bluuebunny/crossref_metadata_2025_split huggingface dataset:
885-P: Efficacy of a Telehealth Preventive Cardiology Lifestyle Intervention Program to Treat High-Risk South Asians
Authors: PARAMESWARAN VIJAYA , JOSAN KIRANBIR , KHANDELWAL ABHA , ABBASI FAHIM , DASH RAJESH 
Published: June 2019

Lifestyle intervention programs (LIPs) are effective in reducing cardiometabolic risk in clinical trials, but real world implementation is often limited by time constraints on physician-patient in clinic counseling. We report preliminary results from a telehealth LIP that provides culturally tailored lifestyle recommendations in Nutrition, Exercise, Sleep and Stress reduction for high-risk South Asians.
Methods: The Stanford South Asian Translational Heart Initiative introduced a telehealth LIP that delivers care via video visits in November 2017. Patients ages 20-60 were enrolled and compared to age-matched traditional in-person clinic patients. Both arms included a comprehensive cardiometabolic risk assessment and personalized treatment plan focused on aggressive risk reduction, with a set of 3 cardiologist and 3 dietitian/diabetes educator visits to be completed in 6 months. Individualized counselling was provided in nutrition, role of physical activity and inactivity, sleep hygiene and stress reduction.
Results: Out of 120 enrollees, 37 have the completed program. Telehealth LIP was associated with salutary changes in lifestyle including decreased prolonged sitting time (32/37 87%) and cardiometabolic markers.
Conclusion: The addition of 3 telehealth LIP sessions to a preventive cardiology clinic produces significant improvements in lifestyle behaviors and cardiometabolic risk.

Disclosure
V. Parameswaran: None. K. Josan: None. A. Khandelwal: None. F. Abbasi: None. R. Dash: None.
892-P: Weight Outcomes from a Lifestyle Change Program vs. Usual Care in Real-World Clinical Practice: A Matched-Cohort Analysis
Authors: ROMANELLI ROBERT , HUANG HISAO-CHING , SUDAT SYLVIA , PRESSMAN ALICE , AZAR KRISTEN M. 
Published: June 2019

Background: Translational diabetes prevention lifestyle change programs are efficacious in promoting weight loss in clinical and community settings. However, we are unaware of observational studies examining the effectiveness of such programs in routine clinical practice compared to usual care.
Methods: In this retrospective cohort study, we identified program participants and usual-care patients, ≥18 years of age, in the electronic health records of a large, community-based healthcare system (2010-2017). The first program encounter was defined as baseline for program participants and a random encounter date was assigned as baseline for usual-care patients. All subjects were required to have weight recorded prior to baseline (≤12 months) and 12 months after (±3 months). We estimated propensity scores (ps) as the probability of lifestyle change program participation conditional on baseline characteristics. We then matched program participants to usual-care patients 1:5 on the ps. We measured differences in mean change in weight post baseline and percentage of patients with clinically meaningful (≥5%) weight loss, using regression modeling.
Results: We identified 3,156 program participants, of which 1,783 were matched to 8,188 usual-care patients. Matched groups were well balanced on characteristics (mean age=54 years; 76% women; mean weight=95 kg). Mean percent weight change from baseline was -2.8% and -0.2% among program participants and usual-care patients, respectively (mean diff: -2.6%; 95% CI: -2.9%,-2.3%; P&lt;0.001). Clinically meaningful weight loss was observed in 28% and 15% of program participants and usual-care patients, respectively (odds ratio: 2.2; 95% CI: 2.0, 2.5; P&lt;0.001).
Conclusion: In real-world clinical practice, a lifestyle change program was more effective than usual care in promoting weight loss, with more than a two-fold greater odds of clinically meaningful weight loss among program participants.

Disclosure
R. Romanelli: None. H. Huang: None. S. Sudat: None. A. Pressman: None. K.M. Azar: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases
898-P: CGM Metrics Identify Dysglycemic States in Subjects with Normal OGTT from the TrialNet Pathway to Prevention Study
Authors: WILSON DARRELL M. , NELSON PATRICK , SCHEINKER DAVID , PIETROPAOLO SUSAN , ACEVEDO-CALADO MARIA , EBRAHIMI MAHDI , STECK ANDREA , DUNNE JESSICA L. , GREENBAUM CARLA , PIETROPAOLO MASSIMO 
Published: June 2019

The TrialNet Pathway to Prevention Study (PtP) has enhanced our understanding of the progression through the stages of T1D identifying individuals at early stages of disease for prevention trials. Individuals with multiple islet AAb and normal OGTT are considered to be at Stage 1 T1D, and those with abnormal OGTT are at Stage 2 T1D. Our aim was to determine whether subtle forms of dysglycemia provide new clues about disease progression (Stage 3). 94 relatives of T1D probands from PtP underwent a 7-day CGM assessment (Dexcom G4 Platinum Professional) Three groups of relatives were evaluated: 1) Relatives at Stage 2 T1D whose 5-year risk for T1D progression is ∼70% (n=33); 2), relatives at Stage 1 T1D whose 5-year risk for T1D progression is ∼ 35% (n=51); and relatives with negative confirmed AAb and normal OGTT (n=10) whose 5-year risk for progression is &lt;1%. CGM variations occur in a significant number of subjects with Stage 1 T1D (Figure) with increased variation in CGM glucose values assessed by mean amplitude of glucose excursion (MAGE) in relatives (n= 4 Stage 0; 31 Stage 1; and 27 Stage 2) at Stage 1 and Stage 2 T1D compared to that of low risk relatives (P = 0.005). Interstitial glucose &gt;140 mg/dL was higher in relatives at Stage 1 and Stage 2 T1D compared to low risk relatives (P = 0.02).
In conclusion, CGM metrics may be useful in identifying dysglycemia in at risk relatives with normal OGTT.

Disclosure
D.M. Wilson: Advisory Panel; Self; Tolerion, Inc. Research Support; Self; Beta Bionics, Dexcom, Inc., Medtronic. P. Nelson: None. D. Scheinker: Advisory Panel; Self; Carta Healthcare. S. Pietropaolo: None. M. Acevedo-Calado: None. M. Ebrahimi: None. A. Steck: None. J.L. Dunne: None. C. Greenbaum: Research Support; Self; Janssen Research & Development. M. Pietropaolo: None.

Funding
National Institutes of Health
9-OR: Cost Effectiveness of the New 2018 ACP Glycemic Control Guideline among U.S. Adults with Type 2 Diabetes
Authors: SHAO HUI , LAXY MICHAEL , GREGG EDWARD , ZHANG PING 
Published: June 2019

The American College of Physicians (ACP) issued a new guideline on A1c targets for adults with type 2 diabetes in 2018, with potential implications for the long-term health and economic outcomes. We evaluated the cost-effectiveness (CE) of the new ACP guideline. Based on the ACP recommendation, 3 groups of patients would be affected by the new guidelines: (1) persons with A1c level &lt;6.5% under antidiabetes medication other than metformin would de-intensify to a target level of 7.0%-8.0%, (2) those with A1c levels of 7.0%-8.0% and life expectancy &lt;10 years would de-intensify to targets level of &gt;8.0%; and 3) persons with a A1c level of &gt;8.0% and life expectancy &gt; 10 years would intensify to a A1c target level of 7.0%~8.0%. The CDC-RTI diabetes simulation model was used to estimate the long-term health/cost consequence of changes in A1c targets, compared with a status of quo. Data from the 2011-2016 National Health and Nutrition Examination Survey and the 2017 Census were used to estimate the numbers of persons in each of the three group. The incremental cost-effectiveness ratio (ICER), measured in cost per quality adjusted life year (QALY), was used to measure the CE in 2017 USD. Implementing the new guideline would result in 243,524 fewer cardiovascular events, 1.38 million QALYs gained and an increase of 3.6 billion dollars in healthcare expenditure nationwide (ICER: $2,367 per QALY). ACP recommendations were cost-effective over status quo in all 3 subgroups using $50,000 threshold: treatment de-intensification saves $8,656 at a cost of 0.122 QALY for individuals with life expectancy &lt;10 years (3.4 million persons), and saves $8,169 at a cost of 0.058 QALY for individuals with A1c &lt;6.5% (3.17 million persons). Intensifying treatment for those with an A1c &gt;8.0% (5.16 million persons) costs additional $11,454 with 0.38 QALY gain. Results are robust according to multiple sensitivity analysis. We conclude that the new ACP glycemic guideline is cost-effective among adult U.S. population with diabetes.

Disclosure
H. Shao: None. M. Laxy: None. E. Gregg: None. P. Zhang: None.
900-P: Long-Term Effectiveness of a DPP for Prediabetic Hispanic Women
Authors: SHAH PALAK D. , FEINN RICHARD , ROCKFELD JENNIFER , CAMP ANNE W. 
Published: June 2019

The prevalence of type 2 diabetes(T2DM) in Hispanic Americans, at 22.6%, is twice that of non-hispanic whites. The NIDDK Diabetes Prevention Program (DPP) showed that an intensive lifestyle intervention can reduce the incidence of T2DM by 58% in many ethnic/racial groups. The DPP at Fair Haven Community Heath Care (FHCHC) in New Haven, CT is a modified NIDDK/CDC DPP which aims to promote weight loss, physical activity and reduced incidence of T2DM among Hispanic patients. A previous randomized controlled study showed that female participants in this DPP benefited with decreased weight, lower glucose excursions and improved fasting insulin one year after enrolling compared to controls. The purpose of this follow-up study is to assess the long-term effectiveness of the FHCHC DPP.
Methods: This study took place at FHCHC after obtaining IRB approval. A retrospective chart review was conducted comparing participants randomly assigned to the DPP with those assigned to control group. Measures abstracted included fasting glucose, 2-hour OGTT, HbA1c, lipids, blood pressure, BMI and medications from all medical visits between the date of enrollment and October 2018.
Results: All 66/66 original subjects in the DPP intervention group as well as 66/66 controls had clinical data beyond 1 year. An average of over 7 years follow-up was available for analysis. ANCOVA test comparing change of weight from baseline to specific time periods showed a significant difference between groups in change from baseline to year 1 of 20.86 lbs. (p=.001), change to year 2 and 3 of 13.8 lbs. (p=.004), but not year 4 and 5 of 11.3 lbs. (p=.067) or year 6+ 10. 0 lbs. (p=.163). There was no statistically significant difference between the two groups in fasting glucose, two-hour glucose tolerance test, or HbAlc.
Conclusion: Weight loss shown after 1 year of the FHCHC DPP was sustained at years 2 and 3 but not at years 4 through 7. HbA1C, two-hour glucose, and fasting glucose were not significantly different between groups after the first 1 year.

Disclosure
P.D. Shah: None. R. Feinn: None. J. Rockfeld: None. A.W. Camp: None.
902-P: Effectiveness of Evidence-Based Diabetes Prevention Program in Adults at High Risk of Developing Type 2 Diabetes: A Systematic Review and Meta-analysis
Authors: WECHKUNANUKUL KANNIKAR H. , BENTON FIONA , MCGILL JOSEPHINE , ULLAH SHAHID 
Published: June 2019

Objective: This systematic review aimed to establish a specific evidence-base of diabetes prevention programs for adults at high risk of developing type 2 diabetes (T2D) based on either the Diabetes Prevention Program (DPP) or the Finnish Diabetes Prevention Study (DPS).
Methods: The bibliographic databases: Medline, Ovid, Embase, CINAHL, Scopus, Web of Science, Joanna Brigg Institute Library, Cochrane Central Register of Controlled Trials, and grey literature were searched for published articles in the English language from January 1996 to December 2018. This review included only RCTs conducted in community settings focusing on adults at high risk of T2D, utilizing an intervention based on either the DPP or DPS and measuring the incidence of T2D as an outcome.
Results: Of 4,964 identified records, eight studies met all inclusion criteria and were suitable for meta-analysis. The meta-analysis revealed positive effects of programs based on either DPP or DPS on prevention T2D in adults at high risk. The pooled incidence rate of T2D in the intervention group was 47% lower than those in the control group (95% CI 9%, 69%). Attending lifestyle change program achieved a pooled mean weight loss of 2.10 kg (95% CI -3.45, -0.74) which was significantly higher than those of the control group. Data in physical activity, dietary and HbA1c were not commonly reported. Although the feasibility of the prevention program was established, this review found a lack of data in enablers and barriers in implementing a diabetes prevention program.
Conclusion: The effectiveness of T2D prevention program based on either the DPP or DPS delivered in community settings is evidenced, and the reduction in cumulative incidence of T2D was reported. Nonetheless, further research on enables and barriers associated with increasing physical activity and improving healthy eating is warranted to help sustain the optimal outcomes of the pragmatic diabetes prevention program.

Disclosure
K.H. Wechkunanukul: None. F. Benton: None. J. McGill: None. S. Ullah: None.
91-LB: Ongoing Requirements for SMBG Testing among isCGM Users
Authors: PRICE DAVID A. 
Published: June 2019

Some factory-calibrated continuous glucose monitoring (CGM) systems are approved for non-adjunctive use, although these systems require adjunctive self-monitored blood glucose (SMBG) tests in specific instances. We estimated how often users of an intermittently-scanned CGM (isCGM) system might be required to perform SMBG testing. Criteria under which an adjunctive SMBG test is required were obtained from the U.S.-specific 14-day isCGM user guide (Figure). Real-world glucose values were obtained from a random sample of 10,000 adults (ages 18+) who used Dexcom G6 real-time CGM at least 90% of the time for at least 14 days between 7/1/2018-9/30/2018. The percentage of values meeting one or more of the criteria for mandatory SMBG testing was calculated as hours per day. Glucose readings were changing &gt; 2 mg/dL/min a mean (SD) of 1.34 (0.77) hours/day, predicted to be &lt; 70 mg/dL within 15 minutes for 1.03 (0.95) hours/day, and &lt; 70 mg/dL for 0.67 (0.79) hours/day; one or more of these criteria were present for 2.35 (1.30) hours/day. Added to the 0.86 hour/day warmup period, SMBG testing would be indicated for an isCGM user for an average of 3.20 (1.30) hours/day. This may be a conservative estimate as the isCGM label demonstrates that the system overestimates hypoglycemia. Users of the isCGM system are likely to confront multiple intervals during which SMBG is required and reliance on their isCGM glucose values for diabetes management decisions is contraindicated.

Disclosure
D.A. Price: Employee; Self; Dexcom, Inc. Stock/Shareholder; Self; Johnson & Johnson.
918-P: Real-World Association of Glucose Monitoring Frequency and Glycemic Metrics in the United States
Authors: WRIGHT EUGENE , VIRDI NAUNIHAL , DUNN TIMOTHY 
Published: June 2019

Global data from real world use of flash glucose monitoring have correlated higher frequency of scanning with better glycemic control. Because flash glucose monitoring became available in late 2017 in the United States, U.S. data was not captured in the early global flash glucose monitoring analysis. The objective of this study was highlight real world outcomes in patients using flash glucose monitoring in the U.S.
A server collected deidentified data from patients who uploaded their flash glucose monitoring system readers. Data from patients within the U.S. were analyzed through September 2018. Individuals were divided into 10 equal sized groups based on scanning frequency. Average time in range (70- 180 mg/dL) and time above range 180 mg/dL was calculated for each group.
This analysis includes 21,853 readers, 115,221 sensors, and 102 million glucose values with an average of 9 scans per day. Patients in the lowest scanning frequency decile (3.4 scans per day) had 55% time in range and 41% time above. Patients in the highest scanning frequency decile (30.7 scans per day) had 74% time in range and 21% time above. This represents a 49% reduction in the time above target and a 34% increase in the time in range.
Real world data from U.S. shows how frequency of scanning correlates with time in range and hyperglycemia. This analysis is consistent with prior analyses concluding that patients with diabetes who monitor their glucose more frequently derive greater benefit than patients who monitor less frequently.

Disclosure
E. Wright: Advisory Panel; Self; Abbott, Sanofi US, Voluntis USA. Consultant; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker's Bureau; Self; Eli Lilly and Company. Other Relationship; Self; American Diabetes Association, Medscape, UpToDate. N. Virdi: Employee; Self; Abbott, Proteus Digital Health. Stock/Shareholder; Self; Johnson & Johnson. T. Dunn: Employee; Self; Abbott Laboratories.
92-OR: Using Bispecific Monoclonal Antibody to Reprogram the Development of Type 1 Diabetes
Authors: CEPEDA JOSEPH RAY , SEKHAR NITIN SESHADRI , HAN JUNYING , ZHANG NINGYAN , PIETROPAOLO MASSIMO , ZHANG LI 
Published: June 2019

Background: In NOD mice, insulin B:9-23 peptide bound to I-Ag7 in an energy unfavorable register 3 (R3) forms the antigenic I-Ag7/B:9-23(R3) complex. Previously we demonstrated that I-Ag7/B:9-23(R3) specific monoclonal antibody mAb287 delayed T1D. Subsequent studies indicate that the IAg7/B:9-23(R3) complex contain two epitopes termed p8E and p8G epitopes. MAb287 binds to the p8E epitope but has a very low affinity to the p8G epitope. In the present study, we assessed whether a new antibody targeting both epitopes enhances disease protection efficacy.
Methods: We immunized young NOD mice with IAg7/B:9-23(R3) p8E and IAg7/B:9-23(R3) p8G proteins alternatively, and generated a new clone Ab757. We then tested the binding affinity of Ab757 to both epitopes and treated NOD mice with this antibody or control antibodies starting from the pre-insulitis or established-insulitis stages monitored the development of T1D.
Results: 1) MAb757 exhibits high binding affinity to both p8E and P8G epitopes, and it suppresses in vitro both p8E and p8G reactive T cells. 2). Compared to mAb287 targeting only one epitope, mAb757 shows significantly enhanced T1D protection. MAb757 injection protected 70% of recipient mice from diabetes (p&lt;0.001 compared to control antibody treatment or mAb287) when treatment was initiated at 4 weeks (pre-insulitis) or 9 weeks of age (established insulitis stage). We previously reported that mAb287 conferred mild T1D protection (35%), but such weak protection was not observed in a repeated experiment. 3). MAb757 treatment significantly delayed the time and the severity of lymphocyte infiltrating islets assessed by immunocytochemical and flow cytometry analysis.
Conclusion: Bi-specific antibody treatment targeting two epitopes within the I-Ag7/B:9-23(R3) complex is a safe approach that significantly suppresses islet autoimmune responses and in turn protects mice from progressing to overt T1D.

Disclosure
J. Cepeda: None. N.S. Sekhar: None. J. Han: None. N. Zhang: None. M. Pietropaolo: None. L. Zhang: None.

Funding
JDRF
920-P: Flash Glucose Monitoring (FGM) in Real-Life: 18-Month Clinical Experience
Authors: RODIA COSIMO , BIANCHI CRISTINA , BERTOLOTTO ALESSANDRA , GIANNARELLI ROSA , CAMPI FABRIZIO , PRATO STEFANO DEL , ARAGONA MICHELE 
Published: June 2019

Background: FGM is less invasive than traditional glucometer. Recent studies show benefits on glycemic control and frequency of hypoglycemia, both in type 1 and type 2 diabetes. Nonetheless, experiences on the impact of this technology in the clinical setting are still scantly reported.
Aim of the Study: To verify impact of FGM on glycemic control in type 1 diabetes subjects (T1DM). Patients and Methods: From January 2017 to December 2018, 397 T1DM subjects (age 43±13 years; diabetes duration 21±13 years; MDI 81%, CSII 19%; BMI 25.4±4.8 Kg/m2; Insulin Requirements (IR) 44±21 U/day; 8 episodes of severe asymptomatic hypoglycemia in the previous 6 months; 3 ketoacidosis; Test strips: 158± 28/month) were started on FGM. A 6-month follow-up (FU) was available for 350 subjects, 204 had a 12-month FU and 39 18-month FU.
Results: Out of 397 subjects, 18 discontinued (patch allergy: 4; inaccuracy: 5; switched to other devices: 3). In 6-month FU patients, HbA1c declined from 58±14 to 56±12 mmol/mol (p&lt;0.00001). The improvement was more apparent in MDI (n=271; from 59±15 to 56±12 mmol/mol, p &lt;0.0001) than in CSII (n=79, 57±11 to 55±10 mmol/mol, p=0.14). In 12-month FU patients (n=204), basal, 6, and 12 month HbA1c was 58±14, 56±12 (p=0.04) and 56±12 mmol/mol (p =0.004) also more apparent with MDI (n=152, 59±14, 57±13 - p=0.05, and 56±12 mmol/mol - p&lt;0.0009) than with CSII (n=52, 56±11, 55±10, 56±9 mmol/mol, p=NS). In 18-month FU subjects (n=35) basal, 6, 12 and 18-month HbA1c were 58±11, 56±10 - p=0.06, 56±9 - p=0.19, 55±9 mmol/mol - p =0.03). In multivariate analysis, HbA1c reduction was not correlated with disease duration, age, and baseline HbA1c.In the whole cohort there was 1 episode of severe asymptomatic hypoglycemia and 2 of ketoacidosis in the CSII group.
Conclusions and comments: In our clinical practice, FGM was associated with small but significant reduction in HbA1c (particularly for patient on MDI) and severe asymptomatic hypoglycemia.

Disclosure
C. Rodia: None. C. Bianchi: None. A. Bertolotto: Speaker's Bureau; Self; Abbott, Lilly Diabetes. R. Giannarelli: None. F. Campi: None. S. Del Prato: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi, Servier, Takeda Pharmaceutical Company Limited. Board Member; Self; AstraZeneca. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. M. Aragona: None.
927-P: Use of Mobile-Enabled Reminders Feature Is Associated with Improved Behavioral and Glycemic Outcomes in the Real World
Authors: ABAD JUAN RICARDO CARLOS , SHENG TONG , BABIKIAN SARINE , GREENFIELD MICHAEL 
Published: June 2019

In the real-world, lifestyle and environmental barriers can adversely impact self-management of diabetes. Emerging health technologies such as mobile diabetes management apps can potentially help people with diabetes navigate such barriers with features like reminders for self-monitoring blood glucose (SMBG) checks and medications. While such features are designed to help people with diabetes improve the structure and adherence of SMBG and medication regimens, real-world evidence of their effectiveness have been inconclusive. In the current study, we assessed whether the use of reminders features corresponded with improved behavioral and glycemic outcomes in the real world. We compared the distributions of SMBG check rates, and low (&lt;70 mg/dL), in-range (between 70-180 mg/dL), and high SMBG readings (&gt;180 mg/dL) between users of a mobile diabetes management app who had set up reminders and app users who did not (n=500 in each sample, balanced by age, gender, and app use duration). Two-sample Kolmogorov-Smirnov tests showed that app users with reminders performed more frequent SMBG checks (D=.20, P&lt;.001), had more in-range readings (D=.096, P=.020), and had fewer high readings (D=.086, P=.049) than users without reminders. No difference was observed in the distributions of low readings, though a trend may be present (D=.084, P=.059). These findings indicate that mobile-enabled reminders can contribute to improved SMBG behavior and glycemic outcomes in the real world. As mobile health/digital therapeutic tools (and their ever-growing features/capabilities) continue to evolve, patients and clinicians have reason for optimism that such tools can improve diabetes management and reduce burden.

Disclosure
R. Abad Juan: Employee; Self; Glooko, Inc. T. Sheng: Employee; Self; Glooko, Inc. S. Babikian: None. M. Greenfield: Stock/Shareholder; Self; Glooko, Inc.