bluuebunny/crossref_metadata_2025 huggingface dataset:
698-P: Parental Education and Family Income Associated with Increased CGM Use in Adolescents with Type 1 Diabetes
Authors: PARMAR ANGELEE , JASER SARAH S. , DATYE KARISHMA
Published: May 2022

Introduction: Consistent continuous glucose monitor (CGM) use has been shown to improve glycemic control in patients with T1D; however, adolescents use CGMs less than any other age group. We utilized data originating from an ongoing trial at two urban diabetes centers to compare CGM use across different demographic factors.

Methods: Surveys were completed by parents (N = 150, 83% female) of adolescents with T1D (Mage 15.4 ± 1.3, MT1D duration 6.5 ± 3.7 years, MA1c 9.1 ± 2.1, 58% female, 59% White, Non-Hispanic, 19% Black, Non-Hispanic, 8% Biracial/Multicultural, 5% Hispanic, 4% Asian, 5% Other) participating in a clinical trial of a positive psychology intervention. Descriptive analyses and regression analyses were employed to compare CGM usage across different demographics. Rural communities were defined as <5,000 residents.

Results: Of the parents surveyed, 81% indicated that their adolescents currently used CGMs. There were no significant differences in adolescent CGM use related to race, X2 = 4.46, p = .49, ethnicity, X2 = 1.79, p = .18, or residence in a rural community, X2 = 0.10, p = .76. CGM use was significantly higher in teens of parents who graduated from college (87%) than those without a college degree (70%) , X2 = 6.19, p = .013. Adolescents from families with an annual income ≥ $90,000 also had higher CGM use (88%) than lower income families (72%) , X2 = 5.56, p = .018. In a multivariable model, parental education and income emerged as the significant predictors of CGM use.

Conclusions: These findings highlight significant associations between parent educational level/income and adolescent CGM use, which may reflect parents with higher SES having greater familiarity with technology. Moreover, while the diverse sample is a strength of this analysis, we did not observe previously reported differences in CGM use related to race/ethnicity. Therefore, future studies with larger samples and qualitative work with stakeholders are needed to identify predictors of CGM use.

Disclosure

A.Parmar: None. S.S.Jaser: None. K.Datye: None.

Funding

National Institutes of Health (R01DK121316) Vanderbilt Katherine Dodd Faculty Scholars Program
702-P: Short-Period CGM Data Are More Useful than HbA1c for Treatment Adjustment in Type 2 Diabetes Patients
Authors: TOTOMIROVA TZVETELINA , ARNAUDOVA MILA
Published: May 2022

Current recommendations for type 2 diabetes treatment are based on targeting HbA1c depending on different factors. HbA1c reflects recent 8-12 weeks glucose control, but amount of data show HbA1c insufficiencies. Continuous glucose monitoring (CGM) is used for insulin dose adjustment but also for control assessment and treatment determination. In our study we compare seven-day non-real time CGM data and HbA1c to find out which is more appropriate for determining drug prescription in patients with type 2 diabetes. Our study includes 85 patients with type 2 diabetes (35 women, 50 men; age 43.93±10.87 years, disease duration 21.91±6.years) , on different treatment regimens (31 on oral therapy, 33 treated with premixed insulin, 21 on multiple insulin injections) . Patients performed Non-Real Time Continuous Glucose Monitoring by using iProTM for seven days and HbA1c was measured at the end of this period. No difference in HbA1c level was found in three observed groups. HbA1c showed moderate negative correlation to percentage of time within the limits (r1=-0.48; r2= -0.654; r3= -0.674) . Based on HbA1c assessment 34.84% of type 2 patients on oral medications, 36.36% of patients on premixed insulin and 19.05% of type 2 patients on multiple daily injection are with good control. CGM defined 54.84% of type 2 patients on oral medication, 18.27% of patients on premixed insulin and 17.80% of type 2 patients on intensified regimen as well controlled. CGM was more precise than HbA1c in defining patients with good control (p<0.05) . HbA1c shows bad correlation with overall glucose excursion (r1=-0.096, r2=0.200, r3=0.377) . No difference was found between studied groups in regard to CGM percentage of time spent above and below the limits and to AUC above upper limit. We conclude that CGM data give more precise information than HbA1c about glucose control and are more useful for defining treatment adjustment. Even performing CGM for short period helps physician to choose the most appropriate drug.

Disclosure

T.Totomirova: n/a. M.Arnaudova: None.
705-P: CGM Attitudes and Adoption among People with Type 2 Diabetes Using One Drop
Authors: SEARS LINDSAY , IMRISEK STEVEN D. , HOY-ROSAS JAMILLAH R. , LAVAYSSE LINDSEY M. , LEE MATTHEW , CHAPMAN MATTHEW R. , DACHIS JEFF
Published: May 2022

Background: Despite research establishing the strong benefits of continuous glucose monitors (CGMs) in the management of diabetes, adoption remains low among people with type 2 diabetes (T2D) . The present mixed-method study describes CGM attitudes and use among people with T2D.

Method: Members with T2D with a paid subscription to One Drop completed a survey about One Drop and their health. Qualitative reasons for and against CGM adoption were coded and reported with descriptive statistics.

Results: Of the 171 respondents, 55% were male, 70% were White, 86% were non-Hispanic and average age was 55.4 (SD=11.7) . Approximately 92% of members reported logging their blood sugar daily or weekly, 96% of members found One Drop’s health logging features helpful, and 95% found the glucose analysis and reports helpful. Most members were familiar with CGM devices (90%) , and of that group, 83% had never tried one. Most of those familiar with CGMs were also open to CGM adoption (N=107; 79%) . Reasons for openness included valuing continuous feedback (28) , relief from fingersticks (15) , convenience (12) and improved diabetes management (12) , while a subset expressed concerns about insurance coverage and costs (12) . Those not open to CGM adoption (N=29) cited a lack of need (9) , lack of familiarity (4) , inconvenience (3) , pain/size of devices (3) and costs (2) .

Conclusion: Despite their established benefit, CGM adoption among people with T2D is concerningly low. While awareness and interest in CGM adoption is high, costs are a concern, and there is a subset that would benefit from more education and exposure. Advancements in device technology, reimbursement policy as well as interventions to increase health knowledge and motivation are warranted to better meet the needs and preferences of people with T2D.

Disclosure

L.Sears: Employee; One Drop. S.D.Imrisek: Employee; One Drop. J.R.Hoy-rosas: None. L.M.Lavaysse: Employee; One Drop. M.Lee: Employee; One Drop. M.R.Chapman: Employee; One Drop. J.Dachis: Board Member; One Drop, Employee; One Drop, Stock/Shareholder; One Drop.
706-P: CGM Disruption: A Common Phenomenon
Authors: CEDENO ANDREA , KRUTILOVA PETRA , MARKOV ALEXANDER , MCGILL JANET B. , MCKEE ALEXIS M.
Published: May 2022

Background: Advances in diabetes technology have led to reliance on continuous glucose monitors (CGM) for glycemic management. Insufficient wear time due to device malfunction, insertion problems, displacement or removal for imaging, medical procedures or hospitalization is common. Prescription practices that provide an exact number of sensors without redundancy fail to account for the realities of CGM use. The aim of this study is to characterize CGM disruption rates and consequences.

Methods: A RedCap survey was completed by adults from a university based diabetes center with T1D or T2D who utilize CGM.

Results: Of 262 surveys sent, 76 were completed. Participants had mean age 54, T1D 69%, female 72%, White 97%, and mean duration of diabetes 28 years. 100% used CGM (85.1% Dexcom, 9.5% Freestyle Libre, 5.4% Medtronic) , 61% insulin pump, and 41% HCL systems. The percent of participants reporting ≥1 CGM disruption events in 1 year: device malfunction (85.1%) , insertion problems (63.0%) , displacement (56.8%) ; removal for imaging (44.6%) , surgery/procedures (13.7%) and hospitalization (4.1%) . Adverse glycemic events attributed to disruption of CGM including hyperglycemia and hypoglycemia occurred ≥1 time in 55.4% and 45.9% of the participants respectively (Figure) .

Conclusion: Loss of CGM use prior to the anticipated change date is common. Lack of redundancy of CGM supplies contributes to disruptions in care and adverse glycemic events.

Disclosure

A.Cedeno: None. P.Krutilova: None. A.Markov: None. J.B.Mcgill: Advisory Panel; Gilead Sciences, Inc., Lilly Diabetes, MannKind Corporation, Novo Nordisk A/S, Provention Bio, Inc., Salix Pharmaceuticals, Consultant; Bayer AG, Boehringer Ingelheim International GmbH, Research Support; Dexcom, Inc., Novo Nordisk. A.M.Mckee: Consultant; Medtronic.
720-P: Change in Body Weight from Baseline with Tirzepatide: Sex Subgroup Analysis of the SURPASS Studies
Authors: PLAT ARIAN W. , RASOULI NEDA , PELESHOK JENNIFER , SAPIN HELENE , WILDING JOHN
Published: May 2022

Five Phase 3 SURPASS trials have shown robust efficacy of novel dual GIP/GLP-1 receptor agonist, tirzepatide, in glycaemic control and body weight (BW) loss in adults with Type 2 Diabetes (T2D) . A key secondary endpoint investigated the effect of tirzepatide (5, 10, and 15 mg) versus placebo or active comparators on mean BW change from baseline to endpoint. To determine whether weight-lowering effects of tirzepatide depend on the sex of study participants, we conducted a post-hoc subgroup analysis of SURPASS (S) -1 to -5 trials. BW change in the sex subgroups was assessed in patients while on treatment without rescue medication (efficacy estimand) in the modified intention-to-treat (mITT) population, defined as all randomized patients who received at least one dose of study drug. All tirzepatide doses significantly reduced BW compared to placebo or active comparators regardless of the sex of study participants (S-1 to -5 p<0.001) . The most frequent AEs were mild-to-moderate, GI-related, and occurred during the dose-escalation period.

Disclosure

A.W.Plat: None. N.Rasouli: Advisory Panel; Eli Lilly and Company, Novo Nordisk, Sanofi, Research Support; Allergan, Eli Lilly and Company, Novo Nordisk. J.Peleshok: Employee; Eli Lilly and Company, Eli Lilly and Company. H.Sapin: Employee; Eli Lilly and Company. J.Wilding: Advisory Panel; Alnylam Pharmaceuticals, Inc., AstraZeneca, Eli Lilly and Company, Mundipharma, Novo Nordisk A/S, Rhythm Pharmaceuticals, Inc., Sanofi, Research Support; AstraZeneca, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk A/S, Takeda Pharmaceutical Company Limited.

Funding

Eli Lilly and Company
727-P: Glycemic Effect of Tirzepatide by Duration of Diabetes
Authors: DE BLOCK CHRISTOPHE , MATHIEU CHANTAL , SAPIN HELENE , KILJANSKI JACEK I. , PELESHOK JENNIFER
Published: May 2022

Results of SURPASS-1 through -5 trials have shown robust efficacy of novel dual GIP/GLP-1 receptor agonist tirzepatide (TZP) in people with type 2 diabetes. To understand whether glucose-lowering effect of tirzepatide depends on the duration of diabetes we conducted a subgroup analysis within each of the 5 Phase 3 trials. The primary endpoint of the 5 SURPASS clinical trials was mean change from baseline in HbA1c for 5mg, 10mg, and 15mg to 40 or 52 weeks against various comparators in adults with type 2 diabetes. This subgroup analysis of the 5 trials assessed whether mean change of HbA1c from baseline in the overall population were consistent when assessed by baseline duration of diabetes category (≤5 years, 5 to years, >years) in patients while they were on-treatment and without rescue medication (efficacy estimand) . For all 5 studies, analysis of change from baseline in HbA1c at 40 or 52 weeks for all 3 duration of diabetes subgroups were consistent with primary study results, with the treatment differences favoring all 3 doses of TZP compared with placebo or active comparator (Figure) . The most frequent adverse events were mild-to-moderate, gastrointestinal-related and occurred during the dose-escalation period. In conclusion, these results suggest that TZP was effective for mean change from baseline Hba1c for patients regardless of baseline duration of diabetes consistent with the overall patient population across the 5 SURPASS studies.

Disclosure

C.De block: Advisory Panel; Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk, Research Support; Indigo Diabetes, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk. C.Mathieu: Advisory Panel; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Imcyse, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, Zealand Pharma A/S, Speaker's Bureau; AstraZeneca. H.Sapin: Employee; Eli Lilly and Company. J.I.Kiljanski: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. J.Peleshok: Employee; Eli Lilly and Company, Eli Lilly and Company.
730-P: Effectiveness of iGlarLixi (Insulin Glargine-Lixisenatide) in People with Type 2 Diabetes According to the Time of Administration through the Day
Authors: HALUZIK MARTIN , SEUFERT JOCHEN , GUJA CRISTIAN , BONNEMAIRE MIREILLE , BIGOT GREGORY , TOURNAY MATHILDE , KIS JANOS T. , FREEMANTLE NICK
Published: May 2022

Pre-Breakfast iGlarLixi efficacy and safety were demonstrated in several randomized controlled trials. Whether time of administration could impact effectiveness in real life clinical practice is unknown. In the European REALI pooled database, we analyzed patient-level data of 1303 people with type 2 diabetes (T2D) treated with iGlarLixi for 24 weeks. Of these, 33% had the injection pre-Breakfast, 20% pre-Lunch, 31% pre-Dinner, while 16% switched time of injection. Overall, baseline characteristics were similar among groups with mean±SD age of 61±9.0 years, BMI 32.2±5.5 kg/m2, and median diabetes duration of 9 years. People with T2D previously used 1 oral glucose-lowering agent (57%) or ≥2 (43%) . A total of 590 people (45%) were insulin pretreated for a median duration of 2.5 years. Mean±SD HbA1c improved from 9.1±1.4% at Baseline to 7.7±1.2% at Week 24, with a least square mean decrease of 1.4% [95% CI: -1.50;-1.36], and most notable reduction in the pre-Breakfast group as shown in Figure 1. Mean±SD fasting plasma glucose decreased by 50.0±54.2 mg/dL and body weight by 1.8±6.6 kg at Week 24 with no difference between groups. Hypoglycemia reports were low in all groups.This analysis confirms the effectiveness of iGlarLixi at all administration times; pre-Breakfast may be preferable when there is a choice.

Disclosure

M.Haluzik: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi, Speaker's Bureau; Abbott Diabetes, AstraZeneca, Lilly Diabetes, Novartis AG. J.Seufert: Advisory Panel; Abbott, Sanofi-Aventis Deutschland GmbH, Research Support; Boehringer Ingelheim International GmbH, Speaker's Bureau; Abbott Diabetes, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Lilly, Novo Nordisk, Sanofi-Aventis Deutschland GmbH. C.Guja: Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Servier Laboratories. M.Bonnemaire: Employee; Sanofi. G.Bigot: None. M.Tournay: None. J.T.Kis: Speaker's Bureau; 77 Elektronika Kft., AstraZeneca, Boehringer Ingelheim International GmbH, EGIS Pharmaceuticals, Lilly Diabetes, Novo Nordisk, Sanofi. N.Freemantle: Consultant; Novo Nordisk, Research Support; Aimmune, ALK-Abelló A/S, Allergan, AstraZeneca, Ipsen Biopharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Sanofi, Vertex Pharmaceuticals Incorporated, Speaker's Bureau; Abbott.

Funding

Sanofi
731-P: Metabolite Biomarkers and Cardiovascular Events in REWIND: A Post Hoc Analysis
Authors: PIRRO VALENTINA , PARE GUILLAUME , LEE SHUN FU , COLHOUN HELEN M. , LIN YANZHU , WILSON JONATHAN M. , QIAN HUI-RONG , HOOVER ANASTASIA , DUFFIN KEVIN L. , GERSTEIN HERTZEL C.
Published: May 2022

Dulaglutide (DU) reduced the risk of CV outcomes compared with placebo (PL) in the REWIND trial (NCT01394952) , with a MACE-3 (major adverse CV events) hazard ratio of 0.88 over 5.4 years. Participants were ≥50 years of age with T2D, A1C ≤9.5%, BMI ≥23 kg/m2, and CV risk and received either DU (1.5 mg weekly) or PL. This post-hoc analysis explored the hypothesized relationship between metabolite biomarkers and MACE-3 in a nested case-control substudy comprising 600 MACE cases and 6non-MACE REWIND participants. A total of 135 plasma metabolites were measured by targeted metabolomics using mass spectrometry. Biomarkers significantly associated with DU were first identified in analyses that adjusted for 135 multiple comparisons (discovery approach) . Predefined clusters of the remainder based on non-REWIND data were then assessed using principal component analyses (hypothesis testing) . DU was associated with 2-year changes in 2-hydroxybutyric acid, threonine, acylcarnitines and homocitrulline; of these, only the acylcarnitines were linked with MACE (Table) . In the literature, higher levels of acylcarnitines are associated with CV events. These analyses suggest that DU-associated reductions in acylcarnitines are associated with its MACE benefit.

Disclosure

V.Pirro: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. H.C.Gerstein: Advisory Panel; Abbott, Eli Lilly and Company, Hanmi Pharm. Co., Ltd., Novo Nordisk, Pfizer Inc., Sanofi, Viatris Inc., Consultant; Kowa Company, Ltd., Other Relationship; DKSH, Eli Lilly and Company, Sanofi, Zuellig Pharma Holdings Pte. Ltd., Research Support; AstraZeneca, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi. G.Pare: Advisory Panel; Amgen Inc., Bayer AG, Sanofi, Research Support; Bayer AG. S.Lee: None. H.M.Colhoun: Advisory Panel; Bayer AG, Eli Lilly and Company, Novo Nordisk, Consultant; AstraZeneca, Research Support; AstraZeneca, Stock/Shareholder; Bayer AG, Roche Pharmaceuticals. Y.Lin: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. J.M.Wilson: Employee; Eli Lilly and Company. H.Qian: Employee; Eli Lilly and Company, Stock/Shareholder; Apple, Eli Lilly and Company. A.Hoover: Employee; Eli Lilly and Company. K.L.Duffin: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company, Pfizer Inc.

Funding

Eli Lilly and Company
767-P: Changes in Ambulatory Glucose Profile (AGP) in Patients with Type 1 Diabetes Mellitus after Switching from Sensor-Augmented Insulin Pump Therapy to a Do-it-Yourself Artificial Pancreas System: A Retrospective Data Analysis of Real-World Data
Authors: MUELLER-KORBSCH MICHAEL , FRUEHWALD LISA , KIETAIBL ANTONIA-THERESE
Published: May 2022

Background: Many patients with type 1 diabetes mellitus are switching from sensor-augmented insulin pump therapy to an artificial pancreas system for various reasons. Since there are no suitable approved Automated Insulin Delivery -AID system in Austria, open-source systems are increasingly being used. The question arises, how does glycemic control change after switching?

Methods: This monocentric retrospective data analysis from 20to 2021 will compare sensor-augmented pump therapy with the open-source AID system using AGP profiles from 25 patients with type 1 diabetes mellitus. The AGP are generated from sensor data 4 weeks with pump therapy AGP1 and 4 weeks with open-source AID system AGP2. AGP is generated with Dexcom application.

Results: Comparing AGP1 and 2 shows a significant reduction of mean glucose from 143mg/dl to 125mg/dl and glucose variability from 50mg/dl to 40mg/dl. The time in target range can be increased from 74% to 84% without changing the time in hypoglycemia. Time in hyperglycemia above 180 and 250 mg/dl and GMI decreased significantly.

Conclusion: Open-source AID system can achieve an improvement in glycemic control. In this data analysis, the open-source AID systems can be considered safe due to the lack of increase in hypoglycemia.

Disclosure

M. Mueller-Korbsch: Research Support; Dexcom, Inc.
779-P: Announced Meals at Will with the MINIMED Advanced Hybrid Closed-Loop
Authors: MINSKY NOGA , HIRSH MAYA LARON , SHALIT ROY , COHEN OHAD , KURTZ NATALIE , ROY ANIRBAN , GROSMAN BENYAMIN , TIROSH AMIR
Published: May 2022

Background: We compared glycemic outcomes and participant experience during MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system use while announcing all meals vs. announcing meals at will.

Methods: Participants with T1DM used the AHCL system at home during two 90 days phases in which they were given instructions first to announce all meals (AM) , and next, for meals containing up to 80 grams of carbohydrates, to announce meals at will (AMW) .

Results: Fourteen subjects (males, mean age 44.3±11) with T1DM were enrolled, with a baseline A1C of 6.9±1%. Table 1 summarizes glycemic indices and AHCL data, demonstrating that patients chose to bolus only slightly less during AMW compared to AM (5.5 vs. 5.2 boluses) , without resultant deterioration in glycemic indices (A1c 6.4 vs. 6.5%, TIR 78.1 vs. 78.8%, p=ns) . Subjects surveyed regarding the option not to have to bolus for all meals experienced a significant reduction in reported effort to manage diabetes (p=0.045) and 86% endorsed worrying less about their diabetes. Most (93%) preferred the AMW phase of the study.

Conclusion: The MinMed™ AHCL system is designed for optimal performance with meal announcement. Nonetheless, when meals containing < 80 grams of carbohydrates are consumed with announcement of meals at will, there is a slight reduction in the number of daily boluses with no decline in glycemic control, yet markedly less diabetes related distress and improved treatment satisfaction.

Disclosure

N. Minsky: None. R. Shalit: Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk. O. Cohen: Employee; Medtronic. N. Kurtz: Employee; Medtronic. A. Roy: Employee; Medtronic. B. Grosman: Employee; Medtronic. A. Tirosh: Advisory Panel; Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim International GmbH, Merck & Co., Inc., Novo Nordisk, Sanofi. Consultant; Bayer AG, DreaMed Diabetes, Ltd. Research Support; Medtronic. Speaker's Bureau; Eli Lilly and Company.
78-LB: Association between Daytime vs. Nighttime Mean Glucose and Time-in-Range with A1C in Adults with Type 1 Diabetes
Authors: SHAH VIRAL , VIGERS TIMOTHY B. , PYLE LAURA , AKTURK HALIS K. , KLONOFF DAVID C.
Published: May 2022

Prior studies using frequent self-monitored blood glucose in patients with type 2 diabetes on oral medications reported that the relative contribution of fasting glucose gradually increased with increasing HbA1c levels (30% for A1c <7.3% and 70% for A1c >10.2%) . This has led to targeting fasting glucose first to lower A1C in uncontrolled diabetes.

Our study evaluated associations between daytime vs. nighttime mean glucose and time-in-range (TIR; 70-180 mg/dL) with A1C in adults with type 1 diabetes (T1D) (n=340) using Dexcom G6 continuous glucose monitoring (CGM) for at least 6 months. The last 2 weeks of CGM mean glucose and TIR were correlated with four A1C categories (<7%, 7- <8%, 8-<9%, 9-<10%, and >10%) .

With increasing A1C, there was increased mean sensor glucose and reduced TIR for daytime and nighttime (p<0.001 for both) . However, there was no difference in daytime vs. nighttime in TIR (p=0.08) or mean glucose (p=0.42) within four A1C groups. The results were similar when TIR target was changed to 70-140 mg/dL.

Our results suggest influence of mean glucose and TIR on A1C is similar during daytime and nighttime in T1D adults. Thus, either postprandial glucose reduction or fasting glucose reduction strategies should be equivalent in lowering A1C. Our results explain the basis for the benefits of the established use of equal doses of basal and bolus insulin for all A1C levels in these patients.

Disclosure

V. Shah: Advisory Panel; Medscape, Sanofi, Consultant; Dexcom, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk. T. B. Vigers: None. L. Pyle: None. H. K. Akturk: Research Support; Dexcom, Inc., Eli Lilly and Company, REMD Biotherapeutics. D. C. Klonoff: Consultant; AI Health, Dexcom, Inc., Eli Lilly and Company, EOFlow Co., Ltd., Fractyl Health, Inc., Integrity, Lifecare, Inc., Medtronic, Novo Nordisk, Rockley Photonics, Samsung, Thirdwayv Inc., Employee; Diabetes Technology Society.
783-P: When Automated Insulin Delivery Technology Meets Behavior: A Pilot Exploration of Human-Machine Coadaptation in Type 1 Diabetes
Authors: COLMEGNA PATRICIO , MCFADDEN RYAN , FABRIS CHIARA , LOBO BENJAMIN , OLIVERI MARY C. , NASS RALF , BROWN SUE A. , KOVATCHEV BORIS
Published: May 2022

Background: Automated Insulin Delivery (AID) devices in type 1 diabetes (T1D) are becoming standard of care, and the need for adaptive AID systems is now well recognized. However, very little is known about how self-treatment behaviors should be adapted to the action of an AID system, especially with hybrid closed-loop (HCL) solutions that still require people with T1D to make several treatment decisions each day.

Methods: A safety and feasibility 8-week study with a randomized two-arm parallel group design was conducted. Both control and experimental groups used a web-based simulation tool, and a commercial AID system (Control-IQ®) enhanced with an auto-titration module (ATM) that adjusted insulin therapy parameters weekly. The experimental group had access to a behavioral adaptation module (BAM) that provided up-to-date risk assessment from CGM data. Primary outcome: Safety assessment of ATM and BAM. Secondary glycemic outcomes: CGM-based metrics computed from the 2-week baseline period and last 2 weeks of treatment data.

Results: Thirty Control-IQ® users completed all study procedures, 17 women and 13 men, age: 40±14 years, diabetes duration: 23±14 years, HbA1c: 6.6%±0.5%. No severe hypoglycemia, DKA, or other serious adverse events were reported. No significant changes were observed in time in 70-180 mg/dL. Changes in time in 70-140 mg/dL and mild hyperglycemia 180-250 mg/dL were significantly different between control (-3.1% and +3.1%) and experimental (+3.6% and -0.7%) groups (P=0.and 0.04) . Overnight time in 70-140 mg/dL increased significantly in the experimental group (6.8%, 95% CI [0.6%,12.9%], P=0.03) . Time < 70 mg/dL decreased in both groups, but significantly only in the control group (-0.9%, 95% CI [-1.6%,-0.3%], P=0.vs. -0.1%, 95% CI [-0.7%,0.5%], P=0.71) .

Conclusions: Results from this pilot study suggest that combining HCL AP with behavioral adaptation feedback to the user is safe and effective.

Disclosure

P.Colmegna: None. R.Mcfadden: None. C.Fabris: None. B.Lobo: Other Relationship; Dexcom, Inc., Research Support; Dexcom, Inc. M.C.Oliveri: None. R.Nass: None. S.A.Brown: Research Support; Dexcom, Inc., Insulet Corporation, Roche Diagnostics USA, Tandem Diabetes Care, Inc., Tolerion, Inc. B.Kovatchev: Other Relationship; Dexcom, Inc., Johnson & Johnson, Novo Nordisk, Sanofi, Research Support; Dexcom, Inc., Novo Nordisk, Tandem Diabetes Care, Inc., Speaker's Bureau; Dexcom, Inc., Tandem Diabetes Care, Inc.

Funding

National Institutes of Health (2R01DK085623-10)
787-P: Quality of Life and Psychological Well-Being among Children with Diabetes Using Open-Source Automated Insulin Delivery Systems: Findings from a Global Survey
Authors: KNOLL CHRISTINE , BRAUNE KATARINA , BALLHAUSEN HANNE , SCHIPP JASMINE , SKINNER TIMOTHY C. , WÄLDCHEN MANDY , O'DONNELL SHANE , GAJEWSKA KATARZYNA A. , CLEAL BRYAN , RAILE KLEMENS
Published: May 2022

Background: Open-source automated insulin delivery (AID) systems have shown to be safe and effective in clinical and real-world studies and to increase quality of life (QoL) in adult users. However, there is a lack of evidence on the effect on health-related QoL and general wellbeing in children and their caregivers. Therefore, the aim of this study was to assess the QoL of children and adolescents with diabetes using open-source AID systems using validated measures.

Method: In this cross-sectional, population-based global online survey we examined the caregiver-reported QoL and psychological well-being of users and non-users of open-source AID. Validated questionnaires assessed general emotional wellbeing (WHO-5 Well-being Index) , diabetes-specific QoL (Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR) , Pediatric Quality of Life Inventory (PedsQL, diabetes module) and subjective sleep quality (Pittsburgh Sleep Quality Index (PSQI)) .

Results: In total 188 caregivers from 27 countries completed at least one questionnaire on behalf of their children, including 132 children with type 1 diabetes using open-source AID (mean age 11.5 (SD 3.5) , 48% female) and 56 children with type 1 diabetes who were non-users at the time of the survey (mean age 10.4 (SD 3.3) , 41% female) . All questionnaire scores showed significant between-group differences with the AID users reporting higher general (WHO-5: p<0.001) , diabetes-related (PAID: p=0.029; PedsQL: p=0.016) and sleep-related QoL (PSQI: p<0.001) .

Discussion: The results show the beneficial impact that open-source AID systems have on the QoL and psychological well-being of children and adolescents, and can therefore help to inform academia, regulatory decision- and policymakers about the potential that open-source AID systems hold. Further research is needed to examine the reasons for the differences between the groups.

Disclosure

C.Knoll: None. K.Raile: Other Relationship; Dexcom, Inc. K.Braune: None. H.Ballhausen: None. J.Schipp: None. T.C.Skinner: None. M.Wäldchen: None. S.O'donnell: None. K.A.Gajewska: None. B.Cleal: None.

Funding

European Commission's Horizon 2020 Research and Innovation Program under the Marie Skłodowska-Curie Action Research and Innovation Staff Exchange (RISE) (grant agreement number 823902)
789-P: Evaluating the Feasibility of Incorporating Nonglucose Signals in Automated Insulin Delivery System
Authors: BANERJEE AYAN , KAUR RAVINDER JEET , ZANILETTI ISABELLA , CHURCH MEI MEI , MCCRADY-SPITZER SHELLY K. , DESJARDINS DONNA , GUPTA SANDEEP , KUDVA YOGISH C.
Published: May 2022

Introduction: There is need to improve glucose control and QoL for type 1 diabetes (T1D) using automated insulin delivery (AID) . We evaluated non-glucose signals in subjects with T1D on AID using the multi-functional Empatica E4 device (E4) .

Method: During a 2-week prospective AID study for 12 participants with T1D, pharmacological stress was induced with three doses of hydrocortisone delivered at 9 am (40 mg) , 1 pm (20 mg) , and 5 pm (20 mg) . Frequent salivary cortisol measurements confirmed pharmacologic stress. The correlation of normalized power spectral density (PSD) of Electrodermal activity (EDA) data from E4 with the salivary cortisol (SC) gold standard was evaluated. EDA PSD was computed at min windows before and after the hydrocortisone administration. Subsequently, the impact of SC and EDA PSD on CGM and insulin delivery data was analyzed. Pearson's moment (R value) was utilized to evaluate correlation between two variables.

Results: Significant change in SC was observed after each dosage: 159.6 ±88.6 ng/dL before to 18247.6 ±18834 ng/dL after (Dose 1/D1) , 1911.9 ±7ng/dL to 7716.1±4485 ng/dL (D2) , and 798.4 ±629 ng/dL to 7458.1±9995 ng/dL (D3) . A positive change was also noted in the EDA PSD with all three doses: -96.5±13.9 dB/Hz to -95.5 ±21.2 dB/Hz (D1) , -96.1±14.02 dB/Hz to -94.6 ±9.1db/Hz (D2) , and -85.9 ±23.6dB/Hz to -81.6 ±23.6dB/Hz (D3) . R value between EDA PSD and SC was 0.82 (p = 0.015) . The post lunch time in hyperglycemia was 78.7 %±9.7 (p = 0.0paired t-test) with an average insulin delivery of 10.36 U±2.24

Conclusions: There is significant effect of pharmacological stress on cortisol and EDA PSD. AID has poor postprandial glycemic outcomes with pharmacological stress indicating need for detecting stress and updating control strategy. E4 EDA can be utilized to monitor pharmacological stress and can be incorporated for testing in Next Gen AID.

Disclosure

A.Banerjee: None. R.Kaur: None. I.Zaniletti: None. M.Church: None. S.K.Mccrady-spitzer: None. D.Desjardins: None. S.Gupta: None. Y.C.Kudva: Advisory Panel; Novo Nordisk, Research Support; Dexcom, Inc., Hemsley Charitable Trust, JDRF, National Institutes of Health, Roche Diabetes Care, Tandem Diabetes Care, Inc.

Funding

JDRF grant (2-SRA-2017-503-M-B)
793-P: Real-World Data of Four-Year Durability of Glycemia Control with V-Go
Authors: VADAKEKALAM JOSEPH , COPPLE TINA , TRIGOSO WILLIAM F.
Published: May 2022

Patients with diabetes may struggle to comply with numerous injections required for blood glucose control. Previous studies have shown subcutaneous insulin infusion devices, such as V-Go, are an effective alternative to injections despite the limitation of the total daily dose of insulin (TDD) . The objective of this study is to validate previous work in a larger population over a longer time frame, showing V-Go significantly improves HbA1c.

A retrospective analysis of patients using V-Go from 2014 to July 2020 was conducted to evaluate changes in HbA1c, TDD, weight, and number of antidiabetic medications. EMR records were obtained at a large endocrine practice in south Texas. Inclusion criteria include a DM diagnosis, baseline HbA1c within 6 weeks prior to V-Go, and at least one HbA1c 3 months after V-Go. Exclusion criteria include pregnancy and undeterminable insulin dosing.

Chart review of 184 patients led to statistical evaluation of 178 patients who met criteria. As noted in Table 1, compared to baseline there was a significant decrease in HbA1c and an increase in percent of patients reaching HbA1c < 8 across measured time points. There were no significant changes to weight, TDD, or number of antidiabetics used at any time points evaluated.

Our data furthers previous studies showing similar benefits to HbA1c remain significantly stable over 4 years without an increase in TDD, weight, or the average number of antidiabetic medications.

Disclosure

J.Vadakekalam: None. T.Copple: Employee; AstraZeneca. W.F.Trigoso: Speaker's Bureau; Amarin Corporation, Amgen Inc., Boehringer Ingelheim International GmbH, Lilly.
794-P: Real-World Uses and Challenges with Hybrid Closed-Looped Systems among Adolescents with T1D
Authors: MORROW TROY , OKONKWO NKEMJIKA , JASER SARAH S.
Published: May 2022

Previous research on hybrid closed loop (HCL) systems has demonstrated their potential to improve glycemic outcomes and reduce the burden of diabetes care for people with T1D. We sought to describe adolescents' real world use the 670G Medtronic and Tandem Control IQ (CIQ) systems including the user-specific challenges that may pose barriers to using these systems as designed. We examined the medical records of 25 adolescents aged 11-17 with HCL-capable devices (mean age = 14.4, 46% female, 96% White, non-Hispanic, mean A1C = 8.4%) , who were enrolled in an ongoing study evaluating a behavioral intervention. We extracted information from participants' medical records over a 12-month period to identify barriers to device use. Using Automode or CIQ reports, each participant was categorized as having consistent (> 70%) , inconsistent (30-70%) , or low (<30%) use. In our sample, 33% of adolescents used the 670G exclusively, 33% used the Tandem CIQ and 33% switched from the 670G to the Tandem CIQ during the study period. We observed consistent use in 52% of adolescents, inconsistent use in 16%, and low use in 32%. Participants using the 670G system averaged 20% of the time in Automode, while participants using the Tandem system were in CIQ 72% of the time. The most prevalent challenges were Reluctance to use a HCL Component, Struggling to input data into HCL, and Technology failing. In our sample, adolescents experienced fewer barriers to use and had significantly higher rates of consistent use with the Tandem CIQ in comparison to the 670G. These findings suggest that HCL systems that require less calibration and user input and are less susceptible to technical difficulties are the most feasible for adolescent use. Prioritizing adolescents' comfort with diabetes technology may promote consistent usage to reap the full benefits. Further insight into the real-world use of HLC systems in different populations is essential to determine additional barriers or disparities in consistent use of these systems.

Disclosure

T.Morrow: None. N.Okonkwo: None. S.S.Jaser: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (R01DK115545-01A1) National Institute of Diabetes and Digestive and Kidney Diseases (3R01DK115545-03S1)
795-P: Significance and Future Trends of AID Systems from the Perspective of Physicians
Authors: HEINEMANN LUTZ , HERMANNS NORBERT , EHRMANN DOMINIC , ROOS TIMM , KULZER BERNHARD
Published: May 2022

Aims: How do physicians assess AID-Systems in terms of their current and future importance for diabetes care?

Methods: In 2021 3diabetologists in Germany (48% female, average age 53.7 years) were asked via online surveys about their current and future assessment of AID-Systems.The results were compared with the 20survey, in which 337 diabetologists (43% female, mean age 53.2 years) participated.

Results: Currently, 58.6% (2020: 51.4%) of diabetologists consider AID-Systems to be important for diabetes care, in 5 years 89.3% (2020: 86.4%) . Diabetologists estimate that in approx. 9 years one in two PwD TD1 in Germany will be a user of an AID-System, and in approx. 17 years 90% will use an AID-System. Currently, they estimate that 57.6% of all PwD-TD1 are suitable for an AID-System. Diabetologists see the clearest impact of AID-Systems in an increased need for diabetes selfmangement education (78.9%) , but also in PwD becoming much more autonomous and empowered (62.8%) . Regarding possible negative effects of AID-Systems, diabetologists see only few risks: 20% fear that PWD will have less contact with the diabetes team, 16.9% are concerned that PWD will not be able to cope with the technological change. Only 7.9% fear that PWD will become riskier with AID-Systems, only 1.7% have fears that the diabetes team will become superfluous.

Conclusions: Overall, diabetologists assess AID-Systems as a important innovation for diabetes care and that this will soon become the standard therapy for T1D. The effort for Diabetes self-management education and support is estimated to be relatively high, possible disadvantages relatively low.

Disclosure

L.Heinemann: Board Member; Lifecare, Inc., Consultant; Becton, Dickinson and Company, Roche Diabetes Care, Stock/Shareholder; Profil Institut für Stoffwechselforschung GmbH, Science Consulting in Diabetes GmbH. N.Hermanns: Advisory Panel; Abbott Diabetes, Research Support; Becton, Dickinson and Company, Roche Diagnostics, Speaker's Bureau; Berlin-Chemie AG, Novo Nordisk, Sanofi. D.Ehrmann: Advisory Panel; Dexcom, Inc., Consultant; mySugr, Roche Diabetes Care, Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. T.Roos: None. B.Kulzer: Advisory Panel; Bayer AG, Bayer AG, Becton, Dickinson and Company, Becton, Dickinson and Company, Berlin-Chemie AG, Berlin-Chemie AG, Dexcom, Inc., Dexcom, Inc., Insulet Corporation, Novo Nordisk, Roche Diabetes Care, Sanofi, Sanofi-Aventis Deutschland GmbH, Research Support; Novo Nordisk, Roche Diabetes Care.
8-OR: Plasminogen Deficiency Protects against Nonalcoholic Fatty Liver Disease and Insulin Resistance, but Not Diet-Induced Obesity
Authors: HUR WOOSUK S. , NGUYEN Y-VAN , PATEL YESHA , KING KATHARINE C. , FLICK MATTHEW J.
Published: May 2022

Obesity affects over 40% of the US population and predisposes individuals to metabolic syndrome, which is associated with a 50% increase in the risk of cardiovascular events. A documented clinical manifestation of obesity is a procoagulant and anti-fibrinolytic state. Elevated levels of circulating plasminogen activator inhibitor (PAI) -1 are correlated with metabolic syndrome, and PAI-1-deficient mice are protected from diet-induced obesity (DIO) . However, an unresolved question is whether plasminogen itself influences the development of obesity and associated disease sequelae? Here, we analyzed the impact of genetically-imposed plasminogen deficiency on the development of DIO and associated pathologies. Over the course of 20 weeks, plasminogen-deficient (Plg-) mice gained as much weight as the control mice (Plg+) on HFD, although HFD-fed Plg- mice had larger epididymal white adipose tissues than those of HFD-fed Plg+ mice. In contrast, while HFD-fed Plg+ animals displayed a fatty liver disease phenotype characterized by histological evidence of steatosis, elevated triglyceride content, and hepatocellular injury, HFD-fed Plg- mice were protected from developing each of these pathologies. HFD-fed Plg+ mice also developed hypercholesterolemia, whereas circulating cholesterol levels in Plg- mice were comparable to LFD-fed mice. Intriguingly, while the brown adipose tissue mass was comparable between diet and genotype, there was an upregulation of uncoupling protein-1 (Ucp1) expression in BAT of HFD-fed Plg- mice. Notably, whereas HFD-fed Plg+ mice showed evidence of insulin resistance as revealed by compromised glucose clearance, HFD-fed Plg- mice were partially protected. Collectively, our data suggest that plasmin (ogen) contributes to HFD-induced fatty liver disease and insulin resistance, and that plasminogen deficiency imposes a state of metabolically healthy obesity.

Disclosure

W.S.Hur: None. Y.Nguyen: None. Y.Patel: None. K.C.King: None. M.J.Flick: None.

Funding

National Institutes of Health (RDK112778)
812-P: Real-World Persistence, Adherence, Health Care Resource Utilization (HRU), and Hypoglycemia in People with Type 2 Diabetes (T2D) Continuing the 2nd-Generation (2nd-Gen) Basal Insulin (BI) (Glargine 300 U/mL [Gla-300]) vs. Switching to a 1st-Generation (1st-Gen) BI (Glargine 100 U/mL [Gla-100] or Detemir [IDet 100 U/mL])
Authors: EDELMAN STEVEN , GOLDMAN JENNIFER D. , MALONE DANIEL C. , PREBLICK RON , MUNAGA KOVIDA , LI XUAN , GILL JASVINDER , GANGI SUMANA
Published: May 2022

This retrospective observational analysis of the Optum Clinformatics database compared outcomes for adults (≥18y) with T2D who either continued treatment with the 2nd-gen (longer-acting) BI, Gla-300, or switched to a 1st-gen (long-acting) BI between Jan 1, 2017, and Apr 30, 2020. Cohorts were propensity score matched (PSM) on baseline characteristics and followed for 12 months. Outcomes included persistence, adherence, HRU, and hypoglycemia. During follow-up, a statistically significantly higher proportion of patients who continued Gla-300 vs. switched to 1st-gen BI were persistent with therapy, while adherence was similar. Hypoglycemia events (26.2 vs. 42.8 /100 person-years follow-up) and emergency room (ER) visits (all-cause: 100.5 vs. 146.8 per 100 person-years) were significantly lower for Gla-300 (p<0.01) , whereas hospitalization rates were similar (p>0.30; Table) . In adults with T2D, continuing treatment with Gla-300 vs. switching to a 1st-gen BI analog (Gla-100 or IDet) was associated with better persistence and lower overall hypoglycemia and ER visit events, but not hospitalizations, suggesting patients presenting at ER were treated, observed then discharged.

Disclosure

S.Edelman: Consultant; Abbott Diabetes, Lilly Diabetes, Sanofi-Aventis U.S., Xeris Pharmaceuticals, Inc. J.D.Goldman: Speaker's Bureau; Abbott Diabetes, Amarin Corporation, Lilly, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc. D.C.Malone: Other Relationship; Sanofi. R.Preblick: Employee; Sanofi-Aventis U.S. K.Munaga: Employee; Sanofi. X.Li: Employee; Eisai Co., Ltd., Sanofi. J.Gill: Employee; Sanofi, Sanofi, Stock/Shareholder; Sanofi, Sanofi. S.Gangi: Other Relationship; Sanofi.

Funding

Sanofi
813-P: Treatment Satisfaction and Health Status in People with T2D Treated with Insulin Glargine 300 U/mL (Gla-300) : Patient-Reported Outcomes (PRO) from ATOS Study
Authors: KHAN NIAZ , TIROSH AMIR , BHANSALI ANIL , VARGAS-URICOECHEA HERNANDO , HARRIS STEWART B. , DE CLIMENS AUDE ROBOREL , MABUNAY MARIA AILEEN N. , COUDERT MATHIEU , PILORGET VALERIE , GALSTYAN GAGIK R.
Published: May 2022

Patients' satisfaction is a key determinant of treatment adherence and persistence, for optimal management of T2D. ATOS, a 12-month prospective observational study conducted in Asia, Middle East, North Africa, Latin America, and Eastern Europe, showed that initiation of Gla-300 in insulin-naïve people with T2D resulted in improved glycemic control with low rates of hypoglycemia. This analysis evaluated changes in treatment satisfaction and health status among participants. Data was collected using PRO questionnaires - Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change versions (DTSQc) , EuroQoL 5-dimension scale version 3L (EQ-5D-3L) at baseline, Month 3, 6 and 12. Overall, 3931 participants completed the questionnaires. Mean ±SD age was 57.5 ±10.6 years, duration of diabetes was 10.1 ±6.2 years and baseline HbA1c was 9.3 ±1.0 %. Treatment satisfaction improved over time (DTSQs score of 21.7 at baseline to 29.8 and 31.3 at Month 6 and 12, respectively) and perceived frequency of hyperglycemia decreased over 12 months. DTSQc results were aligned with DTSQs. EQ-5D-3L results showed that proportion of people with better health status increased over time (Table) . Results showed that initiating Gla-300 in insulin-naïve people with T2D across multiple geographic regions improved treatment satisfaction and health status.

Disclosure

N.Khan: None. G.R.Galstyan: n/a. A.Tirosh: Advisory Panel; Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim International GmbH, Merck & Co., Inc., Novo Nordisk, Sanofi, Consultant; Bayer AG, DreaMed Diabetes, Ltd., Research Support; Medtronic, Speaker's Bureau; Eli Lilly and Company. A.Bhansali: None. H.Vargas-uricoechea: Advisory Panel; Sanofi, Speaker's Bureau; Abbott. S.B.Harris: Consultant; Abbott, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi, Other Relationship; Abbott, AstraZeneca, Bayer Inc., Dexcom, Eli Lilly and Company, HLS Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk, Sanofi, Research Support; Applied Therapeutics Inc., AstraZeneca, Canadian Institutes of Health Research, Juvenile Diabetes Research Foundation (JDRF) , Novo Nordisk, Sanofi, The Lawson Foundation. A.Roborel de climens: Employee; IQVIA Inc., Sanofi. M.N.Mabunay: Employee; Sanofi. M.Coudert: Employee; Sanofi. V.Pilorget: None.

Funding

Sanofi