bluuebunny/crossref_metadata_2025_split huggingface dataset:
904-P: 12-Month Treatment Satisfaction (TS) and Fear of Hypoglycemia (FoH) Outcomes in the ADAPT Study—A Randomized Controlled Trial Comparing an Advanced Hybrid Closed-Loop System (AHCL) to Multiple Daily Injections (MDI) with Intermittently Scanned CGM (isCGM)
Authors: COHEN OHAD , CHOUDHARY PRATIK , EVANS MARK , SHIN JOHN , RE ROSELINE , CASTAÑEDA JAVIER , VORRINK - DE GROOT LINDA H. , ZEYNEP OZDEMIR SALTIK ASLI , DE PORTU SIMONA 
Published: June 2023

Objective: To assess whether TS & FoH improvements achieved with the MiniMed™ 780G AHCL system compared to MDI+isCGM therapy in adults with sub-optimally controlled type 1 diabetes participating in the ADAPT study phase (6 months) are maintained during the continuation phase (12 months) and reproduced in the MDI+isCGM control arm after cross over to AHCL.
Methods: TS was measured with the Diabetes Treatment Satisfaction Questionnaire status and change (DTSQs/c) and FoH with the Hypoglycemia Fear Survey (HFS). Endpoints were within-arm changes from 6 to 12 months.
Results: At 12 months, A1c (7.4%) and TS & FoH scores achieved with AHCL at 6 months were maintained (Fig). In the control arm switching to AHCL, improved A1c (7.5%) was reproduced. Mean DTSQs score increased significantly (21.9 to 29.9, P&lt;0.0001) with significant improvements in perceived frequency of hyper (P&lt;0.001) & hypoglycemia (P=0.0206). Results were consistent for DTSQc except no significant change in perceived frequency of hypo was observed. Median HFS score decreased by 6.5 points (P=0.0306).
Conclusion: At 12 months, improved TS & FoH observed in the AHCL arm were sustained, while substantial improvements in TS & reduced FoH were seen in the MDI+isCGM arm after switching to AHCL.

Disclosure
O.Cohen: Employee; Medtronic. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. J.Shin: Employee; Medtronic. R.Re: Employee; Medtronic. J.Castañeda: Employee; Medtronic. L.H.Vorrink - de groot: Employee; Medtronic. A.Ozdemir saltik: Employee; Medtronic. S.De portu: Employee; Medtronic, Stock/Shareholder; Medtronic.

Funding
Medtronic
905-P: Clinical Comparison of Infusion Sets with Angled and 90° Teflon Cannulas
Authors: COHEN OHAD , COHEN YAEL , CHATTARAJ SARNATH , ZHANG GINA , ANSELMO EVAN , TIROSH AMIR 
Published: June 2023

Objective: Insulin pump users worldwide depend on insulin infusion sets (IISs) for predictable delivery of insulin to the subcutaneous tissue. Yet emerging data indicates that IISs are associated with many pump-related adverse events and may contribute to potentially life-threatening problem of unexplained hyperglycemia. The relative scarcity of published research on IISs to date contributed to the difficulty of IIS section and recommendation. In this cross-over clinical study, a commercial Mio30 infusion set (M30IS) with 30° Teflon cannula was put into head-to-head comparison with a commercial Quick-set infusion set (QIS) with Teflon cannula.
Method: This is a cross over study of M30IS and QIS on 20 subjects with Type 1 diabetes. Each subject wore both sets for a month each on a preferred site that was continuously infused with insulin lispro or insulin aspart subcutaneously via a Medtronic 780G pump system for 3 days or until failure. The overall IIS survival rates, glycemic control outcomes (i.e., mean sensor glucose and time spent in established glucose ranges), total daily insulin delivered (TDD), and satisfaction with both IISs were determined.
Result: The 20 study subjects comprised of 50% men/women, at 41.3 ± 13.7 years, with BMI 25.7 ± 4.3 and HbA1c 7.0 ± 0.8. Based on the data collected, mean wear duration for the M30IS and QIS was 3.03 and 3.20 days, respectively. The M30IS had slightly more set failures (9.9%) than the QIS (4.4%). TDD and %Time in Range were statistically identical for both M30IS and QIS. Between the two IISs, more people preferred QIS over M30IS Teflon cannula.
Conclusion: Choosing between IISs with angled and 90° Teflon cannulas may be a personal preference. In terms of glycemic control, there was no statistical difference between the two IISs.

Disclosure
O.Cohen: Employee; Medtronic. Y.Cohen: None. S.Chattaraj: Employee; Medtronic. G.Zhang: Employee; Medtronic. E.Anselmo: Employee; Medtronic. A.Tirosh: Advisory Panel; Medtronic, Novo Nordisk, Sanofi, Eli Lilly and Company, Research Support; Medtronic, Sanofi, Speaker's Bureau; Medtronic, Novo Nordisk, Sanofi, Eli Lilly and Company.

Funding
Medtronic
907-P: Glycaemic Outcomes Associated with Omnipod DASH Use in the Real World—Results from the Association of British Clinical Diabetologists (ABCD) Omnipod Worldwide Audit
Authors: CRABTREE THOMAS S.J. , HAQ MASUD , HASAN NEBRAS , WILLIAMS DAVID M. , GATDULA ERNEDA R. , CHINNASAMY ESWARI , VARGHESE JEANNY , MODGIL GITA , RYDER ROBERT E. , WILMOT EMMA G. 
Published: June 2023

Introduction: The ABCD Omnipod® Worldwide Audit launched in 2021 with the aim of capturing routine clinical outcomes from users in the real-world. This analysis reports glucose outcomes, including comparisons between pump-naïve and established pump-users starting on Omnipod DASH® Insulin Management System.
Methods: Individuals were included in the analysis if relevant baseline and follow-up data were available. Change in HbA1c, time-in-range (TIR, 70-180mg/dL), time below range (TBR, &lt;70mg/dL) and total daily dose of insulin were assessed using paired T-tests. For glucose outcomes, stratified analyses were performed to compare the outcomes between those new to pump therapy (“new”) and those already established (“established”).
Results: Over a median follow-up of 2.3years (IQR 1.2-3) we included 235 individuals from the UK with baseline mean±SD HbA1c 8.1±1.4%; age 36.0±16.5years; diabetes duration 21.7±14.9years; 34.0% (n=82/235) were new to pump therapy. Across the whole population HbA1c reduced by 0.3% (95%CI 0.1, 0.5; P&lt;0.01). Stratified by previous therapy, HbA1c reductions were statistically significant in the “new” group (0.5%; 95%CI 0.1, 0.8; P=0.01). TIR, TBR and HbA1c levels were maintained in those in the “established” group. Total daily dose decreased from 41.4units to 36.9units (-4.4; 95%CI 0.8, 8.1; P=0.018) between baseline and follow-up. Of those asked to rate on a 7-point Likert scale, 82/84 (97.6%) stated Omnipod DASH had improved their quality of life and 83/86 (96.5%) would recommend the system to other people with diabetes.
Conclusion: In individuals new to pump therapy, Omnipod DASH is associated with clinically meaningful reductions in HbA1c, reduced insulin requirements and improved quality of life. Individuals switching to Omnipod DASH from other pumps maintained previous HbA1c levels, TIR and TBR.

Disclosure
T.S.J.Crabtree: Speaker's Bureau; Abbott Diabetes, Novo Nordisk, Lilly, Sanofi, Insulet Corporation. E.G.Wilmot: Advisory Panel; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, Roche Diabetes Care, Embecta, Consultant; Springer Healthcare, Research Support; Abbott Diabetes, Diabetes UK, Insulet Corporation, Novo Nordisk, NIH - National Institutes of Health, Speaker's Bureau; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, Ypsomed AG, Glooko, Inc. M.Haq: None. N.Hasan: None. D.M.Williams: None. E.R.Gatdula: None. E.Chinnasamy: None. J.Varghese: None. G.Modgil: None. R.E.Ryder: Other Relationship; Novo Nordisk, Speaker's Bureau; GI Dynamics, BioQuest.

Funding
Insulet Corporation
91-OR: AdoShell Islet, a New Biomaterial for Allogenic Islet Encapsulation Shows Six Months Insulin Secretion in Diabetic Immunocompetent Rats
Authors: GEISSLER ALEXANDRE , JOUANNOT OUARDANE , GAFFURI ANNE-LISE , GAUTIER CAMILLE , COURBEBAISSE YANN P. , BOUZAKRI KARIM , ELOY ROSY , SOULA OLIVIER 
Published: June 2023

Islet transplantation is an effective cure for T1D but the requirement for immunosuppression makes its application limited. AdoShell® is an implantable and fully retrievable scaffold for islet transplantation without immunosuppression. It is based on a permselective hydrogel film that allows the diffusion of insulin and prevents immune cell invasion. AdoShell® is a soft biomaterial with 95% water, synthetized from non-degradable polymers cross-linked by bio-orthogonal click chemistry. Encapsulated human islets displayed a gluco-responsive insulin secretion comparable to naked islets in perifusion experiments after 7 days and 1 month (N=3 donors 7 days / N=2 donors 1 month).
Wistar rat allogenic islets encapsulated in AdoShell® were implanted in immunocompetent STZ-induced diabetic rats. Insulin levels in vivo were on average 121pM/day over 41 days (n=22 rats), a significant increase versus negative control (45pM/day, n=9 rats) (M.W. t-test, p&lt;0.0001). AdoShell® Islets led to physiological weight gain, reduction of fasting hyperglycemia, and sustained C-peptide and insulin secretion for over 6 months in diabetic rats. It was well tolerated and did not trigger inflammatory reaction nor fibrosis after the 6-month implantation period in rat peritoneal cavity. Neither biodegradation, nor immune cell penetration were observed.

Disclosure
A.Geissler: Employee; Adocia, Stock/Shareholder; Adocia. O.Jouannot: Employee; ADOCIA, Stock/Shareholder; ADOCIA. A.Gaffuri: Employee; ADOCIA, Stock/Shareholder; ADOCIA. C.Gautier: Employee; Centre européen d'étude du diabète, Biomeostasis, Charles Rivers Laboratories, Institut de recherche contre les cancers de l'appareil digestif, GenOway, NAMSA. Y.P.Courbebaisse: None. K.Bouzakri: Consultant; Adocia, Stock/Shareholder; ILONOV. R.Eloy: Stock/Shareholder; Adocia. O.Soula: Employee; Adocia, Stock/Shareholder; Adocia.
912-P: Comparison of Automated Insulin Delivery Systems—AndroidAPS and Control-IQ in Type 1 Diabetes—The CODIAC Study
Authors: DAT DO QUOC , HÁSKOVÁ ANETA , RADOVNICKÁ LUCIE , KONECNA JUDITA , HOROVA EVA , GRUNBERGER GEORGE , PARKIN CHRISTOPHER , PRAZNY MARTIN , SOUPAL JAN 
Published: June 2023

The number of patients using open-source automated insulin delivery systems (OS-AID) is increasing. Although there is a lack of evidence, some people believe OS-AID provides better results than commercially available AID systems. We, therefore, compared an open-source AndroidAPS (AAPS) and commercially available Control-IQ (CIQ) in a prospective open-label single-arm clinical trial. Adults with T1D who had been using AAPS by their own decision were switched to the CIQ for 3 months. Results of this treatment were compared with those after 3-month phase on AAPS. The primary outcome was %TIR (70-180 mg/dL). Twenty-five patients participated in this study. CIQ was non-inferior to AAPS in achieving TIR (Figure). Similarly, there were no differences in %TAR (&gt; 180 and &gt; 250 mg/dL), in mean sensor glucose (130.3 ± 13.9 vs. 128.3 ± 16.9 mg/dL; p=0.21) and in A1C (6.3 ± 2.1% vs. 6.4 ± 3.1%; p=0.59). Importantly, %TBR (&lt; 70 and &lt; 54 mg/dL) were significantly lower when using CIQ than with AAPS. Even though participants were mostly satisfied with CIQ (63.6% mostly agree, 9.1% strongly agree) they do not plan to switch to CIQ. CIQ and AAPS were non-inferior in TIR. Hypoglycemia was significantly lower with CIQ. The CODIAC study is the first prospective study comparing OS-AID and commercially available AID system. These findings provide further guidance for clinicians and patients when discussing treatment options.

Disclosure
Q.Do: None. A.Hásková: None. L.Radovnická: None. J.Konecna: None. E.Horova: None. G.Grunberger: Advisory Panel; CeQur SA, Nevro Corp., LifeScan Diabetes Institute, Speaker's Bureau; Eli Lilly and Company, Novo Nordisk. C.Parkin: Consultant; Abbott Diabetes, Dexcom, Inc., CeQur SA, Tandem Diabetes Care, Inc., Roche Diabetes Care, Provention Bio, Inc., Lifecare, Inc., Insulet Corporation, Becton, Dickinson and Company. M.Prazny: Speaker's Bureau; Abbott, Boehringer Ingelheim Inc., AstraZeneca, Bayer Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk, Medtronic, Sanofi. J.Soupal: Speaker's Bureau; Dexcom, Inc.

Funding
Czech Ministry of Health (00064165); General University Hospital in Prague
929-P: Adaptive Therapy Settings—Qualitative Insights from People with Type 1 Diabetes Using Multiple Daily Injections Transitioning to an Automated System
Authors: HABIF STEPHANIE , SCHERTZ ELAINE , TRAHAN ALEX , CONSTANTIN ALEXANDRA , WHEATCROFT ALEX , WHITE KIRSTIN N. , PIQUETTE NICOLE J. , CARMELO KAREN , KATCHALSKI RAVID , PINSKER JORDAN E. , MESSER LAUREL H. 
Published: June 2023

Thirty adults with T1D using multiple daily injections (MDI) participated in a prospective single center 13-week study using an advanced hybrid closed-loop (HCL) system (Control-IQ Technology, Tandem Diabetes Care). In addition to advanced HCL, the system included a novel algorithm to accurately initialize insulin delivery settings and adapt them over time. Adaptation recommendations were generated by analyzing uploaded pump data and sent to study providers for safety review. Study results showed reduced hypoglycemia and immediate and sustained improvement in time in range. Here we report on six semi-structured 1-on-1 interviews with participants completed at end of study.
Each interview lasted ~30 minutes using a script of open-ended questions to gather feedback and reactions to the use of advanced HCL as well as trust and confidence in the automated therapy settings recommendations.
All participants reported a positive experience, particularly due to improved glucose control, relief from the burden of managing glucose, improved sleep, and overall better quality of life. Participants were generally confident with the settings that were recommended to them, and while 2 of the 6 participants questioned some therapy suggestions, they were comfortable enough with the recommended changes and felt in the end they had well-tuned therapy settings. One participant expressed hesitation about automating the settings, but this was ameliorated by education about how the algorithm worked and knowing how to stop the automated updates if needed. Two participants mentioned struggling with hypoglycemia due to exercise. All 6 participants wanted to transition from MDI to pump therapy after completing the trial. These qualitative insights reaffirm that algorithm driven workflows must result in outcomes that instill user trust in the system.

Disclosure
S.Habif: Employee; Tandem Diabetes Care, Inc. J.E.Pinsker: Employee; Tandem Diabetes Care, Inc. L.H.Messer: Advisory Panel; Lilly, Consultant; Dexcom, Inc., Capillary Biomedical, Inc., Employee; Tandem Diabetes Care, Inc., Research Support; Beta Bionics, Inc., Medtronic, Insulet Corporation. E.Schertz: Employee; Tandem Diabetes Care, Inc. A.Trahan: Employee; Tandem Diabetes Care, Inc. A.Constantin: Employee; Tandem Diabetes Care, Inc. A.Wheatcroft: Employee; Tandem Diabetes Care, Inc. K.N.White: Employee; Tandem Diabetes Care, Inc. N.J.Piquette: Employee; Tandem Diabetes Care, Inc. K.Carmelo: Employee; Tandem Diabetes Care, Inc. R.Katchalski: Employee; Tandem Diabetes Care, Inc.

Funding
Tandem Diabetes Care, Inc.
93-LB: Discovery of ID110521156, a Small Molecule GLP-1 Receptor Agonist, for the Treatment of Type 2 Diabetes and Obesity
Authors: JE IN-GYU , IM A-RANG , LEE DON-GIL , CHOI WON-GU , JANG EUNHYE , PARK JI-SOO , KIM DOHEE , LEE JUNGWOO , PARK JOONTAE , AN KYUNGMI , YOON HONGCHUL , KIM KI-YOUNG , CHOI SUNGKU 
Published: June 2023

Glucagon-like peptide (GLP)-1 receptor agonists are widely used to treat type 2 diabetes and obesity by enhancing insulin release and suppressing appetite. Even semaglutide administrated orally has been developed, it still has limitation as a drug peptide, including high cost, less stability, and low bioavailability. This is the reason we aimed to discover a small molecule GLP-1 receptor agonist can be orally bioavailable. ID110521156 showed direct binding to GLP-1 receptor in a surface plasmon resonance assay. Treatment of ID110521156 induced a dose-dependent increase of intracellular cAMP levels in the human GLP-1 receptor expressed CHO cells with similar maximal efficacy with GLP-1 (7-36) amide. Partial agonism on the recruitment of β-arrestin was observed, whereas there are no effects on intracellular calcium levels, mitogen-activated protein kinase phosphorylation, and GLP-1 receptor internalization. Oral administration of ID110521156 demonstrated plasma glucose lowering and insulin secretion on intravenous glucose tolerance test using diabetic monkeys. In addition, we assured food intake reduction and body weight loss in a dose dependent manner by once daily dosing. Following oral administration, ID110521156 showed half-lives of 3.69-4.93 hours and bioavailability ranging 18-32% in normal cynomolgus monkeys. The no observed adverse effect level on the 28 days repeated dose toxicity study conducted in nonhuman primates was 100-fold margin with in vivo efficacy dose. ID110521156 demonstrated no liabilities when tested on a battery of safety pharmacology studies, including cardiovascular, respiratory, and neurobehavioral function assessment. No genotoxicity was observed on Ames, in vitro chromosomal aberration, and in vivo micronucleus test. From these nonclinical study results, ID110521156 might be considered as a potent candidate of small molecule selective GLP-1 receptor agonist to treat type 2 diabetes and obesity.

Disclosure
I. Je: None. K. An: None. H. Yoon: None. K. Kim: None. S. Choi: None. A. Im: None. D. Lee: None. W. Choi: None. E. Jang: None. J. Park: None. D. Kim: None. J. Lee: None. J. Park: None.
932-P: Impact of a Titration App for Basal Insulin on Glycaemic Outcomes in People with Type 2 Diabetes on an Oral-Basal Insulin Regimen—Results of an RCT
Authors: HERMANNS NORBERT , EHRMANN DOMINIC , ROOS TIMM , FINKE-GROENE KATHARINA , KULZER BERNHARD 
Published: June 2023

A multicenter RCT analyzed the efficacy of a basal insulin titration app (myDose Coach; MDC) in people with type 2 diabetes and newly initiated or existing basal insulin treatment. We randomized 251 participants in a 1:1 ratio to either the intervention arm (insulin titration with MDC) or the control arm (insulin titration without App). The primary outcome was A1c reduction after 3-month. Baseline data (median age 60.0 years IQR 56.0 - 66.5; HbA1c 8.2 IQR 7.7 - 9.1%) showed no significant differences. After a median follow-up of 91.0 days, the intervention group showed a reduction in HbA1c of 0.93, IQR 0.40 - 1.57 percentage points compared to the control group (0.6; IQR 0.10 -1.40); adjusted difference between groups 0.35; 95% CI 0.35 0.01 - 0.69; p=0.0064. Improvements in follow-up A1c were evident across the range of A1c values (Figure 1). The respective differences between groups in glucose level (19.3; 95% CI 9.10 - 29.97 mg/dl; p=0.0012), fasting glucose (10.5; 95% CI 1.5 - 19. 0 mg/dl) and % &lt; 180 mg/dl (12.2; 95% CI 3.8 - 20.5; p=0.0065) all favored the intervention group, while % &lt; 70 mg/dl (−0.2; 95% CI −1.0 - 0.6; p=0.8778) did not differ substantially. Titration of basal insulin with the MDC app significantly improved glycemic management, without increasing exposure to low glucose values substantially. Thus, titration with the MDC app has a medical benefit beyond usual care.

Disclosure
N.Hermanns: Advisory Panel; Insulet Corporation, Research Support; Sanofi-Aventis Deutschland GmbH, Roche Diagnostics, Becton, Dickinson and Company, Speaker's Bureau; Dexcom, Inc., Berlin-Chemie AG. D.Ehrmann: Advisory Panel; Roche Diabetes Care, mySugr, Dexcom, Inc., Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. T.Roos: None. K.Finke-groene: None. B.Kulzer: Advisory Panel; Berlin-Chemie AG, Abbott Diabetes, Bayer Inc., Dexcom, Inc., Novo Nordisk, Insulet Corporation, embecta, Research Support; Sanofi, Roche Diabetes Care.

Funding
Sanofi
938-P: Dynamic Interference Testing Results with the Dexcom G6 Continuous Glucose Monitoring Device
Authors: PFÜTZNER ANDREAS , JENSCH HENDRICK , SRIKANTHAMOORTHY GEETHAN , KUHL CHRISTIAN , SETFORD STEVEN J. , GRADY MIKE , HOLT ELIZABETH H. , THOMÉ NICOLE 
Published: June 2023

Background: Continuous glucose monitoring (CGM) by means of needle sensors is becoming a standard option to gather the necessary glucose information for treatment of patients with type 1 and type 2 diabetes mellitus. Little is known, however, about the reaction of the glucose oxidase-based sensor technologies to potentially interfering nutritional, endogeneous or pharmaceutical substances. Here we report on results obtained with the Dexcom G6 needle sensor with our in-vitro dynamic intererence testing method.
Method: We used HPLC pump-controlled substance gradients to expose Dexcom G6 needle sensors in a 3D-printed test cartridge to varying concentrations of potentially interfering substances at a fixed glucose concentration of 200 mg/dL. We tested 68 substances in triplicate using YSI Stat 2300 Plus as the glucose reference method. Interference was assumed if a CGM needle sensor showed more than ±10% difference from baseline with a tested substance at the given test concentration.
Results: Interference was seen with the following substances: acetaminophen (&gt;+100% bias from baseline), hydroxyurea (&gt;+100%), uric acid (+33%), mannose (+20%), N-acetyl-cysteine (+18%), gentisic acid (+18%), galactose (+17%), ethyl alcohol (+12%), L-dopa (+11%), dithiothreitol (−18%), L-cysteine (−25%), while no interference was seen with other tested substances. In addition, the needle sensors subsequently ceased to operate when exposed to dithiothreitol, L-cysteine, gentisic acid, and mesalazine (suspected sensor fouling).
Conclusions: Employing our standardized dynamic interference testing protocol, several nutritional and pharmacological substances were identified as influencing the Dexcom G6 signal. If confirmed by clinical trials, such interference will have to be considered when making treatment decisions using Dexcom G6 results in daily routine care.

Disclosure
A.Pfützner: Consultant; Novo Nordisk A/S, Research Support; LifeScan Diabetes Institute, Speaker's Bureau; AstraZeneca, Stock/Shareholder; Lifecare A/S, Diakard. H.Jensch: None. G.Srikanthamoorthy: None. C.Kuhl: None. S.J.Setford: Employee; LifeScan Scotland Ltd. M.Grady: Employee; Lifescan. E.H.Holt: Employee; LifeScan Inc. N.Thomé: None.

Funding
European Union’s Horizon 2020 Research and Innovation Program (951933); LifeScan Global Corporation