bluuebunny/crossref_metadata_2025_split huggingface dataset:
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 &lt;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 &gt; 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 &lt;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&lt;0.001). SAT increased more in M+R (15.7%) than M+L (6.9%, p&lt;0.0001) or M (8.7%, p&lt;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&lt;0.001) or M+L (p&lt;0.001). VAT and SAT increases correlated with higher HbA1c (p&lt;0.001), and lower insulin sensitivity (p&lt;0.033), and c-peptide oral disposition index (p&lt;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&gt;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.