bluuebunny/crossref_metadata_2025 huggingface dataset:
880-P: Polypharmacy Is Not Associated with Emotional Distress in Adults with Type 2 Diabetes
Authors: SOLON CARLY A. , SEARS MALKA Z. , HOOGENDOORN CLAIRE J. , SENG ELIZABETH K. , MARGOLIS SETH A. , GONZALEZ JEFFREY S.
Published: June 2019

Aim: Polypharmacy, depression, and disease-specific distress are prevalent in type 2 diabetes (T2D). Polypharmacy may add to the emotional burden of treatment. Our group previously showed that insulin use is linked with increased distress; however, few studies have examined polypharmacy in relation to mental health in T2D. The present study examined cross-sectional relationships between the number of medications and emotional distress in a T2D sample.

Method: Adults with T2D (N=120, age=56(9.7), 64% female, 25% Hispanic/Latino) self-reported medication regimens and diabetes distress; depression was assessed by clinical interview. Due to severely skewed and kurtotic outcome variables, we used logistic regression with emotional distress dichotomized at clinical cutoffs. Independent relationships were assessed between the total number of medications (oral + insulin) and emotional distress, adjusting for age, sex, presence of diabetes complications, and insulin (yes/no). The moderating effect of insulin was examined.

Results: Number of prescribed medications (M=6.5(3.8)) was not associated with depression (OR=1.09 [95% CI: 0.97-1.21]), diabetes (OR=0.97 [95% CI: 0.88-1.07]) or regimen (OR=0.97 [95% CI: 0.88-1.08]) distress. In multivariate models, age was negatively associated with higher odds of depression (OR=0.95 [95% CI: 0.91-0.99]), diabetes (OR= 0.95 [95% CI: 0.91-0.99]) and regimen (OR=0.94 [95% CI: 0.90-0.99]) distress. Diabetes complications were associated with 3.08-fold increased odds (95% CI: 1.28-7.40) of depression. Insulin use did not moderate the relationship between number of medications and emotional distress.

Conclusion: The number of prescribed medications was not associated with depression or diabetes distress, suggesting that polypharmacy alone does not account for psychological aspects of perceived disease burden. As age was a notable predictor, younger individuals may be at more risk for the negative psychological impact of T2D and its treatment.

Disclosure

C.A. Solon: None. M.Z. Sears: None. C.J. Hoogendoorn: None. E.K. Seng: Consultant; Self; Eli Lilly and Company, GlaxoSmithKline plc. Other Relationship; Self; Haymarket Media. S.A. Margolis: None. J.S. Gonzalez: None.
882-P: Overcoming Family and Cultural Challenges for Chinese American Patients with Diabetes: Provider Guidelines
Authors: CHESLA CATHERINE A. , CHUN KEVIN M. , KWAN CHRISTINE M.
Published: June 2019

Despite unique cultural beliefs regarding health and family roles for Chinese immigrants, limited clinical guidance is available for primary care providers to addresses T2DM in this population. Our aim was to articulate cultural and family challenges in T2DM and detail clinical guidance for clinicians.

Method: As part of a CBPR intervention trial, interdisciplinary Chinese and American researchers, community partners, and a Chinese American CAB created clinical recommendations based on: a) evidence on Chinese health beliefs and practices, b) prior interpretive study of this population by our research team and c) practical clinical wisdom of community partners: a Community Health Center and a historically significant social service agency serving new Chinese immigrants.

Results: A structured clinical guideline (in Chinese and English) highlighted cultural and family challenges to T2DM management, and potential provider responses. Cultural health challenges included (partial list): Chinese health metaphors centered on balance versus control; dietary preferences that contradicted diabetes diets; respect for authority inhibiting querying health providers; face concerns constraining illness disclosure and family support requests; communal concerns that prioritized relationships over diabetes adherence; and preferences for authoritative versus collaborative health care approaches. Provider guidelines included: employing Chinese health metaphors (balance); highlighting self-care as a form of family care; flexibly providing both directive medical advice and encouraging patient agency, and normalizing diabetes as a chronic but not disabling condition. Dissemination of guidelines to local primary care clinics has been positively reviewed.

Implications: Caring for ethnically diverse populations is demanding for diabetes providers and evidence-based guidelines for culturally tailored care is warranted.

Disclosure

C.A. Chesla: None. K.M. Chun: None. C.M. Kwan: None.

Funding

National Institute of Nursing Research (R01NR009111)
884-P: Mi Puente: A Care Transitions Intervention for At-Risk Hispanics with Multiple Cardiometabolic Conditions
Authors: BRAVIN JULIA I. , ANDERSON MICHELLE L. , CLARK TAYLOR , SAVIN KIMBERLY L. , LEDESMA DUVIA LARA , EUYOQUE JOHANNA A. , FORTMANN ADDIE L. , PHILIS-TSIMIKAS ATHENA , GALLO LINDA
Published: June 2019

Hispanics are disproportionately affected by chronic cardiometabolic conditions (e.g., obesity, diabetes). Unmet behavioral health needs (e.g., mental health problems, stress, lack of health care) contribute to these disparities. Sustainably reducing Hispanic health disparities demands innovative, cost-effective interventions that address both behavioral and physical health. A randomized controlled trial is underway to evaluate Mi Puente - i.e., a Behavioral Health Nurse (BHN) + volunteer Community Mentor (CM) intervention designed to reduce readmissions in N = 560 Hispanics with ≥ 2 cardiometabolic conditions and ≥ 1 behavioral health concern(s) hospitalized at a safety-net hospital near the U.S./Mexico border in San Diego, CA. Qualifying patients at high-risk for readmission are identified via automated electronic medical record reports. The BHN triages patients’ needs, provides education, and conducts tailored coaching and goal-setting. Post-discharge, the BHN conducts telephone follow-up at 1-week, and CMs provide referrals to community resources and transition support via phone for up to 1-month. Prevalent behavioral health concerns were: chronic stress (52.5%), health-related distress (37.3%), and lack of routine medical care (19.8%). Preliminary process data indicated that the BHN met with 82.5% of participants prior to discharge; challenges related to medication adherence (28.7%) and access to outpatient care (41.1%) were common. Approximately 80% received ≥1 CM phone call (M = 1.7± 1.1); the transition home and follow-up appointment(s) were frequently addressed (both 97.9%). Findings reveal high levels of unmet behavioral health needs among hospitalized Hispanics, and the feasibility of a sustainable, low-cost, team model that builds upon personnel commonly found in hospital settings - i.e., nurses and volunteers. Important “lessons learned” will be presented to inform future care transitions programs in high-risk, underserved groups.

Disclosure

J.I. Bravin: None. M.L. Anderson: None. T. Clark: None. K.L. Savin: None. D. Lara Ledesma: None. J.A. Euyoque: None. A.L. Fortmann: None. A. Philis-Tsimikas: Advisory Panel; Self; AstraZeneca, Lilly Diabetes, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Dexcom, Inc., Glooko, Inc., National Institute of Diabetes and Digestive and Kidney Diseases. Stock/Shareholder; Spouse/Partner; Ionis Pharmaceuticals, Inc., Novo Nordisk Inc. L. Gallo: None.

Funding

National Institutes of Health
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<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<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 <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 >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 <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 <10 years would de-intensify to targets level of >8.0%; and 3) persons with a A1c level of >8.0% and life expectancy > 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 <10 years (3.4 million persons), and saves $8,169 at a cost of 0.058 QALY for individuals with A1c <6.5% (3.17 million persons). Intensifying treatment for those with an A1c >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 > 2 mg/dL/min a mean (SD) of 1.34 (0.77) hours/day, predicted to be < 70 mg/dL within 15 minutes for 1.03 (0.95) hours/day, and < 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<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<0.00001). The improvement was more apparent in MDI (n=271; from 59±15 to 56±12 mmol/mol, p <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<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 (<70 mg/dL), in-range (between 70-180 mg/dL), and high SMBG readings (>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<.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.
928-P: Capturing Clinical Trends and Lifestyle Behaviour Data of Patients with Diabetes Using an AI-Powered Digital Therapeutic in India
Authors: CHAWLA RAJEEV , KRISHNAKUMAR ARJUN , KHATRY VARSHA , SHAH ABHISHEK , JOSHI SHILPA , PARDIWALA BEHRAM , KOLKE SHARAT , SHAH VIKRANT , IDNANI ROMMEL , MATTOO VINOD
Published: June 2019

Background: Diabetes self-reported clinical and lifestyle journey by the patient is very poor in India, unless significant additional time is spent by HCPs during appointments. We explored the use of an iPDM (integrated personalized self-management) to amplify self-reported data, without adding any additional time burden to the HCP.

Method: Wellthy Care™ (WC) is a digital therapeutic that delivers an artificial intelligence (AI) augmented disease management program for people with diabetes. In this case, WC was given as a companion to Accu-Chek® Active. WC provides coaching in the form of lessons and quizzes, and uses an AI-based digital persuasion model to encourage users to self-report data on blood glucose, weight, meals, and physical activity, with active feedback on each data point. WC also tracks the duration of physical activity through inbuilt sensors on the phone.

Results: At the time of analysis, a total of 883 users (72.71% males) with an average age of 45.41 years, and an average duration of 30.87 days on the app were available for evaluation. There were a total of 7927 interactions, including 3700 logs and 4207 pieces of content consumed by the users. The users reported a total of 2184 blood sugar logs (499 fasting, 674 pre-meal, 755 post-meal, 256 random), 628 meal logs, 396 activity logs, and 232 weight logs.The average total, fasting, pre-meal, post-meal, and random blood glucose levels were 159.41, 137.8, 144.00, 179.17, and 181.74 mg/dL respectively. The average HbA1c (%), weight, and daily physical activity of the users was 8.64, 74.21 Kg, and 23.94 minutes respectively.

Conclusion: The results confirm Wellthy Care amplifies self-reporting of clinically relevant data by users, without any additional time spent by the treating HCP. An iPDM can be used in resource constrained countries like India to enable the practice of data-driven decision making for personalizing evidence-based care and improving diabetes self-management.

Disclosure

R. Chawla: None. A. Krishnakumar: Employee; Self; Wellthy Therapeutics. V. Khatry: Employee; Self; Roche Diabetes Care. A. Shah: Stock/Shareholder; Self; Wellthy Therapeutics. S. Joshi: None. B. Pardiwala: None. S. Kolke: None. V. Shah: None. R. Idnani: None. V. Mattoo: Consultant; Self; Wellthy Therapeutics.
933-P: Overnight vs. Continuous Long-Term Closed-Loop Control: Patient-Reported Experiences
Authors: SHEPARD JACLYN , GONDER-FREDERICK LINDA , BROWN SUE A. , KOLLAR LAURA L. , EMORY EMMA , KOVATCHEV BORIS
Published: June 2019

Objective: To evaluate patient experience and preference of overnight vs. continuous long-term (LT) use of closed-loop control (CLC).

Methods: Ten participants (50% female) with T1D diagnosed for ≥1 year participated in the study, with a mean age of 38.0 years, diabetes duration of 15.7 years, and pre-study HbA1c of 7.5% or 58 mmol/mol. The CLC system is comprised of a CGM and a closed-loop control algorithm embedded on an insulin pump. Participants used the system overnight (ON) for 8 weeks and continuous (24/7) use for another 8 weeks. Semi-structured interviews, based on Technology Acceptance Model, were completed after each condition. As part of the interviews, participants rated difficulty, complexity, trust, and LT use probability on a 5-point Likert scale (1 - not at all, 5 - extremely). They also rated utility of the system in BG management, whether benefits outweigh barriers, and system preference on a nominal scale.

Results: Means for the CLC-ON were Difficulty - 1.1, Complexity - 1.25, Trust - 4.6, and Probability of LT Use - 4.1, while means for CLC-24/7 were Difficulty - 1.1, Complexity - 1.1, Trust - 4.5 and Probability of LT Use - 5.0. There were no differences between conditions with the exception of a trend to prefer long-term use of continuous CLC. All participants reported that CLC-ON and CLC-24/7 made it easier to manage their diabetes and that benefits of using CLC, both overnight and 24/7, outweigh drawbacks. All reported preference for using CLC-24/7 on a LT basis compared to CLC-ON. Only one participant (10%) indicated intention to use different systems based on situation.

Conclusions: Participant-reported experiences with the CLC system were generally consistent for overnight and 24/7 use. The majority did not find the system difficult or complex, found it useful in managing their diabetes, and had high trust in the system. However, for LT adoption, there was a clear preference to use CLC on a continuous basis despite perceived ease of use, utility, and trust in the system overnight.

Disclosure

J. Shepard: None. L. Gonder-Frederick: Employee; Self; HFS-Global. Research Support; Self; Dexcom, Inc., Jaeb Center for Health Research, Tandem Diabetes Care. Speaker's Bureau; Self; Diabetes UK. Stock/Shareholder; Self; BeHealth Solutions. S.A. Brown: Research Support; Self; Ascensia Diabetes Care, Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care. L.L. Kollar: None. E. Emory: None. B. Kovatchev: Advisory Panel; Self; Sanofi. Board Member; Self; TypeZero Technologies, Inc. Consultant; Self; Sanofi, Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker's Bureau; Self; Dexcom, Inc. Stock/Shareholder; Self; TypeZero Technologies, Inc. Other Relationship; Self; Johnson & Johnson, Sanofi.

Funding

National Institutes of Health
934-P: Continuous, Quantitative, Selective, Nonenzymatic Glucose Monitoring Using Conductimetric Analysis
Authors: WANG BING , PENNATHUR SUMITA , CHOU KUANG-HUA
Published: June 2019

Commercially available continuous glucose monitors (CGMs) typically use electrochemical sensing methods and depend on the activity of enzymes, which is subject to drift with time. Newly developed optical CGMs also suffer from drift due to the photobleaching of the fluorescent dyes. Accordingly, existing CGMs must be calibrated over periods of hours to days. Here we developed a new molecule that can be used to sense glucose concentration through conductivity sensing. The new recognition molecule binds glucose with a suitable affinity (Kd = 1 mM) and selectivity, and hosts negative charges in physiological conditions after binding with glucose. The glucose binding and charge change alters the charge spices which contribute to the conductivity of solution. Glucose concentration therefore determines the conductivity of solution. We use a conductimetric method based on low voltage AC (∼20 mV) impedance spectroscopy which offers the promise of long-term stability. Current conductimetric sensors shall be interpreted with selective permeable membrane systems and would be used to monitor sampled fluid soon. This sensor does not need expensive enzyme and fluorescent dyes, and the preparation of the novel molecule is easy and low cost. The sensing strategy only uses low voltage power, and thus is more stable than enzymatic and optical methods, providing the possibility of less or no calibration. Our current conductimetric sensors are compatible with the well-developed high frequency AC microchip technology, which makes it lower-powered and easy to be miniaturized.

Disclosure

B. Wang: None. S. Pennathur: Board Member; Self; Laxmi Therapeutic Devices. Consultant; Self; Alveo Technologies. K. Chou: None.

Funding

American Diabetes Association (1-17-VSN-18 to S.P.)
935-P: Identification of Characteristic Daily Glucose Excursions Associated with Triopathy in Adults with Type 1 Diabetes
Authors: MAEDA YASUTAKA , MORITA MAYUKO , TAMURA AYUMI , TAKASU KYOKO , KUROGI YUKIE , NIMURA IKUMI , YOSHIOKA RIE , MINAMI MASAE
Published: June 2019

Daily glucose profile (DGP) involves various factors contributing to diabetic complications: diet, physical activity, insulin dose, social context and stressors. We aimed to identify specific DGPs susceptive to microvascular complication in T1D, exploring endpoint-oriented CGM metrics.

First, cluster analysis with 5,584 pooled DGPs from 102 T1D subjects detected 4 major clusters characterized as aligned control (A), biphasic dysglycemia (B), continuous nocturnal hyperglycemia (C) and dyscontrol (D) (Figure 1). The presence of neuropathy and nephropathy was significantly associated with the increase of cluster B (+76%, p=0.002) and C (+69%, p=0.002), respectively.

Next, we determined metric ∫B/∫C as the integration of loge (glucose excursions from 70-180 mg/dL):0-12am/:0-6am to represent cluster B/C. To evaluate ∫B/∫C, the retrospective study investigated 18,457 DGPs from 231 adults with T1D (steroid users and available DGPs <10 days were excluded; age 21-78, female 68%, A1c 5.5-12%). The higher ∫B/∫C (Q4) were independent risk factors for retinopathy (OR=3.18), neuropathy (OR=4.69) and the increase of albuminuria (t=2.11) after adjustment for age, gender, duration, smoking, BMI, A1c, HT, HL and T. bilirubin.

New CGM metrics ∫B/∫C derived from vulnerable DGP clusters may support risk assessment and early intervention for diabetic complications.

Disclosure

Y. Maeda: Research Support; Self; Abbott, Arkray, Inc. Speaker's Bureau; Self; Abbott, Arkray, Inc., Astellas Pharma Inc., AstraZeneca, Daiichi Sankyo Company, Limited, Eli Lilly and Company, Kissei Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Terumo Medical Corporation. M. Morita: None. A. Tamura: None. K. Takasu: None. Y. Kurogi: None. I. Nimura: Speaker's Bureau; Self; Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Taisho Pharmaceutical Co., Ltd. R. Yoshioka: None. M. Minami: Speaker's Bureau; Self; Abbott, Eli Lilly and Company, Medtronic, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Terumo Medical Corporation.

Funding

Kondou Kinen Medical Foundation
937-P: Self-Reported Acute Psychological Stress Is Associated with CGM-Based Hyperglycemia in Type 1 Diabetes
Authors: DADLANI VIKASH , PINSKER JORDAN E. , KUMARI KANCHAN , ANDRE CAMILLE C. , CESCON MARZIA , REID COREY , MCCRADY-SPITZER SHELLY K. , THAPA PRABIN , CHURCH MEI MEI , CHOUDHARY DIVYA , DOYLE FRANCIS J. , DASSAU EYAL , KUDVA YOGISH C.
Published: June 2019

Objective: There have been no clear data describing the association between acute psychological stress and glycemic variability (GV) in people with type 1 diabetes (T1D). Patients self-report that acute stress leads to hyperglycemia.

Methods: Twenty adults with T1D on CGM augmented insulin pump completed self-reported psychological stress diaries for a period of 5 weeks at 2 clinical research centers. Participants reported intensity of stress on a 7-point scale, with 1 indicating mild stress and 7 severe stress, and duration of each stress episode. CGM data were analyzed for week 1 and week 5.

Results: Baseline characteristics were age 44.9±15.0 years, F/M 12/8, HbA1c 6.8±0.7%, and diabetes duration 22.9±15.9 years. Total number of stress events reported was 126 over the two-week period. Subjects reported stress on average of 9±2.2 days representing 64.2%±28.2% of days. GV was compared on days of stress vs. days without stress for each subject. Mean BG did not differ; however, % time spent above 250 mg/dl was less in patients who did not report stress events during the day (6.1± 9.8%) compared to patients with stressful episodes (10.1±17.6%) (p=0.02) (Table).

Discussion: Acute stress in patients with T1D was associated with certain measures of GV. We are currently analyzing GV based on duration and intensity of stress and the time between reported stress and change in glucose.

Disclosure

V. Dadlani: None. J.E. Pinsker: Research Support; Self; Ascensia Diabetes Care, Dexcom, Inc., Insulet Corporation, LifeScan, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker's Bureau; Self; Tandem Diabetes Care. K. Kumari: None. C.C. Andre: None. M. Cescon: None. C. Reid: None. S.K. McCrady-Spitzer: None. P. Thapa: None. M. Church: None. D. Choudhary: None. F.J. Doyle: Consultant; Self; ModeAGC. Other Relationship; Self; Insulet Corporation. E. Dassau: Consultant; Self; Eli Lilly and Company, Insulet Corporation. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Ltd., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; Roche Diabetes Care. Other Relationship; Self; ModAGC. Y.C. Kudva: Advisory Panel; Self; Novo Nordisk Inc. Other Relationship; Self; Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care.

Funding

JDRF; The Leona M. and Harry B. Helmsley Charitable Trust (2-SRA-2017-503-M-B); Dexcom, Inc. (IIS-2017-043)
938-P: A Novel Wireless Continuous Glucose Monitoring System Using Semiconductor Integration
Authors: MUJEEB-U-RAHMAN MUHAMMAD , NAZARI MEISAM HONARVAR , SENCAN MEHMET
Published: June 2019

Continuous glucose monitoring (CGM) systems are a key part of modern diabetes management. Although CGMs have advanced significantly, there are still areas of improvement in terms of accuracy, response speed, cost, and size. Such improvements are essential to have a wider adoption among patients. By integrating modern semiconductor and nano technologie, we have created extremely miniaturized (0.1mmx0.6mmx3mm i.e., smaller than a sesame seed) fully wireless, minimally invasive implant for electrochemical glucose sensing in the interstitial fluid. The implant is user-insertable under the skin using a custom injector and is also user-removable. The implant is powered via an external wearable transmitter using standard RFID technology. The transmitter uses a bluetooth low-energy (BLE) link to send the data to a wireless reader for data visualization and further analytics. The smartphone sends data securely to an online database where it is processed, stored, and is shared with caregivers.

We have verified system operation through extensive in-vitro and in-vivo testing (Figure). We have de-risked sensor fabrication and sterilization schemes. The wound healing response and histopathology studies indicate favorable safety and biocompatibility profile for the sensor as it uses standard materials being used in other implants. We are currently working to get FDA IDE for human feasibility testing

Disclosure

M. Mujeeb-U-Rahman: None. M. Honarvar Nazari: None. M. Sencan: Employee; Self; Integrated Medical Sensors Inc. Stock/Shareholder; Self; Integrated Medical Sensors Inc.

Funding

National Institutes of Health; National Science Foundation