bluuebunny/crossref_metadata_2025_split huggingface dataset:
1070-P: Blood Glucose Reduction and Long-Term Sustainability in High-Risk Patients with Type 2 Diabetes over Three Years of Using Digital Platform
Authors: HERSHCOVITZ YIFAT , YANIV NOGA , BUDMAN SOFIA , MANEJWALA OMAR 
Published: June 2023

Introduction: Long-term management of type 2 diabetes (T2D) and sustaining glycemic control remains a challenge and crucial for reducing clinical complications and subsequent economic costs. This study followed glycemic outcomes, average blood glucose (BG avg) and high readings ratio, over 3 years in persons using a digital therapeutic platform.
Objective: To investigate blood glucose (BG) levels in persons with T2D in high-risk who used a digital therapeutic platform to manage their BG levels over three years. Additionally, to compare outcomes between consistently engaged users over 3 years versus less consistent population.
Method: A retrospective data analysis was performed on users with T2D in high-risk (baseline BG avg&gt;169 mg/dL in month1; equivalent to A1C 7.5) who activated between 2017-2020 and measured their BG using Dario platform over 3 consecutive years (months 1,6,12,24 and 36). The ratios assessed were BG avg and high BG readings ratio (&gt;180 mg/dL). Digital engagement was assessed by additional parameters including measurement type (fasting/premeal/post meal/bedtime), carbs intake, meal type, and physical activity alongside glucose measurement.
Results: A group of 1,239 users significantly reduced their BG avg consistently over 3 years by 15.6% (179±55 vs. 212±42) (p&lt;0.05) and high readings ratio by 39% (p&lt;0.05). A subset of users completed at least one engagement type following months 12, 24, and 36 (N=433) demonstrated significantly greater reductions versus the complementary group (N=806): BG avg by 18.8% (172±51 vs. 212±45) and high readings ratio by 45% (p&lt;0.05).
Conclusion: A digital diabetes platform has the potential to affect and sustain glycemic control improvements over 3 years. Moreover, it appears highly likely that engagement to app features in chronic condition management may help users with T2D consistently pay attention to their life behaviors to maintain better clinical outcomes.

Disclosure
Y.Hershcovitz: Employee; DarioHealth Corp. N.Yaniv: Employee; DarioHealth Corp. S.Budman: Employee; DarioHealth Corp. O.Manejwala: Employee; DarioHealth Corp., Stock/Shareholder; DarioHealth Corp.
1154-P: Racially and Ethnically Inclusive Recruitment Strategies from the CoYoT1 to California (CTC) Study
Authors: GONZALEZ FRANCES , REID MARK W. , SALCEDO-RODRIGUEZ ELIZABETH , FLORES GARCIA JAQUELIN , HIYARI SARAH , TORRES SANCHEZ ALEJANDRA , PYATAK ELIZABETH , STEVEN FOX D. , RAYMOND JENNIFER 
Published: June 2023

Background: The prevalence of type 1 diabetes (T1D) is increasing within racially and ethnically marginalized populations, highlighting the need for effective recruitment strategies that not only address healthcare disparities but also rebuild trust in medical research. Recently, the CoYoT1 to California (CTC) study evaluated a person-centered care model designed to support racially and ethnically diverse young adults (YA) who receive care at a hospital-based pediatric T1D clinic. In addition to treatment effectiveness, the study examined the success of recruitment strategies.
Methods: Potential YA participants were approached in-person or remotely (by phone, email, or text). Those with clinic appointments during study recruitment were approached in-person, with recruiters focusing on cultural humility to connect with families; the concept and process of research was introduced, and families were allowed to ask questions as needed. Remote recruitment utilized multiple pre- and post-appointment messages with basic descriptions of the study or follow-up details as needed. Categorical data were compared using chi-squared tests.
Results: The study approached 338 potential participants and recruited 68 (20%). Reflecting successful recruitment of diverse YA, study participants were representative of the clinic population in terms of racial and gender identities, and identified as Latinx (29, 43%) more often than those who declined (100, 37%; P=0.40). Recruitment strategy was significantly associated with participation, as most participants were recruited in-person (40, 59%), while most who declined did so remotely (200, 74%; P&lt;0.0001).
Conclusion: In-person recruitment is more effective for enrolling diverse YA and their families, as it allows recruiters to build rapport, and empowers families with information and choice. Internal and external barriers may prevent diverse YA from attending clinic appointments in-person, ultimately impacting research equity.

Disclosure
F.Gonzalez: None. M.W.Reid: None. E.Salcedo-rodriguez: None. J.Flores garcia: None. S.Hiyari: None. A.Torres sanchez: None. E.Pyatak: Research Support; Abbott Diabetes. D.Fox: None. J.Raymond: None.

Funding
Patrick and Catherine Weldon Donaghue Medical Research Foundation
1205-P: Abnormal Fetal Growth and Adverse Neonatal Outcomes in Pregnancies Affected by Both Gestational Diabetes and Hypertensive Disorders of Pregnancy
Authors: ONUOHA CHIOMA A. , THAWEETHAI TANAYOTT , HSU SARAH , SCHULTE CAROLIN C.M. , JAMES KAITLYN , KAIMAL ANJALI , POWE CAMILLE E. 
Published: June 2023

Objective: We evaluated how the co-occurrence of gestational diabetes (GDM) and hypertensive disorders of pregnancy (HDP) influence fetal growth and neonatal outcomes.
Methods: In a retrospective study of 47720 singleton deliveries from a US medical center, we compared the incidence of appropriate for gestational age birthweight (AGA) in pregnancies affected by GDM alone, HDP alone, or both GDM and HDP (GDM/HDP) to that in pregnancies affected by neither disorder (Control) using generalized estimating equations (covariates: maternal age, parity, BMI, insurance type, race, marital status, and prenatal care site). Secondary outcomes were small for gestational age birthweight (SGA), large for gestational age birthweight (LGA), and a neonatal composite outcome (stillbirth, hypoglycemia, hyperbilirubinemia, respiratory distress, encephalopathy, preterm delivery, neonatal death, NICU admission).
Results: Median [IQR] birthweight (BW) percentile in GDM/HDP (50 [24, 78], N=179) was similar to Control (50 [27, 73], N=35885), while GDM had increased (60 [35, 83], N=1322) and HDP had decreased (43 [18, 71], N=2749) BW percentiles. GDM (OR 0.8, P&lt;0.001), HDP (OR 0.7, P&lt;0.001), and GDM/HDP (OR 0.7, P=0.04) each had decreased odds of AGA. GDM had decreased SGA odds (OR 0.7, P=0.02) and increased LGA odds (OR 1.7, P&lt;0.001). HDP had increased SGA odds (OR 2.0, P&lt;0.001) and no difference in LGA odds (OR 0.99, P=0.914). While unadjusted rates of abnormal growth in GDM/HDP suggested that reduced AGA was due to excess LGA (14.5%) without excess SGA (7.3%), adjusted models suggested that both SGA (OR 1.3, P=0.33) and LGA (OR 1.4, P=0.12) contributed. GDM/HDP conferred the highest risk of neonatal morbidity (OR 3.4, P&lt;0.001 compared to Control).
Conclusion: Although pregnancies with GDM/HDP co-occurrence have a similar median birth weight to unaffected pregnancies, they carry an increased risk of abnormal fetal growth and neonatal morbidity.

Disclosure
C.A.Onuoha: None. T.Thaweethai: None. S.Hsu: None. C.C.M.Schulte: None. K.James: None. A.Kaimal: None. C.E.Powe: Consultant; Mediflix, Inc., Other Relationship; Wolters Kluwer Health.
1223-P: Frequency and Predictors of Level 2 Time Above Range (TAR) in Older Adults with Type 2 Diabetes on Insulin Therapy—Data from the HYPOAGE Prospective Study
Authors: CARIOU BERTRAND , HADJADJ SAMY , SOPHIE BOUREAU ANNE ,   HYPOAGE STUDY GROUP
Published: June 2023

Background: Although type 2 diabetes (T2D) is very common in older patients, there is a lack of real-life data on blood glucose control in this specific population. We aimed to determine the frequency and predictors of hyperglycemia in older patients with T2D on insulin therapy by using continuous glucose monitoring (CGM).
Methods: HYPOAGE is prospective multicenter study including 146 insulin-treated older adults aged 75 and older, with T2D for at least 1 year and treated with insulin for at least 6 months. All patients benefited from ambulatory blinded CGM for 28 consecutive days with FreeStyle Libre Pro® sensor. All participants underwent a geriatric and diabetic assessment. Multivariable logistic regressions were used to identify factors associated with level 2 time above range (TAR)[glucose concentration &gt;13.9 mmol/L] &gt; 10%.
Results: The mean age of the 141 analyzed patients was 81.5±5.3 years and 56.7% were male, 102 participants (72.3%) were considered as complex and 39 (27.7%) as healthy after geriatric assessment. The mean baseline HbA1c was 7.9±1.0% and 43 patients (30%) had TAR (level 2) &gt; 10%. Compared to patients with level 2 TAR ≤ 10%, patients with higher TAR were older (83.5 [5.7] vs 80.6 [4.9] years), with lower BMI (28.0 [5.5] vs 31.3 [6.1] kg/m2), higher HbA1c (8.6 [0.9] vs 7.6 [0.9] %), and a less frequent healthy geriatric status (14.0 vs 33.7%). In multivariate analyses, TAR (level 2) &gt; 10% remains only significantly associated with HbA1c (OR: 3.08 for 1% increase [1.72-5.50], p=0.0002) and BMI (OR: 0.92 [0.84-1.00], p=0.0496). Conversely, HbA1c was not significantly associated with hypoglycemia (i.e. level 2 time below range [glucose concentration &lt; 3.0 mmol/L]).
Conclusions: In this real-life study, 30% of older patients are above the TAR target recommended by the ATTD 2019 consensus (&lt; 10% for level 2) HbA1C is a better predictor of time spent in hyperglycemia than of hypoglycemia in older patients on insulin therapy.

Disclosure
B.Cariou: Board Member; Eli Lilly and Company, Novartis, Research Support; Sanofi, Speaker's Bureau; Abbott, AstraZeneca, Novo Nordisk, Sanofi. S.Hadjadj: Consultant; Bayer Inc., Novo Nordisk, Valbiotis, Research Support; AstraZeneca, Novartis, Speaker's Bureau; Abbott Diagnostics, Boehringer-Ingelheim. A.Boureau: Board Member; Pfizer Inc. Hypoage study group: n/a.

Funding
Sanofi
128-OR: The Effect of Tirzepatide during Weight Loss on Food Intake, Appetite, Food Preference, and Food Craving in People with Obesity
Authors: MARTIN CORBY K. , RAVUSSIN ERIC , SANCHEZ-DELGADO GUILLERMO , NISHIYAMA HIROSHI , LI JING , URVA SHWETA , PRATT EDWARD J. , MILICEVIC ZVONKO , HAUPT AXEL , COSKUN TAMER 
Published: June 2023

Tirzepatide (TZP) promotes significant and clinically meaningful weight loss. In a randomized blinded clinical trial in people with obesity undergoing caloric restriction, we investigated the effect of TZP vs Placebo (PBO) on food intake during ad libitum lunch and dinner, appetite, food preference and craving. In this 18wk phase 1 study, 55 people with obesity, with baseline body weight of 102.8 kg were randomized (1:1) to TZP 15 mg or PBO. Food intake was measured during ad libitum lunch (664 kcal, PBO and 682 kcal, TZP) and dinner (1178 kcal, PBO and 1190 kcal, TZP) at baseline and after 18wk of treatment. We measured appetite during fasting and standardized mixed meal tolerance test (sMMTT) with visual analogue scale (VAS) and retrospective VAS (average ratings over the previous week). Food cravings and preferences were measured with the Food Craving Inventory (FCI) and Food Preference Questionnaire (FPQ) at baseline, 8wk and 18wk. At 18wk, mean body weight loss was 16.7 kg with TZP and 8.3 kg with PBO (p&lt;0.001). TZP significantly decreased food intake from baseline during lunch (-285±42 kcal) and dinner (-631±58 kcal) compared to PBO (60± 42, and -116±58 kcal, respectively). TZP significantly lowered appetite at fasting and at each time point during the sMMTT, resulting in decreased hunger and prospective food consumption and increased fullness. Based on retrospective VAS, appetite changes started at 1wk. TZP significantly decreased food preference scores in 10 of 12 FPQ metrics at 8wk and 18wk compared to PBO. TZP significantly decreased the overall FCI score and the sweets, carbohydrates and starches, and fast-food fats sub scores, but not the high fat and fruit and vegetable sub scores, at 8wk and 18wk, compared to PBO. In conclusion, TZP decreased food intake, appetite and food craving and preference. TZP appears to reduce body weight via reductions in food intake and the drive to eat.

Disclosure
C.K.Martin: Board Member; EHE Health, Wondr Health, Other Relationship; ABGIL, Research Support; Pack Health, Evidation Health, Lilly, WW International, Inc. T.Coskun: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E.Ravussin: Advisory Panel; Novartis, Research Support; Eli Lilly and Company, Novartis AG. G.Sanchez-delgado: Research Support; Eli Lilly and Company, Novo Nordisk, Abbott, Maastricht instruments, Vyaire Medical, ParvoMedics, Cosmed, Speaker's Bureau; Eli Lilly and Company. H.Nishiyama: None. J.Li: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. S.Urva: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E.J.Pratt: Employee; Eli Lilly and Company. Z.Milicevic: Employee; Eli Lilly and Company. A.Haupt: Employee; Lilly, Stock/Shareholder; Lilly.

Funding
Eli Lilly and Company
130-LB: GWave—A Novel Noninvasive Glucose Blood Monitoring Radio Wave–Based Technology
Authors: HIRSCH IRL B. , NAVON AMI 
Published: June 2023

Attempts to achieve an accurate noninvasive glucose monitor to date have been unsuccessful. The GWave device (Hagar, Israel) filters out the “white noise” and uses radiofrequency that detects capillary blood glucose across the physiological range. Measuring blood as opposed to interstitial fluid glucose, allows elimination of the “lag time” and poor accuracy seen in the first day of the current invasive continuous glucose monitors. Calibration of the GWave device is not required. Original data with the first prototype device revealed a 96% and 97% zone A (N = 53) in the Clarke Error Grid (CEG) comparing to venous and capillary blood, respectively. Initial results with second generation devices in non-diabetic subjects compared to capillary blood noted 99% in CEG Zone A and a MARD of 7.1% (N = 120 measurements) (Figure). These data were reproducible with two GWave devices (MARD 5.1%). Combining first and second-generation devices (N = 43 measurements) with a range of glucose of 69 to 400 mg/dL), CEG in Zone A was 98%. Subjects with both type 1 and type 2 diabetes are now being studied to examine accuracy at a wider physiological range of glycemia. Early results from the GWave glucose monitor shows promise as the first noninvasive technology. The current on-going studies will provide more insight for its use in diabetes care.

Disclosure
I. B. Hirsch: Consultant; Abbott Diabetes, Lifecare, Inc., Hagar, Research Support; Beta Bionics, Inc., Insulet Corporation, Dexcom, Inc. A. Navon: Consultant; GWave.

Funding
Hagar Technologies
1321-P: Screening for Liver Fibrosis in Diabetes—Assessing the Performance of Current Recommendations in a Large Unselected Population
Authors: BRIL FERNANDO , GRAY MEAGAN 
Published: June 2023

American Diabetes Association’s Standard of Care 2023 recommended screening patients with T2D for significant liver fibrosis with FIB-4 and transient elastography (TE). However, the evidence supporting this approach is controversial. The aim of this study was to assess the use of FIB-4, and its correlation with TE, in an unselected population of patients with diabetes. Adult patients from NHANES 2017-2020 with complete data on FIB-4 and TE were included. Diabetes was defined based on FPG, A1c or prior history. Patients with secondary causes of liver steatosis were excluded. NAFLD was defined as a controlled attenuation parameter ≥274 dB/m, while clinically significant and advanced liver fibrosis were defined as TE ≥9.6 and ≥12 kPa, respectively. Among 1193 patients with diabetes (Age: 61 ± 13; BMI: 32.6 ± 7.3 kg/m2; A1c: 7.4 ± 1.7%), the prevalence of NAFLD, clinically significant liver fibrosis, and advanced fibrosis were 68%, 15% and 8%, respectively. These were significantly higher than in patients without diabetes even after stratifying for BMI (all p&lt;0.001). Liver fibrosis worsened with increasing insulin resistance (HOMA-IR), but were not associated with A1c levels. FIB-4 performed poorly to predict significant or advanced liver fibrosis in diabetes (AUC: 0.59 [0.54-0.64] and AUC: 0.63 [0.56-0.69], respectively). Moreover, it performed numerically worse than plasma AST alone (AUC: 0.63, p=0.10 and AUC: 0.68, p=0.10, respectively). Among patients with significant and advanced fibrosis based on TE, FIB-4 was &lt;1.30 (suggested cut-off for screening) in 51% and 47% of patients (i.e., false negatives), suggesting a significant disagreement between these tests. Patients with diabetes are at high risk of liver disease, and therefore, screening for liver fibrosis is warranted. However, our results suggest that current screening strategies based on FIB-4 and TE may not be adequate, as they may miss a significant number of patients with advanced fibrosis.

Disclosure
F.Bril: None. M.Gray: Advisory Panel; Takeda Pharmaceutical Co., Ltd., Theratechnologies, Consultant; Novo Nordisk.
1492-P: IL-8/CXCL8 May Identify a New Type 1 Diabetes Endotype
Authors: ALHAMAR GHADEER , FALLUCCA SARA , PIERALICE SILVIA , VALENTE LUCIANA , POZZILLI PAOLO 
Published: June 2023

Recent research focused on identifying mechanisms explaining the observed heterogeneity of type 1 diabetes (T1D) in age at onset, residual β-cell function and rate of disease progression. Mechanisms include changes in both the immune system and β-cells, leading to the loss of tissue-specific immune tolerance and disease onset. Interleukin-8 (IL-8; CXCL8) is a pro-inflammatory chemokine released by macrophages, endothelial, epithelial and airway smooth muscle cells playing a major role in the innate immune response. Macrophages release IL-8 at the site of an injury where they recruit and activate neutrophils by interacting with the IL-8 receptors CXCR1 and CXCR2. An increase in circulating IL-8 has been shown in several autoimmune disorders. IL-8 levels, but not IL-6 or TNF-α, are elevated in adolescents with T1D, and also associated with insulin resistance, suggesting a role for IL-8 beyond acute inflammation in this setting. In vitro experiments revealed that IL-8 transcription is induced by hyperglycaemia. In the present study newly diagnosed T1D patients within the first year of disease onset (mean age 16.2 ± 7.6 yrs and % HbA1c of 10.7 ± 2.7) (N=42) were studied. Clinical and laboratory features included age, gender, body mass index (BMI), disease duration, HbA1c, and C-peptide. Serum IL-8 and myeloperoxidase (MPO) were measured with commercial enzyme-linked Immunosorbent assays. When compared to normal subjects, T1D patients showed a significantly higher IL-8 values (median [IQR] 112.0 [64.74-311.8] vs 43.05 [30.94-49.70], p-value= 0.002, respectively). Furthermore, T1D patients showed a significantly higher MPO levels than controls (median [IQR], 95327 [55718 - 168974] vs 42729 [24147 - 95327], p-value= 0.0349, respectively). This study shows for the first time that IL-8 and MPO are elevated in patients with recent onset T1D compared to normal subjects. There is also a trend for a positive correlation between IL-8 and HbA1c levels suggesting that elevated IL-8 values are associated with poor metabolic control.

Disclosure
G.Alhamar: None. S.Fallucca: Consultant; Dompé. S.Pieralice: None. L.Valente: None. P.Pozzilli: None.
150-OR: Mean HbA1c and Glycaemic Variability Are Associated with Adverse Outcomes following Infrainguinal Bypass for Peripheral Arterial Disease (PAD)—A Retrospective Cohort Study
Authors: DHATARIYA KETAN , BENNETT PHILIP C. , FARNDON DANIEL J. 
Published: June 2023

Introduction: Glycemic variability (GV) is associated with increased risk of several adverse outcomes in people with diabetes (DM). However, on the impact of GV on graft patency following infra-inguinal bypass (IIB) for peripheral arterial disease (PAD) is unknown.
Methods: A 3-year single centre retrospective case notes analysis of those undergoing IIB 2017-2019. HbA1c values for 5 years pre-procedure (minimum of 3) were used to calculate a mean (±SD) HbA1c (MH) and GV. Time to re-intervention, ipsilateral amputation or death were recorded to determine primary (PP) and secondary patency (SP).
Results: 193 IIB outcomes were analysed: mean (±SD) age 68.9 (9.2) years; 135 (69.9%) male. 156 (80.8%) had pre-operative HbA1c for analysis and 88 (45.6%) had DM; 87 (45.1%) were current smokers; 107 (55.4%) underwent emergency procedures. Those without diabetes were more likely to smoke (P=0.011), but those with DM had higher Rutherford stage (p&lt;0.01), underwent more distal bypasses (p&lt;0.01) and more emergency procedures (p=0.04). Those with DM had longer mean [IQR] hospital stays 9 [5-21] vs 7 [4-15] days (p=0.017), lower PP 335 [184-542] vs 883 [436-1437] days (p=0.04) and lower SP 751 [387-1108] vs 1079 [895-1593] days (p=0.037). Both MH and GV were associated with amputation free survival time (r=-0.232, p=0.004 and r=-0.243, p=0.011 respectively). A GV&gt;9.1% was associated with significantly lower PP than GV&lt;9.1%, 198[105-377] vs 713 [313-1287] days (p=0.02). On multivariate adjustment, GV &gt;9.1% and level of bypass remained independent predictors of primary patency, HR 1.96 (95% CI:1.12-3.42, p=0.018) and HR 2.54 (95%CI:1.24-5.22, p=0.038) respectively.
Conclusions: We have shown a significant relationship between MH and GV and risk of adverse outcomes in people undergoing IIB. Lowering glycemic variability should be an additional therapeutic target together with lowering mean HbA1c.

Disclosure
K.Dhatariya: Other Relationship; Novo Nordisk, AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company. P.C.Bennett: None. D.J.Farndon: None.