bluuebunny/crossref_metadata_2025_split huggingface dataset:
903-P: Glycemic Control Enhancement with Imeglimin in Type 2 Diabetes Mellitus
Authors: GUPTA ABHINAV , DUGGAL RANJANA 
Published: June 2024

Imeglimin is a first-in-class oral hypoglycemic agent used for the treatment of T2DM and targets mitochondrial bioenergetics to ameliorate insulin resistance and enhance β-cell function. It has also been shown to improve glycemic control when added to metformin or sitagliptin monotherapy in T2DM inadequately controlled with these drugs alone. We conducted a real World observational study (n=115) for 1 year follow up for the patients in whom Imeglimin was used as a third line agent (GLYCEM-IN Trial). The mean FPG at baseline was 280.8 mg/dl (±61.5, 95% CI 268.6 to 293.1) which reduced to 176.2 mg/dl (±64.9, 95% CI 163.3 to 189), significant reduction by -104.7 mg/dl (p&lt;0.0001). The mean PPG at baseline was 326.4 mg/dl (±64.7, 95% CI 313.6 to 339.2) which reduced to 209.3 mg/dl (±75.3, 95% CI 194.3 to 224.3), significant reduction by -117.7 mg/dl (p&lt;0.0001). The mean HbA1c at baseline was 8.7% (±0.86, 95% CI 8.5 to 8.8) which reduced to 8.2% (±0.77, 95% CI 8.1 to 8.4), significant reduction by -0.45 (p&lt;0.0001). The mean PPG at baseline was 1.1 mg/dl (±0.15, 95% CI 0.14 to 1.13) which reduced to 0.7 mg/dl (±0.1, 95% CI 0.68 to 0.72), significant reduction by -0.39 mg/dl (p&lt;0.0001). Imeglimin demonstrated significant efficacy as a third line treatment for T2DM. It notably decreased mean fasting plasma glucose by 104.7 mg/dl and postprandial glucose by 117.7 mg/dl. HbA1c levels showed a meaningful reduction of 0.45%. These results suggest that Imeglimin effectively enhances glycemic control in T2DM patients inadequately managed with other monotherapies.

Disclosure
A. Gupta: None. R. Duggal: None.
907-P: The Effect of Imeglimin on Glycemic Management in Japanese Patients with Type 2 Diabetes
Authors: MATSUHASHI YUKI , ABE TAKAHIRO , FUJITA TOMOYUKI , CHIKAZAWA SHINJI , FUJITA YUKIHIRO 
Published: June 2024

Background: Imeglimin exerts hypoglycemic actions by stimulating insulin secretion in a glucose concentration-dependent manner and by improving insulin resistance. We evaluated the effects of imeglimin on glycemic management, insulin secretion, body weight(BW) and composition in Japanese patients with type 2 diabetes.
Subjects and Methods: Patients with inadequate glycemic control(HbA1c &gt;7.0%), treated with diet/exercise or oral antidiabetic drugs(OADs) in our outpatient clinic, were eligible. Height, BW and composition were measured and body mass index(BMI) was calculated. Diabetic complications were assessed. HbA1c(A1c), fasting plasma glucose(FPG), and C-peptide(CPR) were measured. CPR-to-glucose ratio(CPR[ng/ml] / glucose[mg/dl] x100: CPR-index) was calculated. Imeglimin 2000mg was administrated without changing the treatment. The change in A1c(ΔA1c), BW, liver function and other items after administration(6 months) were examined with paired t-test, simple and multiple regression analysis. Patients were classified into 4 groups by BMI and CPR-index before imeglimin administration, ΔA1c was evaluated with ANOVA. Data was expressed as mean±SD.
Results: Background of 32 patients(17 male) were as follows: age 60.8±11.9yo, BMI 26.3±5.1kg/m2. OADs(number) were DPP-4i(27), SGLT2i(24), metformin(22), AGi(7) and glinides(4)(overlapped). A1c was significantly decreased(7.5±0.6→6.9±0.7%, p&lt;0.05). FPG and ALT were also decreased, and CPR-index was increased significantly. BW, BMI and body fat mass(BFM) were decreased, but lean body mass was not changed significantly. Simple regression analysis showed that ΔA1c was significantly correlated with AST and ALT, but not with A1c, BMI, CPR-index and other measured items. Noteworthy A1c was significantly decreased in BMI&lt;32 and CPR-index &gt;0.8 group(ΔA1c -0.7±0.3%, p&lt;0.05 vs other 3 groups).
Conclusions: Imeglimin increased insulin secretion, decreased BW and BFM, improved liver function and glycemic management.

Disclosure
Y. Matsuhashi: None. T. Abe: None. T. Fujita: None. S. Chikazawa: None. Y. Fujita: None.
912-P: Kidney and Cardiovascular Effectiveness of SGLT2 Inhibitors Compared with GLP-1 Receptor Agonists in Patients with Type 2 Diabetes
Authors: EDMONSTON DANIEL , MULDER HILLARY , LYDON ELIZABETH , CHISWELL KAREN , LAMPRON ZACHARY , SHAY CHRISTINA M. , MARSOLO KEITH , BOSWORTH HAYDEN B. , PAGIDIPATI NEHA 
Published: June 2024

Introduction & Objective: In placebo-controlled trials, SGLT2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP1RA) improve kidney and cardiovascular outcomes. However, direct comparisons are lacking.
Methods: We analyzed EHR data from 20 US health systems that contribute to PCORnet. Using propensity scores and overlap weighting, we compared kidney and cardiovascular outcomes for initiators of SGLT2i and GLP1RA with type 2 diabetes between 2015-2020. The primary kidney outcome was a composite of 40% eGFR decline, incident ESKD, or all-cause mortality over 2 years or until censoring. We also examined cardiovascular and safety outcomes.
Results: Over a median of 1.2 years, risk for the primary outcome did not differ between the 35,004 SGLT2i and 47,268 GLP1RA initiators, though SGLT2i initiation was associated with lower risk of 40% eGFR decline (Table). Risks for mortality, cardiovascular outcomes, and most safety outcomes did not differ between groups, though genital mycotic infections were more common for SGLT2i initiators. Results were similar in patients with and without CKD.
Conclusion: In a large, real-world population with type 2 diabetes, risk for a composite kidney outcome, all-cause mortality, or cardiovascular outcomes was similar between initiators of SGLT2i and GLP1RA, though SGLT2i initiation was associated with a lower risk of 40% eGFR decline.

Disclosure
D. Edmonston: None. H. Mulder: None. E. Lydon: None. K. Chiswell: None. Z. Lampron: None. C.M. Shay: Employee; Boehringer-Ingelheim. K. Marsolo: Research Support; Boehringer-Ingelheim, Amgen Inc., Bayer Inc., Bristol-Myers Squibb Company, Novartis Pharmaceuticals Corporation, Seqirus, Genentech, Inc., Pfizer Inc. H.B. Bosworth: Research Support; BeBetter Therapeutics, Boehringer-Ingelheim, Improved Patient Outcomes, ESPERION Therapeutics, Inc., Novo Nordisk, Otsuka America Pharmaceutical, Inc., Sanofi, National Institutes of Health, Veterans Administration, elton john foundation. N. Pagidipati: Research Support; Alnylam Pharmaceuticals, Inc., Amgen Inc., Eli Lilly and Company. Consultant; ESPERION Therapeutics, Inc., AstraZeneca. Research Support; Boehringer-Ingelheim, Novartis AG, Novo Nordisk. Consultant; CRISPR Therapeutics. Research Support; Bayer Inc., Merck & Co., Inc. Consultant; Merck & Co., Inc., Boehringer-Ingelheim, Novo Nordisk, Bayer Inc., Novartis Pharmaceuticals Corporation. Other Relationship; Janssen Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation.

Funding
Boehringer Ingelheim
913-P: Risk of Dementia in Diabetes Patients Aged Less than 70 Years Initiating Sodium–Glucose Cotransporter-2 Inhibitor vs. Dipeptidyl-Peptidase-4 Inhibitor
Authors: SHIN ANNA , KYUNG KOO BO , LEE JUN-YOUNG , HA KANG EUN 
Published: June 2024

Objective: To compare the risk of dementia associated with sodium glucose co-transporter 2 inhibitor (SGLT2i) versus dipeptidyl peptidase 4 inhibitor (DPP4i) among relatively young patients with type 2 diabetes (T2DM) patients.
Methods: We conducted a population-based cohort study using 2010-2021 Korea National Health Insurance Service database on T2DM patients aged ≥40 and ≤70 years initiating SGLT2i versus DPP4i. The primary outcome was new onset dementia based on diagnosis codes. Secondary outcomes were dementia requiring medications, individual types of dementia, genital infection (positive control), and osteoarthritis encounter (negative control). We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) using Fine-Gray models adjusting for competing risk of death, after a 1:1 ratio propensity-score (PS) matching for &gt;110 potential baseline confounders. Subgroup analyses were done by age, sex, concurrent metformin use, and baseline cardiovascular risk.
Results: 110,885 PS-matched pairs of SGLT2i and DPP4i initiators were included. The mean follow-up time (standard deviation) were 670 days (650) with 1,172 new cases of dementia. The incidence rate was 0.22 in SGLT2i initiators and 0.35 in DPP4i initiators per 100 person-years, with the corresponding HR (95% CI) of 0.65 (0.57-0.73) for dementia, 0.57 (0.49-0.67) for dementia with medications, 0.63 (95% CI 0.55-0.72) for Alzheimer dementia, and 0.53 (95% CI 0.36-0.77) for vascular dementia. We observed a 2.45 times risk of genital infection with SGLT2i and near-null association for osteoarthritis encounter. The benefits were consistent across subgroups, and after accounting for lag times, but greater beyond than within 2 years of treatment.
Conclusion: Among patients with T2DM, SGLT2i may reduce the risk of dementia.

Disclosure
A. Shin: None. B. Koo: None. J. Lee: None. E. Kang: None.

Funding
This study was supported by the grant from the Korea Health Industry Development Institute (KHIDI)-AZ Diabetes Research Program (#08-2022-0261).
932-P: Clinical Efficacy, Safety, and Tolerability of Single-Pill Combination of Dapagliflozin and Linagliptin in Uncontrolled Indian Type 2 Diabetes Mellitus Patients—A Randomized Double-Blind Study
Authors: AHMAD JAMAL , GHOSH SAYAN , KUMTHEKAR PRASHANT P. , UPADHYAY MIHIR R. , SONAWANE KUNAL S. , KHALSE MANEESHA , PATEL KAMLESH 
Published: June 2024

Introduction: While Dapagliflozin and Linagliptin are known for robust glycaemic efficacy T2DM patients when used individually, although it remained unknown whether their combined use is associated with further improved efficacy, safety and tolerability in Indian scenario.
Objective: To determine whether Dapagliflozin 10mg-Linagliptin 5mg (group 1) is associated with an improved glycemia compared with Linagliptin (group 2) alone in uncontrolled on metformin monotherapy.
Method: In a Phase 3, randomized, double blind, active-controlled, double dummy study, a total of 232 T2DM patients on stable dose of metformin were randomized to a group 1 and 2 for 16 weeks. The endpoints included were mean change in glycemic and metabolic parameters. Statistical analysis was conducted using SAS 9.4.
Results: At baseline, mean (SD) for age, weight, BMI was 46.5 (10.52) years, 62.17 (7.57) kg and 23.76 (2.61) kg/m2. At end of 16 weeks, mean reductions in HbA1c (±SE) in group 1 was -1.36 ±0.05 % with difference in mean (SE) -0.44 (95% CI -0.59 to -0.29) %, in FPG -25.90 (1.23) %, 2-hr PPG -52.41 (2.29)% was reported from baseline. About 49% subjects achieved therapeutic glycaemic response in group 1 compared to 26% of group 2 and modest weight reduction from baseline was observed (LSM (SE) -1.34 (0.07) kg in group 1 with mean difference of -0.93 (0.1) kg. AEs reported were twelve in group 1 and ten in group 2, which were mild-moderate in nature.
Conclusion: Dapagliflozin-Linagliptin combination provided superior glycemic control with good tolerability and safety profile in Indian T2DM patients uncontrolled on metformin monotherapy.

Disclosure
J. Ahmad: None. S. Ghosh: None. P.P. Kumthekar: None. M.R. Upadhyay: None. K.S. Sonawane: None. M. Khalse: Employee; Lupin Limited. K. Patel: None.
935-P: Cardiovascular and Mortality Outcomes with SGLT2 Inhibitors in Patients with Atrial Fibrillation and Type 2 Diabetes
Authors: HUN KIM SO , CHO YONGIN , HEA SEO DA , KIM YOUNGJOON , PARK MINAE , JU SUH YOUNG , SHIN SUNG-HEE 
Published: June 2024

Introduction & Objective: Sodium glucose cotransporter 2 (SGLT2) inhibitors have shown clinical benefits in patients with heart failure (HF), chronic kindey disease and type 2 diabetes(T2DM). However, limited data exist on their effects on clinical outcomes in patients with AF and T2DM.
Methods: We conducted a retrospective cohort study using the National Health Insurance Service database of Korea. A total of 4,771 patients with T2DM and AF who were newly prescribed SGLT2 inhibitors or DPP4 inhibitors were selected and matched by propensity score in a 1:2 ratio. The effect of SGLT2 inhibitors on the composite outcome of either HF hospitalization or death compared with DPP4 inhibitors were examined. Consistency of the drug effect on the primary outcome in subgroups and the effect of SGLT2 inhibitor according to follow-up period after the time of initiation were analyzed.
Results: Over a median follow-up of 31 months, SGLT2 inhibitors showed a lower risk of hospitalizations for HF or death compared to use of DPP4 inhibitors (HR 0.61; 95% CI 0.44-0.85; P=0.004). SGLT2 inhibitor use was also associated with a lower risk of mortality (HR 0.61; 95% CI 0.39-0.94; P=0.025). SGLT2 inhibitors were associated with a lower risk of HF hospitalization or mortality regardless of prior ASCVD or HF history. Patients with SGLT2 inhibitors demonstrated a significantly lower risk of primary outcome from 90 days after initiating the drug to the third year, as compared with those with DPP4 inhibitors (P&lt;0.05).
Conclusion: In a nationwide cohort of patients with T2DM and AF, SGLT2 inhibitors showed a lower risk of mortality compared to DPP4 inhibitors. This may support the use of SGLT2 inhibitors as the first-line antidiabetic medication in patients with T2DM and AF to prevent adverse outcomes.

Disclosure
S. Kim: None. Y. Cho: None. D. Seo: None. Y. Kim: None. M. Park: None. Y. Suh: None. S. Shin: None.

Funding
Inha University
949-P: Android Artificial Pancreas System Use among Patients with Type 1 Diabetes Mellitus in China—A Real-World Study
Authors: LEI MENGYUN , LING PING , NI YING , ZENG XIFENG , YANG DAIZHI , DENG HONGRONG , YANG XUBIN , XU WEN , YAN JINHUA 
Published: June 2024

Objective: The real-world study aimed to investigate the current status of Android artificial pancreas system (APS) use among patients with type 1 diabetes mellitus (T1DM) in China, where market-approved commercial APS is unavailable.
Methods: The healthcare providers of China’s largest online T1DM community (TTQ) helped build up AndroidAPS using a compatible insulin pump, real-time continuous glucose monitoring (CGM), and a heuristic-based algorithm. Patients with T1DM who used AndroidAPS for at least 3 months between January 2020 and July 2023 were included. The baseline data and main glycemic metrics during the last 3 months after using AndroidAPS were collected.
Results: We included 191 patients (56 non-adults and 135 adults) with a median age of 24.80 (15.83, 32.74) yrs, T1DM duration of 6.01(1.63,8.58) yrs, and body mass index (BMI) of 20.74(18.51,22.34) kg/m2. The duration of APS use was 153(114.00,206.00) days. After using AndroidAPS, HbA1c was decreased from 7.1(6.4,8.5) % to 6.3(5.6,6.8) % (p&lt;0.001). The median 24-hour time in range (TIR,70-180mg/dL), time above range (TAR,&gt;180mg/dL), time below range (TBR, &lt;70mg/dL), TBR(&lt;54mg/dL), and glucose management indicator were 81.40(71.99,87.10) %, 13.55(7.20,22.37) %, 4.06(2.63,6.28) %, 0.42(0.20,0.87) %, and 6.45(6.09,6.78) %, respectively. The median overnight TIR, TAR, TBR (&lt;70mg/dL), and TBR(&lt;54mg/dL) were 85.42(77.87,91.87) %, 8.00(3.45,16.52) %, 3.82(2.00,6.44) %, and 0.39(0.11,0.95) %, respectively. A total of 155 patients achieved the recommended TIR of 70%, and 66 achieved TIR, TAR, and TBR targets simultaneously. Multiple linear regression revealed age (β=0.285, p&lt;0.01) and duration of APS use (β=-0.167, p&lt;0.05) as determinants of 24-hour TIR after adjusting gender, duration, BMI, and baseline HbA1c (R2=0.13, p&lt;0.01).
Conclusion: Our study confirmed the efficacy and safety of AndroidAPS on glycemic control among Chinese patients with T1DM, especially at nighttime.

Disclosure
M. Lei: None. P. Ling: None. Y. Ni: None. X. Zeng: None. D. Yang: None. H. Deng: None. X. Yang: None. W. Xu: None. J. Yan: None.

Funding
the Science and Technology Planning Project of Guangzhou (202102010154) and the Diabetes Mellitus Research Fund Program from Shanghai Medical and Health Development Foundation (DMRFP_II_14 from SHMHDF)
952-P: What Happens When People Don’t Bolus for Extended Periods of Time while Using the t:slim X2 with Control-IQ Technology?
Authors: POLIN MIRANDA , JOHNSON ANDREW K. , MESSER LAUREL H. , PINSKER JORDAN E. , CONSTANTIN ALEXANDRA 
Published: June 2024

Objective: The t:slim X2 with Control-IQ technology (CIQ) predicts future hyperglycemia and delivers automatic correction boluses to help improve time-in-range (TIR, 70-180 mg/dl). This is thought to help improve glycemia when users do not initiate boluses for meals. The purpose of this analysis is to determine glycemic results in users who do not bolus for prolonged periods of time.
Methods: Data were analyzed from the Tandem Diabetes Care t:connect database for CIQ users from January 2020 to December 2023. Users were included for analysis if they had a minimum of 7/ 14/ 30/ 182 days without a carbohydrate bolus and ≤ 1 manual bolus. Time in range (TIR) and time-below-range (TBR, &lt;70 mg/dl) were analyzed on days without bolusing compared to days with user-initiated boluses.
Results: Out of 291,769 CIQ users, 28,790 (10% users) had used the system for 7+ consecutive days without bolusing. The average number of days without boluses was 61 per user. There were a total of 1,728,304 days without boluses in the database. 27,688 users had periods of 7-13 consecutive days without user-initiated boluses. 11,127 users had periods of 14-29 consecutive days without user-initiated boluses. 3,813 users had periods of 30-181 consecutive days without user-initiated boluses. And 102 users had periods of more than 6 months of consecutive days without user-initiated boluses. On days without boluses, median TIR was 62% (IQR 50-74%) in all four groups, whereas median TIR for days with boluses was 57%-60% (IQR 46-70%). The TBR was less than 0.6% for both days without boluses and days with boluses.
Conclusion: Users of Control-IQ technology who do not bolus for extended periods of time have slightly higher TIR on days when they do not bolus compared to days when they take manual boluses, with no increase in hypoglycemia. This is likely due to myriad reasons, including that the CIQ system can attenuate hyperglycemia enough to be acceptable for a subset of users who struggle with consistent bolusing.

Disclosure
M. Polin: Employee; Tandem Diabetes Care, Inc. A.K. Johnson: Employee; Tandem Diabetes Care, Inc. L.H. Messer: Employee; Tandem Diabetes Care, Inc. J.E. Pinsker: Employee; Tandem Diabetes Care, Inc. A. Constantin: Employee; Tandem Diabetes Care, Inc.

Funding
Tandem Diabetes Care
961-P: Significant Reduction in Real-World Nighttime Burden with the MiniMed 780G System (MM780G)
Authors: SHIN JOHN , DAI ZHENG , MATHEW NATHAN SATHIYANATHAN NAVEEN , VIGERSKY ROBERT A. , MCVEAN JENNIFER 
Published: June 2024

Introduction: Nighttime burdens of T1D include responding to CGM-generated alerts and delivering manual boluses which interrupt sleep. First-generation automated insulin delivery (AID) systems without autocorrection (e.g., MM670G/770G) have improved overnight glycemic outcomes, but sleep interruptions may still be common. The ability of the MM780G with frequent (every 5-min) autocorrections to decrease nighttime burden, versus the MM770G, was evaluated.
Methods: Nighttime (12AM-6AM) glycemic control, alarms/alerts, and insulin delivery were evaluated in 8019 U.S. MM780G system users (≥7 years) who transitioned from the MM770G and had ≥14 nights on both systems, in addition to those who used recommended settings (RS, a glucose target of 100mg/dL with active insulin time of 2 hours for 95% of the time).
Results: In all MM780G users and those who used RS, alerts decreased 45% and 55%, respectively (Table). Nights with manual boluses decreased to 3.8% and 2.1% and uninterrupted sleep increased by 30 and 36 minutes per night, respectively, compared to the MM770G. All MM780G users and those using RS received 16.4% and 18.2% of their overnight insulin as autocorrections.
Conclusion: MM780G system users have fewer overnight sleep interruptions and better glycemic control due to frequent autocorrections.

Disclosure
J. Shin: None. Z. Dai: Employee; Medtronic. N. Sathiyanathan: None. R.A. Vigersky: Employee; Medtronic. J. McVean: Employee; Medtronic.
963-P: Is Using an Automated Insulin Delivery System Associated with a Higher Physical Activity Frequency? A BETTER Registry Analysis
Authors: WU ZEKAI , YARDLEY JANE E. , CHAHAL TAMANNA , GUÉDET CAPUCINE , MESSIER VIRGINIE , GROU CAROLINE , BOUDREAU VALERIE , BRAZEAU ANNE-SOPHIE , RABASA-LHORET RÉMI 
Published: June 2024

Introduction & Objective: To explore the association between using an automated insulin delivery (AID) system and physical activity (PA) frequency among people with type 1 diabetes (T1D).
Methods: Cross-sectional study using the Canadian BETTER T1D registry. Inclusion criteria: T1D; aged ≥ 18 y/o; reported PA with a validated questionnaire (Canadian Community Health Survey). “PA” includes organized or unorganized sports, fitness or recreational PA lasting ≥ 10 consecutive minutes; “moderate to vigorous PA” is PA that makes participants sweat at least a little and breathe harder. Regression models (with and without adjustment for imbalanced variables - sex, age, T1D duration) were used to compare PA frequency among treatment options, with pairwise comparison between the AID group and each of the other groups.
Results: Among 1213 participants, the AID group and pump+continuous glucose monitoring (CGM) group had a similar frequency of PA and moderate to vigorous PA, but these levels were higher in the AID group than those of injections+CGM and no-CGM groups (Table).
Conclusion: In real-world settings, compared with injections+CGM or No-CGM, AID users within the BETTER T1D registry have a higher frequency of PA and moderate to vigorous PA. However, these frequencies are similar between AID and pump+CGM users.

Disclosure
Z. Wu: None. J.E. Yardley: Speaker's Bureau; Dexcom, Inc. Research Support; LifeScan Diabetes Institute. T. Chahal: None. C. Guédet: None. V. Messier: None. C. Grou: None. V. Boudreau: None. A. Brazeau: Other Relationship; Dexcom, Inc. Research Support; Canadian Institutes of Health Research, Juvenile Diabetes Research Foundation (JDRF), Diabète québec, Fonds de recherche du Québec en Santé. R. Rabasa-Lhoret: Other Relationship; Abbott, AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Dexcom, Inc. Research Support; Diabetes Canada. Other Relationship; Eli Lilly and Company. Research Support; Cystic Fibrosis Canada, Canadian Institutes of Health Research, FFRD - Fondation Francophone pour la Recherche du Diabète. Other Relationship; Janssen Pharmaceuticals, Inc. Research Support; Juvenile Diabetes Research Foundation (JDRF). Other Relationship; Novo Nordisk, GlaxoSmithKline plc. Consultant; HLS Therapeutics Inc., Insulet Corporation. Speaker's Bureau; CPD Networks. Other Relationship; Medtronic. Consultant; Pfizer Inc. Speaker's Bureau; Tandem Diabetes Care, Inc. Other Relationship; Sanofi. Speaker's Bureau; Vertex Pharmaceuticals Incorporated. Research Support; SFD - Société Francophone du Diabète.

Funding
Canadian Institutes of Health Research (JT1-157204) and Juvenile Diabetes Research Foundation (4-SRA-2018-651-Q-R)