bluuebunny/crossref_metadata_2025 huggingface dataset:
715-P: Tirzepatide as Monotherapy Improved Markers of Beta-Cell Function and Insulin Sensitivity in People with Type 2 Diabetes (SURPASS-1)
Authors: LEE CLARE , MAO HUZHANG , THIEU VIVIAN , THOMAS MELISSA K.
Published: May 2022

Tirzepatide (TZP) , a novel dual GIP/GLP-1 receptor agonist, led to greater HbA1c, fasting serum glucose and body weight reductions vs. placebo (PBO) in people with early T2D (baseline mean T2D duration 4.7 y and 54% no prior diabetes medications) from the 40-wk SURPASS-1 trial. In a Phase 2b trial, TZP also improved β-cell function and insulin sensitivity (IS) vs. PBO and selective GLP-1 receptor agonist, dulaglutide 1.5 mg. Similarly, in SURPASS-1, TZP improved β-cell function, as indicated by a 75-80% increase in HOMA2-B, and insulin resistance, as indicated by a 2-12% decrease in fasting insulin and 8-20% decrease in HOMA2-IR. In this analysis, we aimed to explore changes in additional biomarkers of β-cell function and IS after TZP monotherapy (5, and 15 mg) . At 40 wks, proinsulin/C-peptide ratios, a marker of insulin processing, β-cell stress and β-cell function improved with decrease by 47-49% with TZP vs. -0.1% with PBO (p<0.001, all doses) (Table) . Fasting proinsulin decreased by 49-55% with TZP vs. no change with PBO (p<0.001, all doses) . Decreases in fasting C-peptide by 3-9% with TZP did not differ vs. PBO. TZP vs. PBO improved biomarkers of IS evidenced by increases in adiponectin (16-23% vs. -0.2%; p≤0.028, all doses) and IGFBP-2 (38-70% vs. 4.1%; p<0.001, all doses) . As a monotherapy for early T2D, TZP achieved significant improvement in markers of β-cell function and IS.

Disclosure

C.Lee: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. H.Mao: Employee; Eli Lilly and Company. V.Thieu: None. M.K.Thomas: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company.

Funding

Eli Lilly and Company
717-P: Glycemic Control with Tirzepatide in People with Type 2 Diabetes by Baseline HbA1c =8.5% or >8.5%
Authors: ALEPPO GRAZIA , DE BLOCK CHRISTOPHE , LEVINE JOSHUA A. , GOMEZ-VALDERAS ELISA , BENNEYWORTH BRIAN D.
Published: May 2022

Tirzepatide, a once weekly GIP/GLP-1 receptor agonist in development for T2D, demonstrated superior glycemic control in the Phase 3 SURPASS clinical trial program. This post-hoc analysis assessed glycemic control with tirzepatide in participants stratified by baseline (BL) HbA1c (≤8.5%, >8.5%) . Mean change from BL in HbA1c was assessed in tirzepatide-treated participants (5, or 15 mg) from SURPASS-1 (monotherapy) , SURPASS-2 (add-on to MET) , SURPASS-3 (add on to MET ± SGLT2i) , SURPASS-4 (add-on to MET, SGLT2i, or sulfonylurea) and SURPASS-5 (add-on to insulin glargine ± MET) at trial endpoints (40 or 52 weeks) . Safety was also presented. Treatment comparisons were estimated using data while participants were on treatment and without rescue medications (efficacy estimand) . Across each SURPASS trial, ranges in mean BL HbA1c were 7.94-8.52%, mean BMI were 31.9-34.2 kg/m2 and mean diabetes duration were 4.7-13.3 years. At trial endpoints, HbA1c reductions from BL ranged from 1.55-2.14% in the BL HbA1c ≤8.5% subgroup and 2.70-3.46% in the BL HbA1c >8.5% subgroup (Table) . Gastrointestinal side effects were similar to those reported in the incretin class and hypoglycemic events (blood glucose <54 mg/dL or severe) were low. In conclusion, significant and clinically meaningful HbA1c reductions were observed with tirzepatide, irrespective of BL HbA1c.

Disclosure

G.Aleppo: Consultant; Insulet Corporation, Research Support; AstraZeneca, Dexcom, Inc., Eli Lilly and Company, Fractyl Health, Inc., Insulet Corporation, Novo Nordisk, Speaker's Bureau; Dexcom, Inc. 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. J.A.Levine: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E.Gomez-valderas: Employee; Lilly, Stock/Shareholder; Lilly. B.D.Benneyworth: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company.

Funding

Eli Lilly and Company
723-P: The Dual Glucagon and Glucagon-Like Peptide-1 Receptor (GCGR/GLP-1R) Agonist BI 4569Reduces Body Weight in Diet-Induced Obese Mice Based on Food Intake Reduction and an Increase in Energy Expenditure
Authors: ZIMMERMANN TINA , THOMAS LEO , BAADER-PAGLER TAMARA , HAEBEL PETER , NEUBAUER HEIKE , SIMON ERIC , REINDL WOLFGANG , BAJRAMI BESNIK , RIST WOLFGANG , UPHUES INGO , AUGUSTIN ROBERT
Published: May 2022

BI 4569 is a synthetic peptide optimized to simultaneously engage the GCGR and GLP-1R. BI 4569 contains a fatty acid-based half-life extension that supports once-weekly subcutaneous injection in humans, and is currently in clinical investigation in patients with obesity or NASH. BI 4569 activates the human GCGR and GLP-1R in 100% human plasma with a potency (EC50) of 6.3 nM and 1 nM, respectively. BI 4569 potently increases glucose-stimulated insulin secretion from mouse islets (EC50 5.7 nM) and insulin secretion from perifused human islets. On single injection in lean mice, BI 4569 dose-dependently reduced food intake (FI) , gastric emptying (GE) and improved oral glucose tolerance (oGTT) with an ED50 of 90, 41, and 2.1 nmol/kg, respectively. Based on dose-dependent changes in liver NNMT mRNA and plasma amino acids, BI 4569 engages the GCGR, unlike semaglutide. Receptor-specificity of target engagement was further shown in GLP-1R knockout mice (FI, GE, oGTT) . The bodyweight-lowering efficacy of BI 4569 (3, 10, 20, 30 nmol/kg) was compared with semaglutide (20, 100 nmol/kg) in diet-induced obese mice. After 4 weeks of daily dosing, BI 4569 showed a superior bodyweight-lowering efficacy (32% at 30 nmol/kg, p≤0.0vs. vehicle) compared with a maximally effective dose of semaglutide (27% at 100 nmol/kg; p≤0.0vs. vehicle) . This greater bodyweight-lowering efficacy of BI 4569 was associated with changes in GCGR target engagement biomarkers, such as liver lipids, NNMT mRNA, plasma glucagon, FGF21, and cholesterol. Mechanistically, the superior bodyweight-lowering efficacy of BI 4569 was attributed to an increase in energy expenditure (measured at and 20 nmol/kg) .

In summary, the preclinical characterization of the novel dual GCGR/GLP-1R agonist BI 4569 provides strong evidence for its clinical benefit in patients with obesity and associated comorbidities.

Disclosure

T. Zimmermann: Employee; Boehringer Ingelheim Pharma GmbH&Co.KG. L. Thomas: Employee; Boehringer Ingelheim International GmbH. T. Baader-Pagler: Employee; Boehringer Ingelheim International GmbH. P. Haebel: Employee; Boehringer Ingelheim International GmbH. H. Neubauer: Employee; Boehringer Ingelheim International GmbH. E. Simon: Employee; Boehringer Ingelheim Pharma GmbH&Co KG. W. Reindl: Employee; Boehringer Ingelheim International GmbH. B. Bajrami: None. W. Rist: Employee; Boehringer Ingelheim International GmbH. I. Uphues: Employee; Boehringer Ingelheim International GmbH. R. Augustin: None.
726-P: The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES) : Final 24-Month Clinical Characteristics and Treatment Pattern Analyses
Authors: GUERCI BRUNO , GIORGINO FRANCESCO , BOYE KRISTINA , FUECHTENBUSCH MARTIN , HEITMANN ELKE , LEBREC JEREMIE , DIB ANNE , FEDERICI MARCO ORSINI , YU MARIA , GARCIA-PEREZ LUIS-EMILIO
Published: May 2022

TROPHIES was a 24-month, prospective, non-comparative, observational study in adult patients with T2D initiating their first injectable glucose-lowering treatment with once-weekly dulaglutide (DU; N=1,014) or once-daily liraglutide (LIRA; N=991) in France, Germany, and Italy. Secondary objectives included assessments of HbA1c, body weight and treatment patterns. Clinical characteristics of the DU and LIRA cohorts at 24 months are described in the Table. Most patients receiving DU (856/1,014) initiated treatment at 1.5 mg/week and, among 286 patients with a significant treatment change, 237 were still receiving 1.5 mg/week. In the LIRA cohort, most patients (809/991) initiated at the starting dose 0.6 mg/day and 45% increased dose to 1.2 mg/day by Day 90; however, 17% of patients were already receiving 1.8 mg/day by Day 90. At the first significant treatment change 285/448 patients in the LIRA cohort were receiving 1.2 mg/day. Insulin was initiated by 79 and 97 patients in the DU and LIRA cohorts, respectively. Both treatments showed clinically meaningful effectiveness on HbA1c and weight, maintained over the 24-month study period.

Disclosure

B. Guerci: Advisory Panel; Amgen Inc., Medtronic. Board Member; Abbott Diagnostics, AstraZeneca, Bayer AG, Eli Lilly and Company, Novartis Pharmaceuticals Corporation. Consultant; Boehringer Ingelheim International GmbH, Intercept Pharmaceuticals, Inc., Novo Nordisk. 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. K. Boye: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. M. Fuechtenbusch: Advisory Panel; Berlin-Chemie AG. Consultant; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp. Speaker's Bureau; AstraZeneca, Novo Nordisk. E. Heitmann: None. J. Lebrec: Consultant; Eli Lilly and Company. A. Dib: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. M. Orsini Federici: Employee; Eli Lilly and Company. M. Yu: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. L. Garcia-Perez: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company.
738-P: The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES) : Final 24-Month Patient-Reported Outcomes
Authors: FUECHTENBUSCH MARTIN , GUERCI BRUNO , GIORGINO FRANCESCO , GARCIA-PEREZ LUIS-EMILIO , HEITMANN ELKE , LEBREC JEREMIE , BARRETT ANNABEL , DIB ANNE , FEDERICI MARCO ORSINI , BOYE KRISTINA
Published: May 2022

Data on patient-reported outcome (PRO) measures in people living with T2D who initiate injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) medication in routine clinical practice are limited. Here we present final PRO data from the TROPHIES 24-month, prospective, non-comparative, observational study of adult patients with T2D in France, Germany and Italy who started their first injectable GLP-1 RA with either once-weekly dulaglutide (DU) or once-daily liraglutide (LIRA) . Patients’ scores on PRO questionnaires were assessed every 6 months. We present scores at 24 months compared with baseline values before starting DU or LIRA treatment. For each PRO measure, higher scores reflect better outcomes. Baseline characteristics (previously published) for patients prescribed DU (N=1,014) or LIRA (N=991) were similar between groups. Mean changes from baseline to 24 months in PRO scores indicate improvements in health outcomes in patients initiating DU or LIRA (Table) .

In summary, among those patients still evaluable at 24 months we observed improvements in PRO scores from baseline in both groups, but with a more pronounced trend of improvement in the DU cohort for EQ-5D-5L VAS, IW-SP, DTSQs total, and DPM life and work productivity scores.

Disclosure

M.Fuechtenbusch: Advisory Panel; Berlin-Chemie AG, Consultant; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Speaker's Bureau; AstraZeneca, Novo Nordisk. K.Boye: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. B.Guerci: Advisory Panel; Amgen Inc., Medtronic, Board Member; Abbott Diagnostics, AstraZeneca, Bayer AG, Eli Lilly and Company, Novartis Pharmaceuticals Corporation, Consultant; Boehringer Ingelheim International GmbH, Intercept Pharmaceuticals, Inc., Novo Nordisk. 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. L.Garcia-perez: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E.Heitmann: None. J.Lebrec: Consultant; Eli Lilly and Company. A.Barrett: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A.Dib: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. M.Orsini federici: Employee; Eli Lilly and Company.
75-LB: Use of Continuous Glucose Monitoring (CGM) and Its Association with Economic Outcomes in the Real-World Setting
Authors: PEREZ-NIEVES MAGALY , HANKOSKY EMILY R. , FAN LUDI , GELSEY FELICIA , EBY ELIZABETH L. , SIMS TRACY J. , UMEH EMEKA , JUNEJA RATTAN
Published: May 2022

Background: CGM is increasingly used as tool in the management of diabetes, supporting improvements in glycemic control and quality of life.

Objectives: The aim of this retrospective study was to evaluate the association between CGM use and healthcare resource utilization (HCRU) and cost.

Methods: Using medical claims from Clarivate™ Real-World Evidence repository and CGM data from Glooko®, US people with diabetes (≥18 years) (PwD) and on insulin were assigned to mutually exclusive cohorts based on CGM usage status and matched in terms of age, gender, and diabetes type. First CGM use (index) was required to occur within January 1, 2015 - July 30, 2019. HCRU and costs were assessed 12 months post-index.

Results: After matching, 3,918 PwD were assigned into each cohort. Significantly more CGM vs. non CGM users (p<0.0001) were on insulin pump, treated with bolus insulin only, and commercially insured. Mean pre-index Charlson Comorbidity Index (CCI) scores were lower (p<0.00001) and most diabetes-related comorbidities were less prevalent (p<0.01) in the CGM vs. non-CGM cohort.

After adjusting for demographics, diabetes type, CCI, and insurance, the use of CGM vs. no CGM was associated with a 27-70% and 32-76% reduction in HCRU and costs (p<0.0001) , respectively.

Conclusion: The use of CGM (vs. no CGM use) was associated with lower HCRU and costs, which may result in lower healthcare burden for PwD and payers.

Disclosure

M. Perez-nieves: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E. R. Hankosky: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. L. Fan: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. F. Gelsey: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E. L. Eby: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. T. J. Sims: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E. Umeh: None. R. Juneja: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company.

Funding

Eli Lilly and Company
76-OR: Macrophage-Derived Proinflammatory Lipids Play a Role in the Development of Type 1 Diabetes
Authors: ALMUTAIRI ABDULAZIZ , WHITE TAYLEUR , STEPHENSON DANIEL , GAI YING , UBIL ERIC , CHALFANT CHARLES , RAMANADHAM SASANKA
Published: May 2022

Type 1 diabetes (T1D) is a consequence of autoimmune-mediated destruction of pancreatic β-cells, but the leading causes for this process remain elusive. We revealed that Ca2+-independent phospholipase A2β (iPLA2β) , which hydrolyzes membrane phospholipids at the sn-2 position to generate bioactive lipids, modulates polarization of macrophages (MΦ) . Several of the iPLA2β-derived lipid signals (iDLs) are proinflammatory and can initiate immune cell infiltration and β-cell damage. Recently, we showed that production of MΦ- proinflammatory lipids (i.e., PGs, DHETs, LTB4) from spontaneous-T1D prone nonobese diabetic mice (NOD) is high during the pre-diabetic phase. Herein, we examined the impact of bone marrow-derived macrophages (BMD-MΦ) -iDLs on T1D development by generating NOD mice with a conditional reduction in MΦ-iPLA2β (NOD.cMΦ iPLA2 𝛽; -/- and NOD.cMΦ iPLA2 𝛽; +/- ) . Our findings reveal that (1) BMD-MΦ from NOD.cMΦiPLA2 𝛽; -/- or NOD.cMΦiPLA2 𝛽; +/- are skewed towards an M2 (anti-inflammatory) phenotype, in comparison with NOD BMD-MΦ (2) production of proinflammatory lipids (PGs, DHETs, and TXB2) is significantly decreased in BMD-MΦ from NOD.cMΦiPLA2 𝛽; -/- and NOD.cMΦiPLA2 𝛽; +/- (3) selective inhibition of PGE2 or DHETs signaling inhibits NOD BMD-MΦ polarization towards a proinflammatory phenotype M1 (4) selective decrease of iPLA2β in MΦ significantly reduces leukocytes infiltration into the pancreas of NOD mice (5) pancreata from NOD.cMΦiPLA2 𝛽; -/- and NOD.cMΦiPLA2 𝛽; +/- mice have significantly higher M2 macrophages and less activated T cells (6) importantly, selective decrease of iPLA2β in MΦ (NOD.cMΦiPLA2 𝛽; -/- and NOD.cMΦiPLA2 𝛽; +/- ) significantly reduces T1D incidence in NOD mice. The overall reduced macrophages-proinflammatory lipids is associated with increased M2 macrophages and less T1D diabetes pathogenesis in selective decrease of MΦ-iPLA2β NOD mice. And inhibition of selective macrophages-derived iDLs production can be targeted to counter T1D.

Disclosure

A.Almutairi: None. T.White: None. D.Stephenson: None. Y.Gai: None. E.Ubil: None. C.Chalfant: None. S.Ramanadham: None.

Funding

NIH/NIAID R21 (AI 146743) NIH/NIDDK (R01DK110292) Cell, Developmental, & Integrative Biology (CDIB) , the University of Alabama at BirminghamUAB Comprehensive Diabetes CenterKing Saud bin Abdulaziz University for Health Sciences/ Saudi Arabian Cultural Mission
760-P: Performance of the MiniMed 780G System with the Guardian 4 Sensor—Impact on the First 1,570 Real-World Users
Authors: SHIN JOHN , ARRIETA ARCELIA , CASTAÑEDA JAVIER , CORDERO TONI L. , RHINEHART ANDREW S. , VIGERSKY ROBERT A.
Published: May 2022

Objective: Since 2021, the MiniMed™ 780G advanced hybrid closed-loop system with the non-adjunctive Guardian™ 4 sensor, that does not require calibration, has been commercially available in Europe. In this study, the real-world glycemic outcomes of the first 1,570 individuals using the system were evaluated.

Methods: Analyses were based on data collected since November 2021 from consenting users (N=1,570) in 15 countries who had ≥days of sensor glucose (SG) data. Glycemic outcomes including the mean±SD of the glucose management indicator [GMI], SG, and 24-hour and nighttime percentage of time spent within 70-180mg/dL (TIR) , at <54mg/dL [TBR54], <70mg/dL [TBR70] and >180mg/dL [TAR180] were determined. The mean±SD of time spent in closed loop and the number of closed-loop exits/week were also assessed.

Results: For 94±11% of time spent in closed loop, users had an SG of 153±18mg/dL, GMI of 6.96±0.41% and TIR of 73.5±10.7%. Their TBR54, TBR70 and TAR180 were 0.11±0.15%, 1.7±1.5% and 24.8±11.0%, respectively. During the night (12AM-6AM) , TIR was 81.5±12.8%, TBR54 was 0.08±0.20%, TBR70 was 1.1±1.7% and TAR180 was 17.5±12.9%. The number of closed-loop exits was 0.8±0.9/week.

Conclusion: MiniMed™ 780G system use with the Guardian™ 4 sensor involved substantial time in closed loop and favorable glycemic control that aligned with the recommended international consensus for continuous glucose monitoring metrics.

Disclosure

J.Shin: Employee; Medtronic. A.Arrieta: Employee; Medtronic. J.Castañeda: Employee; Medtronic. T.L.Cordero: Employee; Medtronic, Medtronic. A.S.Rhinehart: Employee; Medtronic, Stock/Shareholder; Medtronic. R.A.Vigersky: Employee; Medtronic.
762-P: Comparing Dual-Hormone and Single-Hormone Automated Insulin Delivery System on Nocturnal Glucose Management among Pediatric People Living with Type 1 Diabetes : A Pooled Analysis
Authors: WU ZEKAI , MESSIER VIRGINIE , LEBBAR MAHA , RABASA-LHORET RÉMI
Published: May 2022

Background: Only three studies have directly compared the efficacy of dual-hormone (DH) automated insulin delivery (AID) systems and single-hormone (SH) AID on overnight glucose management in pediatric people living with type 1 diabetes (PPWT1D) . Their conclusions differ. Pooling data could lead to stronger conclusions.

Methods: Pooled data from 3 open-label, randomized, controlled, crossover studies on comparing DH-AID and SH-AID among PPWT1D (8-17 y/o) . The primary outcome was time in range% (TIR%) overnight (00:00-06:00) based on continuous glucose monitoring. Paired t-test was applied to compare the two groups.

Results: Records from 50 PPWT1D [median (Q1-Q3) age: 14.0 years (11.8, 16.0) , mean ± SD HbA1c: 8.2 ± 0.8%] provided 246 nights of data (Table) . TIR% [ (median (IQR) ] for SH-AID and DH-AID was 91.3% (58.3, 100.0) and 94.4% (76.4, 100.0) , respectively (P=0.024) . DH-AID was superior to SH-AID in reducing time in hypo- (<3.9 mmol/L) and hyperglycemia (>13.9 mmol/L) but not glycemic variability.

Conclusion: DH-AID has the potential to provide better overnight glucose management than SH-AID in PPWT1D.

Disclosure

Z.Wu: Other Relationship; Eli Lilly and Company. V.Messier: None. M.Lebbar: None. R.Rabasa-lhoret: Consultant; HLS Therapeutics Inc., Pfizer Inc., Other Relationship; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk Canada Inc., Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Canadian Institutes of Health Research, Cystic Fibrosis Canada, Diabetes Canada, Fondation Francophone pour la Recherche en Diabète (FFRD) , JDRF, National Institutes of Health, Société Francophone du Diabète (SFD) , Speaker's Bureau; Canadian Medical & Surgical Knowledge Translation Research Group (CMS) , CPD Network, Tandem Diabetes Care, Inc.

Funding

Diabetes Canada grant (OG-2-12-3868-RR,OG-2-13-42P, OG-3-14-4500-RR) and Fondation JA De Sève
772-P: Combining Meal-Bolus Reduction and Exercise Announcement Eliminates the Risk of Hypoglycemia during Postprandial Exercise in People Living with Type 1 Diabetes Treated with Automated Insulin Delivery Systems
Authors: RAFFRAY MARIE , RABASA-LHORET RÉMI , MYETTE-CÔTÉ ÉTIENNE , MOLVEAU JOSÉPHINE , DEVAUX MARIE , WU ZEKAI
Published: May 2022

For people living with type 1 diabetes (PWT1D) post-prandial exercise remains a challenge for the maintenance of glycemic control even with automated insulin delivery systems (AID) . During the postprandial phase, elevated insulin levels, rapid changes in glucose levels with increased CGM lag time make it difficult for AID algorithms to mitigate the risk of hypoglycemia by solely relying on basal rate modulation. The main objective of this study was to assess the safety and efficacy of AID using a combination strategy of pre-meal exercise announcement and meal bolus reduction during exercise bouts performed 1- and 2-hours post-meal. Thirteen adults PWT1D chronically treated with AID (6 females; A1c = 7.9 ± 0.6%; Age= 53,5 ± 15,5 years; T1D duration= 29.0 ± 16.0 years) were included. Participants performed in a randomized crossover fashion 2 60-min exercise sessions (60% of VO2peak) , 1 (60Ex) and 2-h (120Ex) post-meal. A standardized meal was given at 8AM with a 33% insulin bolus reduction and exercise was announced to the AID algorithm (target glucose increased from 6 to 9 mmol/L) up to the end of each exercise session. Plasma glucose was collected regularly. Plasma glucose times in range (3.9-10.0 mmol/L) and above range (>10.0 mmol/L) from exercise onset to 90-min-post-exercise, were similar between Ex60 and Ex120 (63.7 ± 41.4% Ex60 vs. 65.9 ±24.9% Ex120, p=0.3; 36.1 ± 41.6% Ex60 vs. 34.1 ± 24.9% Ex120, p=0.4, respectively) . No hypoglycemic events (<3.9 mmol/L) occurred during the study. The mean reduction in plasma glucose levels were similar during exercise in both conditions (-2.6 ± 1.4 mmol/L Ex60 vs. -3.5 ± 2.2 mmol/L Ex120, p=0.2) Conclusion: combining pre-meal exercise announcement with a meal bolus reduction of 33% was effective and safe at preventing postprandial exercise hypoglycemia in PWT1D treated with AID whether exercise was performed 1 or 2-h after a meal.

Disclosure

M.Raffray: None. R.Rabasa-lhoret: Consultant; HLS Therapeutics Inc., Pfizer Inc., Other Relationship; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk Canada Inc., Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Canadian Institutes of Health Research, Cystic Fibrosis Canada, Diabetes Canada, Fondation Francophone pour la Recherche en Diabète (FFRD) , JDRF, National Institutes of Health, Société Francophone du Diabète (SFD) , Speaker's Bureau; Canadian Medical & Surgical Knowledge Translation Research Group (CMS) , CPD Network, Tandem Diabetes Care, Inc. É.Myette-côté: None. J.Molveau: None. M.Devaux: None. Z.Wu: Other Relationship; Eli Lilly and Company.

Funding

National Institutes of Health (A12BC345678)
780-P: Associations between Insulin Pump Self-Management and HbA1c
Authors: RYTTER KAREN , MADSEN KRISTOFFER P. , ANDERSEN HENRIK U. , HOMMEL EVA , PEDERSEN-BJERGAARD ULRIK , SCHMIDT SIGNE , NØRGAARD KIRSTEN
Published: May 2022

Background and Aims: It is well-known that diabetes self-management is important for glycemic outcome, also among insulin pump users. We aimed to explore which factors were independently associated with HbA1c.

Methods: Adult insulin pump users (18+) with type 1 diabetes from the Capital Region of Denmark completed an online questionnaire covering aspects of insulin pump self-management. HbA1c and demographics were collected from medical records and national registries. Backward selected linear regression models were used to investigate associations between HbA1c and each aspect of self-management, adjusted for one another, CGM/isCGM, sex, age, marital status and educational level.

Results: In total, 770 individuals responded; 60% were female, median age was 49 (p25-p75: 36-60) and ranged from 18-86 years, median HbA1c was 56mmol/mol (p25-p75: 50-62) and ranged from 25-135, and 93% used bolus calculator for meal bolus and/or correction. Self-adjustment of pump settings showed the strongest association with lower HbA1c. Avoiding missed boluses, timing of bolus insulin before meals, and timely infusion set change were also associated with a lower HbA1c. No statistically significant associations were found for HbA1c and use of advanced pump features.

Conclusion: Self-adjusting insulin pump settings, low frequency of missed meal boluses, optimal timing of meal bolus and timely change of infusion set are associated with lower HbA1c.

Disclosure

K.Rytter: Other Relationship; Medtronic, Stock/Shareholder; Novo Nordisk A/S. K.P.Madsen: None. H.U.Andersen: Advisory Panel; Abbott Diabetes, Stock/Shareholder; Novo Nordisk A/S. E.Hommel: Stock/Shareholder; Novo Nordisk A/S. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi. S.Schmidt: None. K.Nørgaard: Advisory Panel; Medtronic, Novo Nordisk A/S, Consultant; Novo Nordisk A/S, Research Support; Dexcom, Inc., Medtronic, Novo Nordisk A/S, Zealand Pharma A/S, Speaker's Bureau; Medtronic, Stock/Shareholder; Novo Nordisk A/S.
784-P: An Insulin Infusion Set with Novel Kink-Free Flexible Cannula: In-Vitro/In-Vivo Studies
Authors: CHIU CHIA , ZHANG GINA , CHATTARAJ SARNATH , GOTTLIEB REBECCA
Published: May 2022

Objective: The wear duration of insulin infusion sets (IIS) is impacted by initial local trauma caused by cannula insertion and sustained inflammation due mostly to insulin infusion, both of which affect insulin absorption. Efforts have been made to mitigate cannula kinking at insertion and during use, and other site reactions that contribute to IIS failures. This Medtronic preclinical study investigated performance of a novel flexible and kink-free soft cannula.

Method: In-vitro tests (included buckling kink test, inflammatory macrophage cell culture, and insulin compatibility test by USP insulin monographic methods) were conducted on the Flexible cannula and commercial Teflon cannulas. In-vivo study of 3-day sets with both cannulas were conducted on diabetic swine by having animals wear one set multiple times (on the abdomen) while receiving Novolog™ insulin subcutaneously via a pump for 7 days or until set failure, determined by (1) blood glucose (BG) value not decreasing by ≥50 mg/dL an hour after a correction bolus for a BG level >350 mg/dL, or (2) evidence of infection at the infusion site.

Result: Compared to the control Teflon cannula, kink resistance of the Flexible cannula was significantly improved (Kinked: Teflon 6/6, Flexible 0/6) . In the inflammatory in-vitro cell culture model, the pro-inflammatory cytokines generated by the Flexible cannula trended less (mean MCP-1: Teflon -9.7 ng/mL, Flexible - 7.7 ng/mL; mean MIP-1α: Teflon -24.1 ng/mL, Flexible - 24.0 ng/mL) . Tested by the USP methods, both cannulas were insulin compatible. In the swine diabetes model, the 3-day IIS with the Flexible cannula had a greater 7-day survival rate (50%, n=10) than the corresponding control (36%, n=56) , although not statistically different. No significant increase in total daily dose of insulin was observed.

Conclusion: Preliminary in-vitro and in-vivo test results indicate that the novel Flexible cannula is ideally suited for IIS device performance. Further product development is ongoing.

Disclosure

C.Chiu: Employee; Medtronic. G.Zhang: Employee; Medtronic. S.Chattaraj: Employee; Medtronic. R.Gottlieb: Employee; Medtronic.
786-P: Importance of Data Distribution on Deep Learning Model for Glucose Prediction
Authors: ROMERO-UGALDE HECTOR M. , ADENIS ALICE , DAUDET LAURENT , LOUIS MAXIME , TOURKI YOUSRA , HUNEKER ERIK
Published: May 2022

Objective: This paper analyses the glycemia distribution impact in a deep learning (DL) model for glucose forecast on T1D patients.

Method: Data of 139 adult T1D patients equipped with DBLG1 System are used. Data of 70% of the patients is used for hyperoptimizing a DL model (hyperop set) and 30% for testing (test set) . The model accuracy is evaluated using the RMSE for each patient of the test set. The interquartile range (IQR) is calculated for the entire hyperop set (baseline) and for each patient. The difference between each patient IQR and the baseline is computed. Then the correlation is computed between the differences and the RMSE.

Results: A correlation of -0.77 is found between the difference of IQR and the RMSE (Figure 1 B) . It indicates that when IQR (hyperop set) > IQR (patient) the prediction is more accurate. Conversely if IQR (patient) is higher, the accuracy is worse. High differences are observed between the distributions of the hyperop set and of the two patients on which the model performed worse (Figure 1 A) .

Conclusion: RMSE is larger for patients whose glycemia distribution is really different from glycemia distribution on the hyperop set. IQR difference may be used as a predictor of the prediction accuracy for a given patient.

Disclosure

H.M. Romero-Ugalde: Employee; Diabeloop SA. A. Adenis: Employee; Diabeloop SA. L. Daudet: Employee; Diabeloop SA. M. Louis: Employee; Diabeloop SA. Y. Tourki: Employee; Diabeloop SA. E. Huneker: Board Member; Diabeloop SA.
790-P: Evaluating Psychological Stress Nonglucose Signal for Incorporation 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: Psychological stress may adversely affect glucose control. However, the effect of stress on efficacy of automated insulin delivery (AID) in Type 1 Diabetes (T1D) is still unknown. We evaluated non-glucose signals in subjects with type 1 diabetes on AID using the Empatica E4 device (E4) during psychological stress.

Method: During a 2-week prospective AID study for 12 participants with T1D, psychological stress i.e Trier Social Stress Test (TSST) was induced. Heart rate (HR) measurements using the Nonin sensor 15 mins before and after TSST confirmed psychological stress. Physical activity (PA) was analyzed and HR fluctuations coinciding with PA was rejected. The correlation of HR from E4 with the Nonin HR monitor was evaluated to explore the feasibility of using E4 HR as a substitute for Nonin HR. Pearson's moment is used to evaluate correlation.

Results: The HR from both Nonin and E4 was observed to rise after application of stress from baseline levels. The mean difference of heart rate in Nonin HR was 13.1 bpm (6 bpm) in AID and in E4 was 10.8 bpm (5 bpm) in AID. The Pearson's correlation coefficient between the Nonin and E4 HR was 0.9 in AID (p = 0.0007) . There was a trend towards increase in E4 Electrodermal activity (EDA) of normalized power spectral density (PSD) -92.5 dB/Hz (28.8) before stress to -84.9 dB/Hz (21.9) after stress in AID (p = 0.06) .

Conclusions: The E4 HR can act as a substitute to the gold standard Nonin HR. E4 HR is a good indicator of psychological stress with simultaneous analyses of accelerometry data and could be used to inform the AID controller. E4 EDA PSD is also a good indicator for stress but has a delayed response. On the other hand, HR can be affected by physical activity. Psychological stress could be detected through a fusion of E4 HR, EDA, and accelerometer sensors and incorporated into Next Gen AID for testing.

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)
801-P: Effect of Adding Computerized Insulin Dose Adjustment Algorithms (CIDAA) to a Remote Patient Monitoring (RPM) Program on A1C Levels
Authors: PULICHARAM JUVAIRIYA S. , DAVIDSON JOSH , DAVIDSON MAYER B.
Published: May 2022

The purpose of this study was to determine the effect of adding CIDAA to a subpopulation of an HMO that also had an RPM program. Patients taking insulin for >6 months with A1Cs >8.0% were selected from 3 cohorts, RPM + CIDAA (Group A) , RPM alone (Group B) and usual care (Group C) and followed for 6 months. Glucose readings of Group A patients, given a Bluetooth-enabled glucometer, were analyzed with dose adjustment recommendations sent to their providers (2 MDs, 1 PA) that they could accept or modify. Health educators contacted Group A and B patients for each RPM glucose value of <70 or >200 mg/dl and counseled them how to avoid subsequent episodes. Non-insulin drugs were not allowed to be added to Group A and B patients. A1C levels were measured at baseline and 6 months. Patient demographics, their A1C responses and alerts are shown in the Table. There were no differences among baseline A1Cs but significant differences from baseline. Groups A vs. B (P = 0.01) and A vs. C (P = 0.001) were significantly different but not B vs. C. All alerts (P = 0.02) and those >200 mg/dl (P = 0.002) were significantly less in Group A vs. B but alerts <70 mg/dl were not. Conclusion: A1C levels fell twice as much without increases in hypoglycemia in poorly controlled type 2 diabetic patients taking insulin whose providers received recommendations for dose changes based on CIDAA every 2-3 weeks compared with RPM alone or usual care.

Disclosure

J.S.Pulicharam: None. J.Davidson: None. M.B.Davidson: Other Relationship; Mellitus Health.

Funding

Mellitus Health, Inc
802-P: Safety, Pharmacokinetics, and Pharmacodynamics of Once-Weekly Basal Insulin Fc (BIF) in Japanese Patients with Type 2 Diabetes: A Phase 1 Open-Label, Randomized, Active-Controlled Trial
Authors: NASU RISA , OURA TOMONORI , OHWAKI KENJI , IMORI MAKOTO , FURIHATA KENICHI
Published: May 2022

The aim was to investigate the safety, pharmacokinetics (PK) , and pharmacodynamics (PD) of once-weekly Basal Insulin Fc (BIF) , a novel long-acting IgG Fc-fusion protein being developed for the treatment of diabetes. This multiple-site, open-label, randomized, active-controlled, multiple-dose Phase 1 study investigated individualized weekly subcutaneous injections of BIF compared to once-daily insulin degludec over 6 weeks in Japanese patients with T2D on stable doses of basal insulin, with or without antihyperglycemic medication. In a 5-week lead-in period to treatment, all patients titrated insulin degludec to a fasting glucose (FG) target of 100 to 139 mg/dL. Outcomes included safety (primary) and PK and PD (secondary) . ClinicalTrials.gov NCT04276428. Patients were randomized to receive BIF (n=18) or insulin degludec (n=10) . TEAE incidence was low for both BIF (n=4; 22.2%) and insulin degludec (n=2; 20.0%) . All TEAEs were mild, nonserious, and unrelated to BIF. A total of 6 (33.3%) and 2 (20.0%) patients reported hypoglycemic events during BIF and insulin degludec treatment, respectively, none of which were severe. Median tmax was 3 or 4 days. Geometric mean t1/2 of BIF was 15 days. The peak to trough ratio (Cmax to 168 hours postdose concentration after final dose at Week 6) was 1.13. Mean FG was statistically significantly increased from baseline from Weeks 3 to 7 following first dose of insulin degludec but was not increased with BIF (LS means [SE] change: Week 3 BIF, -6.6 [4.7]; degludec, 22.1 [5.9]; Week 7 BIF, -3.5 [7.1]; degludec, 25.3 [9.3] mg/dL) . The 7-point SMPG profile was unchanged with BIF over treatment. In Japanese patients with T2D, once-weekly BIF was well tolerated and associated with prolonged PK and improved glycemic control. PK/PD profiles in Japanese patients are consistent with prior studies and support participation in Phase 3 studies.

Disclosure

R. Nasu: None. T. Oura: Employee; Eli Lilly Japan K.K. Stock/Shareholder; Eli Lilly and Company. K. Ohwaki: None. M. Imori: Employee; Eli Lilly Japan K.K. K. Furihata: Other Relationship; Eli Lilly and Company, Pfizer Japan Inc.

Funding

Eli Lilly Japan K.K.
805-P: Sarcopenia in Insulin-Treated Older Adult Patients with Type 2 Diabetes
Authors: LEITE SILMARA A.O. , BASTOS MURILO , SILVA MICHAEL , LAVALLE ANA C.R. , BERTOGY MARIA C. , VIEIRA SUELEN C. , UMPIERREZ GUILLERMO E.
Published: May 2022

Background: The relationship of sarcopenia with relevant features of T2D and its treatment are inconsistent in the literature.

Aims: To evaluate the prevalence of sarcopenia in insulin treated older adults with T2DM.

Methods: This is a cross sectional data from a prospective observational cohort study that evaluated subjects older than 65 y/o with T2D on insulin therapy, with or without oral agents, and HbA1c between 7% and 9%, identified from a public hospital and a private diabetes clinic and invited by phone to participate (n= 462) . Patients treated with GLP1 agonists; eGFR <30 ml/min; Hb <11g/dL; ALT> 3x ULN; glucocorticoid use in the previous 3 months, and active malignancy were excluded. The diagnosis of sarcopenia was based on the European Working Group on Sarcopenia in Older People (EWGSOP2) . The SARC-F questionnaire was applied and considered high risk if score > 4. Muscle strength was assessed by handgrip strength (HS) using a manual dynamometer (Jamar®) . The muscle mass was assessed by electrical bioimpedance (BIA - Inbody®) obtaining the skeletal muscle mass index (SMI = MM appendicular / height2) . The physical performance was assessed by the timed up-and-go test (TUG) . The presence of sarcopenia was considered when HS <16Kg for women and <27Kg for men and confirmed when SMI <7.00 kg /m2 for men and ≤5.50 kg / m2 for women. The severity was evaluated when TUG was ≥20s.

Results: We assessed 125 patients aged 72.8 ± 5.8 y/o, 53% women and T2D median duration of 21 years (min 1; max 47) ; HbA1c=8.5 ± 1,5%. 50,5% of patients had macrovascular complications history; 25.8% retinopathy; 48,3% neuropathy and 14,3% nephropathy. 18,8% had SARC-F score > 4 indicating high risk of sarcopenia. However, the clinical tests confirmed sarcopenia in only 1,6% of the participants.

Conclusions: The prevalence of sarcopenia in older adults with T2D on insulin treatment was lower than general population, which may be explained by the insulin anabolic effects.

Disclosure

S.A.O.Leite: None. M.Bastos: None. M.Silva: None. A.C.R.Lavalle: None. M.C.Bertogy: None. S.C.Vieira: None. G.E.Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk.

Funding

Abbott Diabetes Care ADC-OUS-IIS-19-47
811-P: Efficacy and Safety of Ultrarapid Lispro (URLi) vs. Humalog (Lispro) in Chinese Pediatric Patients with Type 1 Diabetes (T1D) : A Subpopulation Analysis of PRONTO-Peds Study
Authors: GU WEI , YANG YUXIN , YUAN YUAN , LUO FEIHONG
Published: May 2022

URLi is a novel formulation of insulin lispro developed to better mimic the physiological glucose response postmeal. This analysis was to evaluate URLi vs. lispro in Chinese subpopulation from a phase 3 global study (PRONTO-Peds) in pediatric patients with T1D. Chinese patients were randomized to double-blind mealtime URLi (n=7) , lispro (n=11) , or open-label URLi dosed up to 20 minutes postmeal (URLi+20; n=4) . The primary endpoint was the difference between URLi and lispro in HbA1c change from baseline to Week 26, with the difference between URLi+20 and lispro in HbA1c change being also assessed. The mixed-effect model repeated measure model was used for analyzing the primary endpoint. Same trend in the treatment difference in HbA1c change from baseline to Week 26 was observed in Chinese patients as the overall population (URLi minus lispro: -0.09% vs. -0.02%; URLi+20 minus lispro: -0.31% vs. -0.02%) , with HbA1c increases in URLi, lispro, and URLi+20 groups by 1.06%, 1.15%, and 0.85%, respectively. In Chinese patients, the premeal to 1-hour postmeal daily mean glucose excursion was numerically lower with URLi (-31.1 mg/dL) than with lispro (15.3 mg/dL) or with URLi+20 (39.2 mg/dL) at Week 26. No clinically meaningful treatment differences were observed at baseline and Week 26 for basal, bolus, and total insulin dose. No death, serious adverse events including severe hypoglycemia, discontinuations due to adverse events, and treatment-emergent injection site reactions occurred. At Weeks 0 to 26, the rate of all documented hypoglycemia and documented hypoglycemia at ≤4 h and >4 h postdose for blood glucose ≤70 mg/dL showed numerically greater decrease from baseline with URLi and URLi+20 than with lispro. Overall, mealtime and postmeal URLi vs. lispro demonstrated same trend in the glycemic control as assessed by HbA1c in Chinese pediatric patients with T1D as the overall population and a similar safety profile.

Disclosure

W.Gu: None. Y.Yang: Employee; Eli Lilly and Company. Y.Yuan: None. F.Luo: None.

Funding

Eli Lilly and Company
814-P: Treatment Satisfaction in People with T2D Switched from Basal Insulin (BI) to Insulin Glargine 300 U/mL (Gla-300) : Patient-Reported Outcomes from ARTEMIS-DM Study
Authors: ALRUBEAAN KHALID , WILMOT EMMA G. , ROBOREL DE CLIMENS AUDE , MABUNAY MARIA AILEEN N. , PILORGET VALERIE , BERTHOU BAPTISTE , FRECHTEL GUSTAVO , SETHI BIPIN
Published: May 2022

Treatment satisfaction is the key for treatment adherence, to improve long-term outcomes and avoid diabetes complications. However, there is limited data on treatment satisfaction in people with T2D who switch to Gla-300 from other BI in regions outside US and Europe. The current analysis of the 26-week ARTEMIS-DM study presents patient perspective on treatment satisfaction using the Insulin Treatment Satisfaction Questionnaire (ITSQ) , in people with T2D, from Asia, Middle East Africa (MEA) and Latin America (LaTAm) , uncontrolled on BI and who switched to Gla-300. A total of 362/372 (97.3%) participants completed the study. Mean ± SD ITSQ total score increased from baseline 76.30 ± 15.63 to 83.51 ± 13.29 and 84.42 ± 13.15 at Weeks 12 and 26, respectively. Improvements were noted for all ITSQ domain scores, especially glycemic control (baseline: 65.83; mean change from baseline to Week 12: 15.12 and Week 26: 16.06) (Table) . Despite similar mean baseline scores (73.to 79.31) , LS mean change in ITSQ total score was numerically greater in LaTAm (10.86) and MEA (10.40) compared with Asia (1.56) at Week 26. In ARTEMIS-DM study, in people with T2D uncontrolled on BI, switching to Gla-300 demonstrated improvement in treatment satisfaction and specifically in glycemic control in a diverse population from multiple geographic regions.

Disclosure

K.Alrubeaan: Research Support; Sanofi. E.G.Wilmot: Advisory Panel; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Sanofi, Research Support; Insulet Corporation, Novo Nordisk, Speaker's Bureau; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi. A.Roborel de climens: Employee; IQVIA Inc., Sanofi. M.N.Mabunay: Employee; Sanofi. V.Pilorget: None. B.Berthou: None. G.Frechtel: None. B.Sethi: None.

Funding

Sanofi
815-P: A Nationwide Cross-Sectional Survey of Knowledge and Practices of Diabetes Drug Injection Techniques of Patients, Nurses, and Physicians: The China IT Improve Study
Authors: GUO LIXIN , JI QIUHE , JIANG SHENG , LIU DONGFANG , LIU JING , RAN XINGWU , XUE YAOMING , ZHANG QIU
Published: May 2022

Introduction: This survey studied the knowledge and/or practices of drug injection techniques of diabetes patients, nurses, and physicians to guide formulating national standardized diabetes drug injection guidelines.

Methods: Patients, nurses, and physicians were recruited from 259 primary, 150 secondary, and 100 tertiary care hospitals chosen using stratified cluster sampling. Their knowledge and/or practices of drug injection techniques were surveyed using the Diabetes Drug Injection Knowledge and Practice Questionnaire for Physicians, Nurses and Patients.

Results: Totally 10694, 2643 and 2816 eligible questionnaires were collected from diabetes patients (92.3% type 2 diabetes) , physicians and nurses, respectively. Needlestick injury occurred in 13.0% patients, 19.8% patients had hypoglycemic episodes and 54.5% patients failed to attain the target HbA1c. Care setting and injection practice were significant determinants of needlestick injury, hypoglycemia and target HbA1c attainment. Overall, 48.9% physicians and 20.4% nurses had a poor knowledge domain score. Care setting, training, and diabetes care experience were significant determinants of diabetes drug injection knowledge domain scores in both physicians and nurses. Furthermore, >92% of the nurses properly performed the steps of injecting diabetes drugs. Needle injury occurred in 24.0% nurses. Care setting, nurse professional levels, and diabetes care experience were significant determinants of needlestick injury.

Conclusions: This nationwide survey offers insights into diabetes drug injection knowledge and practices in China and provides evidence for drafting nationwide guidelines for diabetes drug injection techniques.

Disclosure

L.Guo: None. Q.Ji: None. S.Jiang: None. D.Liu: None. J.Liu: None. X.Ran: None. Y.Xue: None. Q.Zhang: None.