bluuebunny/crossref_metadata_2025_split huggingface dataset:
796-P: Perceived Potential Benefits and Barriers for Using a Bionic Invisible Pancreas
Authors: HERMANNS NORBERT , FINKE-GROENE KATHARINA , KULZER BERNHARD , EHRMANN DOMINIC 
Published: May 2022

A fully implantable automated insulin delivery system consisting of an intraperitoneal pump and an implantable CGM sensor (Bionic Invisible Pancreas - BIP) is under development. The occurrence of potential benefits or barriers to the use of the BIP was assessed in people with diabetes under different treatment regimens (MDI, CSII, CSII and CGM) . They were asked to provide a rating of 9 potential benefits and potential barriers of BIP on a five-point Likert scale ranging from 1 - strongly disagree - to 5 - strongly agree. Data from 38 people with type 1 diabetes were analysed (MDI: n=12; CSII: n=14; CSII and CGM: n=12) . In general, participants reported more expected benefits than barriers. The main benefits were increased flexibility and better glucose levels. The main expected barriers related to problems in transferring control to BIP and fears about side effects of implantation (e.g. inflammation) . The benefits and barriers were similar in all three groups (p=0.861 and p=0.669 for differences between groups, respectively) . 76.3% of participants reported that they would use BIP. Participants reported more positive than negative expectations related to the BIP device, regardless of previous insulin treatment. In addition to the fear of side effects during implantation, giving control to the BIP device was perceived as challenging. The present work was supported by H2020-FETPROACT Project FORGETDIABETS, n. 951933

Disclosure
N.Hermanns: Advisory Panel; Abbott Diabetes, Research Support; Becton, Dickinson and Company, Roche Diagnostics, Speaker's Bureau; Berlin-Chemie AG, Novo Nordisk, Sanofi. K.Finke-groene: Speaker's Bureau; Berlin-Chemie AG. 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. D.Ehrmann: Advisory Panel; Dexcom, Inc., Consultant; mySugr, Roche Diabetes Care, Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc.

Funding
The present work was supported by H2020-FETPROACT Project FORGETDIABETS, n. 951933
797-P: Usability and Satisfaction of a New Affordable Insulin Pen for All: Positive Outcomes of Two Usability Studies
Authors: NIELSEN OLE K. , HUISMAN GEKE , QASEM JAMIL A. , ENG CHEE WEN , JØRGENSEN ANNE F. , TORRONE MARTINO , LARSEN BRIT S. , REDDY AMULYA 
Published: May 2022

Globally, 13 million people (4 million in USA) inject insulin with single use disposable syringes daily. Compared to syringe and vials, pens are known to increase adherence and diabetes control and to reduce healthcare utilization costs. Yet, pens are largely unavailable to low-income groups, due to prohibitive cost. GO-Pen has designed a new affordable pen for use with vial insulin and conducted usability testing in collaboration with Médecins Sans Frontières (MSF) , an international medical humanitarian organization working to improve diabetes care for people living in difficult circumstances.
Here we report the results of two usability studies conducted among insulin pen users (n=19, f/m: 11/8, age: 23-64) and syringe users (n=20, f/m: 10/10, age: 24-70) in refugee populations in Malaysia and Jordan. A convenience sample of the first 20 to accept enrollment was set up after informed consent. After a short introduction, participants were asked to demonstrate the use of the insulin pen in front of a camera, without revealing their faces or any identifying information, while an interviewer noted their correct use and confidence level. Injection was simulated in a sponge. 100% (n=19) of pen users and 75% (n=15) of syringe users performed &gt;90% of the tasks correctly. Among pen users, the most common failed tasks were priming the needle (n=4) . Among syringe users, the most common failed tasks were failing to check the vial label (n=9) and priming the needle (n=6) . 5% (n=1) of pen users preferred the new insulin pen over the pen they were already familiar with. 75% (n=15) of syringe users preferred the new insulin pen over syringes. The most common complaint among pen users was that there were too many steps in the process.
In conclusion, we find current pen users require little training and prefer the pen they are already familiar with. Syringe users who are unfamiliar with pen usage require more training than pen users, however, they have largely favorable attitudes towards this new insulin pen.

Disclosure
O.K.Nielsen: Stock/Shareholder; GO-Pen ApS. G.Huisman: None. J.A.Qasem: None. C.Eng: None. A.F.Jørgensen: None. M.Torrone: None. B.S.Larsen: None. A.Reddy: None.
8-LB: Glucagon—The Forgotten Hormone in Diabetes
Authors: MITCHELL BETH , NELSON DAVID R. , MEEKS ALEXANDRA , YAN YU 
Published: May 2022

The ADA recommends that all people with diabetes at risk of level 2 or 3 hypoglycemia be prescribed glucagon. Studies of conventional reconstituted injectable glucagon showed low rates of successful delivery of a full dose and low prescription filling rates. Since July 2019, ready-to-use glucagon options have become commercially available. IBM® MarketScan® Research Database was used to study prescription patterns among people with T1D or T2D on insulin who had filled a glucagon prescription 2 years prior to July 2019 (pre-period) and/or 2 years after through July 2021 (post-period) . Logistic regression models (for feature selection of independent variables followed by two-way interaction identification from Multivariate Adaptive Regression Splines) were utilized to determine glucagon fills post-period based on variables pre-period (demographics, diabetes type, insurance, comorbidities, history of hypoglycemia, diabetes medications) . Classification trees were used to illustrate the effects of significant variables (variables added &gt;1% accuracy from cross validation) . Of all insulin-treated people (n=138,826) over the 4-year period, 13.5% (T1D 48.4%, T2D 3.5%) had glucagon prescriptions filled. Of those who filled glucagon post-period (n=14,234) , 54.3% filled a ready-to-use glucagon. The primary drivers and % of glucagon fills post-period: overall included age &lt;22 (63.3%) , T1D (37.4%) , and glucagon filled pre-period (62.2%) (each p&lt;.001) ; among people with T1D, age &lt;17 (81.6%) and glucagon filled pre-period (66.7%) (each p&lt;.001) ; among people with T2D, glucagon filled pre-period (34.0%) , basal-bolus insulin filled in the 4-year period (4.4%) , and age &lt;16 (58.6%) (each p&lt;.001) . The results suggest that, despite guideline recommendations, glucagon prescription fills are low, and mostly by young people. Though at increased risk of hypoglycemia, fill was low in the elderly and people with T2D on basal-bolus insulin. After becoming available, ready-to-use glucagon represented over 50% of glucagon fills.

Disclosure
B. Mitchell: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. D. R. Nelson: Employee; Eli Lilly and Company. A. Meeks: Employee; Eli Lilly and Company. Y. Yan: Employee; Eli Lilly and Company.

Funding
Eli Lilly and Company
803-P: Serum Adiponectin Level Is Reduced after Short-Term Intensive Insulin Therapy in Patients with Newly Diagnosed Type 2 Diabetes
Authors: LIU LIEHUA , KE WEIJIAN , CHEN JIE , LI YANBING 
Published: May 2022

Objective: Short-term intensive insulin therapy (SIIT) can induce remission of type 2 diabetes (T2D) , and the improvement of insulin sensitivity is considered essential. This study aimed to evaluate the role of adiponectin change during SIIT in patients with newly diagnosed T2D.
Methods: SIIT was given to 42 patients with newly diagnosed T2D to normalize blood glucose (4.4-6.0 mmol/L for fasting blood glucose [FBG], 4.4-8.0 mmol/L for 2h-postprandial blood glucose [2hBG]) for two weeks. Serum lipids, adiponectin, and high-sensitive C reactive protein levels, insulin resistance and β-cell function were evaluated before and after SIIT.
Results:After the therepy, FBG (11.8±2.9 mmol/L vs. 6.8±1.3mmol/L,P&lt;0.001) and 2hPG (18.4mmol/L± 6.4mmol/L vs. 9.7±2.4mmol/L, P&lt;0.001) were both significantly decreased, with β-cell function (measured by acute insulin response [AIR], HOM-B) and insulin sensitivity (measured by HOMA-IR) improved. Serum adiponectin raised from 2.9±1.2mg/L to 3.4±1.1mg/L (P&lt;0.001) ,while serum triglyceride and LDL-C decreased significantly. Serum adiponectin after treatment was correlated with baseline triglyceride (r = -0.33, P = 0.04) , HDL-C (r = 0.34, P = 0.03) , LDL-C (r = -0.31, P = 0.05) and Hs-CRP (r = -0.33, P = 0.05) ; the change of adiponectin (Δadiponectin) after treatment were significantly correlated with the level of Δtriglyceride (r = 0.38, P = 0.03) . There was no notable correlation between adiponectin and β-cell function index or HOMA-IR. Adiponectin levels were similar between patients who obtained diabetes remission (defined as FBG&lt; 7.0mmol/L, 2hBG&lt;10.0mmol/L without hypoglycemic agents) and those who did not (baseline:3.0±1.5mg/L vs. 2.9±1.0 mg/L; after SIIT:3.4±1.0mg/L vs. 3.3±0.9 mg/L,both P&gt;0.05) .
Conclusion: Adiponectin level was significantly increased after SIIT in patients with newly diagnosed T2D. The change of adiponectin is related to the improvement of lipid metabolism and reduced inflammation.

Disclosure
L.Liu: None. W.Ke: n/a. J.Chen: None. Y.Li: None.

Funding
The National Key R&D Program of China (2018YFC1314100) , the Key-Area Research and Development Program of Guangdong Province (2019B020230001) , the National Natural Science Fund of China (81800716) , the science and technology program of Guangzhou, 202002020053.
810-P: Real-World Performance of IDegAsp over Six Years in Asian-Indian Population
Authors: KESAVADEV JOTHYDEV , SABOO BANSHI D. , SHANKAR ARUN , KRISHNAN GOPIKA , BASANTH ANJANA , ASHIK ASHA , DAVID ASHWIN , JOTHYDEV SUNITHA 
Published: May 2022

There is scarce data on the long-term safety and efficacy of IDegAsp in Asian Indians in a real-world (RW) setting. IDegAsp is a co-formulation of an ultra-long-acting insulin Degludec and a rapid acting insulin Aspart. A multi-centric, retrospective observational study was conducted to evaluate long-term efficacy and safety of IDegAsp in T2D on regular follow up for &gt;5 years. Baseline clinical data of 535 T2D (78.7% males; avg. age= 53.41 ± 12.yrs; HbA1c= 8.88 ±1.96 %; avg. duration of diabetes: 11.34 ± 7.57yrs) , previously on treatment (90.1 %) which included various OADs±insulin regimen, or treatment-naive (9.9 %) , who were switched to or initiated on IDegAsp respectively, from December 2014 - 2021 were analyzed. Significant improvements (P&lt;0.05) in clinical parameters were observed from baseline (Table 1) . The TDD was 15.45 ± 10.53 units/day (at 3 months) which increased (p&lt;o.oo1) to 20.03 ± 11.units/day post-treatment (67 months) . 65.2 % continued twice daily IDegAsp and 3.9 % switched from twice daily to once daily IDegAsp during treatment. 30.9% continued once daily IDegAsp. A total of non-severe hypoglycemic episodes were observed. In this RW study involving T2D from Asia, IDegAsp significantly improved A1C and a range of clinical profiles, with negligible hypoglycemia. Unlike conventional premix/basal bolus regimen, IDegAsp offers a less complex, more physiological, safe and effective solution for glycemic control.

Disclosure
J.Kesavadev: None. B.D.Saboo: None. A.Shankar: None. G.Krishnan: None. A.Basanth: None. A.Ashik: None. A.David: None. S.Jothydev: None.
818-P: Chronic Oral Polymeric Duodenal Exclusion Therapy Has Profound Metabolic Benefits in a T2D Rat Model and Affects Duodenal Morphological Enteroplasticity Similar to RYGB surgery: Implications for T2D Therapy
Authors: NIMGAONKAR ASHISH , GUERINA FLORENCE , KELLEHER SHANNON L. , CARLSON TAYLOR , COLBERT KEVIN , POLOMOSCANIK STEVEN , PETERSEN JOHN S. , HABEGGER KIRK M. , PASRICHA PANKAJ J. , FINEMAN MARK , JOZEFIAK THOMAS H. 
Published: May 2022

Background: RYGB surgery has significant weight loss and improvement in glycemia, attributed predominantly to duodenal exclusion. To mimic this effect non-invasively, we developed oral, gut-restricted, inert polymer (GLY-POL) that interacts with mucus in the proximal small intestine to form a dynamic barrier excluding the duodenal lining from luminal contents. We hypothesized that such treatment would result in significant metabolic improvement and affect morphologic enteroplasticity similar to RYGB.
Methods: Goto-kakizaki (GK) rats were gavaged with GLY-POL daily for 8-weeks (n=7 per group) . Metabolic responses were evaluated weekly (BW, food intake, oGTT, mMTT, HOMA-IR) . Duodenal morphometric analysis (villus height and crypt depth) was performed in excised duodenum after study completion.
Results: There was profound metabolic improvement with chronic GLY-POL therapy; oGTT (iAUC ↓ = 60 - 70%, p&lt;0.0005) , mMTT (iAUC ↓ &gt; 55%, p &lt; 0.005) , HOMA-IR improvement (p&lt;0.005) , 6% weight loss (p&lt;0.005) . There was no difference in food intake between the groups. There was a significant reduction in the duodenal villus height (p&lt;0.0001) and crypt depth (p&lt;0.0001) in treated rats compared to controls.
Conclusion: Our results confirm a key role for chronic duodenal exclusion oral GLY-POL therapy in improving the systemic metabolic milieu with profound reduction in FPG, PPG, insulin resistance and weight loss. Duodenal villus morphological changes are likely due to nutritional depletion from the GLY-POL lining. Similar cellular structural changes have been reported in the bypassed portion of the small intestine after RYGB surgery. GLY-POL therapy offers the potential for a novel non-invasive approach for glycemic and weight control in T2D patients that mimics the effects of gastric bypass without the adverse effects associated with this surgery.

Disclosure
A.Nimgaonkar: Employee; Glyscend Inc. M.Fineman: None. T.H.Jozefiak: Employee; Glyscend Inc., Stock/Shareholder; Glycologix, LLC. F.Guerina: Employee; Glyscend Inc. S.L.Kelleher: Research Support; Glyscend Inc. T.Carlson: Employee; Glyscend Inc. K.Colbert: Stock/Shareholder; Glyscend Inc., LifeSprout. S.Polomoscanik: None. J.S.Petersen: None. K.M.Habegger: Consultant; Glyscend Inc., Research Support; Eli Lilly and Company, Novo Nordisk, Stock/Shareholder; Glyscend Inc. P.J.Pasricha: Consultant; Vanda, Other Relationship; Teva Pharmaceutical Industries Ltd., Stock/Shareholder; Glyscend Inc., Neurogastrx, P4M.
82-LB: Improvement of Glycemic Control in People with Type 2 Diabetes Using Basal Insulin (PwT2D-BI) and Continuous Glucose Monitoring (CGM) —U.S. Study Using Machine Learning (ML)
Authors: CHINTHAMMIT CHANADDA , BRNABIC ALAN J.M. , PEREZ-NIEVES MAGALY 
Published: May 2022

Background: CGM provide real-time glucose data that allows users to manage their diabetes holistically. This study aimed to assess the association between glycemic control and CGM use in PwT2D-BI.
Methods: This retrospective study used IBM MarketScan® 2015 - 2019 Databases to identify PwT2D-BI with (CGM) and without (control) use of CGM. CGM users were followed from first BI until CGM initiation, defined as index date (ID) . The ID of non-CGM controls were randomly assigned based on time between first BI and ID of CGM. . Comparison CGM use for 6 and 12 months were performed using Frequentist Model Averaging (FMA) in a ML framework adjusting for baseline characteristics. Model strategies were applied including matching, weighting, stratification and regression.
Results: A total of 5,934 PwT2D-BI (251 CGM; 5,683 control) were included in the study (Table 1) . Observed A1c reduction from baseline to 12 months was 0.87%, 0.95% for 6 and 12 months of CGM use, respectively vs. 0.32% for controls. FMA analyses found CGM users had a statistically significantly greater reduction in A1c both at 6 months (treatment difference 0.30 [0.13,0.48]) and 12 months (0.50 [0.37, 0.72]) .
Conclusion: Findings suggest that CGM use for at least 6 months in PwT2D-BI has clinical benefit as demonstrated by A1c reduction in the real-world setting.

Disclosure
C. Chinthammit: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A. J. M. Brnabic: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. M. Perez-nieves: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company.

Funding
Eli Lilly and Company
82-OR: Phase Angle of Bioelectrical Impedance Analysis Correlates with Multiple Parameters of Diabetic Polyneuropathy in Patients with Type 2 Diabetes
Authors: SCHIMPFLE LUKAS , MOOSHAGE CHRISTOPH , TSILINGIRIS DIMITRIOS , KENDER ZOLTAN , KURZ FELIX T. , JENDE JOHANN M.E. , SZENDROEDI JULIA M. , BENDSZUS MARTIN , KOPF STEFAN 
Published: May 2022

Background and Aims: Sensorimotor polyneuropathy (DPN) is the most common diabetic complication and a major contributor to increased morbidity and mortality in diabetic patients. With diagnostic methods still being limited, we aimed to correlate the phase angle (PhA) , a marker derived from bioelectrical impedance analysis, with determinants of DPN. In particular we used magnetic resonance neurography (MRN) together with state-of-the-art clinical and electrophysiological measurements of DPN.
Materials and Methods: In this cross-sectional observational study we included 1healthy subjects and 2patients with type 2 diabetes (T2D) , amongst which 63 had DPN. The PhA was calculated using a multi-frequency bioelectrical impedance analyzer. Nerve conduction studies, quantitative sensory testing (QST) and diffusion weighted 3 Tesla MRN to determine the fractional anisotropy (FA) were performed.
Results: In the group comparison lower PhA values were found in T2D patients with DPN in contrast to T2D patients without DPN (5.71+/-0.vs. 6.07+/-0.08, p=0.007) and healthy controls (5.71+/-0.vs. 6.18+/-0.08, p&lt;0.001) . Confounder-adjusted analysis among T2D patients showed positive correlations of the PhA with the FA of MRN (r=0.41, p=0.006) , with conduction velocities and action potentials of the peroneal (r=0.27, p&lt;0.001; r=0.29, p&lt;0.001) and tibial nerve (r=0.22, p=0.005; r=0.30, p&lt;0.001) and with Z-scores of QST (thermal detection r=0.31, p&lt;0.001; thermal pain r=0.20, p=0.010; mechanical pain r=0.19, p=0.015; mechanical detection r=0.19, p=0.013) .
Conclusion: The close association of the PhA with the FA, a marker of structural nerve integrity of MRN, might reflect the similar physics of current or diffusion respectively being impaired by altered nerve composition. Due to correlations of the PhA with classical diagnostics of DPN it could become a novel, easily accessible and powerful marker for a quick assessment of DPN.

Disclosure
L.Schimpfle: None. C.Mooshage: None. D.Tsilingiris: None. Z.Kender: None. F.T.Kurz: None. J.M.E.Jende: None. J.M.Szendroedi: Consultant; Boehringer Ingelheim International GmbH. M.Bendszus: None. S.Kopf: Board Member; Novo Nordisk, Speaker's Bureau; AstraZeneca, Recordati S.p.A.

Funding
The German Research Council (DFG, SFB 1158)
824-P: Dual Amylin and Calcitonin Receptor Agonists Improve Insulin Sensitivity and Increase Tissue-Specific Glucose Uptake Independent of Weight Loss
Authors: LARSEN ANNA T. , SONNE NINA , BREDTOFT EMMA-MARIE , KARSDAL MORTEN A. , HENRIKSEN KIM 
Published: May 2022

Dual amylin and calcitonin receptor agonists (DACRAs) are known to induce a significant weight loss and improve glucose tolerance and glucose control in rats. However, it is unknown if DACRAs has an insulin sensitizing effect beyond that induced by weight loss and if DACRAs affect tissue specific glucose uptake. Additionally, clamp studies with DACRAs have not previously been performed in diabetic rats. Pre-diabetic ZDSD and diabetic ZDF rats were treated with the DACRA KBP-088 (1.5 nmol//kg, s.c.) for 12 days, and a hyperinsulinemic clamp was conducted on day 13, 24 h post-dosing. In ZDSD rats a hyperinsulinemic euglycemic clamp was carried out, while a hyperinsulinemic isoglycemic clamp was carried out in ZDF rats. In addition, specific glucose uptake was assessed during a hyperinsulinemic isoglycemic clamp in ZDF rats. In ZDSD rats, KBP-088 treatment resulted in a significant reduction in body weight and fasting blood glucose, and improved insulin sensitivity by increasing the glucose infusion rate (GIR) (vehicle: 8.6, KBP-088: 12 mg glucose/kg/min) . In ZDF rats, KBP-088 significantly reduced fasting blood glucose and improved insulin sensitivity (GIR, vehicle: 1.5, KBP-088: 16.5 mg glucose/kg/min) , independent on weight loss. In both studies, KBP-088 increased the rate of glucose clearance, likely be increasing glucose storage, but without altering the endogenous glucose production. Direct assessment of tissue specific glucose uptake showed, that KBP-088 significantly increased glucose uptake in both muscles and adipose tissues when compared to vehicle.
In summary, KBP-088 significantly improved insulin sensitivity in both pre-diabetic and diabetic rats and markedly increased tissue specific glucose uptake. Importantly, KBP-088 has an insulin sensitizing effect independent of weight loss, highlighting DACRAs as promising agents for treatment of diabetes.

Disclosure
A.T.Larsen: Employee; Nordic Bioscience. N.Sonne: None. E.Bredtoft: None. M.A.Karsdal: Employee; Nordic Bioscience A/S, Nordic Bioscience A/S, Nordic Bioscience A/S. K.Henriksen: Employee; Nordic Bioscience A/S, Stock/Shareholder; Nordic Bioscience A/S.