bluuebunny/crossref_metadata_2025 huggingface dataset:
1255-P: Overcoming Obstacles for Insulin-Treated Commercial Drivers: A Multidisciplinary Approach
Authors: LORBER DANIEL , HATHAWAY KATIE
Published: June 2019

Background: The prevalence of diabetes in the United States commercial motor vehicle (CMV) driver population is more than twice that of other adults in the U.S. working population. This population is at high risk for type 2 diabetes and for requiring insulin. With the development of the federal highway system and the dramatic increase in interstate commercial driving, in 1970 the Department of Transportation (DOT) put in place safety regulations that included an absolute blanket ban on insulin use. The impact of these regulations for CMV drivers with diabetes was to eliminate an entire career path or choose to avoid insulin with the resulting increased hyperglycemia and long-term sequelae of uncontrolled diabetes.

Interventions: In response to this blanket ban, the American Diabetes Association (ADA), including representation from its advocacy and scientific and medical arms began a strategy of multi-year, multi-disciplinary interventions to address and reverse the blanket ban. From “grassroots” to “grasstops” advocates, every level of the ADA lobbied for this important change. Two diabetes expert panels reviewed relevant data and provided recommendations to both Congress and the DOT. In 2010 ADA convened an expert panel to develop a position statement on Diabetes and Driving. It was necessary for ADA to overcome objections from both a DOT medical review board and other interested parties. The process was characterized by ever-changing obstacles requiring ADA to stay the course for over a decade.

Results: In 2018 the DOT published a new rule on diabetes eliminating the ban against insulin use and simplifying the process of CMV licensure for thousands of insulin-treated drivers.

Conclusions: The ADA’s unique structure and position enabled it to take the lead in dramatically improving the lives of CMV drivers with diabetes. This achievement provides a model for future interdisciplinary collaboration to overcome barriers to employment for people with diabetes.

Disclosure

D. Lorber: None. K. Hathaway: None.
126-LB: Improved Insulin Adherence after Introduction of a Smart Connected Insulin Pen
Authors: ADOLFSSON PETER , HARTVIG NIELS V. , KAAS ANNE , KNUDSEN NIKOLINE NYGÅRD , MÅRDBY ANN-CHARLOTTE , MøLLER JONAS B. , HELLMAN JARL
Published: June 2019

An association between missed insulin injections and its impact on HbA1c levels has been established. The smart connected NovoPen® 6 captures and allows visualization of insulin injections (date and time of injection and number of units) and thus has the potential to move dialog between patients and healthcare professionals (HCPs) away from guessing about doses taken, missed doses and optimal injection time in relation to meals. This non-interventional study investigated whether the use of NovoPen® 6 influenced the behavior of patients with type 1 diabetes (T1D) in terms of missed bolus dose (MBD) injections. Patients were recruited from 12 Swedish diabetes clinics. At baseline they received a NovoPen® 6 for bolus insulin injections. At each HCP visit, pen data were downloaded at the clinic. Follow-up was after ≥5 HCP visits. Adults with T1D (n=81) using continuous glucose monitoring (CGM) and NovoPen® 6 for bolus injections were included in the analyses. The frequency of MBD was analyzed using the GRID algorithm to detect meals from the CGM signal. MBD was defined as meals with no bolus injection within -15 to +60 minutes from the start of the meal, as detected by the algorithm. The change in number of MBD from baseline to ≥5 HCP visits was analyzed using a mixed model. A significant decrease of 43% in the average daily number of MBD was observed from baseline to after ≥5 HCP visits (median time in study 6 months) from 0.74 (95% CI [0.62; 0.88]) to 0.42 (95% CI [0.30; 0.60]) (p=0.002). Based on the assumption that patients have three main meals per day, this corresponded to a decrease from 25% to 14% in MBD. The results indicated that patients achieved more well-dosed meals, even though these are not detected by the GRID algorithm, because of a lower CGM response.

These real-world findings confirm that MBD is a problem for patients with T1D and that a smart connected pen can support good injection behavior, with fewer missed and more well-dosed mealtime injections. This could subsequently lead to better glycemic control.

Disclosure

P. Adolfsson: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Roche Pharma. Employee; Self; Region Halland. Research Support; Self; Region Halland. N.V. Hartvig: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. A. Kaas: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. N. Nygård Knudsen: Employee; Self; Novo Nordisk A/S. A. Mårdby: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. J.B. Møller: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. J. Hellman: Advisory Panel; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk A/S, Sanofi.

Funding

Novo Nordisk
1270-P: Improving ABC Targets through a Quality Improvement Initiative in China
Authors: KAREN LAU KA HEI , YUNXIA LIU , YI LI , LI CHUNRUI , ZHENGGUO YANG , POBER DAVID M. , ZHANG LINDA (YAN) , GABBAY ROBERT A. , HSU WILLIAM C.
Published: June 2019

Strong scientific evidence supports the benefits of ABC control (A1c <7%, blood pressure <140/80 mmHg, and LDL cholesterol <100 mg/dL) in reducing complications. A recent national multicenter study in China showed that the percentage of Chinese patients with type 2 diabetes who met recommended targets for A1c, BP and LDL in 2010 was 5.4%.

A diabetes clinic in a Chinese tertiary hospital conducted a pilot quality improvement project from January to November 2018 to enhance ABC outcomes. Doctors and nurses from the clinic participated in biweekly video case conferences with Joslin Diabetes Center clinicians (endocrinologist and a certified diabetes educator). They also received bi-monthly on-site training, each lasting 10 days, from visiting U.S. clinicians.

A1c, blood pressure and cholesterol levels collected from patients receiving routine care in the diabetes clinic from the first half of 2018 were compared with those collected in the second half of 2018. There were 1,036 patients who had at least one visit at each of these periods, and 683 patients of them (65.9%) had A1c, BP and LDL measured during these two periods. Paired comparisons were done by paired t-test (continuous variables) or McNemar’s test (dichotomous variables) using SAS version 9.4.

The mean age of the patients was 54.7±11.9 years, with 53.8% female, and 95.3% with T2DM. There was a significant increase in the patients who achieved composite A1c, BP and LDL goal from 6.8 to 10.0% (p=0.048). The percentage of patients attaining the BP goal increased from 54.6 to 63.5% (p=0.0016). The systolic pressure decreased from 137.8 ± 20.2 to 133.3 ± 19.4 mmHg (p<0.0001). The LDL cholesterol decreased from 107.5 ± 34.0 to 97.5 ± 34.4 mg/dL (p<0.0001), and resulted in an increase in the percentage of individuals meeting the LDL goal, from 24.5% to 32.9% (p=0.0012).

Interventions through regular case-based video conferences, complemented by live coaching from diabetes specialists, have the potential to improve clinical outcomes for patients with diabetes in China.

Disclosure

K. Lau: None. L. Yunxia: None. L. Yi: None. C. Li: None. Y. Zhengguo: None. D.M. Pober: None. L. Zhang: None. R.A. Gabbay: Advisory Panel; Self; HealthReveal, Hygieia, Lark, Onduo LLC. Consultant; Self; Sanofi. W.C. Hsu: Consultant; Self; Onduo LLC.
1272-P: Population Modeling of Clinical and Economic Impact of the Removal of Sulfonylurea Therapy
Authors: EILERMAN BRADLEY , TESTA LEONARD J. , CANOS MICHAEL
Published: June 2019

Introduction: Advances in decision support have allowed for simulated medical decision making on a population. These models allow for simulation of policy implementation in disease management. Avoidance of high insulin therapy is frequently mentioned as a preferred strategy for the management of type 2 diabetes.

Methods: Using the GlucosePATH decision support software, a sample of 368 patients drawn from the software’s database was clinically and economically optimized for scenarios matching the full therapeutic options, a scenario excluding sulfonylurea and glinides (NoSU), and a scenario excluding high dose insulin, sulfonylurea and glinides (LowInsulin).

Results: Baseline patient data showed an A1c of 8.7% with mean monthly cost of $28 on standard commercial insurance, $84 on basic commercial insurance, and $354 on Medicare. Optimized with full options resulted in an estimated A1c 7.0% on standard, 7.2% on basic, and 7.5% on Medicare. Monthly cost was on $73 on standard, $168 on basic, and $371 on Medicare. Both the NoSU and LowInsulin scenarios did not show significant difference for basic or standard commercial insurance in terms of cost and A1c. In Medicare, A1c was unchanged for the NoSU model, but increased to 7.8% (+0.3%, p=0.01) in the LowInsulin model. Cost increased to $412 in NoSU model(+$41, p=0.004) and $445 in LowInsulin model (+$64, p=0.015). In the basic commercial and Medicare plan, TZD and insulin use increased. Use of incretin and SGLT2 agents did not demonstrate significant change.

Discussion: Traditional commercial models allow for near ideal implementation of modern diabetes strategies in terms of patient cost, challenges develop when coinsurance or shared-risk models are implemented. It will be important to be able to measure benefit in longitudinal economic terms in addition to laboratory markers.

Disclosure

B. Eilerman: Advisory Panel; Self; Dexcom, Inc., Medtronic. Speaker's Bureau; Self; AbbVie Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Corcept Therapeutics, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc. Stock/Shareholder; Self; PATH Decision Support Software LLC. L.J. Testa: Stock/Shareholder; Self; PATH Decision Support Software LLC. M. Canos: None.
1273-P: Outpatient Diabetes Encounter Visit Frequency in the T1D Exchange Quality Improvement Collaborative
Authors: ALONSO GUY T. , THOMAS SARAH , GAREY COLLEEN , BUCKINGHAM DON A. , CABRERA ALYSSA B. , CLEMENTS MARK A. , CORATHERS SARAH , DESALVO DANIEL J. , GARRITY ASHLEY , LEE JOYCE M. , MCDONOUGH RYAN , MOSTAJABI FARIDA , YEE CURTIS , KAMBOJ MANMOHAN K.
Published: June 2019

Less than 20% of pediatric patients with type 1 diabetes (T1D) in the U.S. achieve target A1c values, with rising A1c trends between age 6 to 17 years. The International Society of Pediatric and Adolescent Diabetes recommends outpatient clinic visits at least every 3 months, while the American Diabetes Association recommends every 3-6 months. The T1D Exchange Quality Improvement Collaborative aims to improve the quality of T1D care in the U.S. by identifying variations in care and sharing best practices.

Six pediatric diabetes clinics in the Collaborative reported the mean number of days between outpatient diabetes clinic visits for patients with T1D aged 0-6, 7-12, 13-17, and 17-26 years for each month from 11/2017-10/2018. Patients with new onset T1D were excluded, as were those with visit interval >13 months.

Analysis included 31,358 patients. Age group and clinic site (both p<.001) were associated with interval between clinic visits (Figure 1), but month was not (p=.87). Mean number of days was >90 for each age group.

The majority of patients attended clinic less often than required to meet 4 encounters per year. Older age was associated with longer interval between visits. Improving outcomes will require a combination of increasing the perceived value of clinic attendance, increasing access to outpatient encounters, and innovative methods of care delivery outside regular clinic attendance.

Disclosure

G.T. Alonso: None. S. Thomas: None. C. Garey: None. D.A. Buckingham: None. A.B. Cabrera: None. M.A. Clements: Advisory Panel; Self; Glooko, Inc. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Medtronic. S. Corathers: None. D.J. DeSalvo: Consultant; Self; Dexcom, Inc., Insulet Corporation. A. Garrity: None. J.M. Lee: Consultant; Self; Taiho Oncology, Inc. R. McDonough: None. F. Mostajabi: None. C. Yee: None. M.K. Kamboj: None.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust
1275-P: Cost Effectiveness of Using DPP-4i and SGLT2i Combination Therapy vs. Switching to GLP-1 Therapy for the Management of Type 2 Diabetes
Authors: PAWASKAR MANJIRI , BILIR S. PINAR , DAVIES GLENN M.
Published: June 2019

Background and Aims: Metformin (met) plus [dipeptidyl peptidase-4 inhibitors (DPP-4i), is a commonly used dual therapy among type 2 diabetes (T2D) patients while drug classes such as glucagon-like peptide 1 receptor agonists (GLP-1)] and sodium-glucose co-transporter 2 inhibitors (SGLT2i) are often used as third line agents. We evaluated the long-term cost-effectiveness of a treatment pathway that included 3rd line met+DPP-4i+SGLT2i therapy (pathway 1) vs. switch to met +GLP-1 (pathway 2) in T2D patients not at goal on met+DPP-4i.

Materials and Methods: The validated IQVIA CORE Diabetes Model was used to perform cost-effectiveness analysis over a lifetime for a cohort of T2D patients in the U.S. Treatment effect data were obtained from randomized clinical trials and economic data were obtained from multiple published sources. Several scenario analyses including changes in clinical parameters were performed to assess the robustness of base case results.

Results: Pathway 1 with met+DPP-4i+SGLT2i tripe therapy resulted in increased total life years (Δ=0.049) and quality-adjusted life years (QALY) (Δ=0.026) vs. to pathway 2 (i.e., switching to met+GLP-1). Total medical costs (including drug costs, cost of complications and adverse events (Δ =-$9,511) were lower for patients in pathway 1 vs. pathway 2. Pathway 1 dominates pathway 2, as it is more effective (measured in terms of QALYs) and less costly. Scenario analyses results assessing changes in treatment effect, body mass index, adverse event profiles and different drug cost estimates consistently showed that pathway 1 was either dominant or cost-effective (Incremental cost effectiveness ratio = $76,000/QALY for the most conservative drug costs assumption for DPP-4i plus SGLT2i).

Conclusion: Among patients not at goal on met&ormin and DPP-4i therapy in the U.S., triple therapy wit& met+DPP-4i+SGLT2i was likely to be a cost-effective alternative compared to switching to met+GLP-1.

Disclosure

M. Pawaskar: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. S. Bilir: Employee; Self; IQVIA. G.M. Davies: Employee; Self; Merck & Co., Inc.
1276-P: Effect of Trial Participation on Metabolic Parameters in People with Progressive Diabetic Complications
Authors: PALDÁNIUS PÄIVI M. , STRAIN WILLIAM D.
Published: June 2019

Multiple randomized controlled trials (RCTs) in people with diabetes have demonstrated a substantial placebo effect, as a result of enhanced patient-physician interaction time. In RCTs focused on glycemic control, the non-pharmacological component of clinical inertia was independent of age and presence of microvascular complications. Here we explore if trial participation per se improves metabolic parameters in people with diabetic complications, independent of trial focus. Participants from a clinical development program focusing on progression of diabetic macular edema (DME) randomized to receive either a sham intravitreal injections or laser therapy were pooled. The primary 12-month outcomes were changes in retinal parameters while for this analysis we assessed the least square (LS) mean change in metabolic parameters, HbA1c and fasting plasma glucose (FPG). Participants were stratified by age (<70/≥70 years) and change in eGFR (an internal standard for monitoring disease progression). Participants (n=288, 46% women) had a mean±SD age of 62.9±9.2 years, diabetes and DME durations 12.6±9.0 and 1.5±2.2 years, respectively. The baseline HbA1c was well controlled, 7.4±1.1% and FPG was 8.9±3.3 mmol/l. The mean eGFR was 84.1±25.1 ml/min/1.73m2 and most subjects were at a normotensive target of mean BP 137/78 mmHg. At 12 months, the LS mean HbA1c change ±SEM from baseline was 0.1±0.1 and FPG 0.5±0.2 mmol/l. While no difference was seen between the age groups for HbA1c (0.1% for both), FPG reduction was numerically higher in elderly (0.8 vs. 0.4 mmol/l). The mean decline in eGFR was −6.5±0.8 ml/min/1.73m2 in both age groups. Trial participation per se does not improve metabolic parameters of people with diabetes, where the trial focus is not on metabolic control. This implies providing unfocused time for people with diabetes will not improve metabolic control, suggesting focused consultations between people with diabetes and healthcare providers for management of diabetes.

Disclosure

P.M. Paldánius: Employee; Self; Novartis AG. Stock/Shareholder; Self; Novartis AG. W.D. Strain: Research Support; Self; Bayer AG, Takeda Development Centre Europe Ltd. Speaker's Bureau; Self; NAPP Pharmaceuticals Limited, Novartis AG, Novo Nordisk A/S.

Funding

Novartis AG
1277-P: Diabetes Management Supplies in Youth with Type 1 Diabetes: Don’t Leave Home Without Them!
Authors: QUINN MARYANNE , BAILEY RYAN , FOSTER NICOLE C. , SIMMONS JILL , EYTH EMILY , RODRIGUEZ HENRY , CORATHERS SARAH , LEVY CAROL J. , SHEANON NICOLE M. , WASSERMAN RACHEL M. , SPARLING DAVID , ADKINS DEANNA , ALBANESE-O'NEILL ANASTASIA , DESALVO DANIEL J.
Published: June 2019

Youth with type 1 diabetes (T1D) require 24/7 access to T1D management supplies. This study aims to characterize access to T1D supplies when youth are away from home. We emailed a comprehensive survey to 4756 parents of T1D Exchange participants <18 years old; 752 respondents completed the survey (83% completed by parents). Results were age-stratified: <6 (N=21), 6-12 (N=271) and 13-18 (N=459). The majority of youth carry rapid-acting insulin most of the time or always, yet the proportion decreases as age increases (Table 1). ≥80% of injection users carry an extra pen or syringe, while >55% of pump users carry an extra infusion set. Among CGM users, 100% of ≤6 years old vs. 67% of adolescents carry a receiver or phone; 33% of 13-18 years old never carry an extra sensor. 38% of youth ≤6 years old vs. 27% of teens carry blood or urine ketone testing supplies. In total, 64% reported carrying glucose tablets or gel; 87% carry another rapid acting carbohydrate. 64% of respondents carry glucagon, again decreasing across adolescence. Over 2/3 carry at least one form of T1D identification. Technology to optimize glycemic control and detect/prevent acute complications of T1D have improved. Yet, adolescents are less likely than younger T1D-affected youth, to carry supplies to detect, prevent and/or treat acute events. These findings call for novel and ongoing T1D emergency preparedness training to strike a balance between supervision and autonomy of adolescents.

Disclosure

M. Quinn: None. R. Bailey: None. N.C. Foster: None. J. Simmons: None. E. Eyth: None. H. Rodriguez: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Daiichi Pharm Corp, MannKind Corporation, Medtronic MiniMed, Inc. Research Support; Spouse/Partner; Medtronic MiniMed, Inc. Research Support; Self; Takeda Pharmaceutical Company Limited. Other Relationship; Self; Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc. S. Corathers: None. C.J. Levy: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Allergan. N.M. Sheanon: None. R.M. Wasserman: None. D. Sparling: None. D. Adkins: None. A. Albanese-O'Neill: None. D.J. DeSalvo: Consultant; Self; Dexcom, Inc., Insulet Corporation.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust
1281-P: Proactive Chronic Care Management for Patients with Poorly Controlled Diabetes in an Academic Health-Care System: The Emory Diabetes Management Program
Authors: NAMBI ANDIRAN AYANAMBAKKAM , SMITH ZIRKA T. , PRESSWOOD MARGARET S. , JACOBS SOL , MCALEER ALISA F. , CASTELLANO PENNY A. , KHOSRAVANIPOUR MARJAN , GALINDO RODOLFO J. , TURTON FREDERICK E. , DEE JOSEPH , MASI CHRISTOPHER M. , ESPER GREGORY J. , UMPIERREZ GUILLERMO E.
Published: June 2019

Fragmented care with limited access to specialized diabetes care and self-management education programs and a suboptimal referral system account for the high prevalence of poorly controlled diabetes in academic health systems. In the Emory Healthcare System, the largest health system in Georgia with over 65,000 patients with DM, ∼15-20% of patients have HbA1c >9%. We implemented the Emory Diabetes Management Program (DMP), a chronic care management model that proactively invited patients with HbA1c >9% scheduled to attend an ambulatory clinic to be seen by a Diabetes Educator/Nurse Practitioner team supervised by an endocrinologist.

Among 898 patients scheduled from 01/01/18 to 11/30/2018, 630 (70.2%) patients attended the program (age 56.2 years, females 62%, African-Americans 73%) with a baseline HbA1c of 10.4±2.0%. The intervention resulted in significant reduction in HbA1c levels and higher number of patients achieving HbA1c <9% compared to patients who did not attend the intervention. In addition, more patients in the intervention achieved an LDL < 100 mg/dl and a blood pressure goal <130/80 mm HG (Table 1).

The Emory-DMP, a proactive chronic care model of focused diabetes education and management, is an effective approach for improving care of patients with diabetes, resulting in significant improvement in HbA1c, blood pressure and lipid control.

Disclosure

A. Ayanambakkam Nambi: None. Z.T. Smith: None. M.S. Presswood: None. S. Jacobs: None. A.F. McAleer: None. P.A. Castellano: Advisory Panel; Self; Vizient. M. Khosravanipour: None. R.J. Galindo: Advisory Panel; Self; Abbott, Novo Nordisk Inc., Sanofi US. Research Support; Self; Novo Nordisk Inc. F.E. Turton: None. J. Dee: None. C.M. Masi: None. G.J. Esper: None. G.E. Umpierrez: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc. Research Support; Self; AstraZeneca, Merck & Co., Inc., Novo Nordisk Inc., Sanofi US.
1282-P: Patient-Related Factors Affecting Utilization of Diabetes Care
Authors: GARG RAJESH , CADE WILLIAM H. , BERNAL-MIZRACHI ERNESTO
Published: June 2019

Factors affecting utilization of diabetes care are not well-studied. This information may help develop strategies to improve the efficiency of healthcare systems. We conducted a study to determine factors associated with repeatedly missing an appointment at a major diabetes care center. Data were obtained from electronic medical records. All patients with two or more appointments during the year 2017 were included in analysis. Patients who missed ≥50% of their clinic visits without cancelling an appointment were defined as the repeatedly missed appointment (RMA) group and those who missed <50% appointments were defined as the regularly attended appointment (RAA) group. All patients had equal opportunity to keep or cancel an appointment irrespective of their insurance coverage. Out of 1,417 patients, 147 (10.4%) had missed ≥50% of their scheduled clinic visits. Mean number of appointments was similar in the RMA group (3.0 ± 1.3) and in the RAA group (2.8 ± 1.2; P = 0.29). A comparison of characteristics between the two groups is shown in Table 1. Multivariate regression analysis showed that younger age, higher BMI, higher HbA1c and lower serum albumin were independent predictors of the percentage of missed appointments. We conclude that patients who repeatedly miss their diabetes appointments have poor overall health and worse diabetes control. Strategies need to be developed to improve utilization of diabetes care by these patients.

Disclosure

R. Garg: None. W.H. Cade: None. E. Bernal-Mizrachi: None.
1284-P: Mobile Patient Portal Access and Diabetes Outcomes
Authors: GRAETZ ILANA , HUANG JIE , FIREMAN BRUCE , HSU JOHN , REED MARY
Published: June 2019

Objective: Patient portal use can support self-management and expanding mobile portal access can potentially increase use. We examined the association between adding mobile portal access and medication adherence and glycemic levels among patient with diabetes.

Research Design and Methods: Eligible patients were adults with diabetes in an integrated delivery system who filled an oral diabetes prescription at baseline (4/14-3/15), and who did not use insulin. For each study month (4/15-12/17), we categorized patients’ portal access status: never used, personal computer (PC) only, mobile only, or both PC and mobile (first four-months of any status change was categorized separately as a wash-out period). We measured adherence by monthly percent of days covered (PDC) with oral diabetes drugs. To examine glycemic control, we included the subset of patients with HbA1c results (72% of all patients). We assessed the association between portal access and study outcomes (PDC and HbA1c), using linear regression with patient-level fixed effects to account for unmeasured time-stable patient-level confounders, adjusting for temporal trend, and time-varying numbers of drugs and health events.

Results: Among study patients (N= 111,463), the proportion with PC only portal access decreased from 30% to 13%, while the proportion using both mobile and PC increased from 34% to 62%. At baseline, 71.6% of patients had PDC≥80% and 78.8% had HbA1c<8%. Gaining both mobile and PC access was associated with a 1.67 percentage point increase in PDC among those with no portal access initially, and a 0.50 percentage point increase in among those with PC only access initially. Adding both mobile and PC access was associated with a 0.13 reduction in A1c level among those with no portal access initially, and a 0.07 reduction among those with only PC access initially (N=80,072, all p<0.05).

Conclusions: The addition of mobile portal access is associated with higher medication adherence and improved glycemic control for patients with diabetes.

Disclosure

I. Graetz: None. J. Huang: None. B. Fireman: None. J. Hsu: None. M. Reed: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (R01DK085070 to M.R.)
1285-P: Impact of Adding a GLP-1 Receptor Agonist to the Medication Regimen
Authors: JACOBS MICHELLE , ROSE TAYLA , REID DEBRA J. , BOUWMEESTER CARLA , CONLEY MICHAEL , FATEHI BORNA , MATTA THOMAS M. , BARR JUDITH
Published: June 2019

Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are preferred injectable therapies for type 2 diabetes, but it is uncertain if advantages justify higher medication cost. This real-world, retrospective cohort study at eight ambulatory care sites evaluated change in monthly glucose-lowering medication cost, HbA1c, weight and polytherapy at GLP-1 RA initiation (baseline) and after 6-12 months (follow-up). The population was analyzed as a whole and as subgroups based on baseline medication regimen and demographics.

Results: The study population (n=120) was 67.5% female, age 55.8±11.7 years, obese, 71% minority, equal English and non-English speaking, had high pill and injection burden, and baseline HbA1c 10%. Figure 1 summarizes changes in monthly glucose-lowering medication costs. Overall change in HbA1c was -1.7%, p<0.001. This decrease was consistent in each baseline medication regimen subgroup. Weight decreased overall (-1.8kg, p<0.001), and there was a significant shift to taking fewer oral agents and insulin as well as fewer daily injections, but no meaningful differences were noted when stratified by age (<65 or ≥65 years), gender, English vs. non-English speaking, or race.

Conclusion: Although a positive impact resulted in glycemic control, weight, and reducing polytherapy 6-12 months after adding a GLP-1 RA to the medication regimen, the increase to monthly medication cost will serve as a barrier to treatment.

Disclosure

M. Jacobs: None. T. Rose: None. D.J. Reid: None. C. Bouwmeester: None. M. Conley: None. B. Fatehi: None. T.M. Matta: None. J. Barr: None.
1286-P: U.S. Air Force Project ECHO Diabetes: Our Seven-Year Experience
Authors: BECKMAN DARRICK , TRUE MARK W. , MORROW CONNIE C. , WATSON NINA , WARDIAN JANA L. , TATE JOSHUA M. , SAUERWEIN TOM J.
Published: June 2019

The U.S. Air Force Medical Service (AFMS) provides medical care for active duty and retired service members and their families, which includes approximately 50,000 patients with diabetes at 76 clinics worldwide. With only 12 AFMS endocrinologists, the majority of diabetes care is provided by primary care providers (PCPs).

In a strategic PCP knowledge expansion effort in 2012, the AFMS Diabetes Center of Excellence (DCOE) established a continuing telemedicine education program patterned after the Project Extension for Community Healthcare Outcomes (ECHO) model. Content of twice monthly video teleconference sessions included various diabetes standard of care topics and opportunities to discuss actual cases in real time.

After seven years, this program has reached 560 unique individuals at 93 locations across the three military services and the Veterans’ Administration. Over time, groups of participants have expanded from providers only to a spectrum of diabetes care delivery disciplines: PCP, specialists, PharmD, NP, PA, RN, RD, and educators. From April through September 2018 alone, 11 presentations resulted in 499 potential CMEs at 33 locations. A total of 200 out of a potential 499 surveys were completed (40% response rate), which indicated an increase in moderate or strong agreement from 28 to 84% in knowledge sufficiency as a result of ECHO session participation. More importantly, those who felt moderate or strong confidence in the treatment of complex diabetes patients increased from 33 to 72%. Virtually all survey participants (96%) indicated a likelihood to make changes to their treatment practice based on content learned during ECHO sessions.

In contrast to a traditional tertiary care referral model, models like Project ECHO Diabetes provide far greater reach, leveraging expert knowledge to increase the quality of diabetes care at the primary care level. In the context of the national diabetes epidemic and endocrinologist shortage, this model represents a realistic and responsible use of diabetes experts.

Disclosure

D. Beckman: None. M.W. True: None. C.C. Morrow: None. N. Watson: None. J.L. Wardian: None. J.M. Tate: None. T.J. Sauerwein: Speaker's Bureau; Self; AstraZeneca, Merck & Co., Inc.
1306-P: Cost Effectiveness of Point-of-Care HbA1c in Primary Care Setting in Brazil
Authors: MEDEIROS DANIELLE S. , ROSA LORENA S. , MISTRO SOSTENES , KOCHERGIN CLAVDIA N. , SOARES DANIELA A. , SILVA KELLE O. , LOUZADO JOSÉ A. , CORTES MATHEUS L. , BEZERRA VANESSA M. , AMORIM WELMA W. , OLIVEIRA MÁRCIO G.
Published: June 2019

Background: Point-of-care (POC) devices allow to assess HbA1c results in a single visit and facilitates the physicians’ decision making for DM control. This study aimed to assess the cost-effectiveness of POC in comparison to standard laboratory (HPLC method) for HbA1c testing in Brazilian primary care.

Methods: A Markov model was developed in a 10-year time horizon for the perspective of the public health system. Effectiveness was assessed by the rate of HbA1c control after 6-months follow-up. Data were obtained from an ongoing cohort. Controlled and uncontrolled subjects were included in transition states for negative outcomes (cardiovascular diseases and complications). Probabilities and costs of transition states were extracted from a literature review.

Results: Estimated annual cost for patients monitored by HPLC was U.S. $4,884.92 (SD 629.46) for an effectiveness of 0.39. For those monitored by POC, cost and effectiveness were U.S. $5,960.64 (SD 2,514.00) and 0.91, respectively. The evolution of the net monetary benefit is presented in the chart below.

Conclusions: HbA1c tested by POC appears to be cost-effective in comparison with laboratory testing to improve glycemic control and prevent DM-related cardiovascular diseases and complications.

Disclosure

D.S. Medeiros: None. L.S. Rosa: None. S. Mistro: None. C.N. Kochergin: None. D.A. Soares: None. K.O. Silva: None. J.A. Louzado: None. M.L. Cortes: None. V.M. Bezerra: None. W.W. Amorim: None. M.G. Oliveira: None.

Funding

Medtronic Foundation
1319-P: The Ratio of Unmethylated to Methylated Insulin DNA Is Negatively Correlated to Age in Adolescents with Type 2 Diabetes
Authors: HSIA DANIEL S. , MERCER SHELLY , COLLIER JASON , JOHNSON WILLIAM D. , MCCORMICK KEN
Published: June 2019

Previous studies have inferred that type 2 diabetes diagnosed during adolescence is more fulminant compared to type 2 diabetes diagnosed during adulthood. One hypothesis to explain this disparity is the exaggerated loss of the insulin-producing β-cells in the pancreas. The only known significant source of unmethylated insulin DNA is through the death of β-cells; therefore, the ratio of serum unmethylated to methylated (U/M) insulin DNA, as measured by droplet digital PCR (ddPCR), is predicted to be proportional to the degree of β cell death. While this method has been explored to identify those at risk for type 1 diabetes, it has not been explored to characterize adolescents with type 2 diabetes. Some degree of β-cell loss may account for the exaggerated decompensation in glucose control over time seen in adolescents. The purpose of this pilot study was to determine the extent of β-cell death in adolescents with type 2 diabetes using this novel biomarker. We recruited 18 participants between the ages of 10 and 18 years with an established diagnosis of type 2 diabetes for a single fasting study visit. Genomic DNA was isolated from each participant and was templated for ddPCR using two different primer/probe sets (reported previously by Miramira and colleagues) that discriminated DNA from β-cell sources (unmethylated) and from non-β-cell peripheral tissues (methylated). The U/M ratio was inversely correlated with age (r=-0.72, p<0.001) and with age at diagnosis (r=-0.56, p=0.015) via Spearman correlation. These results suggest that younger adolescents with type 2 diabetes may exhibit more extensive β-cell death compared to older adolescents and that adolescents diagnosed at a younger age may exhibit more extensive β-cell death compared to those diagnosed at an older age as indicated by a higher ratio of U/M insulin DNA.

Disclosure

D.S. Hsia: None. S. Mercer: None. J. Collier: None. W.D. Johnson: None. K. Mccormick: None.

Funding

National Institute of General Medical Sciences (U54GM104940); National Center for Advancing Translational Sciences (UL1TR001417)
1328-P: Racial Differences in Comorbidities in Youth with T2D in the Pediatric Diabetes Consortium (PDC)
Authors: BACHA FIDA , CHENG PEIYAO , GAL ROBIN L. , BEAULIEU LINDSEY C. , KOLLMAN CRAIG , ADOLPH ANNE , JINDAL ISHITA , SHOEMAKER ASHLEY H. , WOLF RISA M. , KLINGENSMITH GEORGEANNA J. , TAMBORLANE WILLIAM V.
Published: June 2019

Background: Racial differences in diabetes control and cardiovascular disease risk factors have been reported in youth with diabetes, with minority youth having worse glycemic control and comorbidities compared with non-Hispanic white (NHW) peers.

Methods: We examined racial differences in comorbidities in youth (<21 years at enrollment) with T2D (N=1217, 63% females) enrolled in the PDC Registry from February 2012 to June 2018. Demographic and clinical data collected from medical records and participant self-report were compared using logistic and linear regression models adjusted for relevant confounders.

Results: The mean age at presentation was 13.4 ± 2.4 years, and mean BMI Z-score was 2.30 ± 0.45. African-American (AA) and Hispanic (H) youth had higher HbA1c and lower C-peptide at diagnosis compared to NHW, with AA 3 times as likely to present in DKA compared with NHW. Microalbuminuria was present in 11%, hypertension in 34% and dyslipidemia in 42% with no significant differences in these comorbidities among racial groups. Nonalcoholic fatty liver disease (NAFLD) was diagnosed in 9% and 11% of H and NHW, respectively vs. 2% in AA (Table).

Conclusion: Minority youth with T2D presented with worse metabolic control compared with NHW, with higher rates of DKA in AA youth. Comorbidities exist in a large percentage of youth with T2D independent of ethnicity, except for NAFLD being less prevalent in AA.

Disclosure

F. Bacha: Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases, Pediatric Diabetes Consortium. Other Relationship; Self; AstraZeneca, Jaeb Center for Health Research. P. Cheng: None. R.L. Gal: None. L.C. Beaulieu: None. C. Kollman: None. A. Adolph: None. I. Jindal: None. A.H. Shoemaker: Advisory Panel; Self; Rhythm Pharmaceuticals, Inc. Research Support; Self; AstraZeneca, GLWL Research Inc., Novo Nordisk Inc., Rhythm Pharmaceuticals, Inc., Soleno Therapeutics. R.M. Wolf: None. G.J. Klingensmith: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. Research Support; Self; Novo Nordisk Foundation. Stock/Shareholder; Spouse/Partner; Dexcom, Inc. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceutical Company Limited.

Funding

Boehringer Ingelheim; Novo Nordisk; Takeda Pharmaceutical Company Limited
1332-P: Complement C3 and C4 Levels Predict Cardiometabolic Risk in Healthy Adolescents
Authors: HOFFMAN ROBERT P. , YU CHACK-YUNG
Published: June 2019

Complement, in addition to its immunologic functions, also helps regulate inflammation and fat metabolism. Thus, complement may play a role in the development of the metabolic syndrome. In adults complement component C3 is a risk factor for the development of type 2 diabetes, and a determinant of cardiometabolic risk. Adult cardiometabolic disease has its origins in childhood and adolescence. Therefore, if we are to fully understand the role of complement in cardiometabolic disease we need to study this age group. 56 healthy, non-Hispanic white adolescents (28 F, age 15.4±1.7 years; BMI 22.0±4.9 kg/m2 (mean±SD) were studied. Cardiometabolic risk factors were studied in the fasting state and included measures of vascular function [reactive hyperemia (RH), augmentation index (AI)], lipids, inflammation [white blood cell (WBC) and neutrophil (ANC) count, c-reactive protein (CRP), interleukin 6 (IL6)], carbohydrate metabolism [OGTT: insulin sensitivity (ISEN), insulin secretion (ISEC), disposition index, DI], endothelin 1 and plasminogen activator inhibitor 1 (PAI-1). RH worsened, HDL decreased and ANC, LDL, triglycerides and ISEC increased with increasing C3. RH and HDL were also negatively related to C4 while WBC, ANC, IL6 and DI were positively related to C4. Adjustment for body habitus eliminated the relationships of HDL, LDL and ISEC but not ANC or triglycerides to C3 and/or C4. Adjusted PAI-1 was significantly related to C3. Except for the positive relationship between C4 and DI these relationships demonstrate that increasing levels of C3 and C4 are associated with increasing cardiometabolic risk in healthy, non-Hispanic white adolescents. Increasing C3 levels may influence increasing triglyceride levels while increasing C4 is more closely related to increasing inflammation.

Disclosure

R.P. Hoffman: Other Relationship; Self; Novo Nordisk A/S. C. Yu: None.

Funding

American Heart Association; National Institutes of Health
1340-P: Higher Morning Serum Cortisol (MSC) Associates with Prediabetes and Other Metabolic Syndrome (MetSyn) Components in Predominantly Latino Adolescents
Authors: TOLEDO-CORRAL CLAUDIA M. , LANE CHRISTIANNE J. , WEIGENSBERG MARC
Published: June 2019

Chronic life stress and “allostatic load” may increase risk for MetSyn. This study examines the associations between MSC, prediabetes, and MetSyn components in adolescents with body mass index (BMI) ranging from underweight to obese. Fasting blood was drawn ∼8AM from 191 healthy adolescents (126F/65M; 16.4±0.6 years; 95% Latino) to measure MSC, glucose, HbA1C, and lipids; triplicate measurements of BMI, waist circumference, and systolic/diastolic blood pressure (BP). All analyses were adjusted for a priori covariates of age, sex, BMI, and ethnicity. MSC was higher in adolescents with prediabetes (fasting glucose 100-125 mg/dL, n=20) vs. normoglycemia (Figure). This relationship was not seen when applying the prediabetes definition of HbA1C 5.7-6.4%. Higher MSC was associated with higher fasting glucose (β=0.02±0.005, p<0.001) and triglycerides (β=0.06±0.02, p=0.003). MSC was not associated with waist circumference, HDL cholesterol, HbA1c, or systolic/diastolic BP in linear modeling. However, adolescents with borderline/high BP (n=27) exhibited higher MSC compared to those with normal BP (516±32 vs. 392±12 nnol/L, p<0.001). The significant relationships between MSC, prediabetes and other MetSyn components suggest further study of the link between allostatic load and diabetes/cardiometabolic risk in adolescents is warranted.

Disclosure

C.M. Toledo-Corral: None. C.J. Lane: None. M. Weigensberg: None.

Funding

National Institutes of Health (R01AT008330)
1344-P: Persistent ß-Cell Responsiveness in Children at High Risk for Type 1 Diabetes (T1D) Is Associated with Decreased Progression to T1D in the Diabetes Prevention Trial-Type 1 (DPT-1)
Authors: SIMS EMILY K. , ISMAIL HEBA M. , NATHAN BRANDON M. , SOSENKO JAY M.
Published: June 2019

High-risk individuals with islet autoantibody positivity (Ab+) vary in their rates of progression to T1D. We hypothesized that changes in C-peptide over time account for some of this variation. Among Ab+ children (<18.0 years) followed with 2-hour OGTTs for development of T1D in DPT-1, we compared Progressors to T1D with Non-Progressors for the change in AUC C-peptide from the baseline OGTT to the last available OGTT (last before diagnosis in Progressors). Results were stratified by low or high baseline DPT-1 Risk Score (DPTRS: fasting C-peptide, sum C-peptide and sum glucose values from 30-120 minutes, age and BMI; DPTRS <7.00= lower risk and ≥7.00= higher risk). As shown in the Table, Non-Progressors from each group exhibited increases in AUC C-peptide over time, while Progressors showed no significant changes in AUC C-peptide. A logistic regression model with adjustment for age indicated an inverse association of T1D development with increasing AUC-C-peptide/year [Odds ratio: 0.587 (0.430, 0.802), p<0.001].

In conclusion, even in individuals with high baseline risk assessments, increasing AUC C-peptide over time is associated with decreased progression to T1D. This persistent C-peptide responsiveness could result from increased β-cell reserve (either functional or mass) or β-cell regeneration.

Disclosure

E.K. Sims: None. H.M. Ismail: None. B.M. Nathan: None. J.M. Sosenko: None.

Funding

National Institutes of Health
135-LB: The Forgotten Populations: Real-World Patients with T2DM Not Meeting Eligibility Criteria of the Glargine 300 U/mL EDITION and BRIGHT RCTs
Authors: MAURICIO DIDAC , WESTERBACKA JUKKA , NICHOLLS CHARLIE , WU JASMANDA , GUPTA RISHAB , MENON ARJUN A. , ELIASSON BJORN
Published: June 2019

RCTs are the gold standard for comparing therapies’ efficacy and safety but can have strict eligibility criteria and may not reflect real-life clinical practice. Electronic medical records such as those from the Predictive Health Intelligence Environment (PHIE) database may be used to assess clinical effectiveness in real-world populations missed by clinical trials. We describe here the proportion and characteristics of patients with T2DM who would have been excluded from RCTs using eligibility criteria adapted from the EDITION 1-3 and BRIGHT trials.

Records from people with T2DM, with a basal insulin prescription on the index date (1 March 2015) and ≥1 HbA1c value in the previous 12 months, were evaluated. Exclusion criteria included HbA1c <7.0 %/>10.0 %, systolic blood pressure >180 mmHg and/or diastolic blood pressure >95 mmHg, or key comorbidities (e.g., heart failure or stroke) in the previous 12 months.

Of 191,218 evaluated records, 157,873 (83%) met ≥1 exclusion criterion; only 33,345 (17%) could have been included in RCTs (Table). Excluded patients were older, with more previous hypoglycemia vs. included patients and were less likely to have HbA1c between 7 and 9 %.

This divergence in clinical characteristics and patient numbers highlights the need for real-world studies assessing clinical effectiveness in populations of interest typically excluded from RCTs.

Disclosure

D. Mauricio: Advisory Panel; Self; Merck Sharp & Dohme Corp., Sanofi. Speaker’s Bureau; Self; Almirall, S.A., Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Urgo Medical. J. Westerbacka: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. C. Nicholls: Employee; Self; Sanofi. J. Wu: Employee; Self; Sanofi US. R. Gupta: None. A.A. Menon: None. B. Eliasson: Advisory Panel; Self; Amgen Inc., AstraZeneca, Merck Sharp & Dohme Corp. Speaker’s Bureau; Self; Boehringer Ingelheim International GmbH. Other Relationship; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi.

Funding

Sanofi
1355-P: HbA1c Trajectories from Time of Diagnosis in Youth with T1D
Authors: SHERR JENNIFER , FOSTER NICOLE C. , BETHIN KATHLEEN , FOX LARRY A. , MASTRANDREA LUCY D. , NATHAN BRANDON M. , REDONDO MARIA JOSE , SILVERSTEIN JANET , SIMMONS JILL , CLEMENTS MARK A. , TAMBORLANE WILLIAM V. , THRAILKILL KATHRYN M. , WONG JENISE C. , WOOD JAMIE
Published: June 2019

Most individuals with type 1 diabetes (T1D) do not achieve glycemic targets, particularly in youth. This analysis examined HbA1c trajectories of youth newly diagnosed with T1D. T1D Exchange registry participants <18 years with at least one HbA1c during the year of diagnosis and ≥3 duration-year aggregated HbA1c values over 10 years of follow-up were included. At diagnosis, the 4183 participants were 48% female, 81% Caucasian, age 6±4 years, and 77% privately insured. Suboptimal control was defined as HbA1c ≥9%. Group-based trajectory modelling was used to identify unique HbA1c trajectories over aggregated duration years. Five trajectories emerged (Figure). The majority of youth had stable trajectories within three distinct categories: those at (1) or above (3) glycemic target and those with suboptimal control (4). Two groups showed deterioration over time, one with suboptimal control from diagnosis (5) while the other had above target glycemia that worsened with time (2). Minority status was higher in groups with upward trend in HbA1c trajectory and suboptimal but stable control. Similar trends were seen for non-private insurance. Several distinct patterns of HbA1c progression exist in youth with T1D, partly dependent on HbA1c at diagnosis. Identifying characteristics of those with progressive deterioration in glycemic control and designing appropriate interventions for these groups is warranted.

Disclosure

J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Eli Lilly and Company, Insulet Corporation. Consultant; Self; Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi. Research Support; Self; Dexcom, Inc., Insulet Corporation. N.C. Foster: None. K. Bethin: Research Support; Self; Novo Nordisk Inc., Xeris Pharmaceuticals, Inc. L.A. Fox: None. L.D. Mastrandrea: Advisory Panel; Self; Pediatric Diabetes Consortium. Research Support; Self; AstraZeneca, JDRF, Novo Nordisk Inc., Sanofi-Aventis, T1D Exchange. Other Relationship; Self; Novo Nordisk Inc. B.M. Nathan: None. M.J. Redondo: None. J. Silverstein: None. J. Simmons: None. M.A. Clements: Advisory Panel; Self; Glooko, Inc. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Medtronic. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceutical Company Limited. K.M. Thrailkill: None. J.C. Wong: Advisory Panel; Self; Tidepool Project. Research Support; Self; Dexcom, Inc. J. Wood: Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc.