bluuebunny/crossref_metadata_2025_split huggingface dataset:
94-OR: Postpartum Circulating MicroRNAs Can Predict the Development of Type 2 Diabetes in Women with Previous Gestational Diabetes
Authors: JOGLEKAR MUGDHA , WONG WILSON K. , EMA FAHMIDA KHAN , GEORGIOU HARRY M. , HARDIKAR ANAND , LAPPAS MARTHA 
Published: June 2020

Type 2 diabetes (T2D) is a major cause of morbidity and death worldwide. Women with gestational diabetes mellitus (GDM) have a seven-fold higher risk of developing T2D later in life. However, accurate methods for post-partum T2D risk stratification of GDM women, are lacking. MicroRNAs are now well recognised as circulating biomarkers or mediators of metabolic disease. We aimed to determine if post-partum circulating microRNAs can predict the devolvement of T2D in women with previous GDM. Participants were part of the GDM follow-up program at the Mercy Hospital for Women, Australia. Plasma samples were collected at 12-week post-partum from 103 women following an index GDM pregnancy. Women were followed for 10 years to assess development of T2D. In a discovery approach, we measured 754 miRNAs in plasma from T2D non-progressors (N=11) and in T2D progressors (N=10) using TaqMan-based real time PCR on an OpenArray platform. Data were analysed using penalised logistic regression followed by bootstrapping. Top 15 miRNAs with high frequencies in this discovery bootstrap analysis were selected for validation in the remaining samples (N=82; 71 non-progressors and 11 progressors). Validation data were normalized to spike-in control (ath-miR-172a). Four miRNAs (miR-543, miR-410, miR-491 and miR-369-3p) were significantly dysregulated (p&lt;0.05) between progressors and non-progressors to T2D, identifying these as risk factors. In a clinical model of prediction of T2D that included six traditional risk factors (age, BMI, pregnancy fasting glucose, post-OGTT change, cholesterol and triglycerides), the addition of these four circulating microRNA biomarkers measured at 12-weeks post-partum improved the prediction of future T2D from traditional AUC=0.8259 (95% CI: 0.68-0.9717) to an AUC= 0.9155 (95% CI: 0.8307-1). Replication of our findings in other cohorts is merited. Improved prediction will be beneficial in facilitating early intervention for T2D.

Disclosure
M. Joglekar: None. W.K. Wong: None. F. Ema: None. H.M. Georgiou: None. A. Hardikar: None. M. Lappas: None.
940-P: 14C-Tirzepatide ADME Studies in Rat and Monkey
Authors: MARTIN JENNIFER , CASSIDY KENNETH , CZESKIS BORIS , ALBERTS JEFF , LAO YANBIN , GLUFF JENNIFER , NIEDENTHAL ANDREA M. 
Published: June 2020

Novel dual GIP and GLP-1 receptor agonist, tirzepatide (TZP), is being developed as a potential weekly treatment for type 2 diabetes (T2DM), weight management and nonalcoholic steatohepatitis. The absorption, metabolism and excretion of a single subcutaneous (SC) dose of 14C-tirzepatide was investigated in Sprague Dawley rat and cynomolgus monkey. In addition, tissue distribution of 14C-tirzepatide was assessed in quantitative whole-body autoradiography (QWBA) study in pigmented Long Evans rat following a single SC dose.
14C-Tirzepatide was prepared by incorporating four 14C’s in the mini-PEG linker between the peptide backbone and the di-acid chain to provide a specific activity of ∼ 40 µCi/mg. Following a single SC dose of 14C-tirzepatide in rat (3 mg/kg) and monkey (0.5 mg/kg), total radioactivity recovery was &gt; 97% over the course of study (336 hours for rat and 672 hours for monkey). The dosed radioactivity was similarly excreted via urine and feces in rats and monkeys. Metabolism of 14C-tirzepatide was characterized in plasma and excreta. Parent drug was the major component in circulation accounting for approximately 87% of total radioactivity in rat and 84% in monkey. Tirzepatide was primarily metabolized via catabolism of the peptide backbone and β-oxidation of the di-acid chain.
Following a single SC dose of 14C-tirzepatide in rats (3 mg/kg), radioactivity was distributed to tissues as early as the first collection time point at 1-hour post dose. The tissues with the highest radioactivity concentrations were observed in the dose site, kidney, cecum, urinary bladder, intervertebral ligaments, arterial wall, lungs, and liver, generally at 12 to 48 hours post dose.

Disclosure
J. Martin: Employee; Self; Eli Lilly and Company. K. Cassidy: Employee; Self; Eli Lilly and Company. B. Czeskis: None. J. Alberts: Employee; Self; Eli Lilly and Company. Y. Lao: Employee; Spouse/Partner; Eli Lilly and Company. J. Gluff: None. A.M. Niedenthal: None.
951-P: Cotadutide (MEDI0382), a Dual Receptor Agonist with Glucagon-Like Peptide-1 and Glucagon Activity, Is Well Tolerated (&lt;600 µG) with Robust Effects on Blood Glucose in Patients with T2DM
Authors: ROBERTSON DARREN , HANSEN LARS , JAIN MEENA , PARKER VICTORIA , PETRONE MARCELLA , WANG TAO , HEISE TIM , JERMUTUS LUTZ 
Published: June 2020

Background and Aims: Previously, cotadutide demonstrated significant glucose- and body weight-lowering effects in doses up to 300 µg. We examined the safety and efficacy of cotadutide in doses up to 600 µg in patients with T2DM.
Methods: In this double-blind, phase 2a study, 20 adults with T2DM (HbA1c ≤8.5%) were randomized to receive QD SC cotadutide (n=15) or placebo (n=5) for 77 days. A dose-escalation committee approved titrations &gt;400 µg and ≤600 µg following a safety data review. Patients underwent continuous glucose monitoring.
Results: The adverse event profile suggests that the highest clinically tolerated dose has not been identified. Nausea was reported by 3 (20%) patients treated with cotadutide, with one episode of vomiting. There was a significant reduction from baseline in the 7-day average glucose levels (Figure). By day 77, 76.9% of patients in the cotadutide group achieved a &gt;5% body weight loss. A significant reduction in least-squares mean from baseline in ALT level with cotadutide versus placebo was reported (-7.17 U/L, 90% CI: -12.21, -2.14).
Conclusions: Cotadutide was well-tolerated at doses up to 600 µg and reduced hyperglycemia, with clinically significant weight loss and beneficial effects on liver enzymes.

Disclosure
D. Robertson: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca. L. Hansen: Employee; Self; AstraZeneca. M. Jain: Employee; Self; CSL Behring. Stock/Shareholder; Self; AstraZeneca. M. Petrone: Employee; Self; AstraZeneca. T. Wang: Employee; Self; AstraZeneca. T. Heise: Advisory Panel; Self; Mylan, Novo Nordisk A/S. Research Support; Self; ADOCIA, Aerami, Becton, Dickinson and Company, Biocon, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Gan & Lee Pharmaceuticals, MedImmune, Merck KGaA, Mylan, Nordic Bioscience, Novo Nordisk A/S, Poxel SA, Sanofi, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. L. Jermutus: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca.

Funding
AstraZeneca
969-P: Effects of Tirzepatide on Meal Intake and Appetite in Japanese Patients with Type 2 Diabetes
Authors: OHWAKI KENJI , FURIHATA KENICHI , OURA TOMONORI , IMAOKA TAKESHI 
Published: June 2020

Dual GIP and GLP-1 receptor agonist, tirzepatide (TZP), showed clinically meaningful HbA1c reduction and dose-dependent weight loss in Japanese patients with type 2 diabetes in an 8-week, Phase 1, multiple ascending dose study. Decreased appetite was the most frequently reported treatment-emergent adverse event, with nearly half of TZP-treated patients experiencing decreased appetite without nausea or vomiting. We explored the effects of TZP 5 mg, 10 mg, and 15 mg on meal intake and appetite sensation in these patients. Standardized lunch and dinner meals were provided on Days -1, 2 and 51 (700 kCal; 20% protein, 25% fat, 55% carb). Amount (%) of meals consumed were recorded. Subjective ratings of appetite sensations were measured by a 100-mm visual analogue scale for parameters of hunger, fullness, satiety, and prospective food consumption pre- and 4-5h post-meal. Meal intake decreased on Day 2 (TZP 5 mg) and dose-dependently decreased with TZP vs. PBO on Day 51 (Figure). The proportion of meal occasions with ≥50% meal leftover was 0% (PBO) and 16.7% (TZP 5 mg) on Day 2 and 0% (PBO), 13.6% (TZP 5 mg), 18.2% (TZP 10 mg) and 30.0% (TZP 15 mg) on Day 51. There was a trend in decreasing hunger and fullness scores with all TZP doses vs. PBO on Day 51. However, satiety, prospective food consumption and overall appetite scores did not differ among groups. TZP dose-dependently reduced meal intake and demonstrated a trend in decreased hunger.

Disclosure
K. Ohwaki: Employee; Self; Eli Lilly Japan K.K. K. Furihata: None. T. Oura: Employee; Self; Eli Lilly Japan K.K. Stock/Shareholder; Self; Eli Lilly and Company. T. Imaoka: Employee; Self; Eli Lilly Japan K.K.

Funding
Eli Lilly and Company
979-P: Improved Technology Satisfaction and Sleep Quality with Medtronic Minimed Advanced Hybrid Closed-Loop Delivery Compared with Predictive Low Glucose Suspend in People with Type 1 Diabetes in a Randomized Crossover Trial
Authors: COLLYNS OLIVIA , MEIER RENEE , BETTS ZARA , CHAN DENNIS , FRAMPTON CHRIS , FREWEN CARLA M. , GALLAND BARBARA , HEWAPATHIRANA NIRANJALA , JONES SHIRLEY , KURTZ NATALIE , SHIN JOHN , VIGERSKY ROBERT , WHEELER BENJAMIN J. , DE BOCK MARTIN 
Published: June 2020

Background: Automated insulin delivery aims to lower treatment burden and improve quality of life as well as glycemic outcomes.
Methods: This dual-centre, randomized, open-label, two-sequence cross-over study in automated insulin delivery naïve users, compared Medtronic Minimed® Advanced Hybrid Closed Loop (AHCL) to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP+PLGM). At the end of each 4 week intervention impacts on quality of life were compared using age-appropriate scales: Diabetes Treatment Satisfaction Questionnaire status and change (DTSQs and DTSQc), Diabetes Technology Questionnaire (DTQ), Pittsburgh Sleep Quality Index (PSQI), World Health Organisation-Five Well-Being Index (WHO-5), Hypoglycemic Fear Survey (HFS-II) and Hypoglycemia Confidence Scale (HCS).
Results: 59/60 people completed the study (mean age 23.3±14.4yrs). Statistically significant differences favouring AHCL were demonstrated in several scales (data shown as mean±SE). Technology satisfaction favoured AHCL over PLGM as shown by a higher score in the DTSQs during AHCL (n=28) vs. SAP+PLGM (n=29) (30.9±0.7 vs. 27.9±0.7, p=0.004) and DTSQc AHCL (n=29) vs. SAP+PLGM (n=30) (11.7±0.9 vs. 9.2±0.8, p=0.032) in adults. Adolescents also showed a higher DTSQc score during AHCL (n=16) vs. SAP+PLGM (n=15) (14.8±0.7 vs. 12.1±0.8, p=0.024). The DTQ “change” score (n=59) favoured AHCL over SAP+ PLGM (3.5±0.0 vs. 3.3±0.0, p&lt;0.001). Improved sleep quality was demonstrated by the lower PSQI in those aged over 16 years (n= 36) during AHCL vs. SAP+PLGM (4.8±0.3 vs. 5.7±0.3, p=0.048) with &gt; 5 indicating poor quality sleep. No differences were found in the other scales.
Conclusion: The findings from this RCT suggest AHCL compared to SAP + PLGM mode has the potential to increase treatment satisfaction and improve subjective sleep quality in adolescents and adults with T1D.

Disclosure
O. Collyns: None. R. Meier: None. Z. Betts: None. D. Chan: None. C. Frampton: None. C.M. Frewen: None. B. Galland: None. N. Hewapathirana: Other Relationship; Self; Sanofi. S. Jones: None. N. Kurtz: Employee; Self; Medtronic. J. Shin: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic. B.J. Wheeler: Research Support; Self; Medtronic. M. de Bock: None.
988-P: Do-It-Yourself Artificial Pancreas Systems for Type 1 Diabetes Reduce Hyperglycemia without Increasing Hypoglycemia
Authors: ZABINSKY JENNIFER , HOWELL HALEY , GHEZAVATI ALIREZA , LEWIS DANA M. , NGUYEN ANDREW , WONG JENISE C. 
Published: June 2020

Background: Patient-driven innovation has led to the development of do-it-yourself artificial pancreas systems (DIYAPS) for the management of type 1 diabetes (T1D). There have been few studies comparing glycemic outcomes for DIYAPS compared to conventional sensor-augmented pump (SAP) therapy.
Methods: A retrospective double cohort study was performed. The DIY group consisted of people with T1D using DIYAPS (OpenAPS, Loop, and AndroidAPS) who contributed data to the OpenAPS Data Commons. The SAP group included age-matched SAP users whose sensor data was obtained through the Tidepool Big Data Donation Project. The primary outcome of percent of sensor glucoses (SG) in low glucose range (&lt;70 mg/dL) was determined for both groups and compared. Secondary outcomes included mean SG, number of &gt;=15-minute hypoglycemic episodes (&lt;70 mg/dL) per month, and percent of SG in high glucose range (&gt;=180 mg/dL) and in target range (70-180 mg/dL).
Results: The DIY group included 90 days of data from 74 individuals with mean age of 36 ± 15 years and 24 ± 16 years since T1D diagnosis. The SAP group had 98 individuals with mean age of 35 ± 14 years and 20 ± 13 years since diagnosis. There was no significant difference in percent of SG &lt;70 mg/dL between the two groups (3.8% for DIY vs. 4.7% for SAP, p=0.17). There was also no difference in number of hypoglycemic episodes per month (32.9 for DIY vs. 33.4 for SAP, p=0.87) or in percent of SG &lt;54 mg/dL (0.8% for DIY vs. 1.3% for SAP, p=0.09). Mean SG was lower for the DIY group (134.9 ± 19.1 mg/dL for DIY vs. 150.3 ± 25.7 mg/dL for SAP, p&lt;0.0001). Percent of SG &gt;=180 mg/dL was lower (16.9% for DIY vs. 26.1% for SAP, p&lt;0.0001) and percent in target glucose range was greater for the DIY group (79.3% for DIY vs. 69.2% for SAP, p&lt;0.0001).
Conclusion: Users of DIYAPS had a comparable amount of hypoglycemia to those using SAP and had less hyperglycemia. This study suggests that the glycemic benefit of DIYAPS is in reducing hyperglycemia without compromising the low occurrence of hypoglycemia.

Disclosure
J. Zabinsky: None. H. Howell: None. A. Ghezavati: None. D.M. Lewis: Research Support; Self; JDRF. A. Nguyen: None. J.C. Wong: Consultant; Self; pH Pharma. Research Support; Self; Dexcom, Inc.

Funding
JDRF
990-P: Inhaled and Background Basal Insulins Improved A1C and QoL Subdomains in Patients with Type 2 Diabetes: An Observational Study
Authors: KIPNES MARK , SALHIN AMNA , RYAN TERRI , VADAKEKALAM JACOB , PAMAR VIJAYVEER , TRIGOSO FERNANDO , AKHRASS FIRAS 
Published: June 2020

Rapid-acting inhaled (Afrezza) and injected mealtime insulins are available for patients with type 2 diabetes who are also treated with basal insulin. In this interim analysis of a single-site, observational, investigator initiated study, time spent in glycemic goal range (70-180 mg/dL) without significant hypoglycemia (primary endpoint) was assessed in the intent-to-treat population of patients with type 2 diabetes (N=25; 60%M; age 62y; wt 95.7±4.4kg; A1c 8.3±0.2%). Patients were titrated from pre-meal insulin plus basal insulin to inhaled insulin plus basal insulin over 2 weeks and followed for 14 weeks. At Week 14, mean (±SE) times spent above (&gt;180 mg/dL; -1.7±3.2 mins; P=0.60), in (70 180 mg/dL; -1.2±2.6 mins; P=0.65), and below (&lt;70 mg/dL; +2.9±2.5 mins; P=0.26) glycemic goal range were not significantly different from baseline. However, A1c significantly decreased from baseline at Week 14 (-0.76%±0.18; P=0.0002). At Week 14, Quality of Life (QoL) Total score did not significantly change from baseline (+0.19±0.13; P=0.15). However, Useful (+0.46±0.20; P=0.03), Freeing (+0.92±0.24; P=0.0008), and Difficult ( 0.68±0.28; P=0.02) QoL subdomains significantly improved from baseline at Week 14. There were no deaths, no serious hypoglycemic events, but 4 patients discontinued (3 upper respiratory tract, 1 diarrhea). Five patients experienced cough, 2 patients chest mucus/congestion, and 2 patients cough/chest congestion. Most upper respiratory events were associated with use of &gt;60 units/day inhaled insulin. Although this interim analysis did not achieve its primary endpoint of significant increase of time spent in glycemic goal range, possibly caused by patients not self-adjusting post-prandial dosing as instructed. Patients treated with inhaled insulin with background basal insulin for 14 weeks experienced significant reduction of A1c and significant improvements of Useful, Freeing, and Difficult QoL subdomains compared to baseline.

Disclosure
M. Kipnes: None. A. Salhin: None. T. Ryan: None. J. Vadakekalam: None. V. Pamar: None. F. Trigoso: None. F. Akhrass: None.

Funding
MannKind Corporation
992-P: Patient-Reported Outcomes for 2,335 Adults with Type 2 Diabetes Using the Omnipod Insulin Management System Show Glycemic Improvement over First 90 Days of Use
Authors: CARLSON ANDERS L. , HUYETT LAUREN M. , JANTZ JAY , CHANG ALBERT , VIENNEAU TODD , LY TRANG T. 
Published: June 2020

Patient-reported outcomes are a useful tool to understand the impact of treatments in clinical application on a large scale. This retrospective study characterized patient-reported outcomes of a large cohort of adults in the United States with type 2 diabetes using a tubeless insulin pump (Omnipod® or Omnipod DASH™ Insulin Management System, Acton, MA). From Jan. 2015-Jan. 2020, patient-reported outcomes were recorded before and ≥90 days after initiating system use. Primary outcomes were change in self-reported A1C and total daily dose of insulin.
Patients (N=2,335) were aged (mean±SD) 58±11y and 53% female. The percentage of users with a self-reported A1C ≤8% increased from 33% pre-tubeless pump to 64% post-tubeless pump, and the percentage with a self-reported A1C &gt;9% decreased from 44% to 15% (p&lt;0.001, Table). Self-reported A1C decreased from 9.2±2.7% to 7.9±2.2% (p&lt;0.001). The self-reported total daily insulin for those with data available (n=2,130) was 33±49 U/d lower on average from pre-tubeless pump to post-tubeless pump, from 104±68 U/d to 71±40 U/d (p&lt;0.001).
These patient-reported outcomes provide positive evidence that use of a tubeless insulin pump was associated with glycemic outcomes that exceed U.S. National Healthcare Effectiveness Data and Information Set (HEDIS) standards for adequate diabetes management.

Disclosure
A.L. Carlson: Consultant; Self; Medtronic. Research Support; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk A/S, Sanofi, UnitedHealth Group. L.M. Huyett: Employee; Self; Insulet Corporation. J. Jantz: Employee; Self; Insulet Corporation. A. Chang: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation.

Funding
Insulet Corporation
996-P: A Randomized Study to Evaluate the Efficacy of Insulclock Pen Device in Insulin-Treated Patients with Uncontrolled Type 2 Diabetes
Authors: RAMOS CLEMENTINA , GALINDO RODOLFO J. , ALAM MUHAMMAD M. , CARDONA SAUMETH , ALBURY BONNIE S. , OLADEJO OMOLADE , PASQUEL FRANCISCO J. , VELLANKI PRIYATHAMA , FAYFMAN MAYA , MIGDAL ALEXANDRA , DAVIS GEORGIA , HAW JEEHEA SONYA , UMPIERREZ GUILLERMO E. 
Published: June 2020

Insulin pen devices have been reported to improve patient satisfaction and treatment adherence compared to the traditional vial/syringe. Insulclock® is a small electronic device plugged onto insulin pen to track information via Bluetooth to smart-phone technology on date, time and dosage of injections and with an alarm system to reduce insulin omissions. We performed a randomized, cross-over design study in patients with type 2 diabetes (T2D) on basal insulin to assess the efficacy and satisfaction of Insulclock device. Eighty T2D patients on basal insulin ± oral agents with HbA1c between 7.0% and 12.0% were randomized to a 12-week ’intervention’ phase receiving reminders or to a 12-week ’control’ phase with device without feedback. Basal insulin was titrated every 2 weeks to a target fasting and premeal glucose between 70-130 mg/dl. Study outcomes included differences between groups on glycemic control, treatment adherence and satisfaction (DTSQc survey).
Baseline characteristics were similar between groups (56±11 years, HbA1c 9.2%±1.5). HbA1c improved significantly from baseline, with reduction of 0.9 % in the intervention and 0.7% in the control group. Insulclock improved glycemic control with an estimated reduction in average mean daily blood glucose (BG), fasting BG, and pre-meal BG of 6.03 (95% CI: [-3.21, 15.3]), 6.66 (95% CI: [-1.72, 15.04]), and 5.57 (95% CI: [-6.15, 17.31]) mg/dl, respectively. Repeated measures analyses based on linear mixed models suggest significant effects of insulclock on the trajectory of mean daily BG, fasting BG, pre-meal BG (p&lt;0.01, p=0.03, p=0.01). There were no differences in treatment adherence or on the rate of hypoglycemia, and patients were equally satisfied with the device during intervention and control phase (DTSQc 15.5±3.7 and 15.2±3.1, respectively).
In conclusion, the use of Insulclock resulted in improved glycemic control and treatment satisfaction in insulin treated patients with T2D.

Disclosure
C. Ramos: None. R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. M.M. Alam: None. S. Cardona: None. B.S. Albury: None. O. Oladejo: None. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. M. Fayfman: None. A. Migdal: None. G. Davis: None. J. Haw: None. G.E. Umpierrez: None.
997-P: Testing a Novel Infusion Set for Extended Wear Duration
Authors: BUCKINGHAM BRUCE A. , MARCAL TATIANA , HOFFMAN LANCE , MUSOLINO GIANLUCA , EKHLASPOUR LAYA , ZHANG GINA , CHATTARAJ SARNATH 
Published: June 2020

This was a randomized double blinded study of a novel infusion set with and without heparin, hypothesizing that small doses of heparin would decrease thrombosis and subcutaneous inflammation.
The MiniMed™ Quick-set™ infusion set was modified with a new tubing connector from current P-Cap. The P-Cap was modified to contain a foam (F) or a foam with heparin (F+H) connector. Visibly the sets appeared identical. Each participant wore two F and two F + H sets for 7 days or until set failure. The order of infusion set wear was randomly assigned. Infusion set failure was determined by unexplained hyperglycemia &gt;250mg/dL with a failed correction dose, ketones &gt;0.6mmol/L, evidence of infection, occlusion alarms, or adhesive failure. Infused set survival was compared to similar published 1-week studies using standard Quick-sets.
There were 20 participants (mean age 29.5±8 years). Each set was worn 40 times. Length of wear and causes of failure are shown below. Length of wear was not different between the F and F+H groups, but both had improved length of wear compared to historical Quick-sets (p&lt;0.05). There was no significant increase in insulin requirements or mean glucose values throughout the seven days of wear in any group.
There was no difference in overall duration of wear between the F and F+H groups. Both infusion set groups intended for extended wear had significantly better survival than the historical Quick-Set™ group. Further studies are planned with the F group.

Disclosure
B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Medtronic. Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. T. Marcal: None. L. Hoffman: None. G. Musolino: None. L. Ekhlaspour: None. G. Zhang: None. S. Chattaraj: Employee; Self; Medtronic.

Funding
Medtronic Diabetes