bluuebunny/crossref_metadata_2025_split huggingface dataset:
First Assessment of the Performance of an Implantable CGM System through 180 Days in a Primarily Adolescent Population with Type 1 Diabetes
Authors: ARONSON RONNIE , RASTOGI RAVI , MDINGI COLLEEN , CHEN XIAOXIAO , TWEDEN KATHERINE 
Published: June 2018

Background: An implantable continuous glucose monitoring (CGM) system (Eversense® XL, Senseonics, Maryland U.S.A) recently received CE Mark for 180-day duration in adults. The current study is the first investigation of the performance of the Eversense XL through 180 days in a primarily adolescent population with type I diabetes (T1D).
Methods: This study was a prospective, single-center, single-arm, 180-day evaluation of the effectiveness and safety of the implantable CGM system among Canadian adolescent and adult participants with T1D. Effectiveness measures included mean absolute relative difference (MARD), system agreement with Yellow Springs Instrument (YSI) glucose values, and Clarke Error Grid analysis using paired CGM and reference YSI glucose analyzer values. Adult participants were inserted with two sensors and adolescent participants were inserted with one sensor in the upper arm. CGM system accuracy studies were performed every 30 days. The safety assessment included the incidence of insertion or removal procedure-related and device-related serious adverse events (SAEs) through 180 days post-insertion.
Results: Thirty-Six participants (30 adolescent/6 adult, 13 female/23 male, mean age 17±9.2 years, mean BMI 22±4 kg/m2) received the CGM system. One subject withdrew at Day 1 due to intravenous access issues. CGM system agreement with YSI glucose within 15 mg/dL or 15% of YSI glucose values (N = 7163) through 60, 120 and 180 days was 82.9% (95% CI: 78.4%-86.1%), 83.6% (95% CI: 80.4%-85.7%) and 83.4% (95% CI: 79.7%-85.5%), respectively. Overall MARD was 9.4% (95% CI: 8.6%-10.5%). Clarke Error Grid analysis showed 99% of paired values in clinically acceptable error zones A and B. No insertion/removal or device-related SAEs were reported.
Conclusions: The Eversense XL CGM system is safe and accurate through 180 days of Sensor wear in a primarily adolescent population.

Disclosure
R. Aronson: Other Relationship; Self; Novo Nordisk Inc., Janssen Pharmaceuticals, Inc., Sanofi, AstraZeneca. Research Support; Self; Eli Lilly and Company, Becton, Dickinson and Company, Merck & Co., Inc., Senseonics, Boehringer Ingelheim Pharmaceuticals, Inc. R. Rastogi: Employee; Self; Senseonics. C. Mdingi: Employee; Self; Senseonics. X. Chen: Employee; Self; Senseonics. K. Tweden: Employee; Self; Senseonics.
The Pros and Cons of Gastric Bypass Surgery in Obese Individuals with Type 2 Diabetes—Nationwide, Matched, Observational Cohort Study
Authors: LIAKOPOULOS VASILEIOS , SVENSSON ANN-MARIE , NASLUND INGMAR , ELIASSON BJORN 
Published: June 2018

Introduction: Long-term effects of gastric bypass (GBP) surgery have been presented in observational and randomized studies, but there is still only limited data for obese persons with type 2 diabetes (T2DM), in particular regarding postoperative complications. We investigated postoperative outcomes after GBP in a nation-wide cohort.
Research Design and Methods: In this observational study, we merged data from the Scandinavian Obesity Surgery Registry, the National Diabetes Register and national databases. We matched persons with type 2 diabetes who had undergone GBP with persons not surgically treated for obesity, based on sex, age, BMI and propensity score. The risks of postoperative outcomes were assessed using Cox regression model adjusted for sex, age, BMI and socioeconomic status.
Results: 5321 T2DM patients who had undergone GBP and 5321 control persons were followed for up to 9 years. We confirm lower risks of all-cause mortality (49%) and cardiovascular disease (34%), found positive effects on severe kidney disease, but also demonstrate significantly increased risks (2 to 9-fold) of several short-term complications after GBP. There were higher rates of abdominal pain and gastrointestinal conditions frequently requiring additional surgical procedures, apart from reconstructive plastic surgery. Long-term, the risk of anemia was 92% higher, malnutrition appeared approximately 3-fold more often, while psychiatric diagnoses were 33% increased, and alcohol abuse was 3-fold higher than in the control group.
Conclusions: This nation-wide study confirms the benefits but also describes the panorama of adverse events after bariatric surgery in obese persons with T2DM. In order to maximize the benefit and minimize the risk of unfavorable results after bariatric surgery, a thorough and long-term follow-up and support of these patients seems paramount. Better selection of patients for such treatment could probably also improve results.

Disclosure
V. Liakopoulos: None. A. Svensson: None. I. Naslund: Other Relationship; Self; Baricol Bariatrics AB, Sweden. B. Eliasson: Advisory Panel; Self; Amgen Inc.. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Merck Sharp & Dohme Corp.. Speaker's Bureau; Self; Novo Nordisk A/S. Consultant; Self; Sanofi.
T1D and T2D Youth in the Pediatric Diabetes Consortium (PDC) Registries—Comparing Clinical Characteristics and Glycemic Control
Authors: TAMBORLANE WILLIAM V. , CHENG PEIYAO , GAL ROBIN L. , KOLLMAN CRAIG , VAN NAME MICHELLE A. , LYNCH JANE L. , NELSON BRYCE A. 
Published: June 2018

Objective: To compare characteristics of youth with T1D (n = 484) vs. T2D (n = 1169) in the PDC.
Methods: Participants were 10 to &lt;21 years at diagnosis. Mann-Whitney U and Chi-square tests were used to compare demographics. Linear regression models were used to compare BMI and HbA1c at diagnosis; logistics regression was used to compare DKA at diagnosis. Post-diagnosis HbA1c differences between cohorts were assessed through repeated measures.
Results: T2D youth were more likely to be female (62 vs. 45%, p&lt;0.001), overweight/obese (99 vs. 16%, p&lt;0.001) and from low income (75 vs. 30%, p&lt;0.001), minority (82 vs. 29%, p&lt;0.001) families. T1D youth were more likely to present with DKA (32 vs. 11%, p&lt;0.001) and have higher mean HbA1c levels (12.0 vs. 10.0%, p&lt;0.001) at diagnosis. More than 70% in both cohorts achieved target HbA1c levels &lt;7.5% within 6 months but fewer T1D patients were able to maintain HbA1c target after 6 months (Figure). In 410 participants with T2D duration ≥ 24 months at enrollment, 185 (45%) required no insulin therapy; c-peptide was 1.45 mmol/l in the subset of 74 measured at enrollment.

Conclusion: While families of youth with T2D face greater socio-economic obstacles and risk factors for poor diabetes outcomes, the greater retention of residual endogenous insulin secretion likely contributes to the increased ability of T2D youth to to maintain target HbA1c levels over time.

Disclosure
W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceuticals U.S.A., Inc.. P. Cheng: None. R.L. Gal: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Development Center Americas, Inc., Novo Nordisk Inc. C. Kollman: Research Support; Self; JDRF, Bigfoot Biomedical, Dexcom, Inc., Tandem Diabetes Care, Inc., Medtronic MiniMed, Inc., Helmsley Charitable Trust. M.A. Van Name: None. J.L. Lynch: Other Relationship; Self; Novo Nordisk Inc.. Research Support; Self; Daiichi Sankyo Company, Limited. B.A. Nelson: Speaker's Bureau; Self; Dexcom, Inc..
Development of a National Minimal Set of Patient-Important Outcome Domains for Value-Based Diabetes Care in Denmark
Authors: SKOVLUND SOREN E. , TROELSEN LISE , DØMGAARD MIKALA , JAKOBSEN POUL ERIK O. , EJSKJAER NIELS 
Published: June 2018

Aim: To identify a minimal set of patient-reported (PRO) domains for use in value-based diabetes care in Denmark.
Methodology: A structured mixed-methods research protocol was applied to ensure an evidence-based approach to involvement of people with diabetes in the identification of patient-centered outcome domains. 20 people with diabetes and 4 caregivers of people with diabetes selected for representativeness in age, gender, type of therapy, duration of diabetes, type of diabetes, and disease burden were recruited for qualitative research and co-creation to examine 1) psychological, physical and social impacts of diabetes and desired outcomes of treatment, 2) dis-utilities of therapy and 3) factors enabling sustainability in line with the value based care model. Qualitative research based on interviews, structured focus group and co-creation workshop sessions together with desk research on patient, clinical, health economic, and societal relevance of identified domains informed the final identification of domains by a multi-disciplinary and multi-sector working group using strict criteria of patient importance, clinical relevance and applicability, measurability and mutability.
Results: The following PRO domains were selected to complement the clinical outcome domains: Self-reported health, psychological well-being, symptom burden (e.g., sleep, sexual dysfunction, complications), multi-faceted impact of diabetes on life including diabetes distress, treatment burden and impacts of hypoglycemia, and specific indicators of care confidence, quality and diabetes self-care ability.
Conclusions: The assessment of patient-important outcomes for value based diabetes care in Denmark require the implementation of PRO questionnaires in standard diabetes care.

Disclosure
S.E. Skovlund: None. L. Troelsen: None. M. Dømgaard: None. P.O. Jakobsen: None. N. Ejskjaer: None.
Obstructive Sleep Apnea in Pediatric Type 2 Diabetes—Prevalence, Demographics, and Screening Practices
Authors: MATLOCK KRISTAL A. , GUO YUPING , KHOURY JANE C. , GURBANI NEEPA , CRIMMINS NANCY A. 
Published: June 2018

Background: Managing pediatric type 2 diabetes (T2D) requires provider proficiency in addressing co-morbidities. Adults with T2D are at high risk for obstructive sleep apnea (OSA) but data is limited in children. Study aims were to 1) develop a screening process to assess OSA symptom prevalence in children with T2D and 2) characterize patients with T2D and proven OSA (confirmed by polysomnography [PSG]).
Methods: Michigan Sleep-Disordered Breathing questionnaire was implemented for patients age 8-18 years with T2D (2017). A score &gt;0.33 defined positive screening for OSA symptoms, resulting in Sleep Medicine referral. Data collected included age, sex, race/ethnicity, duration of T2D, surgical and medication history, body mass index (BMI), blood pressure, lipid profile and hemoglobin A1c. Patients with positive screenings were followed prospectively to describe clinical course.
The same data was collected on patients with T2D and proven OSA via retrospective chart review (2010-2016). Wilcoxon rank sum or Fisher’s exact test were used to compare 1) patients with and without OSA symptoms and 2) patients with and without proven OSA.
Results: Over 10 months, 43 children with T2D completed OSA screening. Forty percent (17/43) screened positive for OSA symptoms leading to referral. Thus far, four children have completed PSG; three had OSA and 1 had primary snoring. No significant differences between youth with or without OSA symptoms were detected.
Chart review of 225 children with T2D showed 42 had PSG and 29/42 (69%) had proven OSA. Only BMI and associated z-score were significantly higher when comparing children with proven OSA to those without OSA.
Conclusion: Prevalence of OSA symptoms is high (40%) in children with T2D when routinely screened in a small cohort. Furthermore, the majority who complete PSG have proven OSA. There were no consistent factors that identified children with OSA symptoms; thus, screening all patients is crucial to prevent complications of delayed diagnosis.

Disclosure
K.A. Matlock: None. Y. Guo: None. J.C. Khoury: None. N. Gurbani: None. N.A. Crimmins: None.
Motivational Stage at CGM Initiation Is Less Important than Timing of CGM Initiation in Predicting CGM Adherence
Authors: VERBEETEN KATE , CHAN JASON , SOURIAL NADIA , LAWSON MARGARET L. ,   CGM TIME TRIAL STUDY GROUP,   JDRF CANADIAN CLINICAL TRIALS NETWORK
Published: June 2018

Background: Readiness for making behavioral changes is a key factor determining success in the adoption of technologies like CGM in type 1 diabetes (T1D). SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale-Diabetes Version) can classify individuals into 1 of 5 motivational stages: Precontemplation, Contemplation, Determination, Action and Maintenance. It was used in the CGM TIME Trial, a multicenter pediatric RCT comparing simultaneous pump and CGM (“SIM” group) to initiation of CGM 6 months later (“DEL” group) (MiniMed Veo™ System).
Aim: To examine the association of SOCRATES scores with 1) A1C at trial entry and 2) CGM adherence and change in A1C 6 months after CGM initiation.
Methods: 97/99 eligible children aged 10-18 years and 136/141 eligible parents completed SOCRATES at trial entry and 6 months. Multivariable linear regression tested the association between motivational stage and 1) child’s A1C at trial entry, and 2) change in A1C and CGM adherence 6 months after CGM initiation, adjusted for randomization group, gender, age, and diabetes duration.
Results: At trial entry, mean adjusted A1C was 1.02% lower for children in Precontemplation than those in Action (p&lt;0.0001). The A1C of children whose parents were in Precontemplation was 0.83% lower than those in Maintenance (p=0.02) and 0.35% lower than those in Action (p=0.048). Motivational stage of children and parents at CGM initiation was not associated with CGM adherence or change in A1C 6 months later whereas there was an intervention effect with the SIM group using CGM an additional 3.4 hours per day (p=0.03) compared to the DEL group.
Conclusions: SOCRATES scores were associated with A1C at trial entry, but did not predict future CGM adherence or change in A1C. SOCRATES was a poor measure of readiness for change in children with T1D and their parents who were participating in a clinical trial. CGM adherence was related more to timing of CGM initiation than motivational stage.

Disclosure
K. Verbeeten: None. J. Chan: None. N. Sourial: None. M.L. Lawson: None.
Early and Later C-Peptide Responses during Oral Glucose Tolerance Testing (OGTT) Are Independently and Oppositely Predictive of Type 1 Diabetes (T1D) in Autoantibody-Positive (Ab+) Individuals
Authors: ISMAIL HEBA M. , BECKER DOROTHY J. , GEYER SUSAN , XU PING , LIBMAN INGRID , HEROLD KEVAN C. , ATKINSON MARK A. , REDONDO MARIA J. , PALMER JERRY P. , SOSENKO JAY 
Published: June 2018

A longitudinal study showed that early C-peptide (C-P) responsiveness during OGTTs declined during progression to T1D, whereas later C-P responsiveness increased until the diagnosis was imminent. Here we exmaine: 1) whether the baseline C-P response pattern predicts T1D as suggested by the findings from that longitudinal study, and 2) the basis for the higher later C-peptide response during progression. Baseline 2-hour OGTTs from 670 Diabetes Prevention Trial-type 1 participants (age: 13.8±9.6 years; BMI-z: 0.3±1.1; 56% male) were analyzed. In univariate regression models, the early C-P response (30-0 min) was inversely predictive of T1D (X2=28.8, p&lt;0.001), whereas the later C-P response (120-60 min) was positively predictive (X2= 23.3, p&lt;0.001). Each was at least as predictive as the AUC C-peptide (inverse association; X2 = 20.4; p&lt;0.001), a standard prediction measure. In a model including both early and late C-P responses, both remained oppositely predictive of T1D with a stronger overall association (X2=41.1; p&lt;0.001 for both). To explain the positive association of greater T1D risk with a high later C-P, we examined the association between the sum of glucose levels from 60 to 120 min and the 120-60 min C-P; there was a strong positive association (r=0.44, p&lt;0.001). All associations persisted after age and BMI-z adjustments.
In conclusion, the findings show that lower early and higher later C-P responses are both indicators of risk for progression to T1D. Moreover, the findings suggest that the increasing later C-P response reflects an attempt by the β-cell to compensate for higher glucose levels due to a deficient early C-P response. These findings are similar to the evolution of C-P responses during type 2 diabetes development. Partitioning C-peptide into early and later responses appears beneficial for T1D prediction and for studying β-cell deterioration during progression.

Disclosure
H.M. Ismail: None. D.J. Becker: None. S. Geyer: None. P. Xu: None. I. Libman: Consultant; Self; Novo Nordisk A/S. K.C. Herold: None. M.A. Atkinson: Other Relationship; Self; Patent Issued. M.J. Redondo: None. J.P. Palmer: None. J. Sosenko: None.
Nasal Glucagon Budget-Impact Model Shows Reduced Health Care Payer Costs for Severe Hypoglycemia Due to Emergency Services Costs Savings
Authors: MITCHELL BETH , POEHLMANN JOHANNES , OSUMILI BEATRICE , BAJPAI SANJAY K. , VALENTINE WILLIAM J. 
Published: June 2018

Background: Nasal glucagon [NG] is a compact, portable, ready-to-use nasal spray for the treatment of severe hypoglycemic events [SHE] via intranasal absorption. Current treatment with intramuscular glucagon [IMG] requires multiple steps to administer, including reconstitution, and is difficult to administer for caregivers or passersby. Due to its mode of administration, NG has been demonstrated to result more often in successful (full-dose) administration of glucagon than IMG. The advantage of NG is expected to reduce payer costs due to less use of emergency services, including more treat and release, fewer ambulance trips and fewer emergency department visits.
Objective: Model 2-year budget impact of different scenarios of current (IMG, no kit) vs. future intervention mix (NG, IMG, no kit).
Methods: Populations defined by diabetes type, age and treatment were assessed using population-specific SHE incidence and mortality data. Budget impact was calculated from the U.S. Medicare perspective, with cost data sourced from literature and fee schedules. For adults with type 1 diabetes, an incidence of 366 SHEs per 1,000 person-years and a kit ownership proportion of 60% were assumed. Of patients with kits, 20% and 30% were assumed to own NG kits in the first and second year, respectively. Both NG and IMG kits were modeled using current glucagon list price. All model inputs were varied in sensitivity analyses.
Results: Reduced spending on SHE with the new mix was observed in all modeled populations with higher cost-savings in populations at higher risk of SHE. For 10,000 adults with type 1 diabetes, Medicare pays USD 11.7 million with the current mix and would pay USD 10.6 million for the new mix over 2 years. Savings with NG resulted from reductions in emergency services due to a higher probability of successful SHE treatment by caregivers or passersby.
Conclusions: NG as a treatment option for SHE is associated with substantial cost savings for U.S. payers.

Disclosure
B. Mitchell: Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. J. Poehlmann: Consultant; Self; Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Roche Pharma, UCB, Inc. B. Osumili: Employee; Self; Eli Lilly and Company. S.K. Bajpai: Employee; Self; Eli Lilly and Company. W.J. Valentine: Consultant; Self; Air Liquide, Astellas Pharma US, Inc., Edwards Lifesciences, Janssen Pharmaceuticals, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Roche Pharma, UCB, Inc..
Association of Age, Sex, and Weight with Moderate-to-Vigorous Physical Activity in a Pediatric Type 1 Diabetes Population
Authors: THOMPSON NELS E. , WATSON DAVID A. , BARNES TIMOTHY L. , GANDRUD LAURA M. 
Published: June 2018

Current guidelines from the ADA recommend that children and adolescents with T1D engage in at least 60 minutes of moderate-to-vigorous physical activity (MVPA) every day. However, subjectivity of MVPA reporting methods and short study durations compromise the applicability of existing data; there is not a clear picture of MVPA in this population. Therefore, objective measures of MVPA in children and adolescents with T1D are necessary to better understand the importance of other factors related to MVPA like sex, age, and weight.
In a prospective cohort of 1children and adolescents with T1D, physical activity was objectively monitored for 6 months using commercially available activity monitors. Weekly MVPA was summarized as the average number of hours of MVPA for weeks with valid activity monitor use. Regular weekly MVPA in children and adolescents was described by age, sex, and weight. The Mann-Whitney U test was used to assess associations.
In the study population, we observed an average (SD) weekly MVPA of 2.4 (1.7) hours and median (Q1, Q3) weekly MVPA of 1.9 (0.9, 3.0) hours. Sex was significantly associated with MVPA (p&lt;0.0001) with average (SD) weekly MVPA of 3.5 (2.4) hours for males and 1.4 (1.0) hours for females. There was no significant difference in weekly MVPA between children (8-12 years) and adolescents (13-17 years). Interestingly, overweight children (BMI z-score above 85th percentile) were more active than non-overweight children (average weekly MVPA of 3.0 and 2.1 hours respectively), however this difference was not statistically significant.
This study presents data on MVPA in children and adolescents with T1D over a long duration using objectively measured physical activity. Our results suggest that sex is an important factor associated with MVPA and that over 75% of children in this population do not regularly meet the ADA MVPA recommendations.

Disclosure
N.E. Thompson: None. D.A. Watson: None. T.L. Barnes: None. L.M. Gandrud: Consultant; Self; UnitedHealth Group.