bluuebunny/crossref_metadata_2025_split huggingface dataset:
178-LB: Prevalence of Vitamin D Deficiency among Patients with Type 2 Diabetes in Qingdao, China
Authors: ZHANG LEI , WANG JUN , YANG YUXIU , DONG YANHU 
Published: May 2022

The aim of the current study is to investigate the prevalence of vitamin D deficiency among patients with type 2 diabetes (T2DM) in a Chinese cohort. We enrolled 3025 patients with T2DM (aged 30-91 yrs) who were hospitalized in Qingdao Endocrine and Diabetes Hospital from Jan 2018 to Jan 2019. The exclusion criteria were as follows: (1) with other types of diabetes; (2) pregnant or lactating females; (3) with acute complications of diabetes or other stress states, such as surgery and trauma; (4) with rheumatologic, serious hepatic, cardiac, renal failure, malignancy, and endocrine diseases that affect the metabolism of vitamin D. Serum level of 25-OH-vitamin D ≥ 30 ng/mL was defined as normal, 20 ng/mL ≤ 25-OH-vitamin D &lt; 30 ng/mL as vitamin D insufficiency (VDI) , and serum 25-OH-vitamin D &lt; 20 ng/mL as vitamin D deficiency (VDD) . The chi-square test was used for group comparison of VDD or VDI prevalence. In all subjects, the prevalence of VDI was 35%. Male patients had higher prevalence of VDI than female patients (40.0% vs. 28.9%, P&lt;0.05) . The prevalence of VDD was 48.8% in total while female had higher prevalence than male patients (57.2% vs. 41.8%, P&lt;0.001) . We found a clear trend toward decreasing serum vitamin D concentration with rising HbA1c levels (P&lt;0.001 in male and P&lt;0.003 in female) . Dividing the HbA1c into deciles showed a linear association.
In conclusion, VDI and VDD is prevalent in patients with type 2 diabetes. Poor glucose control is related to lower serum level of vitamin D. Future studies are required to verify if vitamin D supplementation could be beneficial in patients with diabetes.

Disclosure
L. Zhang: n/a. J. Wang: None. Y. Yang: None. Y. Dong: None.
189-OR: Immune-Profiling of Pancreatic Tissue Affected by Immune Checkpoint Inhibitor–Induced Diabetes (CPI-D)
Authors: QUANDT ZOE , YOUNG ARABELLA , BARLOW GRAHAM , DONG SHEN , SMITH JENNIFER , KUSMARTSEVA IRINA , BRUSKO TODD M. , COOPER STEWART , ANDERSON MARK S. 
Published: May 2022

Intro: CPI-D is a rare but morbid side effect of cancer immunotherapy. Limited availability of affected pancreatic tissue is a critical barrier to understanding its molecular and cellular underpinnings.
Methods: We procured pancreatic tissue and blood from a 68-year-old man who had developed CPI-D during immunotherapy for metastatic melanoma and was then diagnosed with pancreatic cancer, leading to partial pancreatectomy. Tumor-uninvolved pancreatic tissue was examined using H&E, IHC (including an advanced form of IHC, CODEX) , and single cell RNA sequencing (scRNAseq) .
Results: The pancreatic tissue harbored few islets, which were identified by the presence of glucagon given lack of insulin production. The islets were surrounded by immune cells that were composed primarily of B cells, CD4+ T and CD8+ T cells, some of which expressed PD-1, as demonstrated by scRNAseq and CODEX, which also identified FOXP3+ regulatory T cells that highly expressed OX40. Discussion: We report the first analysis of CPI-D-affected pancreatic tissue at single cell resolution, combining scRNAseq and spatial imaging to provide evidence for an autoimmune etiology for CPI-D. The pancreatic immune composition shared similarities with tertiary lymphoid organs (TLOs) , as previously observed in the pancreas of T1D patients. The presence of PD-1 was further notable, given the specific association of CPI-D with PD-1 inhibitor therapy. Despite the presence of B cells, this patient was negative for typical T1D autoantibodies (GAD65, insulin, IC512, zinc transporter 8) , which occur in approximately half of CPI-D cases.
Conclusion: Profiling the pancreatic histology and immune composition in a patient with CPI-D offered a rare opportunity to explore pathogenesis. This portion of CPI-D affected pancreas was significantly depleted of insulin expressing islets and displayed an immune cell infiltrate reminiscent of T1D in composition and topology, supporting that CPI-D is an autoimmune state.

Disclosure
Z.Quandt: Advisory Panel; Novartis AG, Consultant; Novartis AG. A.Young: None. G.Barlow: None. S.Dong: None. J.Smith: None. I.Kusmartseva: None. T.M.Brusko: None. S.Cooper: None. M.S.Anderson: Advisory Panel; Imcyse, Consultant; Provention Bio, Inc., Sana Biotechnology Inc., Stock/Shareholder; Medtronic, Merck & Co., Inc.

Funding
American Diabetes Association (1-19-PDF-131) ; Parker Institute for Cancer Immunotherapy
2-LB: Semaglutide 2.4 mg Reduces the 10-Year T2D Risk in People with Overweight/Obesity
Authors: TIMOTHY GARVEY W. , HOLST-HANSEN THOMAS , LAURSEN PETER N. , RINNOV ANDERS R. , WILKINSON LUA J. 
Published: May 2022

The effect of once-weekly s.c. semaglutide 2.4 mg (sema) on the risk of developing T2D in people with obesity is unknown. Weight management with sema vs. PBO plus diet/exercise was assessed in participants (pts) with overweight/obesity in STEP 1 (68 wks) and STEP 4 (20-wk run-in on sema, 48-wk randomized withdrawal) . The 10-yr T2D risk was calculated post hoc using Cardiometabolic Disease Staging (CMDS) , a validated Bayesian logistic regression of T2D risk factors. Risk scores decreased after 68 wks from 18% to 7% with sema, and 18% to 16% with PBO (61% vs. 13% reduction [p&lt;0.01]; STEP 1; Figure) . Most of the risk score reduction with sema occurred during wks 0-20, from 21% to 11%; risk score decreased further to 8% with continued sema during wks 20-68, but increased to 15% with switch to PBO (32% reduction vs. 41% increase [p&lt;0.01]; STEP 4; Figure) . Wk 0 risk scores were higher in pts with prediabetes vs. normoglycemia (Figure) , but treatment effects were comparable at wk 68 (p=0.45 for interaction [STEP 1]) . Risk score changes mirrored weight loss, which was 17% with sema vs. 3% with PBO in STEP 1, and in STEP 4 was ‍11% for wks 0-20 with sema, and a further 9% with continued sema vs. a 6% regain with switch to PBO for wks 20-68.
In summary, treatment with sema reduces the 10-yr risk of T2D by ∼60% regardless of initial glycemic status, with sustained treatment required to maintain this benefit. These data suggest sema could help prevent T2D in people with obesity.

Disclosure
W. Garvey: Other Relationship; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Epitomee, JAZZ Pharmaceuticals, Novo Nordisk, Novo Nordisk, Pfizer Inc., Pfizer Inc. T. Holst-hansen: Employee; Novo Nordisk A/S, Stock/Shareholder; Novo Nordisk A/S. P. N. Laursen: Employee; Novo Nordisk A/S. A. R. Rinnov: Employee; Novo Nordisk. L. J. Wilkinson: Employee; Novo Nordisk.

Funding
Novo Nordisk A/S
215-OR: Once Weekly (QW) Basal Insulin Fc (BIF) Demonstrated Similar Glycemic Control to Once Daily (QD) Insulin Degludec (DEG) in Insulin-Naïve Patients with Type 2 Diabetes (T2D)
Authors: BUE-VALLESKEY JULIANA M. , KAZDA CHRISTOF M. , MA CHENCHEN , CHIEN JENNY , ZHANG QIANYI , CHIGUTSA EMMANUEL , LANDSCHULZ WILLIAM , SWAN JENNIFER , HAUPT AXEL , FRIAS JUAN PABLO 
Published: May 2022

Basal Insulin Fc (BIF; LY3209590) , a fusion protein combining a novel single-chain insulin variant with a human IgG Fc domain, is designed for QW administration. This randomized, parallel, open-label Ph2 study assessed safety and efficacy of BIF vs. DEG in insulin-naïve patients with T2D previously treated with oral antihyperglycemic medication. BIF was injected QW, and DEG was injected QD. Both groups were titrated to fasting blood glucose (FBG) ≤100 mg/dL. The primary endpoint was HbA1c change from baseline (CFBL) to Wk 26 (non-inferiority margin=0.4%) . Patients randomized to BIF (N=129) and DEG (N=135) had a mean age of 58.4 yrs and baseline HbA1c of 8.0%. After 26 wks, BIF showed non-inferiority vs. DEG for HbA1c CFBL with a treatment difference of 0.06% (90% CI = -0.11, 0.24; p = .56) , and both groups had &gt;75% time in range (70-180 mg/dL) on average at Wk 26 (Figure) . BIF and DEG significantly reduced FBG from baseline (treatment difference BIF vs. DEG = 4.7 mg/dL [90% CI = 0.1, 9.3]; p = .09) . Rate of Level 2 hypoglycemia was low and not significantly different (BIF = 0.22; DEG = 0.15 events/pt/yr; p = 0.64) . Occurrence of treatment-emergent adverse events was similar between BIF and DEG. QW BIF achieved excellent glycemic control similar to DEG with no concerning hypoglycemia or other safety findings, supporting continued development of BIF in Ph3.

Disclosure
J.M. Bue-Valleskey: None. C.M. Kazda: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. C. Ma: None. J. Chien: Employee; Eli Lilly and Company. Q. Zhang: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. E. Chigutsa: Employee; Eli Lilly and Company. W. Landschulz: Employee; Eli Lilly and Company. J. Swan: Employee; Eli Lilly and Company. A. Haupt: Employee; Lilly. Stock/Shareholder; Lilly. J. Frias: Advisory Panel; Altimmune, Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi. Consultant; 89bio, Inc., Akero Therapeutics, Inc., Altimmune, Becton, Dickinson and Company, Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk, Pfizer Inc., Sanofi. Research Support; Afimmune Limited, Akero Therapeutics, Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Carmot Therapeutics, Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi. Speaker's Bureau; Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi.

Funding
Funded by Eli Lilly and Company.
243-LB: Glucometabolism Benefited Differently from Bariatric Surgery within Four Artificial Intelligence–Assisted Metabolic (AIM) Subtypes of Obesity
Authors: LIU YAO , SHENG CHUNJUN , LIN ZIWEI , QU SHEN 
Published: May 2022

Objectives: The purpose of this study was to look into the benefit of a bariatric surgery in four artificial intelligence-assisted metabolic (AIM) subtypes of obesity with respect to the improvement of glucometabolism, as well as the remission of diabetes and hyperinsulinemia.
Methods: This multicenter retrospective study prospectively collected data from 5 hospitals in China from 2010 to 2021. A total of 1008 patients who underwent a bariatric surgery were enrolled (median age 31 years; median BMI 38.1kg/m2; 57.40% women) and grouped into four AIM subtypes of obesity. Data at baseline, 3- and 12-months post-surgery were collected for the longitudinal effect analysis.
Results: At baseline, the hypermetabolic obesity-hyperinsulinemia (HMO-I) group was characterized by severe insulin resistance and high incidence of hyperinsulinemia (87.8%) . After surgery, HMO-I with hyperinsulinemia had achieved remission, yet the prevalence of hypoglycemia was still high (42.9%) . Hypometabolic obesity (LMO) group showed decompensated insulin secretion and high incidence of diabetes (99.2%) at baseline. After surgery, 62.1% of LMO patients with diabetes achieved remission, lower than the other three groups. Still, the bariatric surgery significantly reduced their blood glucose (median HbA1c decreased by 27.2%) . For both metabolic healthy obesity (MHO) and hypermetabolic obesity-hyperuricemia (HMO-U) groups, who showed a relatively healthy glucometabolism at baseline, prevalence of glucometabolic comorbidities improved moderately after surgery.
Conclusion: This multicenter study found that the four AIM subtypes of obesity benefited differently from a bariatric surgery in terms of glucometabolism. Bariatric surgery significantly relieves hyperinsulinemia and hyperglycemia for HMO-I and LMO, respectively. As a result, patients of the two subtypes should be motivated for a bariatric surgery for the improvement of glucometabolism.

Disclosure
Y. Liu: None. C. Sheng: None. Z. Lin: None. S. Qu: n/a.

Funding
Clinical Research Plan of SHDC (No.SHDC2020CR1017B) , National Natural Science Foundation of China (82170861,81970677) , Shanghai Medicine and Health Development Foundation (DMRFP_I_07) , Shanghai Commission of Science and Technology (19DZ1910200)
243-OR: Effect of Menstrual Cycle on Glycemic Responses to Exercise in Female Participants with Type 1 Diabetes
Authors: MOMENI ZEINAB , YARDLEY JANE E. 
Published: May 2022

Fear of hypoglycemia is a major barrier to exercise in people with type 1 diabetes (T1D) . Females with T1D tend to be less active than males with T1D, which might be due to significant knowledge gaps around blood glucose responses to exercise, especially with regards to the menstrual cycle. We compared the effect of a moderate aerobic exercise (cycling at 50% of pre-determined VO2peak for 45 min) on glycemic responses between the early follicular and late luteal phases of the menstrual cycle in 9 female participants with T1D (mean±SD: age 30.2±9 years, A1C 7.4±0.7%, VO2peak 32.5±4.2 mL/kg/min) with regular menstrual cycles not using oral contraceptives. In both phases, serum glucose decreased from pre to post exercise and increased throughout the 60-min recovery (effect of time p&lt;0.05) but was not significantly different between the two phases (effect of phase p&gt;0.05) . Serum insulin (log transformed) decreased from pre to post exercise in both phases (effect of time p&lt;0.05) but was not significantly different between the two phases (effect of phase p&gt;0.05) . The number of participants needing glucose supplementation (Dex4) to prevent hypoglycemia before and during exercise and recovery was significantly higher in the luteal versus the follicular phase (6/9 vs. 1/9, Fisher’s p=0.049) . Continuous glucose monitoring, however, showed no increase in the number of hypoglycemic episodes post exercise during the luteal phase. There were more post-exercise hyperglycemic episodes in the follicular versus the luteal phase (3±0.5 vs. 1.3±0.3, p=0.029) . These data suggest that females with T1D may be more prone to post-exercise hyperglycemia during the follicular phase, while needing more glucose supplementation to prevent hypoglycemia during the luteal phase of the menstrual cycle. These data should help guide recommendations for carbohydrate and insulin adjustment.

Disclosure
Z.Momeni: None. J.E.Yardley: Research Support; Abbott, Dexcom, Inc., LifeScan, Speaker's Bureau; Abbott Diabetes.
257-OR: Pen-Administered Low-Dose Dasiglucagon vs. Usual Care for Prevention and Treatment of Nonsevere Hypoglycemia in People with Type 1 Diabetes during Free-Living Conditions: A Phase 2, Randomized, Two-Period, Crossover Outpatient Study
Authors: LAUGESEN CHRISTIAN , RANJAN AJENTHEN G. , SCHMIDT SIGNE , NØRGAARD KIRSTEN 
Published: May 2022

Objective: To evaluate the efficacy, safety and feasibility of pen-administered low-dose dasiglucagon for prevention and treatment of non-severe hypoglycemia in people with type 1 diabetes during free-living conditions.
Methods: Twenty-four adults with insulin pump-treated type 1 diabetes completed a phase 2, randomized, open-label, 2-period cross-over study with 2-week periods. During the usual care (UC) and dasiglucagon (DASI) period, participants managed impending and manifest episodes of hypoglycemia with regular carbohydrate consumption or pen-administered low-dose (80 µg) s.c. dasiglucagon, respectively. Glycemic control was evaluated using continuous glucose monitoring (Dexcom G6) and event-registration of prevention and treatment episodes. Patient-reported outcomes (PRO) were collected following study completion.
Results: Participants administered dasiglucagon (IQR: 7-15) times during the 2-week period. Compared with UC, the mean difference (±SEM) in time in range (70-180 mg/dL) was 2.4%-point (±1.5%) (UC: 61.5%, DASI: 63.9%, p=0.129) , difference in time below range (&lt;70 mg/dL) was 0.5%-point (±0.4%) (UC: 3.1%, DASI: 2.6%, p=0.170) , while total daily carbohydrate intake was significantly reduced (UC: 192 g, DASI: 172 g, p=0.007) . Dasiglucagon use was safe and well tolerated with nausea being the most frequent adverse effect (no. of participants: UC: 4, DASI: 8, p=0.206) . PRO demonstrated that 96% (p&lt;0.001) of participants were likely to include dasiglucagon as part of their future routine management of hypoglycemia.
Conclusion: Utilization of pen-administered, low-dose dasiglucagon for prevention and treatment of non-severe hypoglycemia during free-living conditions was safe and efficacious while significantly reducing the total daily carbohydrate intake and yielding high treatment satisfaction.

Disclosure
C.Laugesen: None. A.G.Ranjan: None. S.Schmidt: None. K.Nørgaard: Advisory Panel; Medtronic, Novo Nordisk A/S, Consultant; Novo Nordisk A/S, Research Support; Dexcom, Inc., Medtronic, Novo Nordisk A/S, Zealand Pharma A/S, Speaker's Bureau; Medtronic, Stock/Shareholder; Novo Nordisk A/S.

Funding
SteDiabetes Center Copenhagen is the sponsor of this investigator-initiated trial. Zealand Pharma provided financial support to the conduct of the study and supplied the study medication.
260-OR: iGlarLixi vs. Basal plus Rapid-Acting Insulin in Adults with Type 2 Diabetes Advancing from Basal Insulin Therapy: The SoliSimplify Real-World Study
Authors: MCCRIMMON RORY J. , CHENG ALICE Y. , GALSTYAN GAGIK R. , DJABALLAH KHIER , LI XUAN , COUDERT MATHIEU , FRIAS JUAN PABLO 
Published: May 2022

Introduction: Indirect evidence suggests iGlarLixi is as efficacious as basal insulin (BI) + rapid acting insulin (RAI) for management of type 2 diabetes (T2D) . However, there are no direct comparisons of iGlarLixi (once-daily [QD]) vs. a BI+RAI regimen (multiple daily injections [MDI]) . SoliSimplify compared these treatments using real-world data from a US database.
Methods: Electronic medical records were analyzed retrospectively using propensity score matching (PSM) to compare therapy advancement with iGlarLixi or BI+RAI in adults ≥18 years with T2D on BI and ≥1 HbA1c available value at baseline and 6-month follow-up. The primary objective was non-inferiority of iGlarLixi to BI+RAI in HbA1c change from baseline to 6 months (margin 0.3 %) .
Results: PSM generated cohorts with balanced baseline characteristics (N=814 in each group; Table) . HbA1c reduction from baseline to 6 months with iGlarLixi was non-inferior to BI+RAI (p&lt;0.025) . Weight gain was significantly lower with iGlarLixi than with BI+RAI (p&lt;0.for the difference) . At 6 months, achievement of HbA1c &lt;7 % without hypoglycemia and weight gain was similar between groups. Hypoglycemia was low in both groups, likely due to underreporting.
Conclusions: In this real-world study, QD iGlarLixi was as effective as MDI BI+RAI in HbA1c reduction and had a favorable body weight benefit.

Disclosure
R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. A.Y.Cheng: Advisory Panel; Abbott, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, HLS Theraoeutics, Insulet Corporation, Janssen Pharmaceuticals, Inc., Medtronic, Novo Nordisk, Sanofi, Board Member; Type 1 Diabetes Think Tank Network, Other Relationship; Diabetes Canada, Speaker's Bureau; Bausch Health, Canada, Merck & Co., Inc. G.R.Galstyan: n/a. K.Djaballah: Employee; Sanofi. X.Li: Employee; Eisai Co., Ltd., Sanofi. M.Coudert: Employee; Sanofi. J.Frias: Advisory Panel; Altimmune, Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi, Consultant; 89bio, Inc., Akero Therapeutics, Inc., Altimmune, Becton, Dickinson and Company, Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk, Pfizer Inc., Sanofi, Research Support; Afimmune Limited, Akero Therapeutics, Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Carmot Therapeutics, Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Speaker's Bureau; Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi.

Funding
Sanofi
262-OR: Recruiting Historically Underrepresented Individuals into Clinical Trials: Key Lessons from Project ECHO Diabetes
Authors: ADDALA ANANTA , ROQUE XANADU , FIGG LAUREN , ANEZ-ZABALA CLAUDIA , CLARK CATHERINE , LAL RAYHAN , HALLER MICHAEL J. , MAAHS DAVID M. , WALKER ASHBY F. 
Published: May 2022

Background: Individuals underrecruited in diabetes studies include those not seen by an endocrinologist and those from rural, low socioeconomic, and racial/ethnic minority groups. Project ECHO Diabetes aimed to recruit historically excluded participants with insulin-requiring diabetes.
Objective: The purpose of this descriptive analysis is to outline and evaluate our recruitment efforts at 9 sites affiliated with the University of Florida.
Results: In total, 340 participants with type 1 diabetes and 1225 participants with type 2 diabetes were eligible and approached for recruitment. Local community health centers were funded to recruit for and participate in Project ECHO. Participants were contacted on average 2 times (range 1-13 times) to finalize a consent disposition: Yes, No, or No Response (Table 1) . For those individuals who we categorized as “No Response,” the most common reason was lack of reliable contact information.
Conclusions: Recruiting historically underrepresented populations is feasible with repeated touch points. Funding the partnerships with community health centers, who have the trust of the local community and are equipped to address local needs, was key in our recruitment strategy. Language, a common exclusion criteria and barrier to diverse recruitment, was overcome through multi-lingual study staff.

Disclosure
A.Addala: None. X.Roque: None. L.Figg: None. C.Anez-zabala: None. C.Clark: None. R.Lal: Advisory Panel; Provention Bio, Inc., Consultant; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Deep Valley Labs, Gluroo, Morgan Stanley, Tidepool. M.J.Haller: Advisory Panel; SAB Biotherapeutics , Consultant; MannKind Corporation, Sanofi. D.M.Maahs: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Sanofi, Consultant; Aditx Therapeutics, Inc., Biospex. A.F.Walker: None.

Funding
The Leona M. and Harry B. Helmsley Charitable Trust