bluuebunny/crossref_metadata_2025 huggingface dataset:
871-P: Study of Glucagon Response and Its Association with Glycemic Control and Ketogenesis after Administration of Ipragliflozin as an Adjunctive Treatment in Patients with Type 1 Diabetes (Suglat-AID)—A Multicenter, Open-Label, Prospective Exploratory Trial
Authors: NAKAMURA YUTA , HORIE ICHIRO , ABIRU NORIO , KITAMURA TADAHIRO , KUSUNOKI YOSHIKI , NISHIDA KENRO , YAMAMOTO AKANE , HIROTA YUSHI , FUKUI TOMOYASU , MAEDA YASUTAKA , MINAMI MASAE , MATSUI TAKANORI , KAWAKAMI ATSUSHI
Published: June 2023

Objective: SGLT2 inhibitors including ipragliflozin have been used as adjunctive to insulin therapy for the treatment of type 1 diabetes (T1D) in Japan. Previous studies showed glucagon levels increased after initiating SGLT2 inhibitors, however, the effects of increased glucagon on glycemic control and ketogenesis in T1D remains unclear.

Methods: Twenty-five patients with T1D with HbA1c >7.5% were administered ipragliflozin 50 mg as an add-on to insulin therapy. The patients underwent a mixed-meal tolerance test (MMTT) twice before (1st-MMTT) and 12 weeks after administration of ipragliflozin (2nd-MMTT) to evaluate glucagon responses and its associations with glycemic parameters including CGM data.

Results: The values of area under the curve from fasting to 120 min (AUC0-120min, pg/mL) of plasma glucagon in 2nd-MMTT were significantly increased than 1st-MMTT (75±37 vs. 66±37, p=0.044), but fasting glucagon levels were not changed. The levels of fasting β-OHBA and AUC0-120min of β-OHBA were significantly elevated in 2nd-MMTT compared to 1st-MMTT, but there were no correlations between glucagon and β-OHBA levels. In CGM analyses, the values of glycemic variability (SD, CV% and MAGE) significantly ameliorated and the percentage of time in range (70-180 mg/dL) significantly increased from baseline to 12 weeks (46±14% vs. 54±20%, p=0.005) without an increase of the time below range (TBR, <70 mg/dL). A negative correlation between TBR% and fasting glucagon levels (r=-0.45, p=0.048) was found at 12 weeks but not at baseline. No severe adverse events including ketoacidosis developed in the participants during the study.

Conclusion: Adjunctive treatment of ipragliflozin was found to increase postprandial glucagon secretion and might contribute to prevention of hypoglycemia via mitigating glycemic variability in T1D.

Disclosure

Y.Nakamura: Research Support; Astellas Pharma Inc. Y.Maeda: None. M.Minami: None. T.Matsui: None. A.Kawakami: Research Support; Astellas Pharma Inc. I.Horie: Research Support; Astellas Pharma Inc. N.Abiru: None. T.Kitamura: None. Y.Kusunoki: None. K.Nishida: None. A.Yamamoto: None. Y.Hirota: Other Relationship; Lilly, Sanofi K.K., Terumo Corporation, Sumitomo Dainippon Pharma Co., Ltd., Research Support; Sumitomo Dainippon Pharma Co., Ltd. T.Fukui: None.

Funding

Astellas Pharma Inc.
873-P: Empagliflozin Compliance and Influencing Factors in Patients with Heart Failure and Diabetes
Authors: ALVAREZ CARLOS A. , PERKINS AARON , SIGLER MEREDITH A. , YANG HUI , CABERWAL HARJEET , EBRAHIMI RAMIN
Published: June 2023

Treatment paradigms for patients with type 2 diabetes mellitus (DM) and heart failure (HF) has changed. Sodium glucose cotransporter 2 inhibitors, such as empagliflozin, are now considered potential first line therapies. Compliance to empagliflozin and the factors that may influence compliance are unknown. Methods: We assessed compliance and associated factors in patients with DM and HF from Veterans Affairs national data from 2015-22. Compliance was calculated using proportion of days covered (PDC). Compliance to empagliflozin was defined as PDC > 80%. Patients who compliance could not be calculated were excluded. Generalized linear models were constructed to evaluate 1) demographic, 2) patient level, and 3) system level data.

Results: Total 28,581 patients exposed to empagliflozin were included. Proportion of empagliflozin compliance was 66.2%. Table 1 displays the significant demographic, patient, and system level factors associated with poor empagliflozin compliance.

Conclusions: There were demographic, patient, and system level factors that were associated with poor empagliflozin compliance.

Disclosure

C.A.Alvarez: Research Support; Boehringer Ingelheim Inc. A.Perkins: None. M.A.Sigler: None. H.Yang: None. H.Caberwal: Employee; Boehringer Ingelheim Inc. R.Ebrahimi: Consultant; Pfizer Inc., Speaker's Bureau; Novo Nordisk.

Funding

Boehringer Ingelheim
875-P: Association of Continued Sodium–Glucose Cotransporter-2 Inhibitors from the Ambulatory to Inpatient Setting with In-Hospital Outcomes in Patients with Diabetes Mellitus—A Nationwide Study
Authors: SINGH LAKSHMI G. , NTELIS SPYRIDON , SIDDIQUI TARIQ , SELIGER STEPHEN L. , SORKIN JOHN D. , (ELIAS) SPANAKIS ILIAS
Published: June 2023

Objective: Limited data are available on continuation of outpatient sodium glucose co-transporter-2 inhibitors (SGLT2i) during hospitalization.

Design: Nationwide study of admissions of veterans with diabetes where SGLT2i was continued (CONT) in the hospital (N=5,943) compared to those where it was discontinued (DC) (N=30,634). Primary outcome was in-hospital mortality. Secondary outcomes were acute kidney injury (AKI), intensive care unit (ICU) transfer and length of stay (LOS). Propensity-weighted Poisson regression analyses adjusted for age, sex, race, BMI, Elixhauser comorbidity index were performed.

Results: Mean (SE) age was 67.2 (0.1) and 67.5 (0.1) years (p=0.03), male 97.0% and 96.6% (p=0.1), white 71.3% and 72.1%, black 20.8% and 20.5% (p=0.52) in CONT vs. DC groups, respectively. After covariate adjustment, CONT had 44% lower mortality rate (IRR 0.56, 95% CI 0.43, 0.74, p=0.0001), no difference in AKI (IRR 0.95, 95% CI 0.89, 1.01, p=0.12), and 41% lower rate of ICU transfer (IRR 0.59, 95% CI 0.53, 0.65, p<0.0001). LOS was 4.5 vs. 4.9 days (IRR 0.93, 95% CI 0.91, 0.95, p<0.0001), in the CONT vs. DC. Similar trends observed after adjusting for additional models.

Conclusion: Continued SGLT2i during hospitalization was associated with lower mortality and ICU transfer, no increased AKI, and shorter LOS.

Disclosure

L.G.Singh: None. S.Ntelis: None. T.Siddiqui: None. S.L.Seliger: Other Relationship; Tricida, Inc., Research Support; Reata Pharmaceuticals, Inc., Palladio Bioscences, Roche Diagnostics. J.D.Sorkin: None. I.Spanakis: Research Support; Dexcom, Inc.
889-P: Effectiveness of Dapagliflozin as Add-on to Metformin Alone or Metformin with Other Oral Antidiabetic Drug Classes in Type 2 Diabetes Mellitus—A Multicentre, Retrospective, Real-World Evidence Study
Authors: SETHI BIPIN , SAHAY RAKESH K. , TIWASKAR MANGESH H. , DHEDIYA RAJNISH , GAURAV KUMAR , RATHOD RAHUL T. , KOTAK BHAVESH P. , DHANAKI GAURI D. , SHAH SNEHAL
Published: June 2023

Background: Present real-world study evaluated the effectiveness of dapagliflozin as an add-on modality, in adult patients with T2DM.

Method: We conducted an EMR-based retrospective, multicentre study in adult T2DM patients inadequately controlled on existing antidiabetic therapy and receiving dapagliflozin as add-on therapy. Baseline characteristics (visit 1) and treatment-related outcomes (visit 2 considered between 60 days-140 days after adding dapagliflozin) which included HbA1C, BMI, SBP & DBP were analyzed.

Results: 3616 patients were included from 478 centres, of which 55.7% were males. Mean age was 51 years (range: 40-64 years). Most patients had received dapagliflozin + metformin + at least one other OAD [D+M+OAD, n=2907 (80.4%), 408 followed-up], while 709 patients (19.6%, 138 followed-up) received dapagliflozin + metformin (D+M). For D+M group, significant mean change was noted for all parameters at follow-up except SBP and DBP (non-significant reductions for HbA1c ≥ 8% subgroup). For D+M+OAD group, significant change was noted for all parameters at follow-up except BMI (non-significant reduction). (Table 1)

Conclusion: Dapagliflozin showed significant improvement in glycemic parameter, BMI and BP when added to metformin, with or without other OADs in real-world.

Disclosure

B.Sethi: None. R.K.Sahay: Advisory Panel; Torrent Pharmaceuticals Ltd, Speaker's Bureau; Novo Nordisk A/S, USV Private Limited, Intas Pharmaceuticals Ltd., Eris Lifesciences Ltd. M.H.Tiwaskar: None. R.Dhediya: None. K.Gaurav: None. R.T.Rathod: None. B.P.Kotak: Employee; Dr. Reddy's Laboratories Ltd. G.D.Dhanaki: None. S.Shah: None.

Funding

Dr. Reddy’s Laboratories, Ltd.
892-P: Influence of Preceding Medications on the Renal Outcomes of Japanese Diabetics Treated with SGLT2 Inhibitors and GLP-1 Receptor Agonists
Authors: KOBAYASHI KAZUO , TOYODA MASAO
Published: June 2023

Background/Objective: Evidence of cardiovascular and renal outcomes has already been shown for SGLT2 inhibitors (SGLT2i) and GLP1 receptor agonists (GLP1Ras); therefore, combination therapy with these drugs is of clinical interest. This study aimed to evaluate the effect of the preceding drug for patients with the combination treatment of SGLT2i and GLP1Ra on renal outcomes.

Methods: We retrospectively extracted data of patients with type 2 diabetes mellitus who had received both SGLT2i and GLP1Ra treatment for at least 1-year at 18 medical facilities in Japan. Finally, 341 patients in the GLP1Ra-preceding group and 319 in the SGLT2i-preceding group were analyzed. The renal composite outcome was progression of the albuminuria stage, ≥30% decrease in eGFR, or both. The multiple imputation method for missing values and an inverse probability weighting method using the propensity score were used for the comparison of outcome.

Results: The median observation period and the incidence of the renal composite outcome in the SGLT2i-preceding group and the GLP1Ra-preceding group was 55.1months, 26.9% and 58.7months, 25.6%, respectively, with an odds ratio (OR) [95% confidence interval] of 1.50 [0.89, 2.53] (p=0.13). The ORs for the ≥30% decrease in eGFR and the progression of albuminuria stage were 0.96 [0.47, 2.00] (p=0.93) and 1.76 [0.97, 3.69] (p=0.06), respectively. Compared to the GLP1Ra-preceding group, the annual change in eGFR and change in the logarithmic value of urine albumin-to-creatinine ratio (LnACR) was 0.27mL/min/1.73 m2/year [-0.60, 1.14], and 0.18 [-0.10, 0.43] respectively. LnACR at baseline, pioglitazone use, and baseline mean arterial blood pressure were independent factors for renal composite outcome with ORs [95% CI] of 1.15 [1.01, 1.31], 0.47 [0.23, 0.96], and 1.03 [1.01, 1.05], respectively.

Conclusion: In combination therapy with SGLT2i and GLP1Ra, the difference in the preceding drug did not affect the renal composite outcome.

Disclosure

K.Kobayashi: None. M.Toyoda: None.
893-P: Relation between Combination Therapy with SGLT2 Inhibitors and GLP-1 Receptor Agonists and Renal Functions among Japanese Diabetics
Authors: TOYODA MASAO , KOBAYASHI KAZUO
Published: June 2023

Background/Objective: SGLT2 inhibitors (SGLT2i) and GLP1 receptor agonists (GLP1Ra) have already shown evidence of cardiovascular and renal outcomes; therefore, combination therapy with these drugs is now of interest in clinical practice for the management of type 2 diabetes mellitus (T2DM). However, there are few reports on the effect of combination therapy on renal functions. This study aimed to investigate the effect of combination therapy on renal functions.

Methods: We retrospectively extracted data of patients with T2DM who had received both SGLT2i and GLP1Ra treatment for at least 1-year at 18 medical facilities in Japan. Finally, 341 patients in the GLP1Ra-preceding group and 319 in the SGLT2i-preceding group were analyzed. The multiple imputation method was adopted for missing values, and propensity score (PS) matching with the algorithm of 1:1, neighbor match, and no replacement, was performed for comparison between the two groups.

Result: In each group, 152 patients were matched. On the matched model, mean observational period was 54 months. Regarding the annual change in eGFR (mL/min/m2/year) before and after combination treatment, the SGLT2i-preceding group showed a significant increase from -3.76±10.48 to 0.04±6.29 (p=0.002), whereas the GLP1Ra-preceding group showed no significant change from -2.09±13.44 to -1.97±6.16. The logarithmic value of urine albumin-to-creatinine ratio at the time of the initiation of either drug, at the time of the initiation of combination treatment, and after the combination treatment, were 3.77±1.63, 3.83±2.21, 3.73±1.80 in GLP1Ra-preceding group, and 3.65±20.4, 3.56±1.29, 3.75±0.91 in SGLT2i-preceding group, respectively, and there was no significant difference among two groups. Conclusion: The addition of GLP1Ra to SGLT2i-treated patients significantly improved the annual change in eGFR. The renal benefits by combination therapy with SGLT2i and GLP1Ra may be affected by preceding drug.

Disclosure

M.Toyoda: None. K.Kobayashi: None.
895-P: Effect of Long-Term Empagliflozin Therapy on Plasma Beta-Hydroxy Butyrate (ß-OHB)—Lack of Effect of Concomitant Insulin, GLP-1 Agonist, or Pioglitazone Therapy
Authors: ORTIZ LUIS C. , WORTHAM JOY , PINKSON SHEILA , TREJO JONATHAN , MENDOZA AMIEL S. , CHEN XI , TRIPATHY DEVJIT
Published: June 2023

Sodium-glucose transporter 2 (SGLT2) inhibitors are associated with increased risk of euglycemic diabetic ketoacidosis in T2DM. Possible mechanisms include increased lipolysis, elevated glucagon, and decreased plasma insulin levels. Therefore, concomitant high dose insulin as well as thiazolidinediones could potentially attenuate the rise in β-OHB because of anti-lipolytic effects. However, this has not been examined in the real-world clinical studies. We examined the effect of long-term Empagliflozin therapy on plasma β-OHB in veterans with T2DM. A retrospective chart review was performed in 43 subjects who had fasting β-OHB, C-peptide and detailed anthropometric measurements and were followed for 23 ± 2.5 months. Subjects were categorized into two groups based on fasting β-OHB concentrations (< or ≥2.8mg/dl). Eleven patients (24.4%) had high (6.03 ±1.22mg/dl) while 32 (74.6%) had normal β-OHB (1.42±0.09 mg/dL). There was no difference in age (59 ± 4 vs 62 ±2 yrs), BMI (35±1 vs 32 ±1 kg/m2), or the duration of diabetes (15 ± 3 vs 18±2 yrs) between the two groups. Subjects with higher β-OHB had higher HbA1c (8.9 ±0.7 vs 7.9 ± 0.3%, p<0.05). There was no difference in fasting C-peptide (3.2 ± 0.9 vs 3.5 ± 0.5ng/ml), total daily insulin dose (184± 43 vs 214±19 units/day), number of subjects on Pioglitazone (54 vs 35%) or GLP-1 agonist therapy (36 vs 52%) between the two groups. In conclusion, long-term therapy with Empagliflozin leads to elevated β-OHB in 25% of T2DM and it was associated with poor glycemic control. Concomitant insulin or pioglitazone therapy did not alter plasma β-OHB concentration.

Disclosure

L.C.Ortiz: None. J.Wortham: None. S.Pinkson: None. J.Trejo: None. A.S.Mendoza: None. X.Chen: None. D.Tripathy: None.
896-P: Effectiveness of Newly Prescribed SGLT2 Inhibitors as Second-Line Therapy following DPP-4 Inhibitors or Metformin as First-Line Therapy in Type 2 Diabetes Patients
Authors: TAKAHASHI HIROSHI , SUGANUMA YUKA , OHNO TAKAYUKI , NISHIMURA RIMEI
Published: June 2023

Prescriptions of SGLT2 inhibitors (SGLT2i) for patients with type 2 diabetes (T2DM) are increasing. In this study real-world data were used to evaluate the long-term benefits of SGLT2i as a second-line drug for glycemic control in people with T2DM being treated with DPP-4 inhibitor (DPP4i) or metformin (MET) monotherapy. People with T2DM patients on DPP4i or MET monotherapy were followed for at least 12 months after receiving a new SGLT2i prescription. Patients were divided into DPP4i and MET groups, and patient background factors were controlled for using propensity score matching (PM). Changes in HbA1c and other indexes during the 12 months after the new prescription were compared using t-tests, and the factors affecting changes in HbA1c were examined using multiple regression analysis. After PM, there were 192 patients in the DPP4i (n=96) and MET (n=96) groups, with no significant differences in patient backgrounds. HbA1c levels 12 months after a new SGLT2i prescription were significantly lower in both groups compared to base line (8.1% to 7.0%, p<0.001; 8.1% to 7.1%, p<0.001), but there were no significant differences between the two groups in the change in HbA1c level (p=0.271), body weight (p=0.371), systolic blood pressure (p=0.828), eGFR (p=0.642), and Fib-4 index (p=0.674). The change in HbA1c was greater for those with initially higher HbA1c levels (-0.629 [-0.722-0.536], p<0.001) and those with shorter diabetes histories (0.024 [0.001-0.048], p=0.044), but it was not significantly different between the two groups (p=0.236). After controlling for patient background, there was no significant difference in the long-term effects of a new SGLT2i prescription between those previously receiving either DPP4i or MET monotherapy, but higher previous HbA1c levels and a shorter diabetes history may be prediction of better HbA1c 12 months after a new SGLT2i prescription, regardless of prior medication.

Disclosure

H.Takahashi: Speaker's Bureau; Eli Lilly Japan K.K., Boehringer Ingelheim Japan, Inc., Medtronic, Novo Nordisk. Y.Suganuma: None. T.Ohno: None. R.Nishimura: Speaker's Bureau; Sanofi K.K., Medicure Inc., Boehringer Ingelheim Inc., Takeda Pharmaceutical Company Limited, Kissei Pharmaceutical Co., Ltd., Novartis Pharma K.K., Eli Lilly Japan K.K., Novo Nordisk, Merck & Co., Inc., Abbott Japan Co., Ltd., Astellas Pharma Inc., Teijin Pharma Limited, Taisho Pharmaceutical Holdings Co., Ltd., Ono Pharmaceutical Co., Ltd., AstraZeneca.
898-P: Real-World Glycemic Outcomes of >3,300 Children and Adolescents with Type 1 Diabetes Using the Omnipod 5 Automated Insulin Delivery (AID) System with Cloud-Based Data Management
Authors: SHERR JENNIFER , DESALVO DANIEL , HUYETT LAUREN M. , SNOW KENNETH , MENDEZ JOSE J. , HADJIYIANNI IRENE , LY TRANG T.
Published: June 2023

The Omnipod 5 AID System is a novel tubeless hybrid closed-loop system that allows for personalized therapy through customizable glucose targets from 110-150mg/dL in 10mg/dL increments. The System enables automatic upload of data for all users initiating the system, facilitating unprecedented access to evaluate real-world outcomes. Continuous glucose monitoring (CGM) and insulin data from Omnipod 5 users with type 1 diabetes (T1D) aged <18y in the US with ≥90 days of data available in the cloud-based data management system were included. Data from 3,369 users with sufficient CGM data (≥75% of days with ≥220 readings) and using the lowest target (110mg/dL) for ≥50% of the time, aged <6y (n=182), 6 to 12y (n=2,050), and 13 to 17y (n=1,137) were available at the time of analysis. Users were aged mean±SD 10.9±3.4y with median 146 days of system use. Outcomes are shown in the Table for each age group. Median time in target range (70-180mg/dL) was 74.0%, 70.7%, and 67.1% for each age group, respectively. Time <70mg/dL in each age group was low: median 2.7%, 1.8%, and 1.2%, respectively. These results are the first to demonstrate that in over 3,000 children and adolescents using the Omnipod 5 System in a real-world setting, highly favorable glycemic outcomes are achievable and are similar to those first reported in pivotal trials.

Disclosure

J.Sherr: Advisory Panel; Bigfoot Biomedical, Inc., Insulet Corporation, Medtronic, Vertex Pharmaceuticals Incorporated, Cecelia Health, StartUp Health T1D Moonshot, Consultant; Bigfoot Biomedical, Inc., Insulet Corporation, Medtronic, Lilly, Research Support; Insulet Corporation, Medtronic, NIH - National Institutes of Health, Juvenile Diabetes Research Foundation (JDRF), Speaker's Bureau; Insulet Corporation, Zealand Pharma A/S, Lilly, Medtronic. D.Desalvo: Consultant; Dexcom, Inc., Research Support; Insulet Corporation. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. K.Snow: Employee; Insulet Corporation. J.J.Mendez: None. I.Hadjiyianni: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation, Eli Lilly and Company. T.T.Ly: Employee; Insulet Corporation.

Funding

Insulet Corporation
90-LB: Real-World Effectiveness of an Oral Superabsorbent Hydrogel for Weight Management
Authors: BIALONCZYK DAMIAN , ZHOU MEGAN S. , BROFFMAN LAUREN , DORON TZVI Y. , BOWLES JENNIFER , CHIQUETTE ELAINE
Published: June 2023

Background and Objective: Plenity is a non-systemic oral superabsorbent hydrogel which promotes fullness by increasing the volume and elasticity of ingested food in the stomach and small intestine. The efficacy and safety of the oral hydrogel have been demonstrated in clinical trials. This study evaluated weight change in people with overweight or obesity following treatment with the oral hydrogel in a real-world setting.

Research Design and Methods: Data was analyzed using chart records from a national telehealth platform. Demographic and health information and anthropometric measures were self-reported by patients during online visits. Patients were included in the analysis if they had received a prescription for the oral hydrogel, had a follow-up visit at 180 ± 30 days, reported having access to treatment for ≥ 75% of days, and reported taking it at least 1 day per week. Descriptive statistical analysis and tests of differences (χ2, t-tests) were performed in R Version 4.2.2.

Results: Patients (n=894) were 74% female, aged 50 ± 11 years, with a mean pre-treatment body weight of 90 ± 16 kg and BMI of 32.0 ± 4.1 kg/m2. One-third (35%) of patients had overweight (BMI 25-30 kg/m2) at baseline and mean treatment duration was 160 ± 16 days. Weight loss of any amount (>0 kg) was reported by 85.9% of patients, with a mean weight change of -6.1 ± 3.9% (-5.6 ± 3.8 kg) in this group. About half (48%) of all patients achieved clinically significant weight loss of ≥ 5%. Among these treatment responders, mean weight loss was 8.7 ± 3.3% (8.0 ± 3.4 kg). Clinically significant weight loss response ≥ 5% was more likely among people that reported poor baseline diet quality (P = 0.02).

Conclusions: Treatment with an oral superabsorbent hydrogel in people with overweight and mild obesity in a real-world environment was associated with clinically significant weight loss response at 6 months. People with self-assessed poor baseline diet quality, in particular, were more likely to have a meaningful response to therapy.

Disclosure

D. Bialonczyk: Employee; Gelesis. M. S. Zhou: Employee; Ro. L. Broffman: Employee; Roman Health Adventures. T. Y. Doron: Employee; Roman Health Adventures. J. Bowles: Employee; MCPHS University, Gelesis. E. Chiquette: Consultant; Gelesis.
902-P: Patient Experience and Clinical Outcomes in Pregnant Patients with Type 1 Diabetes Using Open-Source Automated Insulin Dosing Systems
Authors: YANG YIFAN , HALPERIN ILANA
Published: June 2023

Type 1 diabetes (T1D) in pregnancy is associated with increased obstetrical and neonatal complications; thus, stringent glycemic targets are imperative. While commercial automated insulin dosing (AID) systems represent an important development in management of T1D, a limitation is that the glycemic targets are not adjustable for pregnancy. Before commercial AID, a community of people with T1D combined CGM sensors, insulin pumps and open-source code, developing open-source automated insulin delivery systems (OSAIDS). Given customizable glycemic targets, OSAIDS may fill an important clinical gap in pregnancy. We included participants ≥18 years old with T1D who had at least one pregnancy using OSAIDS. Of 37 completed surveys, motivations for using OSAIDS included commercial AID targets being too high for pregnancy (78%), increased ownership over diabetes (53%) and transparency (44%). The INsulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) questionnaire showed that 100% strongly agreed or agreed with: helped in pregnancy (89% strongly agree), better quality of life (94% strongly agree) and better sleep (83% strongly agree). With a glycemic target of 3.5-7.8mmol/L (63-140mg/dl), 86% exceeded the time-in-range (TIR) target of ≥ 70% set by the Advanced Technologies & Treatments for Diabetes Congress. The majority (66%) had a more stringent TIR of ≥ 80%. The vast majority (97%) did not have severe hypoglycemia; 74% had time-below-range ≤ 4%. Of the 71% who experienced labor and delivery, 90% delivered at 37 weeks gestational age or greater; 90% did not have shoulder dystocia. Median birth weight was 3374g (SD 600g), 19% of newborns had macrosomia (>4000g). Neonatal hypoglycemia (<2.5mmol/L/<45mg/dl) occurred in 24% with 14% requiring NICU. OSAIDS provides excellent glycemic control, maternal quality of life and neonatal outcomes. More data is needed to validate these initial promising outcomes.

Disclosure

Y.Yang: None. I.Halperin: Advisory Panel; Sanofi, Speaker's Bureau; 3Boehringer Ingelheim Canada Ltd./Ltée, Abbott Diabetes, Dexcom, Inc., Novo Nordisk.
903-P: Correlation of Gene Expression and Cellular Pathways in Insulin-Expressing Mouse Liver Cells Transduced with an Integrating Adeno-associated Viral Vector (AAV)
Authors: JOSHUA SERGIO , NASSIF NAJAH T. , SIMPSON ANN M.
Published: June 2023

Gene therapy is being considered as a treatment/cure for type 1 diabetes (T1D). Previously we used a clinically-applicable AAV to deliver furin cleavable insulin (INS-FUR) to the livers of diabetic non-obese diabetic mice. The traditional AAV8 that allows predominantly episomal expression, and the hybrid AAV8/piggyBac that results in transgene integration into the host genome were used. Euglycaemia was achieved in mice (n=4) that received AAV8/piggyBac-INS-FUR, but not in mice that received AAV8-INS-FUR. In the current study global transcriptomic profiling was carried out, by total RNA sequencing, to compare the key pathways modulated in hepatocytes that reversed diabetes with those that did not. Using Qiagen CLC Workbench, significant genes were identified based on fold change expression cut offs of, and a false discovery rate p-value of <0.05. Selected genes were mapped onto the various cellular pathways using Qiagen Ingenuity Pathway Analysis (IPA) software to determine trends in pathway activation/ inactivation related to the altered gene expression. IPA analysis showed that the canonical pathways identified between the treatments remained largely the same, however their downstream biological processes differed. Key canonical pathways identified include pathways related to insulin signalling, glucose and lipid metabolism. Key pathway players identified as significantly altered in the comparative treatments included insulin, major histocompatibility complex class I, A, glucose-6-phosphatase catalytic subunit 1 and insulin like growth factor binding protein 1. The profile of AAV8/piggyBac-INS-FUR transduced mouse livers resembled that of a normal liver compared to livers transduced with AAV8-INS-FUR. This study confirms the correlation of transcriptomic data mapping and has identified differences in the cellular effects of both vector systems used to deliver INS-FUR for T1D treatment.

Disclosure

S.Joshua: None. N.T.Nassif: None. A.M.Simpson: None.

Funding

National Health and Medical Research Council of Australia (1086256)
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<0.0001) with significant improvements in perceived frequency of hyper (P<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, <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<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<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 (> 180 and > 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 (< 70 and < 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 % < 180 mg/dl (12.2; 95% CI 3.8 - 20.5; p=0.0065) all favored the intervention group, while % < 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