhang: None. H. Li: None. Y. Chen: None. Y. Hu: None. E.W. Gregg: None. P.H. Bennett: None. G. Li: None.
A Population-Based Program Improving Diabetes Care
Authors: MARIOTTO ALDO , MONTE ARIELLA DE
Published: June 2018

Objective: The aim of this study was to evaluate whether implementation of an integrated regional program can be effective in producing improvement in diabetes care.

Methods: Friuli Venezia Giulia is an Italian region accounting for about 1,250,000 population. A diabetic patients register based on administrative databases merging accounted in 2015 for a morbidity prevalence rate of 6.7%. Guidelines on diabetes integrated care were approved by the regional government. They were disseminated through a multifaceted intervention based on training, incentives to family physicians, primary care reorganization, modeling and proactive medicine. The program was assessed through the before-after intervention measure of process indicators. Analysis excluded gestational patients, those who didn’t consent for privacy reasons and those not included in the same family physician administrative list over the study period.

Results: Regionally, significant improvement in 2016 vs. 2015 was observed for all measures. Analysis included 54593 patients. The percentage of patients who received one ore more: A1C test arose from 73.8% in 2015 to 79.1% in 2016 (+7.2%), Microalbuminuria test arose from 44.7% in 2015 to 56.3 in 2016 (+26.0%), Blood Creatinine test arose from 70.7% in 2015 to 76.2% in 2016 (+7.8%), Lipid profile arose from 69.6% in 2015 to 72.6% in 2016 (+4.3%). Those who received at least one Fundus Oculi arose from 42.1% in 2014-2015 to 47.9% in 2015-2016 (+13.8%). Hospital specific diabetes patients admission rate decreased from 342/1000 in 2015 to 328/1000 in 2016 (-4.2%). However, there was significant regional variation among all measures.

Conclusions: The evidence based introduction of an integrated professional and organizational intervention improved adherence to diabetes specific process measures in 2016 compared with 2015 baseline for patients assisted in Friuli Venezia Giulia region. A better integration with hospital care and a partial revision of IT system are needed.

Disclosure

A. Mariotto: None. A. De Monte: None.
Improving the Recognition and Management of Elevated Blood Pressure among Youth with Type 1 Diabetes
Authors: GANDHI KAJAL , BUCKINGHAM DON A. , HEHMEYER JESSICA , KRAMER ALYSSA M. , OBRYNBA KATHRYN , INDYK JUSTIN A. , KAMBOJ MANMOHAN K.
Published: June 2018

Background: Studies show that youth with type 1 diabetes (T1D) harbor cardiovascular risk factors and exhibit clinical signs suggestive of cardiovascular disease. ADA and ISPAD guidelines promote regular blood pressure screening to reduce cardiovascular risk, and strategies should involve effective screening and management. The diabetes clinic previously had limited measures in place to manage T1D youth with elevated blood pressure.

Objective: The aim of this quality improvement (QI) project was to increase provider recognition and follow-up of TID patients with elevated blood pressure readings ≥ 95%tile for age/gender/height, from 0% to 50%, by 12/31/17 and sustain through 12/31/2018.

Methods: After the QI team clarified project goals, a Key Driver Diagram (KDD) and elevated blood pressure process map was established. This algorithm aided to clarify the care process to efficiently recognize and manage youth with T1D who presented with elevated blood pressure in the outpatient diabetes clinic. A “Best Practice Alert” (BPA) was created within the electronic medical record, which alerted the diabetes care team of the presence of elevated blood pressure among T1D patients in clinic. This allowed the provider to choose electronically tracked care options in the medical record to manage elevated blood pressure among T1D patients and coordinate care among subspecialties that manage elevated blood pressure. Data reports were compiled to track utilization of the blood pressure BPA from May 2017 (initiation date) to December 2017 with ongoing data collection.

Results: Upon BPA creation, process mean of the utilization and management of elevated blood pressure BPA among T1D youth increased to 73% over a 7 month period.

Conclusions: This project successfully improved screening and management of T1D youth with elevated blood pressure in the outpatient setting. This project builds on comprehensive diabetes care, with the hope of reducing future cardiovascular burden for youth with T1D.

Disclosure

K. Gandhi: None. D.A. Buckingham: None. J. Hehmeyer: None. A.M. Kramer: None. K. Obrynba: None. J.A. Indyk: None. M.K. Kamboj: None.
Incorporating Depression Screening into Diabetes Clinics across the T1DX Learning Collaborative
Authors: MAJIDI SHIDEH , JOLLY MARY C. , ALONSO GUY T. , BUCKINGHAM DON A. , CABRERA ALYSSA B. , CLEMENTS MARK A. , GARRITY ASHLEY , GIBBS KATE A. , GLICK BETHANY , MING HONG K. , KAMBOJ MANMOHAN K. , LAMBERT KATHRYN L. , LEE JOYCE , NADKARNI PRASHANT V. , MCDONOUGH RYAN , OHMER AMY L. , RIOLES NICOLE , STANEK KELLY R. , THOMAS SARAH , WEINSTOCK RUTH S. , CORATHERS SARAH
Published: June 2018

Objective: Depression contributes to suboptimal health outcomes amongst people with type 1 diabetes (T1D). The ADA standards of care recommend regular psychosocial screening, however these guidelines are not universally implemented.

Aim: Demonstrate feasibility of expanding depression screening across clinics in the national T1D Exchange Learning Collaborative (T1DX-LC) using a quality improvement (QI) approach.

Methods: Six clinics in T1DX-LC participated in bi-monthly calls and three learning sessions for depression screening. Sites shared existing resources and used QI methodology to design iterative plan-do-study-act cycles to develop or refine existing processes and adopt interventions in their respective contexts around the following themes: 1) consistent screening and referral criteria, 2) integration of screening into work flow, 3) acceptance from families and staff, 4) adequate social work and psychology referral resources, and 5) incorporation of health information technology.

Results: Screening increased from baseline of 10% across sites to 60% of eligible patients at all sites over 18 months (Figure).

Discussion: Through the T1DX-LC, a network of centers were successful at completing depression screening in alignment with ADA standards of care. Sites expanded screening to individuals with type 2 diabetes and additional centers are joining the screening intervention.

Disclosure

S. Majidi: None. M.C. Jolly: None. G.T. Alonso: None. D.A. Buckingham: None. A.B. Cabrera: None. M.A. Clements: Speaker's Bureau; Self; Medtronic. Advisory Panel; Self; Glooko, Inc.. A. Garrity: None. K.A. Gibbs: None. B. Glick: None. K. Hong: None. M.K. Kamboj: None. K.L. Lambert: None. J. Lee: Consultant; Self; Unitio. P.V. Nadkarni: None. R. McDonough: None. A.L. Ohmer: None. N. Rioles: None. K.R. Stanek: None. S. Thomas: None. R.S. Weinstock: Research Support; Self; Medtronic MiniMed, Inc., Mylan, Kowa Pharmaceuticals America, Inc., Diasome Pharmaceuticals, Inc., Calibra Medical, Dexcom, Inc., Ultradian Diagnostics LLC., JAEB Center For Health Research, JDRF, National Institute of Diabetes and Digestive and Kidney Diseases. S. Corathers: None.