bluuebunny/crossref_metadata_2025_split huggingface dataset:
783-P: When Automated Insulin Delivery Technology Meets Behavior: A Pilot Exploration of Human-Machine Coadaptation in Type 1 Diabetes
Authors: COLMEGNA PATRICIO , MCFADDEN RYAN , FABRIS CHIARA , LOBO BENJAMIN , OLIVERI MARY C. , NASS RALF , BROWN SUE A. , KOVATCHEV BORIS 
Published: May 2022

Background: Automated Insulin Delivery (AID) devices in type 1 diabetes (T1D) are becoming standard of care, and the need for adaptive AID systems is now well recognized. However, very little is known about how self-treatment behaviors should be adapted to the action of an AID system, especially with hybrid closed-loop (HCL) solutions that still require people with T1D to make several treatment decisions each day.
Methods: A safety and feasibility 8-week study with a randomized two-arm parallel group design was conducted. Both control and experimental groups used a web-based simulation tool, and a commercial AID system (Control-IQ®) enhanced with an auto-titration module (ATM) that adjusted insulin therapy parameters weekly. The experimental group had access to a behavioral adaptation module (BAM) that provided up-to-date risk assessment from CGM data. Primary outcome: Safety assessment of ATM and BAM. Secondary glycemic outcomes: CGM-based metrics computed from the 2-week baseline period and last 2 weeks of treatment data.
Results: Thirty Control-IQ® users completed all study procedures, 17 women and 13 men, age: 40±14 years, diabetes duration: 23±14 years, HbA1c: 6.6%±0.5%. No severe hypoglycemia, DKA, or other serious adverse events were reported. No significant changes were observed in time in 70-180 mg/dL. Changes in time in 70-140 mg/dL and mild hyperglycemia 180-250 mg/dL were significantly different between control (-3.1% and +3.1%) and experimental (+3.6% and -0.7%) groups (P=0.and 0.04) . Overnight time in 70-140 mg/dL increased significantly in the experimental group (6.8%, 95% CI [0.6%,12.9%], P=0.03) . Time &lt; 70 mg/dL decreased in both groups, but significantly only in the control group (-0.9%, 95% CI [-1.6%,-0.3%], P=0.vs. -0.1%, 95% CI [-0.7%,0.5%], P=0.71) .
Conclusions: Results from this pilot study suggest that combining HCL AP with behavioral adaptation feedback to the user is safe and effective.

Disclosure
P.Colmegna: None. R.Mcfadden: None. C.Fabris: None. B.Lobo: Other Relationship; Dexcom, Inc., Research Support; Dexcom, Inc. M.C.Oliveri: None. R.Nass: None. S.A.Brown: Research Support; Dexcom, Inc., Insulet Corporation, Roche Diagnostics USA, Tandem Diabetes Care, Inc., Tolerion, Inc. B.Kovatchev: Other Relationship; Dexcom, Inc., Johnson & Johnson, Novo Nordisk, Sanofi, Research Support; Dexcom, Inc., Novo Nordisk, Tandem Diabetes Care, Inc., Speaker's Bureau; Dexcom, Inc., Tandem Diabetes Care, Inc.

Funding
National Institutes of Health (2R01DK085623-10)
787-P: Quality of Life and Psychological Well-Being among Children with Diabetes Using Open-Source Automated Insulin Delivery Systems: Findings from a Global Survey
Authors: KNOLL CHRISTINE , BRAUNE KATARINA , BALLHAUSEN HANNE , SCHIPP JASMINE , SKINNER TIMOTHY C. , WÄLDCHEN MANDY , O'DONNELL SHANE , GAJEWSKA KATARZYNA A. , CLEAL BRYAN , RAILE KLEMENS 
Published: May 2022

Background: Open-source automated insulin delivery (AID) systems have shown to be safe and effective in clinical and real-world studies and to increase quality of life (QoL) in adult users. However, there is a lack of evidence on the effect on health-related QoL and general wellbeing in children and their caregivers. Therefore, the aim of this study was to assess the QoL of children and adolescents with diabetes using open-source AID systems using validated measures.
Method: In this cross-sectional, population-based global online survey we examined the caregiver-reported QoL and psychological well-being of users and non-users of open-source AID. Validated questionnaires assessed general emotional wellbeing (WHO-5 Well-being Index) , diabetes-specific QoL (Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR) , Pediatric Quality of Life Inventory (PedsQL, diabetes module) and subjective sleep quality (Pittsburgh Sleep Quality Index (PSQI)) .
Results: In total 188 caregivers from 27 countries completed at least one questionnaire on behalf of their children, including 132 children with type 1 diabetes using open-source AID (mean age 11.5 (SD 3.5) , 48% female) and 56 children with type 1 diabetes who were non-users at the time of the survey (mean age 10.4 (SD 3.3) , 41% female) . All questionnaire scores showed significant between-group differences with the AID users reporting higher general (WHO-5: p&lt;0.001) , diabetes-related (PAID: p=0.029; PedsQL: p=0.016) and sleep-related QoL (PSQI: p&lt;0.001) .
Discussion: The results show the beneficial impact that open-source AID systems have on the QoL and psychological well-being of children and adolescents, and can therefore help to inform academia, regulatory decision- and policymakers about the potential that open-source AID systems hold. Further research is needed to examine the reasons for the differences between the groups.

Disclosure
C.Knoll: None. K.Raile: Other Relationship; Dexcom, Inc. K.Braune: None. H.Ballhausen: None. J.Schipp: None. T.C.Skinner: None. M.Wäldchen: None. S.O'donnell: None. K.A.Gajewska: None. B.Cleal: None.

Funding
European Commission's Horizon 2020 Research and Innovation Program under the Marie Skłodowska-Curie Action Research and Innovation Staff Exchange (RISE) (grant agreement number 823902)
789-P: Evaluating the Feasibility of Incorporating Nonglucose Signals in Automated Insulin Delivery System
Authors: BANERJEE AYAN , KAUR RAVINDER JEET , ZANILETTI ISABELLA , CHURCH MEI MEI , MCCRADY-SPITZER SHELLY K. , DESJARDINS DONNA , GUPTA SANDEEP , KUDVA YOGISH C. 
Published: May 2022

Introduction: There is need to improve glucose control and QoL for type 1 diabetes (T1D) using automated insulin delivery (AID) . We evaluated non-glucose signals in subjects with T1D on AID using the multi-functional Empatica E4 device (E4) .
Method: During a 2-week prospective AID study for 12 participants with T1D, pharmacological stress was induced with three doses of hydrocortisone delivered at 9 am (40 mg) , 1 pm (20 mg) , and 5 pm (20 mg) . Frequent salivary cortisol measurements confirmed pharmacologic stress. The correlation of normalized power spectral density (PSD) of Electrodermal activity (EDA) data from E4 with the salivary cortisol (SC) gold standard was evaluated. EDA PSD was computed at min windows before and after the hydrocortisone administration. Subsequently, the impact of SC and EDA PSD on CGM and insulin delivery data was analyzed. Pearson's moment (R value) was utilized to evaluate correlation between two variables.
Results: Significant change in SC was observed after each dosage: 159.6 ±88.6 ng/dL before to 18247.6 ±18834 ng/dL after (Dose 1/D1) , 1911.9 ±7ng/dL to 7716.1±4485 ng/dL (D2) , and 798.4 ±629 ng/dL to 7458.1±9995 ng/dL (D3) . A positive change was also noted in the EDA PSD with all three doses: -96.5±13.9 dB/Hz to -95.5 ±21.2 dB/Hz (D1) , -96.1±14.02 dB/Hz to -94.6 ±9.1db/Hz (D2) , and -85.9 ±23.6dB/Hz to -81.6 ±23.6dB/Hz (D3) . R value between EDA PSD and SC was 0.82 (p = 0.015) . The post lunch time in hyperglycemia was 78.7 %±9.7 (p = 0.0paired t-test) with an average insulin delivery of 10.36 U±2.24
Conclusions: There is significant effect of pharmacological stress on cortisol and EDA PSD. AID has poor postprandial glycemic outcomes with pharmacological stress indicating need for detecting stress and updating control strategy. E4 EDA can be utilized to monitor pharmacological stress and can be incorporated for testing in Next Gen AID.

Disclosure
A.Banerjee: None. R.Kaur: None. I.Zaniletti: None. M.Church: None. S.K.Mccrady-spitzer: None. D.Desjardins: None. S.Gupta: None. Y.C.Kudva: Advisory Panel; Novo Nordisk, Research Support; Dexcom, Inc., Hemsley Charitable Trust, JDRF, National Institutes of Health, Roche Diabetes Care, Tandem Diabetes Care, Inc.

Funding
JDRF grant (2-SRA-2017-503-M-B)
793-P: Real-World Data of Four-Year Durability of Glycemia Control with V-Go
Authors: VADAKEKALAM JOSEPH , COPPLE TINA , TRIGOSO WILLIAM F. 
Published: May 2022

Patients with diabetes may struggle to comply with numerous injections required for blood glucose control. Previous studies have shown subcutaneous insulin infusion devices, such as V-Go, are an effective alternative to injections despite the limitation of the total daily dose of insulin (TDD) . The objective of this study is to validate previous work in a larger population over a longer time frame, showing V-Go significantly improves HbA1c.
A retrospective analysis of patients using V-Go from 2014 to July 2020 was conducted to evaluate changes in HbA1c, TDD, weight, and number of antidiabetic medications. EMR records were obtained at a large endocrine practice in south Texas. Inclusion criteria include a DM diagnosis, baseline HbA1c within 6 weeks prior to V-Go, and at least one HbA1c 3 months after V-Go. Exclusion criteria include pregnancy and undeterminable insulin dosing.
Chart review of 184 patients led to statistical evaluation of 178 patients who met criteria. As noted in Table 1, compared to baseline there was a significant decrease in HbA1c and an increase in percent of patients reaching HbA1c &lt; 8 across measured time points. There were no significant changes to weight, TDD, or number of antidiabetics used at any time points evaluated.
Our data furthers previous studies showing similar benefits to HbA1c remain significantly stable over 4 years without an increase in TDD, weight, or the average number of antidiabetic medications.

Disclosure
J.Vadakekalam: None. T.Copple: Employee; AstraZeneca. W.F.Trigoso: Speaker's Bureau; Amarin Corporation, Amgen Inc., Boehringer Ingelheim International GmbH, Lilly.
794-P: Real-World Uses and Challenges with Hybrid Closed-Looped Systems among Adolescents with T1D
Authors: MORROW TROY , OKONKWO NKEMJIKA , JASER SARAH S. 
Published: May 2022

Previous research on hybrid closed loop (HCL) systems has demonstrated their potential to improve glycemic outcomes and reduce the burden of diabetes care for people with T1D. We sought to describe adolescents' real world use the 670G Medtronic and Tandem Control IQ (CIQ) systems including the user-specific challenges that may pose barriers to using these systems as designed. We examined the medical records of 25 adolescents aged 11-17 with HCL-capable devices (mean age = 14.4, 46% female, 96% White, non-Hispanic, mean A1C = 8.4%) , who were enrolled in an ongoing study evaluating a behavioral intervention. We extracted information from participants' medical records over a 12-month period to identify barriers to device use. Using Automode or CIQ reports, each participant was categorized as having consistent (&gt; 70%) , inconsistent (30-70%) , or low (&lt;30%) use. In our sample, 33% of adolescents used the 670G exclusively, 33% used the Tandem CIQ and 33% switched from the 670G to the Tandem CIQ during the study period. We observed consistent use in 52% of adolescents, inconsistent use in 16%, and low use in 32%. Participants using the 670G system averaged 20% of the time in Automode, while participants using the Tandem system were in CIQ 72% of the time. The most prevalent challenges were Reluctance to use a HCL Component, Struggling to input data into HCL, and Technology failing. In our sample, adolescents experienced fewer barriers to use and had significantly higher rates of consistent use with the Tandem CIQ in comparison to the 670G. These findings suggest that HCL systems that require less calibration and user input and are less susceptible to technical difficulties are the most feasible for adolescent use. Prioritizing adolescents' comfort with diabetes technology may promote consistent usage to reap the full benefits. Further insight into the real-world use of HLC systems in different populations is essential to determine additional barriers or disparities in consistent use of these systems.

Disclosure
T.Morrow: None. N.Okonkwo: None. S.S.Jaser: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (R01DK115545-01A1) National Institute of Diabetes and Digestive and Kidney Diseases (3R01DK115545-03S1)
795-P: Significance and Future Trends of AID Systems from the Perspective of Physicians
Authors: HEINEMANN LUTZ , HERMANNS NORBERT , EHRMANN DOMINIC , ROOS TIMM , KULZER BERNHARD 
Published: May 2022

Aims: How do physicians assess AID-Systems in terms of their current and future importance for diabetes care?
Methods: In 2021 3diabetologists in Germany (48% female, average age 53.7 years) were asked via online surveys about their current and future assessment of AID-Systems.The results were compared with the 20survey, in which 337 diabetologists (43% female, mean age 53.2 years) participated.
Results: Currently, 58.6% (2020: 51.4%) of diabetologists consider AID-Systems to be important for diabetes care, in 5 years 89.3% (2020: 86.4%) . Diabetologists estimate that in approx. 9 years one in two PwD TD1 in Germany will be a user of an AID-System, and in approx. 17 years 90% will use an AID-System. Currently, they estimate that 57.6% of all PwD-TD1 are suitable for an AID-System. Diabetologists see the clearest impact of AID-Systems in an increased need for diabetes selfmangement education (78.9%) , but also in PwD becoming much more autonomous and empowered (62.8%) . Regarding possible negative effects of AID-Systems, diabetologists see only few risks: 20% fear that PWD will have less contact with the diabetes team, 16.9% are concerned that PWD will not be able to cope with the technological change. Only 7.9% fear that PWD will become riskier with AID-Systems, only 1.7% have fears that the diabetes team will become superfluous.
Conclusions: Overall, diabetologists assess AID-Systems as a important innovation for diabetes care and that this will soon become the standard therapy for T1D. The effort for Diabetes self-management education and support is estimated to be relatively high, possible disadvantages relatively low.

Disclosure
L.Heinemann: Board Member; Lifecare, Inc., Consultant; Becton, Dickinson and Company, Roche Diabetes Care, Stock/Shareholder; Profil Institut für Stoffwechselforschung GmbH, Science Consulting in Diabetes GmbH. N.Hermanns: Advisory Panel; Abbott Diabetes, Research Support; Becton, Dickinson and Company, Roche Diagnostics, Speaker's Bureau; Berlin-Chemie AG, Novo Nordisk, Sanofi. D.Ehrmann: Advisory Panel; Dexcom, Inc., Consultant; mySugr, Roche Diabetes Care, Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. T.Roos: None. B.Kulzer: Advisory Panel; Bayer AG, Bayer AG, Becton, Dickinson and Company, Becton, Dickinson and Company, Berlin-Chemie AG, Berlin-Chemie AG, Dexcom, Inc., Dexcom, Inc., Insulet Corporation, Novo Nordisk, Roche Diabetes Care, Sanofi, Sanofi-Aventis Deutschland GmbH, Research Support; Novo Nordisk, Roche Diabetes Care.
8-OR: Plasminogen Deficiency Protects against Nonalcoholic Fatty Liver Disease and Insulin Resistance, but Not Diet-Induced Obesity
Authors: HUR WOOSUK S. , NGUYEN Y-VAN , PATEL YESHA , KING KATHARINE C. , FLICK MATTHEW J. 
Published: May 2022

Obesity affects over 40% of the US population and predisposes individuals to metabolic syndrome, which is associated with a 50% increase in the risk of cardiovascular events. A documented clinical manifestation of obesity is a procoagulant and anti-fibrinolytic state. Elevated levels of circulating plasminogen activator inhibitor (PAI) -1 are correlated with metabolic syndrome, and PAI-1-deficient mice are protected from diet-induced obesity (DIO) . However, an unresolved question is whether plasminogen itself influences the development of obesity and associated disease sequelae? Here, we analyzed the impact of genetically-imposed plasminogen deficiency on the development of DIO and associated pathologies. Over the course of 20 weeks, plasminogen-deficient (Plg-) mice gained as much weight as the control mice (Plg+) on HFD, although HFD-fed Plg- mice had larger epididymal white adipose tissues than those of HFD-fed Plg+ mice. In contrast, while HFD-fed Plg+ animals displayed a fatty liver disease phenotype characterized by histological evidence of steatosis, elevated triglyceride content, and hepatocellular injury, HFD-fed Plg- mice were protected from developing each of these pathologies. HFD-fed Plg+ mice also developed hypercholesterolemia, whereas circulating cholesterol levels in Plg- mice were comparable to LFD-fed mice. Intriguingly, while the brown adipose tissue mass was comparable between diet and genotype, there was an upregulation of uncoupling protein-1 (Ucp1) expression in BAT of HFD-fed Plg- mice. Notably, whereas HFD-fed Plg+ mice showed evidence of insulin resistance as revealed by compromised glucose clearance, HFD-fed Plg- mice were partially protected. Collectively, our data suggest that plasmin (ogen) contributes to HFD-induced fatty liver disease and insulin resistance, and that plasminogen deficiency imposes a state of metabolically healthy obesity.

Disclosure
W.S.Hur: None. Y.Nguyen: None. Y.Patel: None. K.C.King: None. M.J.Flick: None.

Funding
National Institutes of Health (RDK112778)
812-P: Real-World Persistence, Adherence, Health Care Resource Utilization (HRU), and Hypoglycemia in People with Type 2 Diabetes (T2D) Continuing the 2nd-Generation (2nd-Gen) Basal Insulin (BI) (Glargine 300 U/mL [Gla-300]) vs. Switching to a 1st-Generation (1st-Gen) BI (Glargine 100 U/mL [Gla-100] or Detemir [IDet 100 U/mL])
Authors: EDELMAN STEVEN , GOLDMAN JENNIFER D. , MALONE DANIEL C. , PREBLICK RON , MUNAGA KOVIDA , LI XUAN , GILL JASVINDER , GANGI SUMANA 
Published: May 2022

This retrospective observational analysis of the Optum Clinformatics database compared outcomes for adults (≥18y) with T2D who either continued treatment with the 2nd-gen (longer-acting) BI, Gla-300, or switched to a 1st-gen (long-acting) BI between Jan 1, 2017, and Apr 30, 2020. Cohorts were propensity score matched (PSM) on baseline characteristics and followed for 12 months. Outcomes included persistence, adherence, HRU, and hypoglycemia. During follow-up, a statistically significantly higher proportion of patients who continued Gla-300 vs. switched to 1st-gen BI were persistent with therapy, while adherence was similar. Hypoglycemia events (26.2 vs. 42.8 /100 person-years follow-up) and emergency room (ER) visits (all-cause: 100.5 vs. 146.8 per 100 person-years) were significantly lower for Gla-300 (p&lt;0.01) , whereas hospitalization rates were similar (p&gt;0.30; Table) . In adults with T2D, continuing treatment with Gla-300 vs. switching to a 1st-gen BI analog (Gla-100 or IDet) was associated with better persistence and lower overall hypoglycemia and ER visit events, but not hospitalizations, suggesting patients presenting at ER were treated, observed then discharged.

Disclosure
S.Edelman: Consultant; Abbott Diabetes, Lilly Diabetes, Sanofi-Aventis U.S., Xeris Pharmaceuticals, Inc. J.D.Goldman: Speaker's Bureau; Abbott Diabetes, Amarin Corporation, Lilly, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc. D.C.Malone: Other Relationship; Sanofi. R.Preblick: Employee; Sanofi-Aventis U.S. K.Munaga: Employee; Sanofi. X.Li: Employee; Eisai Co., Ltd., Sanofi. J.Gill: Employee; Sanofi, Sanofi, Stock/Shareholder; Sanofi, Sanofi. S.Gangi: Other Relationship; Sanofi.

Funding
Sanofi
813-P: Treatment Satisfaction and Health Status in People with T2D Treated with Insulin Glargine 300 U/mL (Gla-300) : Patient-Reported Outcomes (PRO) from ATOS Study
Authors: KHAN NIAZ , TIROSH AMIR , BHANSALI ANIL , VARGAS-URICOECHEA HERNANDO , HARRIS STEWART B. , DE CLIMENS AUDE ROBOREL , MABUNAY MARIA AILEEN N. , COUDERT MATHIEU , PILORGET VALERIE , GALSTYAN GAGIK R. 
Published: May 2022

Patients' satisfaction is a key determinant of treatment adherence and persistence, for optimal management of T2D. ATOS, a 12-month prospective observational study conducted in Asia, Middle East, North Africa, Latin America, and Eastern Europe, showed that initiation of Gla-300 in insulin-naïve people with T2D resulted in improved glycemic control with low rates of hypoglycemia. This analysis evaluated changes in treatment satisfaction and health status among participants. Data was collected using PRO questionnaires - Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change versions (DTSQc) , EuroQoL 5-dimension scale version 3L (EQ-5D-3L) at baseline, Month 3, 6 and 12. Overall, 3931 participants completed the questionnaires. Mean ±SD age was 57.5 ±10.6 years, duration of diabetes was 10.1 ±6.2 years and baseline HbA1c was 9.3 ±1.0 %. Treatment satisfaction improved over time (DTSQs score of 21.7 at baseline to 29.8 and 31.3 at Month 6 and 12, respectively) and perceived frequency of hyperglycemia decreased over 12 months. DTSQc results were aligned with DTSQs. EQ-5D-3L results showed that proportion of people with better health status increased over time (Table) . Results showed that initiating Gla-300 in insulin-naïve people with T2D across multiple geographic regions improved treatment satisfaction and health status.

Disclosure
N.Khan: None. G.R.Galstyan: n/a. A.Tirosh: Advisory Panel; Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim International GmbH, Merck & Co., Inc., Novo Nordisk, Sanofi, Consultant; Bayer AG, DreaMed Diabetes, Ltd., Research Support; Medtronic, Speaker's Bureau; Eli Lilly and Company. A.Bhansali: None. H.Vargas-uricoechea: Advisory Panel; Sanofi, Speaker's Bureau; Abbott. S.B.Harris: Consultant; Abbott, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi, Other Relationship; Abbott, AstraZeneca, Bayer Inc., Dexcom, Eli Lilly and Company, HLS Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk, Sanofi, Research Support; Applied Therapeutics Inc., AstraZeneca, Canadian Institutes of Health Research, Juvenile Diabetes Research Foundation (JDRF) , Novo Nordisk, Sanofi, The Lawson Foundation. A.Roborel de climens: Employee; IQVIA Inc., Sanofi. M.N.Mabunay: Employee; Sanofi. M.Coudert: Employee; Sanofi. V.Pilorget: None.

Funding
Sanofi