bluuebunny/crossref_metadata_2025_split huggingface dataset:
695-P: Engagement and Glycemic Outcomes over 24 Weeks among New Level2 Members
Authors: KAMRUDIN SAMIRA , CLARK CALLAHAN , MONDEJAR JOYVALERIE P. , VARGAS MAYNARD F. , THOMPSON NELS , MACFARLANE ELIZABETH , DEFAIL ANTHONY , OECHLER AMANDA L. , COOK DAVID J. 
Published: May 2022

Level2’s virtual specialty clinic, offered across the United States to people with type 2 diabetes on participating insurance plans, includes continuous glucose monitors (CGM) , fitness trackers, lifestyle recommendations, and/or coach/clinician interactions. We retrospectively assessed differences in engagement and glycemic measures over 24 weeks following Level2 enrollment. From 01/01/21 to 07/31/21, 9,137 individuals newly joining Level2 had at least 12 prior months of continuous enrollment in a participating commercial health plan to assess demographics using medical and pharmacy claims. This group was 47% female, averaged 55 years of age (SD 9) , and averaged 0.7 (SD 1.1) Diabetes Complications and Severity Index conditions. Most (60%) had fill histories for 1 or 2 diabetes drug classes; 7% had four or more.Over 24 weeks, participants averaged 175 days of enrollment and coaching interactions; two in three (N = 5,760) wore a CGM at least once. We used least absolute shrinkage and election operator regression analysis, multivariable logistic regression analysis, and zero inflated negative binomial to find features associated with coaching visit frequency and CGM wear; associations included younger age and nephropathy-related claim history. For a subset with available A1c values in the 3 months before starting Level2 and sufficient CGM data at week 12 (N = 458) or week 24 (N = 512) , GMI-based glycemic improvement of 0.5% or greater was evident for 63 - 67% of those with initial A1c between 7 - 9% and 94 - 97% of those with an initial A1c above 9%. Over 24 weeks, Level2 engagement outcomes were associated with younger age and nephropathy-related claim history; improvements in glycemic control were evident at weeks 12 and 24, particularly for those entering Level2 with A1c above 9%. Additional research is needed to characterize longitudinal clinical and engagement outcomes, including features associated with achieving and sustaining type 2 diabetes remission.

Disclosure
S.Kamrudin: Employee; UnitedHealth Group. C.Clark: Employee; UnitedHealth Group, Stock/Shareholder; UnitedHealth Group. J.P.Mondejar: None. M.F.Vargas: None. N.Thompson: Employee; Level2. E.Macfarlane: Employee; Level2. A.Defail: Employee; Level2. A.L.Oechler: Employee; Level2. D.J.Cook: None.
763-P: Real-World Use of the MiniMed 780G Advanced Hybrid Closed-Loop (AHCL) System with the Guardian 4 Sensor and the Guardian Sensor 3
Authors: VIGERSKY ROBERT A. , CASTAÑEDA JAVIER , ARRIETA ARCELIA , CORDERO TONI L. , RHINEHART ANDREW S. , SHIN JOHN 
Published: May 2022

Objective: The MiniMed™ 780G system with the adjunctive Guardian™ sensor 3 that requires calibration has been commercially available in Europe, since October 2020. Since October 2021, the system has been available with the non-adjunctive Guardian™ 4 sensor, which does not require calibration. In this study, glycemic outcomes during real-world MiniMed™ 780G system use with both sensors were evaluated.
Methods: Analyses were based on data collected on Dec 10, 2021, from consenting system users (N=674) residing in Europe with ≥days of sensor glucose (SG) data from both sensors. Glycemic outcomes including mean±SD of the glucose management indicator (GMI) and percentage of time spent in target range of 70-180mg/dL (TIR) , at &lt;54mg/dL and &lt;70mg/dL (TBR) and at &gt;180mg/dL (TAR) were assessed. The time spent in AHCL, number of AHCL exits/week and self-monitoring of blood glucose (SMBG) measurements/day were also determined. Results:
System use with the Guardian™ 4 sensor versus Guardian™ sensor 3 demonstrated 94±9% vs 93±11% of time in AHCL, 73.1±11.4% vs 74.6±9.8% TIR, 0.11±0.16% vs 0.51±0.58% TBR&lt;54, 1.6±1.4% vs 2.4±1.8% TBR&lt;70, and 25.3±11.7% vs 23.1±10.0% TAR&lt;180. During the night (12AM-6AM) , greater glycemic control was observed: with 81.6±13.3% vs 82.8±11.0% TIR, 0.09±0.22% vs 0.42±0.69% TBR&lt;54, 1.1±1.5% vs 1.8±1.9% TBR&lt;70 and 17.3±13.3% vs 15.4±11.0% TAR&gt;180. The GMI was 6.98±0.43% vs 6.84±0.38%. Closed-loop exits were 0.83±1.02 vs 1.1±1.06/week and SMBG measurements were 0.9±0.9 vs 3.3±0.9/day. Conclusion: Real-world MiniMed™ 780G system use findings indicate reduced burden related to SMBG measurements and closed-loop exits, with the Guardian™ 4 sensor, while maintaining favorable glycemic outcomes of the MiniMed™ 780G + Guardian™ sensor 3 system.

Disclosure
R.A. Vigersky: Employee; Medtronic. J. Castañeda: Employee; Medtronic. A. Arrieta: Employee; Medtronic. T.L. Cordero: Employee; Medtronic, Medtronic. A.S. Rhinehart: Employee; Medtronic. Stock/Shareholder; Medtronic. J. Shin: Employee; Medtronic.
776-P: Glycemic Outcomes after Six Months of Real-World MiniMed 780G Advanced Hybrid Closed-Loop (AHCL) Therapy Use in Chile
Authors: CASTRO MATIAS , CARRASCO BONILLA CAMILA NICOLE , LEON MACEDO JOANA C. , GUTIERREZ MARIA FERNANDA , VALERA LOPEZ ZEUDI C. , DAGHERO ANDREA 
Published: May 2022

Objective: MiniMed™ 780G system use has improved glycemic control in clinical trials1,2 and real-world data analyses3. This study evaluated real-word glycemic outcomes before and 6 months after AHCL initiation by individuals with T1D living in Chile.
Methods: Data from 37 MiniMed™ 780G users (aged 5-76 years, mean±SD of 29.3±19.3 years) at 12 centers throughout Chile were prospectively collected and analyzed. Mean glucose management indicator (GMI) , sensor and system use, and time spent at SG ranges including target SG range (TIR, 70-180mg/dL) were determined using 14 days of SG data at baseline and 2, 14, 28, 90 and 180 days post-AHCL initiation.
Results: Overall, ≥95% of time was spent in AHCL (Figure 1) and GMI was &lt;7% throughout the study. TIR increased from 68.9% to 79.5% in 7 former MiniMed™ 640G users and from 75.3% to 78.1% in 30 former MiniMed™ 670G users. The percentage of users achieving TIR &gt;70% and GMI &lt;7.0% increased from 63.6% to 86.5% and from 70.3% to 82.4% by 180 days post-AHCL initiation, respectively.
Conclusion: MiniMed™ 780G use in Chile allowed most to increase TIR within 2 weeks, an important outcome that was sustained over 6 months.

Disclosure
M.Castro: Employee; Medtronic. C.Carrasco bonilla: Employee; Medtronic. J.C.Leon macedo: Employee; Medtronic. M.Gutierrez: Employee; Medtronic. Z.C.Valera lopez: Employee; Medtronic. A.Daghero: Employee; Medtronic.
798-P: A Real-Life Experience with Hybrid Closed-Loop Insulin Delivery Systems in People with Type 1 Diabetes: One Year After
Authors: CONVERTINO ALESSIO , GIULIANI CHIARA , BITTERMAN OLIMPIA , NAPOLI ANGELA 
Published: May 2022

Objective: evaluate the metabolic impact and metrics of the new hybrid closed loop insulin delivery system on the quality of life in patients with type 1 diabetes.
Methods: Metrics obtained with CGM with &gt;80% of CGM readings over a 4-week period in real life: Time in Range (TIR%) [target 70-180 mg/Dl (3.9-10mmol/L) ], Time Above Range (TAR%) [ (&gt;180mg/dl (&gt;10mmol/L) ], Time Below Range (TBR%) [&lt;70mg/dl (3.9mmol/L) ], CV (&lt;36%) referred to 30 consecutive days. Statistics ANOVA post-hoc Bonferroni/Tukey tests were used as appropriate.
Results: Fifty-two type 1 diabetic patients (38F; 14M) on SAP therapy aged 45.5±12.0 yrs, BMI 27.7±15.5 kg/m2, duration of diabetes 24.6±13.4 yrs, were studied. In these patients, who were treated with total daily insulin (TDI) 0.55±0.16 UI/kg/day, basal 0.27±0.UI/kg/day, bolus 0.28±0.UI/kg/day, mean glucose was 158.6 mg/dl (8.8 mmol/L) (121-250) , TIR% 62.4±13.5%, TBR% 4.6±4.5%, TAR% 33.0±15.1%, CV% 36.1±5.2%. Only 19 of 52 patients reached TIR≥70%. A subgroup of 30 patients (21F; 9M) , mean age 44.2±12.2 yrs, BMI 29.2±19.7 kg/m2, duration of diabetes 24.2±13.6 yrs, HbA1c 7.7±1.4%, TDI 0.59±0.14 UI/kg/day, basal 0.30 UI/kg/day, bolus 0.29 UI/kg/die, shifted from SAP to HCL. CGM Metrics regarding our patient's glucose status at baseline and 1, 2, 3, 6 and 12 months after, showed that: mean sensor BG decreased from 158.6 mg/dl (8.8 mmol/L) at baseline to 144.3 mg/dl (8.2mmol/L, p&lt;0.05) at the 2nd month, p&lt;0.05. TIR% significantly increased from 62.4% (TBR 4.6%, TAR 33.0%, CV 36.1%) to 76% at the first month, to 76.5% (TBR 2.6%, TAR 20.9%, CV 33%) at the 3rd month, p&lt;0.05. After 12 months (n=10) TIR% was 73.4±8.8%, TBR% 2.7±3.1%, TAR% 23.9±7.2%, CV% 35.5±5.2%, p&lt;0.05.
Conclusions: HCL improves glucose status increasing TIR% and reducing TAR%, TBR% and glycemic variability, improving the quality of life.

Disclosure
A.Convertino: None. C.Giuliani: None. O.Bitterman: None. A.Napoli: None.
80-LB: At Home, Monitoring Device for Prevention and Interception of Diabetic Ketoacidosis Events in Children
Authors: EDGAR SOPHIE L. , PAUNESCU ALEX , DONG MING 
Published: May 2022

Diabetic ketoacidosis (DKA) is often the first sign of type 1 diabetes (T1D) , especially in those children under the age of 3, with 55-100% of those in this age range diagnosed in DKA. Furthermore, 10-12% of children diagnosed with Stage 3 T1D are 3 or less, highlighting a critical need to identify those children at highest risk of a potentially life threatening DKA event at diagnosis. Commercially available urine analysis strips are not easily used with young children, so a simpler solution is urgently needed for early detection of DKA. In order to change the T1D diagnosis and treatment paradigm, we have developed a non-invasive monitoring solution that integrates into a child’s everyday routine and can alert caretakers real time when some of the early indicators of diabetes and DKA arise. The solution comprises of a single use sensing pad and a reusable Bluetooth® connected device which together fit into standard diapers. The pad collects urine and saturates two specialized colorimetric biosensor membranes which react with glucose and ketones. The device detects sufficient saturation of the biosensors and at a prescribed optimal time point, takes a reading via a photodetector to quantify the color change. Data is then sent to a mobile app which converts the readings to glucose & ketone levels using an algorithm. It sends alerts to the child’s caregiver if values indicate a threshold limit of ketones have been met, which can be early signs of diabetes or DKA. The data captured by the device can be stored and analyzed over time, so caregivers and healthcare providers may know days or weeks in advance if their child is headed toward diabetes, hoping to fend off a DKA event. This feature may provide an earlier and less precipitous diagnosis and treatment, rather than experiencing a life-threatening emergency. This at home, mobile smart monitoring solution provides a practical solution for at-home, real-time monitoring of urine glucose and ketones in young children at risk of developing T1D.

Disclosure
S. L. Edgar: None. A. Paunescu: None. M. Dong: Employee; Johnson & Johnson.
80-OR: Proinflammatory Macrophage Impairs Retrograde Axonal Transport via Inflammation and Insulin Resistance in Sensory Neurons
Authors: OSONOI SHO , MIZUKAMI HIROKI , OGASAWARA SAORI , KUDOH KAZUHIRO , DAIMON MAKOTO , YAGIHASHI SOROKU 
Published: May 2022

Inflammation, insulin resistance (IR) , and deficit of retrograde axonal transport (RAT) are implicated in the pathogenesis of diabetic polyneuropathy (DPN) . Pro-inflammatory macrophage (M1) skewed by diabetic insults causes IR in adipose tissue. The activation of Advanced Glycation End products (AGEs) - Receptor for AGEs (RAGE) signaling is involved in the macrophage polarization into M1, while its contribution to the deficit of RAT in DPN is still unclear. In this study, we investigated the implication of M1-related inflammation to RAT deficit in sensory neurons. We evaluated the activation of macrophage cell line RAW 264.7 (RAW) and neurons isolated from dorsal root ganglia (DRG) of C57BL/6 mice stimulated by 200 μg/ml of AGE. A DRG neurons-RAW co-culture system was established by seeding RAW onto DRG neurons. After 12h co-culturing, we added AGE to the co-culture and stimulated RAW. A DRG neuronal mono-culture was treated with 500 nM of insulin receptor antagonist (BMS-754807) , and 20 ng/ml of TNF-α with/without 50 nM JNK inhibitor (SP600125) . Axonal transport was visualized by Lysotracker and captured by time-lapse microscopy. The movements were quantified on kymographs generated from 100 μm axonal segments. AGE induced the M1 phenotype in RAW with elevated expressions of iNOS and TNF-α mRNA, while no effects on DRG neuron were identified. In the co-culture, the frequency of RAT (RAT%) was significantly reduced when RAW was stimulated by AGE compared to naive RAW (p &lt; 0.001) . In the mono-culture, RAT% was significantly reduced when neurons were treated with BMS-7548 and TNFα (vs. control, both p &lt; 0.001) . TNFα stimulation also increased the phosphorylation of JNK in the axons, a major target of TNFα, which was confirmed by immunofluorescence. The reduction of RAT% by TNFα was rescued by SP600125.
In summary, RAT could be impaired by TNF-α and IR, which suggests inflammation induced by M1 in SN can attenuate RAT, which contributes to the DPN pathology.

Disclosure
S.Osonoi: None. H.Mizukami: None. S.Ogasawara: None. K.Kudoh: None. M.Daimon: None. S.Yagihashi: None.

Funding
Japan Society for the Promotion of Science (18K16220)
809-P: Digital-Tool-Supported Basal Insulin (BI) Titration: Real-World Effectiveness of My Dose Coach (MDC) in People with Type 2 Diabetes (T2D) in Colombia
Authors: GOMEZ ANA MARIA , RINCON ALEX RAMIREZ , FERIZ KAREN , SALAMANCA CARLOS F. , SILVA LILIANA P. 
Published: May 2022

BI therapy is recommended in people with T2D uncontrolled on oral antidiabetic agents. However, due to delay in BI initiation and titration, many people with T2D fail to achieve recommended glycemic targets. MDC, an FDA-approved digital app, helps people with T2D to adjust their BI doses based on their fasting blood glucose (FBG) readings and hypoglycemic event data. We evaluated real-world outcomes from people with T2D on BI therapy, who registered on MDC app from 08/01/2018 to 09/30/2021 and received insulin glargine 100 U/mL or 300 U/mL. FBG target achievement (≥3 consecutive measurements within the target range) , change in FBG, and hypoglycemia events were assessed. A total of 5MDC users from Colombia with mean (SD) age 56.6 (15.1) years (55.8% female) were included (Table) . Overall, 4 (80.9%) users achieved individualized FBG target, 44 (8.7%) were still titrating and 52 (10.3%) stopped using MDC. The mean (SD) time to reach FBG target was 10.3 (15.8) days. Mean (SD) FBG at baseline was 141.7 (55.0) mg/dL, which decreased to 117.3 (31.7) mg/dL and mean (SD) BI dose increased from 22.2 (11.3) U to 24.2 (12.4) U. Hypoglycemia events were reported in 72 (14%) participants overall. These results show that people with T2D from Colombia using MDC were able to successfully titrate their BI doses and achieve FBG target with low risk of hypoglycemia.

Disclosure
A.Gomez: Advisory Panel; AstraZeneca, Research Support; Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company, Medtronic, Novo Nordisk, Sanofi. A.Rincon: Advisory Panel; AstraZeneca, Medtronic, Sanofi, Consultant; Abbott, Medtronic, Novo Nordisk, Novo Nordisk, Sanofi, Other Relationship; Boehringer Ingelheim International GmbH, Novo Nordisk, Sanofi. K.Feriz: Other Relationship; Abbott, Boehringer Ingelheim International GmbH, Novo Nordisk, Sanofi, Speaker's Bureau; AstraZeneca, Lilly Diabetes, Medtronic, Merck Sharp & Dohme Corp. C.F.Salamanca: Employee; Sanofi. L.P.Silva: Employee; Merck KGaA, Sanofi.

Funding
Sanofi
81-LB: Continuous Glucose Monitoring Strategies and Devices at a Diabetes Camp
Authors: GLEICH SARAH E. , TECCA HEATHER R. , GIBSON-NORTH NATHANIEL D. , SCHUSTER ERIKA , GREEN COURTNEY R. , WALKER TOMAS C. 
Published: May 2022

Background: Safe management of T1D in congregate settings such as diabetes camps may involve continuous glucose monitoring (CGM) devices, and managers of these facilities face choices regarding systems and deployment strategies. We aimed to compare individual versus multiplex monitoring strategies and to separately compare CGM systems from Dexcom (G6) and Abbott (Libre Pro) .
Methods: G6 users included 45 campers ages 8-17 years. Four used individual SMBG with G6 Pro systems in blinded mode; 41 used unblinded G6 systems whose data were available for remote review on an investigational multiplex display. Separately, data from 17 campers using G6 systems were compared to data from 17 campers using Libre Pro systems.
Results: As shown in the Table, most metrics of glycemic control favored the multiplex-monitored group over the individually SMBG-monitored group; the between-groups difference reached statistical significance with respect to nocturnal percent of time &lt;54 mg/dL (%&lt;54) . Analysis of data from G6 and Libre Pro systems revealed significantly lower mean glucose levels and more hypoglycemia among Libre Pro users, especially at night.
Conclusion: Meaningful differences in CGM-measured overall and nocturnal hypoglycemia may result from choices in monitoring strategies and device manufacturers.

Disclosure
S. E. Gleich: Research Support; Dexcom, Inc. H. R. Tecca: Employee; Dexcom, Inc. N. D. Gibson-north: n/a. E. Schuster: Employee; Dexcom, Inc. C. R. Green: Employee; Dexcom, Inc. T. C. Walker: Employee; Dexcom, Inc., Stock/Shareholder; Dexcom, Inc.

Funding
Dexcom, Inc.
870-P: Newer Glucose-Lowering Drugs and Risk of Dementia: A Meta-analysis of Cardiovascular Outcome Trials
Authors: TANG HUILIN , NIU SHU , BROWN JOSHUA D. , WEI JINGKAI , WINTERSTEIN ALMUT G. , BIAN JIANG , GUO JINGCHUAN 
Published: May 2022

Background: Existing observational studies yielded mixed results between cognitive and dementia outcomes and newer glucose-lowering drugs (GLDs) , i.e., dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1RAs) , and sodium-glucose co-transporter-2 (SGLT2) inhibitors, while individual randomized trials have inadequate power to examine such an effect. Thus, we aimed to evaluate the effect of these newer GLDs on the risk of dementia by performing a meta-analysis of randomized outcome trials.
Methods: We included published randomized placebo-controlled cardiovascular and renal outcome trials that evaluated DPP-4 inhibitors, GLP-1RAs, and SGLT2 inhibitors and reported dementia events. The study outcomes were all-cause dementia and vascular dementia, extracted from clinicaltrials.gov. We calculated pooled odds ratios (OR) and 95% CIs using the Peto method.
Results: We included 21 trials involving 1all-cause dementia cases (including 22 vascular dementia cases) among 167,5patients with or without type 2 diabetes over a median follow-up of 2.2 years. Neither DPP-4 inhibitors (OR, 0.65 [0.33-1.29]) , GLP-1RAs (OR, 0.88 [0.51-1.52]) , or SGLT2 inhibitors (OR, 1.22 [0.54-2.74]) were significantly associated with all-cause dementia incidence. For vascular dementia, compared with placebo, SGLT2 inhibitors were significantly associated with a decreased risk (OR, 0.[0.02-0.66]) , while DPP-4 inhibitors (OR, 0.67 [0.12-3.85]) and GLP-1RAs (OR, 0.37 [0.12-1.14]) did not significantly decrease the risk. No evidence of statistical heterogeneity or publication bias was detected in the meta-analysis (p &gt;0.05) .
Conclusion: SGLT2 inhibitors may have a beneficial effect on lowering the vascular dementia risk, thus may be a drug repurposing signal. Nevertheless, future randomized controlled trials and/or comparative effectiveness studies using real-world data are warranted to further confirm our conclusion.

Disclosure
H.Tang: None. S.Niu: None. J.D.Brown: None. J.Wei: None. A.G.Winterstein: Consultant; Genentech, Inc., Research Support; Merck & Co., Inc. J.Bian: None. J.Guo: None.
885-P: Real-World Evidence on Health Care Costs Related to Self-Monitoring of Blood Glucose (SMBG) Compared with Continuous Glucose Monitoring (CGM) in Nonintensively Treated Type 2 Diabetes Mellitus (T2DM)
Authors: KERR DAVID , DUNCAN IAN , GIORGINO FRANCESCO , REPETTO ENRICO , PERKINS CHRISTOPHER , MAROUN RANA , RIVERS MEREDITH , WU ALEXANDER 
Published: May 2022

Background: Type 2 diabetes poses an economic burden to healthcare systems. For individuals with non-intensively treated T2DM, it is unclear whether the use of CGM would add health-economic value. The aim of this study was to compare the costs of SMBG compared to CGM in non-intensively treated T2DM.
Methods: A retrospective cost-analysis using the IBM® MarketScan® Databases was conducted. T2DM patients aged ≥18 years who were using SMBG or initiated CGM between Jan 2018 and March 20were eligible for inclusion. Inclusion criteria included two consecutive claims for T2DM or one claim for T2DM and a claim for glucose lowering therapy, at least one pharmacy claim for SMBG strips or CGM sensors and continuous enrollment for 1-year before and after the index date. Individuals with CGM in pre-index period, pregnancy, rapid-acting insulin, glucagon, T1DM, gestational or secondary diabetes were excluded. SMBG and CGM patients were matched using a propensity score and all cause costs during a one-year follow-up period were compared.
Results: A total of 3,498 patients were included in each matched cohort. For CGM patients, 77% used flash monitoring and 23% a real-time CGM. 35% of SMBG and 37% of CGM users were on basal insulin. Considering median values, SMBG total healthcare costs per person/year were $1,934 less vs. CGM users (p &lt; 0.05) . SMBG patients had significantly lower pharmacy cost (-$2,257, p&lt;0.05) and lower expenses for glucose-lowering treatments (-$1,045, p&lt;0.05) than CGM. Both SMBG and CGM cohorts had similar costs related to inpatient and emergency room admissions.
Conclusion: This analysis shows that SMBG is less costly than CGM in non-intensively treated T2DM patients and is associated with lower pharmacy costs, including glucose-lowering medications. Furthermore, no significant differences in the number of emergency room visits or hospitalizations are seen in SMBG and CGM users.

Disclosure
D. Kerr: Advisory Panel; Abbott Diabetes, Novo Nordisk A/S, Sanofi. Consultant; Evidation Health. Research Support; Novo Nordisk A/S. Stock/Shareholder; Glooko, Inc., Hi.Health. I. Duncan: Consultant; Onduo LLC. F. Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk. Consultant; Lilly Diabetes, Sanofi. Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. E. Repetto: Employee; Roche Diabetes Care. C. Perkins: Employee; Roche Diagnostics USA. R. Maroun: Employee; Amgen Inc., Roche Diagnostics. M. Rivers: Employee; Roche Diabetes Care. A. Wu: None.