bluuebunny/crossref_metadata_2025 huggingface dataset:
Inpatient Use of Insulin Pens—Eliminating Risk for Inappropriate Use of Pen on More than One Patient
Authors: MACMASTER HEIDEMARIE W. , MARUOKA ANDREW , LUIS CRAIG SAN , GONZALEZ SABINA , RUSHAKOFF ROBERT J.
Published: June 2018

Use of insulin pens for inpatient insulin administration is accurate and safe. However, if the pen is used on more than one patient, there is potential risk of infection with pathogens including hepatitis viruses and HIV. Rapid-acting insulin (RAI) is a time-critical medication, both for correctional and nutritional doses. Many hospitals using insulin pens choose to dispense them with a patient specific ID barcode from the pharmacy. This workflow ensures the correct patient ID for scanning, yet it may result in dispensing duplicates and may create time-critical delays. At UCSF, automated dispensing machines (ADM) on adult-units house time-critical medications, including RAI. In this workflow, the RN labels the insulin pen with the patient specific 3D barcode generated on the unit. Prior to insulin pen administration, 3 barcodes must be scanned: 1. Patient armband, 2. Patient label on insulin pen. (NEW) 3. Insulin pen manufacturer (confirms an active order for this type of insulin). The EMR will flash a screen size alert with a red stop sign and a warning if the patient’s armband ID and the pen label’s patient ID do not match. Implemented in 2/2017, this workflow and alert system, for the approximately 18,000 insulin pen SQ injections administered per month has triggered 10-25 alerts per month. As of 11/1/2017, all alerts have stopped the process and the correct patient’s insulin pen was retrieved and administered. Each alert is followed by an investigation. Significant factors contributing to the triggering of an alert involve RNs caring for >1 patient with RAI insulin orders, pens returned to the wrong patient specific cassette in centralized medication rooms, carrying > 1 patient’s insulin pen at a time and opening > 1 patient’s EMR in the patient’s room when scanning. We conclude that pen misuse can be avoided with compliance to our triple scanning system, in conjunction with best practices, while preserving the critical timing of rapid-acting insulin.

Disclosure

H.W. Macmaster: None. A. Maruoka: None. C. San Luis: None. S. Gonzalez: None. R.J. Rushakoff: None.
Pharmacist-Led Digital Care Improved Community Diabetes Control in China—An Observational Study in a Large Population Sample
Authors: CAO JIUMEI , LI YINGJIE , WANG WEI , WANG ZHEN , LI DONGXING , ZHANG HONGGUANG , LIU KAI
Published: June 2018

Objective: To evaluate the effects of digital diabetic care and pilot-test the healthcare ecosystem with retail pharmacists as the care provider.

Methods: We managed to build a digital healthcare ecosystem that engages diabetic patients and pharmacists with a cloud engine that operates 5 different algorithms for diabetic care support. A set of glucose tele-monitor and an App was installed in the drug stores and pharmacists provided personalized interventions to the walk-in patients according to the onsite glucose tests and the supporting App contents generated by the cloud engine in real-time. Between Jun 6th 2015 and Dec 26th 2017, we served a total of 283,938 patients in 4,035 pharmacies in 183 cities, and 14,609 of them were selected in this analysis following 4 inclusion criteria: 1) the baseline fasting blood glucose (FBG) or random blood glucose (RBG) were diabetic, 2) the intervention duration was ≥ 1 month, 3) the number of received diabetic care was ≥ 3 times, and 4) the baseline characteristics were complete. Among them, 11,131 received FBG tests, 4,731 had RBG tests and 1,253 had both.

Results: FBG and RBG were reduced on average by 0.8 mM (baseline: 9.1 ± 2.2 mM, last time: 8.3 ± 2.2 mM, n=11,131, P< 0.001) and 3.2 mM (baseline: 14.5 ± 3.2 mM, last time: 11.3 ± 4.0 mM, n= 4,731, P<0.001), respectively. The diabetes control rates were improved with 3,165 patients of the FBG population (28%) and 2,545 patients of the RBG population (54%) returning to normal. The greatest glycemic control effect took place following the initial intervention with the reduction of FBG by 11% and RBG by 18%. Nonlinear fitting using compound function identified descending glucose reduction to time: FBG, y = 1.122x-1/3 + 7.970; RBG, y = 2.927x-1-0.003x + 11.070.

Conclusion: Retail pharmacists equipped with digital tools can effectively control diabetes and are valuable resources to help streamline the process of community healthcare delivery.

Disclosure

J. Cao: None. Y. Li: None. W. Wang: None. Z. Wang: None. D. Li: None. H. Zhang: None. K. Liu: None.
Cost and Cost-Effectiveness of a Faith-Based Lifestyle Intervention for Diabetes Prevention among African-Americans—A Within-Trial Analysis
Authors: RHODES ELIZABETH C. , CHANDRASEKAR EESHWAR , PATEL SHIVANI , NARAYAN K.M. VENKAT , JOSHUA THOMAS V. , MARION LUCY , WILLIAMS LOVORIA B. , ALI MOHAMMED K.
Published: June 2018

Background: Estimates of the economic value of investing in real-life diabetes prevention lifestyle interventions are scarce. We assessed the cost of implementation and cost-effectiveness of a church-based lifestyle intervention (Fit Body and Soul [FBAS]), in which African American participants received 18 lifestyle education sessions.

Methods: An incremental cost-effectiveness ratio (ICER) was calculated using data from a cluster randomized controlled trial comparing FBAS with a health education (HE) control group among 604 overweight participants in 20 churches. We calculated the ICER as the difference in costs to deliver FBAS vs. HE over the difference in weight change at one-year follow-up. Costs included those incurred for participant identification (screening at baseline) and program implementation (payment for health advisors to lead sessions, materials, equipment, and incentives to churches and participants). To estimate adjusted difference in weight (kg) change between FBAS and HE, we fit mixed linear models, accounting for clustering of participants within churches and for age, sex, and educational attainment. We repeated this analysis for waist circumference (cm).

Results: The per-person intervention cost of FBAS was $50.39 more than HE (per-person FBAS cost: $442.22; per-person HE cost: $391.83). The adjusted difference in weight change between the FBAS group and the HE group was 1.9 kg (95% CI 1.0, 2.8), and the adjusted difference in waist circumference change was 2.4 cm (95% CI, 1.3 to 3.4). Compared to HE, implementation of FBAS cost an additional $26.52 per kg weight lost and $21.00 per cm reduction in waist circumference.

Conclusion: For a modest increase in cost, FBAS led to greater weight loss and reduction in waist circumference among African Americans compared to standard HE at a church setting.

Disclosure

E.C. Rhodes: None. E. Chandrasekar: None. S. Patel: None. K. Narayan: None. T.V. Joshua: None. L. Marion: None. L.B. Williams: None. M.K. Ali: None.
Shared Telemedicine Appointments in Young Adults with T1D—An Economic Evaluation of the CoYoT1 Trial
Authors: WAN WEN , SKANDARI REZA , NATHAN AVIVA , ZAREI PARMIDA , REID MARK W. , RAYMOND JENNIFER , HUANG ELBERT
Published: June 2018

Background: Young adults with type 1 diabetes (T1D) experience significant difficulties adhering to glucose control standards. An innovative care model - shared medical appointments through home telemedicine - was recently examined and found to improve patient attendance and diabetes care engagement.

Objective: To evaluate within-trial cost-effectiveness of the intervention in Colorado Young adults with T1D (CoYoT1) aged 18-25.

Methods: In the prospective pilot trial, patients self-selected into the CoYoT1 or usual care groups. We collected baseline, 6, and 12 months data on patients’ self-reported healthcare use and trial medical care time related to group and/or individual visits.

Results: The health-related utility in the control group declined to a greater extent than the CoYoT1 group (p=0.04), but QALYs did not differ between the groups (p=0.5). We also found significantly lower direct, indirect, and total costs during the trial (CoYoT1: $2,341 vs. control: $6,935) (all p <0.01). The benefits were mainly due to CoYoT1 patients having fewer hospitalizations (p=0.09) and fewer primary care visits that occurred outside the trial (p=0.01), although the CoYoT1 group ($199) had higher annual costs of trial medical care time than controls ($84).

Conclusion: With long-term implementation, the CoYoT1 intervention may help patients to maintain a higher quality of life and save overall healthcare costs.

Disclosure

W. Wan: None. R. Skandari: None. A. Nathan: None. P. Zarei: None. M.W. Reid: None. J. Raymond: None. E. Huang: None.
Long-Acting Insulin Analogues and Risk of Breast Cancer—Meta-analysis
Authors: BOTA MARIA , AUTIER PHILIPPE , BOYLE PETER
Published: June 2018

Observational studies on the association between prescription of long acting insulin analogues (glargine and detemir) and the risk of breast cancer (BC) report conflicting results. We performed a meta-analysis of prospective studies on the risk of breast cancer among diabetic patients exposed to long acting insulin analogues following PRISMA guidelines. Summary relative risks (SRR) were computed using a random-effect model. Thirteen studies were identified which reported data on insulin glargine which included 438,214 subjects and 4,041 BC cases over a median follow-up of 2.8 years. In 11 studies, including 94.8 % of BC, the comparator groups included diabetic patients treated with non-glargine insulin. The SRR was 1.11 (95% CI: 0.98, 1.24), with little heterogeneity (I2=27%). Among prevalent users of insulin, based on 7 studies, the SRR of BC (1,425 cases) associated with prescription of glargine was 1.(95% CI: 0.90, 1.23), with moderate heterogeneity among studies (I2=40%). One influential study (Wu et al. 2017) accounted for most of the heterogeneity. When it was removed from the meta-analysis, the I2 dropped to 0% with a SRR of 0.99 (95% CI: 0.88, 1.12). Among new users of insulin, based on 10 studies, the SRR of BC (3,847 cases) associated with prescription of glargine was 1.12 (95% CI: 0.96, 1.29), with moderate heterogeneity among studies (I2=41%). One influential study (Ruiter et al. 2012) accounted for most of the heterogeneity. When it was removed from the meta-analysis, the I2 dropped to 0% with a SRR of 1.07 (95% CI: 0.96, 1.21). Only three studies reported on detemir, with a SRR for BC (1,947 cases) of 1.09 (95% CI: 0.77, 1.57). There seems to be consistent evidence showing no association between the prescription of long acting insulins and risk of BC. However, most of these studies had a short duration of follow-up. In addition, only three studies were identified reporting the risk of BC associated with use of detemir.

Disclosure

M. Bota: None. P. Autier: Other Relationship; Self; Sanofi. P. Boyle: Other Relationship; Self; Sanofi.
Patient Quality of Life and Benefits of Leptin Replacement Therapy (LRT) in Generalized and Partial Lipodystrophy (GL, PL)
Authors: ALI OMER A. , COOK KEZIAH , SHAMPANIER KRISTINA S. , TUTTLE EDWARD , GERRITS CHARLES , BROWN REBECCA
Published: June 2018

Effects of LRT on metabolic disease in GL and PL have been studied; however, little is known about consequences of GL and PL, or the effect of LRT, on quality of life (QoL).

To characterize health utility consequences of GL and PL attributes on patients, a discrete choice experiment (following a tutorial on the disease) was conducted with 1,000 members of the general population. Multinomial logit regression was used to estimate utility decrements associated with each attribute using an approach similar to Bansback et al. (2012).

Results were combined with data on prevalence of attributes before and after 1 year of LRT, derived from a retrospective chart review, to assess overall QoL consequences of GL, PL, and the impact of LRT in Quality-Adjusted Life Years (QALYs).

Overall, QALY gains associated with LRT were estimated at 0.423 across all patients. Impaired work/school ability, hyperphagia and organ damage were the largest contributing attributes.

A subgroup analysis for GL and PL found total QALY gains associated with LRT were 0.569 and 0.199, respectively.

This study indicates that lipodystrophy is associated with a large QoL impairment and that the benefits of LRT may be substantial in these patients. Attribute utility decrements appear to be consistent with those reported in other research (e.g., for diabetes), yet the cumulative impact of attributes makes the burden of GL and PL high.

Disclosure

O.A. Ali: Consultant; Self; Aegerion Pharmaceuticals. K. Cook: Consultant; Self; Aegerion Pharmaceuticals. K.S. Shampanier: Consultant; Self; Aegerion Pharmaceuticals. E. Tuttle: Consultant; Self; Aegerion Pharmaceuticals. C. Gerrits: None. R. Brown: None.
Metabolic Differences among Children of Different Ethnicities Are Magnified when Hepatic Insulin Extraction Is Included
Authors: PICCININI FRANCESCA , GOWER BARBARA , FERNANDEZ JOSE R. , BERGMAN RICHARD N.
Published: June 2018

Disposition index (DI) combines insulin sensitivity (SI) and beta-cell function (acute insulin response AIRg), and is a predictor of type 2 diabetes (T2DM). Insulin clearance, an important factor in glucose metabolism, is not included, yet can vary among ethnic groups. Our aim is to examine the differences among the DI in different ethnicities, and group subjects considering not only SI and AIRg, but also fractional hepatic insulin extraction (FEL). We used data from 203 normal glucose tolerant children that underwent FSIGT [55 African American (AA), 88 European American (EA), 60 Hispanic American (HA), ages 7-13 years, mean BMI = 19 kg/m2, basal glucose = 99 mg/dL, insulin = 78 pM, C-peptide = 511 pM]. Recent studies proved that HA and AA adults have an increased risk of developing T2DM. However, such studies are of interest for children of different ethnicities. The three DI hyperbolas, associated with ethnic groups (Figure 1A), are similar to each other. In contrast, cluster analysis also including FEL (Figure 1B), reveals that in these children 3 different clusters exist, (silouhette values > 0.6 in 63% of subjects in cluster 1, 87% in cluster 2, and 95% in cluster 3), and they do not necessarily coincide with ethnicity. Thus, FEL differs among children and it needs to be considered, together with SI and AIRg, in order to clarify diabetes risk among children of different ethnicities.

Disclosure

F. Piccinini: None. B. Gower: None. J.R. Fernandez: None. R.N. Bergman: Advisory Panel; Self; Ingredion, Inc.. Research Support; Self; AstraZeneca. Consultant; Self; GI Dynamics Inc.. Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases. Consultant; Self; Novo Nordisk A/S.
Rosiglitazone Increases Visceral and Subcutaneous Fat in Youth with Type 2 Diabetes (T2D) in the TODAY Study
Authors: DHALIWAL RUBAN , SHEPHERD JOHN A. , GHORMLI LAURE EL , COPELAND KENNETH C. , GEFFNER MITCHELL , HIGGINS JANINE , LEVITSKY LYNNE L. , NADEAU KRISTEN J. , WEINSTOCK RUTH S. , WHITE NEIL H.
Published: June 2018

Objective: In TODAY, metformin + rosiglitazone (M+R) was better in maintaining glycemic control than metformin alone (M) or metformin + lifestyle (M+L), but longitudinal differences in whole body adiposity were small and unrelated to treatment group. As excess visceral adipose tissue (VAT) and nonalcoholic fatty liver disease (NAFLD) are common in T2D, we hypothesized that changes in VAT, subcutaneous adipose tissue (SAT), and liver enzymes, as a marker of NAFLD, would be related to treatment effect.

Methods: TODAY enrolled 699 youth 11-17 y/o with T2D <2 year. In 626 subjects, VAT and SAT (by DXA) and AST and ALT were measured at baseline (BL) and 24 mo. Changes from BL to 24 mo were analyzed in baseline-adjusted repeated measures models.

Results: At BL, mean age was 13.9 year, 66.4% were female, 41.1% hispanic, 31.1% non-hispanic black, 20.3% non-hispanic white (NHW). Mean BMI was 33.7 kg/m2 and BMI z-score +2.2. 3.3% had ALT ≥1.5 upper limit of normal (ULN), suggestive of NAFLD, and 0.3% had AST ≥1.5 ULN. At 24 mo, BMI, BMI z-score, VAT, and SAT all increased. VAT increased most in M+R and least in M+L (14.2% vs. 3.1%, p<0.001). SAT increased more in M+R (15.7%) than M+L (6.9%, p<0.0001) or M (8.7%, p<0.001). At 24 mo, between-group differences in VAT:SAT ratio and AST were not significant, but ALT increased more in M+L than M+R (23.1% vs. 2.7%, p=0.015). Sex did not moderate treatment effects on VAT and SAT. Greater increases in VAT occurred in NHW in M+R than M (p<0.001) or M+L (p<0.001). VAT and SAT increases correlated with higher HbA1c (p<0.001), and lower insulin sensitivity (p<0.033), and c-peptide oral disposition index (p<0.038), but did not differ by treatment group.

Conclusion: Unlike in adults, in youth in TODAY, VAT rise was greater in M+R than M+L. VAT and SAT changes were not related to treatment group differences in glycemic control. Increased VAT and SAT correlated with lower insulin sensitivity and secretion. In T2D youth, R may blunt the rise in ALT, but does not lower the VAT:SAT ratio.

Disclosure

R. Dhaliwal: None. J.A. Shepherd: None. L. El Ghormli: None. K.C. Copeland: Other Relationship; Self; Novo Nordisk Inc. M. Geffner: Other Relationship; Self; Daiichi Sankyo Company, Limited. J. Higgins: None. L.L. Levitsky: Consultant; Self; Eli Lilly and Company. K.J. Nadeau: None. R.S. Weinstock: Research Support; Self; Medtronic MiniMed, Inc., Mylan, Kowa Pharmaceuticals America, Inc., Diasome Pharmaceuticals, Inc., Calibra Medical, Dexcom, Inc., Ultradian Diagnostics LLC., JAEB Center For Health Research, JDRF, National Institute of Diabetes and Digestive and Kidney Diseases. N.H. White: None.
Estimating Plasma Glucose with FreeStyle Libre Pro CGM during OGTT in Youth
Authors: GHANE NEJLA , BROADNEY MIRANDA , COLLINS SHAVONNE M. , DAVIS ELISABETH K. , BRADY SHEILA , YANOVSKI JACK A.
Published: June 2018

Objective: To evaluate the accuracy and practicality of the FreeStyle Libre Pro continuous glucose monitor (CGM) during oral glucose tolerance testing (OGTT) in a nondiabetic pediatric sample.

Background: The FreeStyle Libre Pro CGM has been found, in adults, to have acceptable accuracy compared to lab-measured glucose without requiring individual patient calibrations. No studies have assessed lab-measured glucose accuracy for this CGM in children.

Hypothesis: FreeStyle Libre Pro CGM glucose will not differ significantly from lab-measured plasma glucose during OGTT in youth.

Methods: Healthy weight and overweight volunteers (n =8; 63% male), aged 7-11y wore FreeStyle Libre Pro Flash CGM for 6 days, with a 2-hour OGTT (1.75mg/kg, max 75g) on day 6. Laboratory (Cobas E6000, Roche) plasma glucose was measured at 30min intervals for 120min, and compared with the 15min average simultaneously obtained CGM glucose value. Glucose at each timepoint and Area Under the Curve (AUC) for CGM and lab-measured glucose were compared using paired t-tests. A correlation coefficient was calculated for each timepoint. Potential systematic errors were examined using Bland-Altman analyses.

Results: AUC for CGM and lab glucose were well correlated (r= 0.91, p=0.006) and did not differ in mean value (p=0.84). CGM and lab glucose readings were not significantly different at any timepoint (all p’s>0.18). There were no significant systematic or magnitude errors as assessed by Bland-Altman analyses at any timepoint. No adverse events occurred with CGM use and all participants considered the device easy to wear.

Conclusions: The Freestyle Libre Pro CGM device was well tolerated and, even without individual calibration, provided quantitatively similar glucose readings during OGTT for healthy weight and overweight children when compared to lab-measured glucose. If confirmed in larger studies, this CGM may provide adjunctive data during evaluations of glucose excursions that may be useful for pediatric clinical care and research.

Disclosure

N. Ghane: None. M. Broadney: None. S.M. Collins: None. E.K. Davis: None. S. Brady: None. J.A. Yanovski: Research Support; Self; Rhythm Pharmaceuticals Inc., Zafgen.
Evaluation of Treatment Persistence in Individuals with Type 2 Diabetes in a Real-World Setting
Authors: CEFALU WILLIAM T. , DARSOW TAMARA , PETERSEN MATT , PALMER LIISA , THIEL ELLEN , LATTS LISA
Published: June 2018

Medication persistence is imperative for successful treatment of type 2 diabetes (T2D). Prior research has shown that discontinuation of prescribed medication within the first year is common for number of chronic disease treatments and that this is associated with poor clinical outcomes.

We performed a retrospective, observational study using claims data from the Truven Health MarketScan® Commercial and Medicare Supplemental Databases (2013-2016) to identify T2D patients initiating T2D therapy. Patients with at least one diagnosis for T2D and one outpatient pharmacy claim for a T2D medication preceded by 12 months without such medications were included. Patients were required to have at least 12 months of continuous enrollment in the database before and after the therapy initiation date. The primary outcome was initial treatment regimen discontinuation, defined as a gap of at least 45 days with no T2D medications on hand. Re-starting therapy with any T2D medication from the discontinuation date through the end of the 12-month follow-up was also assessed. Those with continuous treatment were censored at the end of the 12-month follow-up period.

A total of 324,136 patients initiating therapy were identified. The sample was 46% female and had an average age of 55 years. Following initiation, 31% of patients discontinued within the first 3 months, 44% within 6 months and 58% within 12 months. Among those who discontinued within the 12-month follow-up, 27% restarted therapy within 60 days, and 39% re-started therapy anytime during the 12-month follow-up. Those who discontinued and re-started therapy spent a mean of 107 days without treatment on hand.

This study provides real-world evidence that a majority of T2D medication patients discontinue within one year of initiation. Interventions aimed at improving treatment persistence should be targeted early after initiation to avoid gaps in therapy and associated clinical consequences.

Disclosure

W.T. Cefalu: None. T. Darsow: None. M. Petersen: None. L. Palmer: None. E. Thiel: None. L. Latts: Other Relationship; Self; Medtronic, Novo Nordisk Inc., Sanofi.
The Association between Breakfast Skipping and the Risk of Obesity, Diabetes, Hypertension, or Dyslipidemia—A Meta-analysis from 44 Trials Including 65,233 Cases and 381,051 Controls
Authors: MA XIU M. , XU YONG
Published: June 2018

Objective: Many epidemiologic studies have explored the relationship between breakfast skipping and risk of chronic diseases. But the conclusions are inconsistent. The purpose of this study was to assess the association between breakfast skipping and risk of obesity, diabetes, hypertension and dyslipidemia.

Research Design and Methods: A literature search was performed in Pubmed, Web of science and Embase for relevant articles update to November 2017. Pooled odds risks(ORs) with 95% CI were used as a measure to calculate the differences for dichotomous data (outcome events: obesity, diabetes, hypertension and dyslipidemia).

Results: A total of 44 papers including 65233 cases and 381051 controls were included in the present meta-analysis. Skipping breakfast compared to eating breakfast, the risk of obesity increased significantly, the OR was 1.54 (1.39,1.71). In addition, people who skip breakfast had increased risk of hypertension, diabetes and dyslipidemia, the OR of hypertension was 1.07(1.06, 1.07);the OR of diabetes was 1.16 (1.05, 1.29); the OR of elevated triglyceride was 1.22 (0.99,1.49); the OR of elevated cholesterol was 1.15 (1.07,1.22). Subgroup analysis shows that the OR of obesity was 1.56 (1.26,1.93) in Asia and 1.40 (1.15,1.71) in Europe. Besides, the OR of diabetes was 1.13 (0.98,1.29]) in Asia and 1.56 (1.04,2.34) in Europe. And the OR of hypertension was 1.07 (1.07,1.08) in Asia and 1.17 (0.71,1.92) in Europe.There was no significant publication bias was found in the studies identified by both Begg’s test and Egger’s test.

Conclusion: This meta-analysis confirmed that breakfast skipping positively increases the risk of obesity, diabetes, hypertension and dyslipidemia. In particular, it increases the risk of obesity. In Asia, the risk of obesity is more pronounced. However, Europeans who skip breakfast have a greater risk of diabetes and hypertension.

Disclosure

X.M. Ma: None. Y. Xu: None.
Cost-Effectiveness of Once-Weekly Semaglutide 1.0 mg vs. Dulaglutide 1.5 mg as Add-On to Metformin in the Treatment of Type 2 Diabetes in Canada
Authors: JOHANSEN PIERRE , HÅKAN-BLOCH JONAS , LIU AIDEN R. , PERSSON SOFIE , GRIP EMILIE TORESSON
Published: June 2018

Semaglutide is a novel GLP-1R agonist with prolonged half-life due to enhanced binding to albumin and inhibition of degradation by dipeptidyl peptidase-4. SUSTAIN 7, an open-label, parallel-group, phase 3b trial of 1,201 individuals with type 2 diabetes inadequately controlled on metformin monotherapy compared semaglutide to dulaglutide over 40 weeks. Semaglutide 1.0 mg demonstrated statistical superiority to dulaglutide 1.5 mg in HbA1c lowering (-1.8% vs. -1.4% [ETD -0.41%; 95% CI -0.57 to -0.25]) and reductions in body weight (-6.5 kg vs. -3.0 kg [ETD -3.55 kg; -4.32 to -2.78]).

We used a validated non-product specific cost-effectiveness cohort model (the IHE Cohort Model of Type 2 Diabetes) to extrapolate outcomes and costs associated with semaglutide 1.0 mg vs. dulaglutide 1.5 mg over a 40-year time horizon. Treatment effects (e.g., HbA1c, BMI, and systolic blood pressure) as well as cohort characteristics were sourced from SUSTAIN 7. Treatment with semaglutide 1.0 mg and dulaglutide 1.5 mg were assumed to continue for three years, after which the cohort discontinued the initial treatments, and started insulin therapy. Costs and health-related quality of life impact associated with developing macro- and microvascular complications were sourced from a Canadian perspective where possible.

In the base case, semaglutide 1.0 mg was associated with fewer micro- and macrovascular complications (driven by observed differences in risk factors). For example, for every 1,000 individuals, four fewer patients in the semaglutide 1.0 mg arm were simulated to experience a stroke. Fewer events led to an increase in quality-adjusted life years of 0.05 at lower total costs for patients in the semaglutide 1.0 mg arm compared to the dulaglutide 1.5 mg arm. Results were tested in sensitivity analyses and found to be robust, suggesting that semaglutide 1.0 mg provides better health outcomes at a lower cost, compared to dulaglutide 1.5 mg.

Disclosure

P. Johansen: Consultant; Self; Janssen Global Services, LLC.. Employee; Self; Novo Nordisk A/S. J. Håkan-Bloch: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Novo Nordisk A/S. A.R. Liu: None. S. Persson: None. E. Toresson Grip: None.
Impact of Intensive Remote Monitoring on Blood Glucose Measurements in a Cohort of T1D Pediatric Patients
Authors: GANDRUD LAURA M. , BARNES TIMOTHY L. , WATSON DAVID A.
Published: June 2018

Intensive and frequent contact with diabetes care providers has been shown to improve glycemic control and reduce risk of complications among T1D pediatric patients. However, remote monitoring utilizing newer Bluetooth enabled technology has not been fully evaluated. In a randomized clinical trial, 117 children and adolescents with T1D were assigned to either intensive remote therapy (IRT) or conventional care (CC) for 6 months. Both groups continued routine clinic appointments quarterly and uploaded blood glucose (BG) and device data weekly. Data for patients assigned to IRT were reviewed weekly, and patients were contacted if a regimen adjustment was indicated. The primary outcome of the trial was change in HbA1c from baseline, but the focus of this summary is weekly BG measurements reported from BG meters.In total, 107 subjects (53 in the IRT group) uploaded weekly data. In the first 26 weeks, patients uploaded data an average of 24.7 weeks. The outcomes of interest were summaries of BG measurements, namely average and standard deviation of BG levels and whether measurements were in, below, or above the target range (70-140 mg/dL). Multiple observations per subject were analyzed using generalized linear mixed effects models. Patients in the IRT group had average BG levels 19.3 mg/dL lower than the CC group (P=0.0007). The difference between standard deviations of BG levels was not statistically significant. IRT increased the odds of BG measurements in the target range (OR: 1.25, P=0.0037), as well as the odds of being below the target range (OR: 1.47, P=0.0031), presumably because BG levels were lower. The IRT and CC groups had 24.6% and 20.6% of measurements in the range respectively and 4.7% and 3.2% below the range respectively. These results suggest that IRT can lower BG levels in children and adolescents. Given these promising findings, further research is warranted, as this technology has potential to add convenience and efficiency to T1D management and increase time in target.

Disclosure

L.M. Gandrud: Consultant; Self; UnitedHealth Group. T.L. Barnes: None. D.A. Watson: None.
Type 1 Diabetes Transition Program at a Children’s Hospital—Lessons Learned and Future Directions
Authors: CORNWELL HOLLY , YIGIT SEVKET , PURUSHOTHAMAN RADHIKA
Published: June 2018

Background: Transitioning a child with type 1 diabetes (T1DM) poses many challenges. Structured programs decrease loss to follow-up and hospitalization rates. We created a transition program, modeled after the Sweet transition program (Queensland, Australia) and monitored the outcomes.

Methods: The program was implemented in April 2015. Steps included: Assessing T1DM knowledge at age 12, education based on need/age, providing an adult provider list, sending providers a clinical summary and maintaining a referral registry. The program was revised in October 2016, now included follow-up by a coordinator and a patient survey evaluating the program.

Results: There was increased attendance to education sessions. Transition to adult care within 6 months also improved. No one was lost to follow-up. We received useful feedback from patients about the program.

Lessons learned:

1. The ADA guidelines need to be customized based on available resources.

2. Starting at age 12 helps improve transition.

3. A transition registry and coordinator are important.

Future directions:

1. Provide subjective assessments for patients to gauge their T1DM knowledge.

2. Collaborate with adult providers via combined clinic.

Table 1: Comparison of Program OutcomesApril 2015-16October 2016-17Total No. of Type 1 Patients910875High School and Beyond Education22 (8%)71 (30%)Transfer of Care Education 16 (8%)44 (29%)Referred Patients Seen within 6 months59%80%Referred Patients Seen >6 months17%20%Referred Patients Lost to Follow Up24%0%

Disclosure

H. Cornwell: None. S. Yigit: None. R. Purushothaman: None.
Analysis of the Social Network and Physical Activity Performed as Perceived by Young Patients with Type 1 Diabetes
Authors: FRANCIA PIERGIORGIO , PICCINI BARBARA , SANTOSUOSSO UGO , IANNONE GIULIA , CAPIRCHIO LAURA , VITTORI ALESSANDRO , GULISANO MASSIMO , TONI SONIA
Published: June 2018

In addition to the knowledge of the daily physical activity performed (PAP), the analysis of the social network perceived directly by the same young patients with type 1 diabetes mellitus (T1DM) could provide useful information to manage their diabetes. The aim of this study was to evaluate the presence of a relationship between the patients’ social networks, the PAP and the metabolic control maintained in young subjects with T1DM. Interviews were conducted in 16 subjects with T1DM (males/females: 7/9), mean age 15,5±3,8 years, duration of diabetes 6,6±4,9 years, mean HbA1c (at baseline) 7,3±1,7% (year before) 7.3±1.6%, body mass index (BMI) 21,6±2,9 kg/m2 and in 12 age and BMI matched healthy control subjects. Participants were asked to fill in an egocentric social network map, which was divided into 5 areas: family, school, health care, leisure and sport activities, other. It was assigned a value ranging from 0 (none) to 5 (maximum) to define importance and frequency of the relationships reported. The PAP was evaluated by the Physical Activity Questionnaire for Children (PAQ-C) and Adolescents (PAQ-A). While the analysis of the PAP and of the glycemic control maintained did not show any correlation with the other parameters, the analysis of the network showed that the frequency reported on the area of leisure and sport activities was significantly lower in the patient group in comparison to controls (4,2±1,8 vs. 3,1±1,0; p<0,05). From the analysis of the two groups, the young patients investigated reported to attend significantly fewer sports clubs (3.3±0.8 vs. 4.2±0.8, p<0.01) and have less contact with teammates (2.8±1.5 vs. 4.2±1.3; p<0.05). However, they mainly attend hospital (2.0±1.1 vs. 0.6±0.7; p <0.001) and friendly societies (1.5±1.1 vs. 0.1±0.4; p<0.001). The results of this pilot study showed that the analysis of patients’ social networks could contribute to improving knowledge and therefore providing additional information useful for better management of these patients.

Disclosure

P. Francia: None. B. Piccini: None. U. Santosuosso: None. G. Iannone: None. L. Capirchio: None. A. Vittori: None. M. Gulisano: None. S. Toni: None.
A Paradoxical Relationship between Physical Activity and HbA1c in Pediatric T1D Patients
Authors: WATSON DAVID A. , BARNES TIMOTHY L. , GANDRUD LAURA M.
Published: June 2018

Regular physical activity (PA) has been found to contribute to lower HbA1c in T1D pediatric populations, but this relationship is not conclusive.

In a recent study, we examined associations between PA and HbA1c over 6 months in 1T1D pediatric patients. PA was measured with Fitbit monitors and summarized as average weekly steps and hours of moderate to vigorous PA (MVPA). Linear regression was used to analyze associations and adjust for variables including baseline HbA1c.

Counter to expectations, PA across patients was positively associated with HbA1c. An increase of 10K average steps/week was associated with a 0.115 mmol/mol increase in HbA1c (P=0.017). In addition, an increase of 1 hour of average weekly MVPA was associated with a 0.088 mmol/mol increase in HbA1c (P=0.038). However, within patients, weekly PA levels were negatively associated with weekly BG levels in 75% of patients.

This reversal of trend between within and between patient measures is an interesting example of what is called Simpson’s paradox in statistics. The Figure illustrates how these relationships coexist: weekly data show a negative trend for 3 patients (dashed lines); however, averaged data show a positive trend (solid line).

Although across patients, higher PA tended to be associated with higher HbA1c, the within patient association suggests an encouraging effect in which PA among pediatric patients may actually help to lower HbA1c levels.

Disclosure

D.A. Watson: None. T.L. Barnes: None. L.M. Gandrud: Consultant; Self; UnitedHealth Group.
Sustained CGM Use in Low Income Youth following Insurance Coverage
Authors: PRAHALAD PRIYA , BUCKINGHAM BRUCE , WILSON DARRELL , MAAHS DAVID M.
Published: June 2018

California Children’s Services (CCS) is a supplemental state medical insurance for low income children with chronic medical conditions. Until June 2016, continuous glucose monitors (CGM) were rarely covered by CCS for children with type 1 diabetes (T1D). Current CCS criteria for CGM includes: checking blood sugar 4 times/day and concerns that interfere with T1D management (such as fear of hypoglycemia). Ongoing approval requires CGM use for 5/7 days/week.

We evaluated 6 months of CGM use by the first 41 children approved by CCS attending our clinics (age= 11.1 ± 4.7 years [range 3-21 years], T1D duration=4.8 ± 3.7 years, 59% male, 66% on pumps, 63% ethnic minorities and 15% non-English speakers). Most patients used the Dexcom receiver (73%). Thirty-three (81%) remained on CGM for ≥6 months. Of the 8 who stopped, 2 were due to lapses in insurance coverage. The other 6 stopped due to personal preference (5 within 3 months). All who stopped CGM use were English speakers. Among those who continued CGM with complete data (n=29, 71%), the mean percentage time worn at 6 months was 97±8% based on review of the CGM download. HbA1c remained stable over 6 months of CGM use (8.2±1.2%). Blinded CGM use was not available prior to initiation of personal CGM, so we cannot assess if hypoglycemia decreased. However, many of these children with CCS started CGM due to hypoglycemia and/or fear of hypoglycemia. Time in hypoglycemia as low at 6 months (4.3±4.8%). The number of fingersticks remained stable with 6.3/d at initiation and 5.6/d at 6 months.

Our clinic data from the first 41 CCS patients approved for CGM demonstrates sustained CGM use for 6 months, even among non-English speakers. In this initial chart review, the incidence of hypoglycemia is low while on CGM. These data on sustained usability of CGM support CCS coverage of CGM. Given FDA approval of CGM use for insulin dosing decisions, expansion of CCS coverage of CGM should be considered to improve bolus adherence. Further studies are needed to promote improved clinical use and outcomes with CGM in this population.

Disclosure

P. Prahalad: None. B. Buckingham: Advisory Panel; Self; Novo Nordisk Inc., ConvaTec Inc.. Research Support; Self; Medtronic, Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Consultant; Self; Tandem Diabetes Care, Inc., Becton, Dickinson and Company. D. Wilson: Research Support; Self; T1D Exchange, Medtronic MiniMed, Inc., Dexcom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases, Insulet Corporation. Advisory Panel; Self; Tolerion. D.M. Maahs: Advisory Panel; Self; Insulet Corporation. Consultant; Self; Abbott. Research Support; Self; Medtronic, Bigfoot Biomedical, Dexcom, Inc., Insulet Corporation, Roche Diabetes Care Health and Digital Solutions.
Inhibition of Nox-1 Activity Attenuates Diabetic Ketoacidosis-Induced Blood Brain Barrier Permeability and Edema Formation
Authors: MARTINEZ-REVOLLAR GABRIELA
Published: June 2018

Diabetic ketoacidosis (DKA) is a condition characterized by hyperglycemia and high ketone bodies production conducting to acidosis. DKA is highly prevalent in pediatric patients. Approximately 0.5%-1% of these children develop cerebral edema, with a mortality rate of 20-90%. Our research examined the effects of DKA in Blood Brain Barrier (BBB) permeability using Ins2Akita mice as a T1D model. Using magnetic resonance (MR)-based detection of the contrast agent gadolinium diethylenetriaminepenta-acetic acid (Gd-DTPA) we observed BBB permeability and fluid accumulation in the brain, during DKA episodes from day 1 to 5. Our data indicated that increased BBB permeability was present in the thalamus, partial cortex and basal forebrai. Furthermore, the analysis of the morphological and functional changes of BBB under DKA conditions both in vitro and in vivo in vitro showed alterations in TJ proteins, manifested as a slight alteration in ZO-1 and Claudin-5 expression which could represent the ground for BBB leakage. We have further identified that DKA promotes the high production of ROS due to Nox-1 activation, leading to actin reorganization, the subsequent TJ disorganization and increased BBB permeability. The inhibition of Nox-1 activity via Nox-1 inhibitor ML-17 improved the BBB integrity and reduced leakage. Collectively, these studies will provide new information related to novel therapeutic strategies to prevent or reverse vascular hyperpermeability in DKA.

Disclosure

G. Martinez-Revollar: None.
Fetal Brain Activity in Pregnancy of Women with Type 1 Diabetes Mellitus
Authors: FEHLERT ELLEN , SCHLEGER FRANZISKA , LINDER KATARZYNA , HENI MARTIN , HAERING HANS-ULRICH , PREISSL HUBERT , FRITSCHE ANDREAS
Published: June 2018

We previously found gestational diabetes mellitus (GDM) to be associated with prolonged fetal auditory evoked brain responses (fAER) in fetal magnetoencephalography (fMEG). We asked whether maternal type 1 diabetes mellitus (T1D) may alter fetal brain activity.

Pregnant women with well-controlled T1D (n=4, A1c <6.5%) were measured with fMEG before and 60 min. after a defined meal. Latencies of fAER were analyzed. We obtained two control groups of women with GDM (n=8) and normal glucose tolerance (NGT, n=8) out of 151 pregnant women with fAER measurements during a 75g OGTT. The groups were carefully matched by gestational age and pre-pregnancy maternal BMI.

ANOVA showed a main effect of group on the change in latency between baseline and postprandial state (F(2)=4.14, p=.034). In accordance with our previous results, in post-hoc tests the change of latency was smaller in the GDM than the NGT group (p=.032). No difference was found in the change of latency between T1D and NGT or GDM. The number of fetuses showing faster fAER postprandially is higher in T1D and NGT than in GDM. For details see Table.

To our knowledge, this is the first study investigating fAER in maternal T1D. In contrast to GDM, our preliminary results indicate that well-controlled maternal T1D does not impair fetal postprandial brain activity. These findings may indicate that fAER are associated with metabolic features mainly present in maternal insulin resistance.Latency of fetal auditory evoked responses in ms (mean±SD)GroupnBaseline (0 min)Postprandial (60 min)ChangeNumber of fetuses with speeding up of fAERNGT8277 (±103)204 (±89)- 72 (±81)7/8 (88%)T1D4257 (±57)262 (±151)+ 6 (±119)3/4 (75%)GDM8222 (±82)288 (±74)+ 65 (±100)3/8 (38%)

Disclosure

E. Fehlert: None. F. Schleger: None. K. Linder: None. M. Heni: Research Support; Self; Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Novo Nordisk Inc.. H. Haering: None. H. Preissl: None. A. Fritsche: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Novo Nordisk A/S, Eli Lilly and Company, Boehringer Ingelheim GmbH.
Plasma Triglyceride Concentrations during Pregnancy Are Associated with Fetal Hyperinsulinemia, Insulin Resistance, and Birth Weight Independent of Maternal Hyperglycemia and Insulin Resistance
Authors: CHEN KUAN YU , LI HUNG-YUAN
Published: June 2018

Objective: Intra-uterine environment has a great influence on fetal glucose metabolism and growth. Unlike gestational diabetes, the effect of maternal lipid metabolism on fetal glucose metabolism remains unknown. In this study, we evaluate the relationship between maternal plasma triglyceride concentrations during pregnancy, cord blood c-peptide, fetal insulin resistance index and birth weight.

Research Design and Methods: 663 pregnant women who delivered singleton at National Taiwan University Hospital from 2013 to 2017 were enrolled in this cohort study. We measured plasma lipid profile at each trimester, cord blood c-peptide concentrations and birth weight. Fetal insulin resistance was measured by homeostatic model assessment 2-insulin resistance index (HOMA2-IR).

Results: Maternal plasma triglyceride, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol increased significantly during pregnancy (all p<0.05). Maternal plasma triglyceride at the visit for oral glucose tolerance tests (OGTT) was associated with cord blood c-peptide (adjusted p<0.05) and fetal HOMA2-IR (adjusted p<0.05), adjusted for family history of diabetes, history of gestational diabetes, pre-pregnancy body mass index (BMI), gestational age, gestational weight gain, maternal hemoglobin A1c, maternal HOMA2-IR and cord blood glucose. Maternal plasma triglyceride at delivery was significantly associated with birth weight (adjusted p<0.05), adjusted for family history of diabetes, history of gestational diabetes, pre-pregnancy BMI, gestational age, gestational weight gain and maternal hemoglobin A1c. Similar associations were also found in women without gestational diabetes.

Conclusions Maternal plasma triglyceride concentrations during pregnancy are associated with fetal hyperinsulinemia, insulin resistance and birth weight.

Disclosure

K. Chen: None. H. Li: None.
Sleep Disordered Breathing—An Unrecognized Contributor to Abnormal Glycemic Profiles in Pregnancy
Authors: FARABI SARAH S. , BARBOUR LINDA A. , HERNANDEZ TERI L.
Published: June 2018

Sleep disordered breathing (SDB), particularly obstructive sleep apnea (OSA), is poorly understood in pregnancy, yet may insidiously worsen metabolic function. We hypothesized that worse SDB in part accounts for higher 24 hour patterns of glycemia in late pregnancy complicated by obesity without gestational diabetes. At 33±1 weeks, 18 pregnant women without OSA symptoms (29.4±1.2 years [mean±SEM], BMI 34.3±0.6 kg/m2) were provided a eucaloric diet (50% carb, 35% fat) for 72 hour while wearing a continuous glucose monitor (CGM). SDB severity was measured in-home with a WatchPAT200 wrist-worn device and quantified by the apnea hypopnea index (AHI; apneas and hypopneas/hour) and oxygen desaturation index (ODI; O2 desaturations ≥4%/hour). Surprisingly, (12/18) women had an AHI≥5 (mild OSA). Total sleep time was 370.3±12.4 min (∼6 hours), sleep efficiency was impressively low (80.1±1.5%), and AHI and ODI were at least mild at 11.6±2 and 5.2±1.3, respectively. Importantly, AHI was correlated with 24 hour glucose area-under-the-curve (AUC) (r=0.50, p=0.03) and mean 24 hour glucose (r=0.55, p=0.02). ODI was correlated with both 24 hour AUC (r=0.54, p=0.02, Figure 1a) and mean 24 hour glucose (r=0.58, p=0.01, Figure 1b). Poor sleep and undiagnosed mild OSA are common in late pregnancy complicated by obesity, and may contribute to higher patterns of glycemia. SDB may be a treatable risk factor potentially improving maternal and fetal outcomes.

Disclosure

S.S. Farabi: None. L.A. Barbour: None. T.L. Hernandez: None.