bluuebunny/crossref_metadata_2025_split huggingface dataset:
1053-P: Dasiglucagon Hypopal Autoinjector as a Fast and Effective Treatment for Severe Hypoglycemia: Results of a Phase 3 Trial
Authors: BAILEY TIMOTHY S. , WILLARD JULIE , KLAFF LESLIE J. , LIST LENA S. , MELGAARD ANITA E. , TEHRANCHI RAMIN 
Published: June 2020

Severe hypoglycemia is a major concern for patients with diabetes on insulin therapy. Rescue requires caregivers to provide effective treatment, including glucagon injections. Dasiglucagon is a stable glucagon analog in development to be administered with the HypoPal® auto-injector for treatment of severe hypoglycemia. This phase 3 trial, ZP4207-17145, assessed the clinical efficacy and safety of 0.6 mg dasiglucagon subcutaneous (SC) administered via the HypoPal® auto-injector compared with placebo. In total, 45 eligible patients with T1D were randomized (3:1) to dasiglucagon or placebo and dosed following induced hypoglycemia. The primary endpoint was time to plasma glucose (PG) recovery, defined as first PG increase ≥20 mg/dL after treatment initiation without rescue glucose. Dasiglucagon injection provided a fast and effective increase in PG. The median time (95% CI) to recovery based on sampling time was 10 (8.0, 12.0) min for dasiglucagon and 35 (20.0, -) min for placebo (p&lt;0.0001). The median (95% CI) estimated true time to recovery (interpolated between sampling times) was 9.3 (7.8, 10.3) min for dasiglucagon and 25.8 (19.2, 34.8) min for placebo. Nausea and vomiting are well-known side effects of glucagon and were reported in 61.8% and 29.8% of patients receiving dasiglucagon, respectively. Nausea was reported in 10% of patients receiving placebo. No safety concerns were raised for dasiglucagon.
In conclusion, dasiglucagon 0.6mg SC administered via the HypoPal® auto-injector provided fast and effective recovery from hypoglycemia. The results are consistent with previously reported results from a pivotal phase 3 trial testing dasiglucagon administered via a pre-filled syringe, NCT03378635, where a median time to recovery of 10 min was also observed.

Disclosure
T.S. Bailey: Consultant; Self; Abbott, LifeScan, Inc., Novo Nordisk A/S, Sanofi US. Research Support; Self; Abbott, Ascensia Diabetes Care, Capillary Biomedical, Inc., Dance Biopharm Holdings, Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Kowa Pharmaceuticals America, Inc., Lexicon Pharmaceuticals, Inc., Medtronic, Medtrum, Novo Nordisk A/S, REMD Biotherapeutics, Sanofi-Aventis, Senseonics, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S. Speaker’s Bureau; Self; Medtronic, Sanofi US. J. Willard: None. L.J. Klaff: Research Support; Self; Abbott, Ascensia Diabetes Care, Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, REMD Biotherapeutics, Roche Diabetes Care, Sanofi-Aventis, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. L.S. List: Employee; Spouse/Partner; Novo Nordisk A/S. Employee; Self; Zealand Pharma A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S, Zealand Pharma A/S. A.E. Melgaard: Employee; Self; Zealand Pharma A/S. R. Tehranchi: Employee; Self; Zealand Pharma A/S.
1070-P: Bromocriptine-QR (BQR) Ameliorates a Pro-oxidative Stress/Proinflammatory (POS/PI) Monocyte Phenotype in Poorly Controlled T2DM Subjects
Authors: EZROKHI MICHAEL , CINCOTTA ANTHONY , CERSOSIMO EUGENIO , ADAMS JOHN M. , ALATRACH MARIAM , AGYIN CHRISTINA , TRIPLITT CURTIS L. , COMINOS NICHOLAS , DEFRONZO RALPH A. 
Published: June 2020

Background: Elevated sympathetic tone stimulates a POS/PI leucocyte phenotype that promotes cardiovascular disease (CVD) and augments postprandial hyperglycemia in T2D. BQR, a sympatholytic dopamine agonist for treatment of T2DM, improves postprandial dysglycemia and reduces CVD events.
Aim: To examine the effect of BQR on POS/PI phenotype of blood monocytes in T2DM.
Study Design: 15 T2DM subjects treated with a GLP-1 RA received BQR (3.2 mg/day) for 16 weeks. Endothelial function was measured by post-occlusion hyperemia. Blood monocytes were isolated and expression (PCR) of the following genes was quantitated: (i) master antioxidant gene regulators that increase in response to systemic oxidative stress (OS) (oxidation resistance gene 1 [OXR1] and nuclear factor erythroid 2 like 2 [NRF2]); (ii) genes known to induce a proinflammatory profile in T2DM (toll like receptor 2 [TLR2], nuclear factor kappa B p65 [NFkBp65], and L-selectin, a surface adhesion protein that stimulates transendothelial migration and PI biochemistry); (iii) glucocorticoid receptor [GCR] that produces a PI environment.
Results: BQR significantly improved HbA1c (-0.6%; baseline HbA1c=8.3%), postprandial hyperglycemia (by 22%) and endothelial dysfunction (by 36%). BQR reduced OS response gene transcript levels of OXR1 and NRF2 by 30% (P&lt;0.03) and of PI genes TLR2, NFkBp65, GCR, and L-selectin by 40, 33, 26, and 32% respectively (P&lt;0.05). Plasma levels of OS markers (TBARS and nitrotyrosine) and PI cytokines (MCP1 and IL-18) also were significantly reduced (p&lt;0.01-0.05) by BQR.
Conclusion: BQR reduces postprandial dysglycemia, improves endothelial function, and improves multiple aspects of the POS/PI state in T2DM, providing a potential mechanism for BQR’s cardiovascular protective effect.

Disclosure
M. Ezrokhi: Employee; Self; VeroScience LLC. A. Cincotta: Employee; Self; VeroScience LLC. E. Cersosimo: None. J.M. Adams: None. M. Alatrach: None. C. Agyin: None. C.L. Triplitt: Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Xeris Pharmaceuticals, Inc. N. Cominos: Employee; Self; VeroScience LLC. R.A. DeFronzo: None.
1076-P: A 12-Week Treatment with Ciclosporin A Improves Insulin Secretion in Patients with Adult-Onset Autoimmune Diabetes: An Open-Label, Single-Arm, Pilot Study
Authors: ZHANG LEI , MENG WEI , CHEN SHUFANG , YANG YUXIU , WANG JUN , DONG YANHU 
Published: June 2020

Objectives: Adult-onset autoimmune diabetes, defined as having latent autoimmune diabetes in adults (LADA), is characterized by a less intensive autoimmune process, in which a lymphocytic infiltration of the exocrine pancreas is involved. immunosuppressive agents may have potential therapeutic benefit. This is a pilot study examining the therapeutic effects of ciclosporin A on insulin secretion in patients with LADA.
Methods: The study was an open label, single arm, pilot trial. A total of 18 patients (12 men and 6 women with mean age of 40.6 yrs old) diagnosed with LADA were prospectively evaluated. All patients underwent insulin treatment at least for 3 months without any oral anti-hyperglycemic agent. All patients were prescribed ciclosporin A (50mg/day) for 12 weeks. Serum C-peptide concentrations were measured at baseline and 3 months after ciclosporin A intervention. We also evaluated total bilirubin (TBIL), direct bilirubin (DBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine (Cre) before and after ciclosporin A treatment. The primary outcome of the study was the change in serum C-peptide concentrations.
Results: A total of 17 patients completed the study. One patient was withdrawn at day 32 due to discontinuation of medication. Serum fasting C-peptide concentrations significantly increased from 0.12 ng/ml up to 0.32 ng/ml (P&lt;0.001). After 12-week ciclosporin A intervention, there was no significant difference on TBIL (14.65 vs. 12.83umol/L, P&gt;0.05), DBIL (4.70 vs. 4.65 umol/L, P&gt;0.05), AST (17.41 vs. 17.82 U/L, p&gt;0.05), ALT (18.19 vs. 18.08 U/L, p&gt;0.05), or Cre (67.40 vs. 67.53 umol/L, P&gt;0.05) compared with the corresponding baseline levels.
Conclusions: This pilot study demonstrates the potential therapeutic effects of oral administration of ciclosporin A for patients with LADA. Larger, controlled studies are needed to verify the findings.

Disclosure
L. Zhang: None. W. Meng: None. S. Chen: None. Y. Yang: None. J. Wang: None. Y. Dong: None.
108-OR: Application of a European Genetic Risk Score for Type 1 Diabetes in a Han-Chinese Population
Authors: WAN RAYMOND , SHARP SETH A. , TAM CLAUDIA H.T. , WEEDON MICHAEL N. , CHAN JULIANA C. , HAGOPIAN WILLIAM , ORAM RICHARD A. , MA RONALD C. 
Published: June 2020

Increasing childhood obesity and young-onset diabetes have made clinically distinguishing between type 1 diabetes (T1D) and type 2 diabetes (T2D) more difficult. A Genetic risk score (GRS) for T1D was developed in European populations, with good discrimination of diabetes type. Here, we aim to evaluate T1D-GRS in a Han-Chinese cohort. We utilized whole genome genotyping data for 533 nondiabetic controls, 182 patients with T1D, and 6,209 patients with T2D. We computed the T1D-GRS for each subject using 30 T1D associated SNPs. The mean ages of the controls, T1D, and T2D subjects were 47±11, 32±15, and 57±13 years, respectively. Violin plots of the GRS for the 3 groups are shown in the Figure, along with p-values. The mean GRS across the controls, T1D, and T2D were 0.242, 0.256, and 0.242, respectively. The area under the curve (AUC) for GRS in T1D vs. T2D was 0.677 (95% CI: 0.635-0.718), and 0.678 (95% CI: 0.631-0.725) for T1D patients vs. controls. We conclude that T1D-GRS detects significant differences in T1D genetic risk between T1D and non-T1D in a Han-Chinese population, with subjects with T1D having a higher score. Further refinement incorporating single nucleotide polymorphisms (SNPs) specific for a Han-Chinese population is currently underway, and is expected to further improve classification of T1D in Han-Chinese.

Disclosure
R. Wan: None. S.A. Sharp: None. C.H.T. Tam: None. M.N. Weedon: None. J.C. Chan: None. W. Hagopian: Consultant; Self; Novo Nordisk Inc. R.A. Oram: None. R.C. Ma: Advisory Panel; Self; AstraZeneca. Stock/Shareholder; Self; GemVCare. Other Relationship; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Merck & Co., Inc., Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis, Tricida Inc.

Funding
Research Grants Council (T12-402/13N); Research Impact Fund (CUR4012-18)
1083-P: Bromocriptine-QR (BQR) Reduces Hypertriglyceridemia (HTG) in Hypertensive Type 2 Diabetes (T2D) Subjects
Authors: CHAMARTHI BINDU , EZROKHI MICHAEL , CINCOTTA ANTHONY H. 
Published: June 2020

Chronically elevated sympathetic nervous system (SNS) activity increases hepatic triglyceride (TG) synthesis and secretion and adipose free fatty acid mobilization leading to further hepatic TG synthesis and HTG. HTG often occurs in the presence of hypertension and this can be a biomarker of chronically elevated SNS activity. BQR, a dopamine agonist, is the only sympatholytic antidiabetes agent approved for T2D. Preclinical studies have repeatedly demonstrated that circadian-timed bromocriptine therapy ameliorates HTG. This study evaluated if circadian-timed BQR (1.6-4.8 mg/day) reduces HTG in a population of hypertensive HTG T2D subjects. Hypertensive HTG T2D subjects from the Cycloset Safety Trial (HbA1c ≥ 7.0) treated at baseline with diet +/- any one or two antidiabetes agents of sulfonylurea, metformin, thiazolidinedione or insulin (N = 378) and randomized to BQR or placebo for 24 weeks were analyzed for between group difference in change from baseline fasting plasma TG level. After 24 weeks of therapy, BQR significantly reduced fasting TG levels by between 34 to 219 mg/dl (13 to 36%) and HbA1c from -0.4 to -1.2 as the baseline fasting TG level rose from ≥ 150 to ≥ 400 mg/dl (Figure). These TG effects were even more pronounced in such subjects with elevated resting heart rate. Circadian-timed BQR reduces hypertriglyceridemia in T2D and this effect increases with increasing fasting TG level.

Disclosure
B. Chamarthi: Employee; Self; VeroScience LLC. M. Ezrokhi: Employee; Self; VeroScience LLC. A.H. Cincotta: Employee; Self; VeroScience LLC.
1091-P: PK/PD of Glucagon and the Novel Glucagon Analog Dasiglucagon in Aqueous or Nonaqueous Formulations following SC Administration in Rats
Authors: WENANDER CAROLA , VALEUR ANDERS H. , ELANDER MIKAEL 
Published: June 2020

Endogenous peptide hormones, such as glucagon used for treatment of severe hypoglycemia events in patients with diabetes, are commonly unstable in aqueous solution making development of ready-to-use injection solutions a challenge. Analogs of endogenous peptide hormones can be designed to increase the stability of the molecules. Another approach to enable easy administration of unstable peptides is to formulate them in non-aqueous formulations, such as DMSO (dimethyl sulfoxide).
The current study was conducted to compare the PK/PD of glucagon following SC administration in rats when formulated in DMSO or an aqueous formulation (Phosphate buffered solution (PBS)). The PD data were compared to data generated for the stable glucagon analog dasiglucagon in rats.
Four to six male Sprague-Dawley rats received 3 nmol/kg of glucagon in DMSO or in a PBS formulation or dasiglucagon at 2 nmol/kg in a PBS formulation. Blood samples for bioanalysis (glucagon groups only) and blood glucose measurement were taken at pre-dose (0) and 15, 30, 45, 60, 75, 90, 105 and 120 min post dose.
Glucagon in PBS demonstrated a faster absorption, a higher Cmax (98.3 versus 39.9 pmol/L) and faster Tmax (15 versus 45 minutes) compared to glucagon in DMSO. The increase in blood glucose was similar for glucagon and dasiglucagon in PBS and faster compared to glucagon in DMSO.

Disclosure
C. Wenander: Employee; Self; Zealand Pharma A/S. A.H. Valeur: Employee; Self; Zealand Pharma A/S. M. Elander: Employee; Self; Zealand Pharma A/S.
1111-P: Real-World Evidence of SGLT2 Inhibitor (SGLT2i) Use among Adults in the T1D Exchange Registry (T1DX)
Authors: HUGHES MICHAEL S. , BAILEY RYAN , CALHOUN PETER , LYONS SARAH , DESALVO DANIEL , SHAH VIRAL N. 
Published: June 2020

Little is known about SGLT2i use in T1D outside a clinical trial setting. This cross-sectional analyses compares characteristics among T1DX registry participants using SGLT2i off-label compared with those not using SGLT2i and assess glycemic outcomes pre-post SGLT2i initiation. The analysis cohort included 204 SGLT2i users and 7124 non-users (n=7,328) in the T1DX registry aged ≥18 yrs with T1D for ≥1 yr. Demographic and clinical characteristics were compared between SGLT2i users and non-users. To assess the effect of SGLT2i use on glycemic outcomes, A1c pre and post-SGLTi initiation was compared. Of 7,328 participants analyzed, 2.8% reported using SGLT2i. Use of canagliflozin, dapagliflozin, and empagliflozin was reported by 50%, 27%, and 27% of SLGT2i users. SGLT2i use was associated with older age, longer T1D duration, higher BMI, and higher socioeconomic status. Glycemic outcomes for the cross-sectional comparison are shown in the Table. There was little difference in mean A1c pre- and post-SGLT2i initiation (8.1±1.0% vs. 8.0±1.1%, P=0.25), but % with A1c &lt;7% nearly doubled (10% vs. 18%, P=0.02). Less than 3% of adults in the T1DX reported SGLT2i use and glycemic benefits were unclear. SGLT2i users reported similar incidence of DKA to non-users, but higher SH rates. While observational data must be interpreted with caution, these findings suggest a need for prospective evaluation of SGLT2i use in T1D.

Disclosure
M.S. Hughes: None. R. Bailey: None. P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. S. Lyons: Other Relationship; Self; Springer Publishing Company. D. DeSalvo: Consultant; Self; Dexcom, Inc., Insulet Corporation. V.N. Shah: Research Support; Self; Dexcom, Inc., JDRF, Mylan, Novo Nordisk A/S, Sanofi, vTv Therapeutics. Other Relationship; Self; Dexcom, Inc., Sanofi US.

Funding
The Leona M. and Harry B. Helmsley Charitable Trust (G-2016PG-T1D053)
1126-P: Randomized Controlled Trial of Ipragliflozin or Sitagliptin Combined with Metformin in Type 2 Diabetes: NISM Study
Authors: KITAZAWA MASARU , KATAGIRI TAKASHI , SUZUKI HIROMI , MATSUNAGA SATOSHI , YAMADA MAYUKO H. , IKARASHI TOMOO , YAMAMOTO MASAHIKO , FURUKAWA KAZUO , IWANAGA MIDORI , HATTA MARIKO , FUJIHARA KAZUYA , YAMADA TAKAHO , TANAKA SHIRO , SONE HIROHITO 
Published: June 2020

DPP-4i do not increase weight and SGLT2i are expected to reduce weight; thus, are widely used in daily practice. SGLT2i are recommended as second-line drugs after metformin (Met) in those at high risk of atherosclerotic cardiovascular disease (ASCVD), but suitable second-line drugs for the majority of patients not at high risk are not yet determined. Furthermore, reports of appropriate second-line drugs in East Asians who have a lower risk of ASCVD than Europeans are scarce. We compared the effects of ipraglifrozin (Ipra) and sitagliptin (Sita) after Japanese patients with type 2 diabetes had been taking Met and were without prior ASCVD in a 52-week randomized open-label trial (jRCTs031180205). The primary endpoint (PE) was a HbA1c reduction of ≥0.5% with no weight gain at 52 weeks. Among 111 patients (mean age 59.2 y, mean BMI 26.6 kg/m2, and male 61.3%), 54 and 57 patients received Ipra and Sita, respectively. After 52 weeks, achievement of the PE was statistically the same (37.0% and 40.3%, p=0.72), as was the HbA1c reduction ≥0.5% (38.9% and 54.4%, p=0.13). Lack of weight gain was higher for Ipra than Sita (94.4% and 54.4%, p&lt;0.01). BMI, C-peptide and HDL-C improved with Ipra vs. Sita (p&lt;0.05). Withdrawal for any adverse event occurred in 8 with Ipra and 4 with Sita (14.8% and 7.0%, p=0.23).Although glycemic control did not differ between Ipra and Sita, some ASCVD risk factors improved with Ipra.

Disclosure
M. Kitazawa: None. T. Katagiri: None. H. Suzuki: None. S. Matsunaga: None. M.H. Yamada: None. T. Ikarashi: None. M. Yamamoto: None. K. Furukawa: None. M. Iwanaga: None. M. Hatta: None. K. Fujihara: None. T. Yamada: None. S. Tanaka: None. H. Sone: Research Support; Self; Kyowa Hakko Kirin Co., Ltd., Novartis AG, Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co.

Funding
Astellas Pharma Inc.
1139-P: Remogliflozin (SGLT2 Inhibitor) Significantly Reduces Albuminuria and Delays the Progression of Nephropathy in Type 2 Diabetes Mellitus Patients
Authors: GUPTA VISHAL K. 
Published: June 2020

Remogliflozin is a novel SGLT2 inhibitor approved and available in India for the treatment of type 2 diabetes mellitus patients. This study was designed to determine the effect of Remogliflozin on diabetic nephropathy patients compared with placebo on the reduction of the albuminuria. We conducted a 24 week, double-blind, randomized, parallel-group study with 94 type 2 diabetics subjects with diabetic nephropathy (micro albuminuria range from 30 to 300) and HbA1c of 7.5 - 9.3%. Subjects were randomized to Remogliflozin (100 mg bid) and placebo with 1000 mg metformin OD. The primary end point was change in HbA1C from baseline, with secondary end points including change in fasting plasma glucose (FPG), body weight, and change in albuminuria. Safety and tolerability were also characterized. Result: As shown in Table in image.
Conclusion: Result of our study revealed that Remogliflozin significantly reduced albuminuria (p value &lt;0.001) in type 2 diabetes mellitus patients with delay in progression of diabetic nephropathy as compared to placebo.

Disclosure
V.K. Gupta: None.
116-OR: Comparison of Pancreas vs. Islet Transplantation Outcomes from a Large Single Center
Authors: MARFIL-GARZA BRAULIO A. , LAM ANNA , BIGAM DAVID , SENIOR PETER , SHAPIRO A.M. JAMES 
Published: June 2020

Background: Pancreas and islet transplantation can achieve optimal glycemic control in patients type 1 diabetes (T1DM) and persistent problematic hypoglycemia. We describe our experience with these two therapies over a 20-yr period.
Methods: Patients with T1DM undergoing pancreas (PT) or islet (IT) allotransplantation from January 1st 1999 to May 1st 2019 were included. Univariate analyses were done using X2 tests and Student’s t tests for categorical and continuous variables, respectively.
Results: We include 413 patients with a mean duration of T1DM of 30.6 yr (SD 10.8), 272 (65.9%) underwent IT and 141 (34.1%) PT. Mean follow-up was 7.4 yr (SD 5.2). More female patients (55.9% vs. 34.0%, p&lt;0.001), and an older age at transplant were observed in the IT group (48.4 yr vs. 41.0 yr, p&lt;0.001) compared to PT. Baseline mean glycated hemoglobin (HbA1c) was 8.4% (SD 1.2) which decreased to 6.6 (SD 0.8) and 5.6 (SD 0.7) in the IT and PT groups over the following 3 months after transplant, respectively. HbA1c remained lower as compared to baseline values up to 15 yr after transplant in both groups (7.3 [SD 1.4) in IT and 6.1 [SD 0.8) in PT, p=0.01 for both). Insulin independence rates were lower in the IT group vs. the PT group (77.2% vs. 95.0%, p&lt;0.001), as well as the percentage of follow-up time off-insulin (46.6% [SD 31.2] vs. 92.3% [SD 18.5], p&lt;0.001). However, the mean number of hospital admissions was lower in IT patients (1.2 [SD 0.7] vs. 1.7 [SD 1.2], p=0.009), similarly to 1-yr mortality rates (0.0% vs. 3.6%, p=0.002); mortality rates were equivalent thereafter.
Discussion: PT provides better glycemic control than IT. However, caveats including higher early mortality rates and greater long-term morbidity should be thoroughly discussed with patients. This study provides robust information to guide evidence-informed practice and establish more realistic expectations for both physicians and patients involved the care of IT and PT patients.

Disclosure
B.A. Marfil-Garza: None. A. Lam: None. D. Bigam: None. P. Senior: Research Support; Self; Allergan, Novo Nordisk. A. Shapiro: Consultant; Self; Viacyte, Inc.
117-OR: Islet Cell Transplantation for Type 1 Diabetes: The UIC Experience, 2004-2020
Authors: DANIELSON KIRSTIE K. , MONSON REBECCA S. , LI YI , OBERHOLZER JOSE 
Published: June 2020

Allogeneic islet cell transplantation (ICT) can be an effective therapy for many patients with brittle type 1 diabetes, as it may reestablish hypoglycemic awareness and better attain optimal glycemic control. The ICT program at the University of Illinois at Chicago (UIC) began in 2004 and we herein present the summary of all patients’ outcomes to date. The 43 patients receiving ICT at UIC include 10 patients in the phase1/2 trial, 20 patients in the phase 3 trial, 10 patients in the Clinical Islet Transplant Consortium trials (CIT-02, n=2; CIT-06, n=4; CIT-07, n=4), and 3 University of Chicago patients transplanted with islets manufactured at UIC. Overall, the sample had a mean baseline age of 46.7 years, BMI 23.4, HbA1c 7.4%, and insulin dose 0.48 units/kg/day, and 74.4% were female, and 95.3% Non-Hispanic white. Single ICTs were performed in n=18, two ICTs in n=18, and three ICTs in n=7. Thirty seven completed 1-year follow-up after last ICT. The following results at 1-year post-last ICT are presented respectively for the phase 1/2 trial (21 ICTs), phase 3 trial (35 ICTs), and supplemental group (CIT and University of Chicago; 19 ICTs). The primary outcome of attaining both an HbA1c ≤6.5%, and no severe hypoglycemic episodes (SHEs) between 1-month and 1-year post-last ICT, was achieved in: 90%, 50%, and 54%. Insulin independence was attained in: 80%, 60%, and 54%. Graft failure occurred in: 0%, 25%, and 39%. In the two UIC trials combined, HbA1c decreased from 7.4% at baseline to 6.0%; and SHEs decreased from 1.0/month at baseline to 0.1/month. At 5-years post-last ICT in the two UIC trials, 11 of 15 (73.3%) still met the criteria for a successful primary outcome. In terms of safety, the frequency of serious adverse events across the three groups, respectively, were: 50%, 50%, and 54%. Despite the documented risks of ICT for type 1 diabetes primarily due to the chronic use of immunosuppression, many patients may potentially benefit in terms of eliminating SHEs and optimizing glycemic control.

Disclosure
K.K. Danielson: None. Y. Li: None. J. Oberholzer: Research Support; Self; JDRF. Stock/Shareholder; Self; Sigilon Therapeutics. Other Relationship; Self; CellTrans Inc., Sigilon Therapeutics.

Funding
American Diabetes Association (1-16-ICTS-022 to K.K.D.); National Institutes of Health (U42RR023245, UL1RR029879, UC4DK114839, U01DK070431, R01DK091526)