bluuebunny/crossref_metadata_2025_split huggingface dataset:
Performance of the GLUCOCARD® Shine XL Blood Glucose Monitoring System Compared with FDA 2016 Guidance Accuracy Criteria
Authors: WALKER JULIE , GILL PATRICIA , MAHER DANIELLE , GLEISNER JOHN M. 
Published: June 2018

Background: Blood Glucose Monitoring Systems (BGMS) are important tools used in the management of diabetes mellitus. Accurate BGMS readings are needed to prevent potential micro and macrovascular complications due to uncontrolled blood glucose levels. The FDA’s 2016 Guidance, “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter (OTC) Use”, is FDA’s recommendation for measuring the accuracy of OTC BGMS. The accuracy boundaries of the guidance require that 95% of all results fall within ±15% of reference and 99% within ±20% of reference.
Purpose: This study evaluated the GLUCOCARD® Shine XL BGMS performance against the accuracy boundaries set by the FDA’s 2016 Guidance.
Methods: Three lots of test strips were evaluated in a side-by-side comparison at the ARKRAY Factory in Minneapolis, Minnesota. Blood samples were drawn from the fingertip of people with diabetes (n=180) by trained laboratory professionals between November and December 2017. Reference values were obtained using the YSI Model 2300 Analyzer. Data was evaluated against the accuracy boundaries of the FDA’s 2016 Guidance for Self-Monitoring Blood Glucose Test Systems for OTC Use.
Results: 98.3% (177/180) of the combined results for the three lots of GLUCOCARD® Shine XL BGMS fell within the ±15% of reference and 99.4% (179/180) were within ±20% of reference. Overall bias was 2.2% and the correlation coefficient was 0.99 (r).
Conclusion: The GLUCOCARD® Shine XL BGMS performed within the accuracy boundaries of the FDA’s 2016 Guidance, Self-Monitoring Blood Glucose Test Systems for OTC Use.

Disclosure
J. Walker: Employee; Self; Arkray, Inc. P. Gill: Employee; Self; Arkray, Inc. D. Maher: Employee; Self; Arkray, Inc. J.M. Gleisner: Employee; Self; Arkray, Inc..
Improvement of Glycemic Control after Three Months’ Use of the Predictive Low-Glucose Management System and Persisting for 18 Months in Patients with Diabetes Mellitus Type 1
Authors: DIDANDELOS TRIANTAFYLLOS , GIANNOULAKI PARTHENA , KARLAFTI ELENI , KOTZAKIOULAFI EVANGELIA , KONTONINAS ZISIS , TZIOMALOS KONSTANTINOS , HATZITOLIOS APOSTOLOS I. 
Published: June 2018

Aim: To study the efficacy of the Medtronic MiniMed 640G insulin pump (CSII with Suspend before low (Predictive Low-Glucose Management [PLGM]) on glycemic control in patients with diabetes mellitus type 1 (DMT1) at baseline, after the first trimester and after 18 months’ use.
Patients/Methods: Thirteen patients with DMT1 participated who were on PLGM system (Minimed 640G system-Medtronic), 8 females, age 45.8±12.5 years, DM duration 28.1±8.5 years and PLGM duration 17.5±7.4 months. HbA1c, anthropometric measurements and medical history were recorded at baseline, after 3 months and after 18 months’ use of the PLGM system. The continuous glucose measurements (CGM) data of the last two weeks of each interval were downloaded using the software Carelink Pro and Personal.
Results: The glycemic control after using PLGM system was significantly better compared with baseline at 3 and 18 months’ use (HbA1c 7.2±0.7% vs. 6.6±0.5 vs. 6.7±0.5, p=0.006). There was an improvement at first trimester compared with baseline (HbA1c 6.6±0.5 vs. 7.2±0.7, p=0.027) and at 18 months’ use compared with baseline (HbA1c 6.7±0.5 vs. 7.2±0.7, p=0.046). There was no difference in glycemic control between 3 and 18 months’ use. There was no difference of time duration &lt; 3.9 mmol/l (min/day), hypoglycemic episodes and AUC &lt; 3.9 mmol/l compared with baseline at 3 and 18 months’ use. There was a reduction of the time duration &gt; 9.9 mmol/l (min/day) between baseline and after 18 months’ use (3281.3±2175.9 vs. 1891.6±555.7, p=0.037). Hyperglycemic events were reduced significantly after 18 months compared to baseline (median 28.5, interquartile range (IQR) 14 vs. median 39.5, IQR 19, p=0.045).
Conclusion: Patients with DMT1 using CSII with PLGM system for 18 months improved their glycemic control due to the reduction of hyperglycemic fluctuation. Glycemic control improved after 3 months and that improvement persisted for 18 months of follow-up.

Disclosure
T. Didandelos: None. P. Giannoulaki: None. E. Karlafti: None. E. Kotzakioulafi: None. Z. Kontoninas: None. K. Tziomalos: None. A.I. Hatzitolios: None.
Characteristics of Children Discontinuing Flash Glucose Monitoring
Authors: MESSAAOUI ANISSA , TENOUTASSE SYLVIE , CRENIER LAURENT 
Published: June 2018

Aims: To study characteristics of type 1 diabetic patients who stop Flash Glucose Monitoring (FGM) during the first year of use in a pediatric hospital.
Methods: This retrospective study included all type 1 diabetic children and adolescents who switched to FGM in our center and for whom A1c, FGM data, sensor related adverse events and satisfaction scores were available.
Results: On the 278 subjects (aged 4-20 years) included in the study, 44 (15.8%) came back to SMBG during the first 12.7 (11.9-13.5) months [median (IQR)] of follow-up. Adverse events were more often reported, including premature loss of the sensor (31.8% vs. 12.4%; p=0.001), skin reactions (18.2% vs. 2.6%; p&lt;0.001) and local pain (6.8% vs. 0%; p&lt;0.001). They were also less satisfied by the FGM than continuing users (p&lt;0.001). Subjects who discontinued FGM had a diabetes of longer duration (7.3 (4.5-10.5) vs. 5.2 (3.1-7.7) years; p=0.002) and a higher A1c (7.9% (7.5-8.4) vs. 7.5 (6.8-8.0); p=0.002). After two months, they scanned less often (6.0 [4.0-7.8] vs. 7.0 [5.0-10.0] per day; p=0.022) and those scanning less than 7 times a day stopped FGM more quickly (p&lt;0.001).
Conclusions: In a pediatric population FGM is discontinued more often in patients experiencing adverse events, with higher A1c and scanning less. These patients are also older and have a diabetes of longer duration.

Disclosure
A. Messaaoui: None. S. Tenoutasse: None. L. Crenier: None.
Retrospective Flash Glucose Monitoring Analysis in Patients with Type 2 DM, Closer to Target
Authors: CHAWLA MANOJ S. , CHAWLA PURVI M. , KOTHARI MIKHIL C. , SHAIKH AMBARI F. , WADHWA NAVNEET 
Published: June 2018

Undiagnosed or poorly managed diabetes may be associated with several complications including cardiac ailments, lower limb amputations, blindness or renal disease. Projections state that India would lead this increasing public health concern with a staggering incidence of 134.3 million patients by the year, 2045 based on current trends. We utilized the FreeStyleLibre Pro Flash Glucose Monitoring (FGM) system, a novel automated ambulatory glucose profile (AGP) reporting system to identify precise hyperglycemic spikes in a specific patient population. There were 53 T2DM patients with an AGP-estimated HbA1c close to target levels (HbA1c between 7-8%). The 24-hour glycemic patterns were divided into 2-hour time slot patterns for review and analyses; thus, identifying precise spikes contributing to hyperglycemia in patients not achieving their target HbA1c. The highest glycemic peaks were observed between 10 am to 12noonand between 10 pm-12 am [mean interstitial glucose (mg/dL) ± SD of 204 ± 36 and 186 ± 23] coinciding with the post-breakfast and post-dinner periods, respectively. As shown in Table 1, the variation in glycemic spikes ofeach of the 2-hour slots was statistically significant (p&lt;0.0001). FGM helped us identify glycemic variability and specifically, the contribution of post-breakfast hyperglycemia in precluding patients from achieving their target metabolic goals.

Disclosure
M.S. Chawla: Speaker's Bureau; Self; IPCA Laboratories, Eli Lilly and Company, Novo Nordisk A/S, MSD Pharmaceutical Pvt. Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca. Speaker's Bureau; Spouse/Partner; Sanofi. P.M. Chawla: Speaker's Bureau; Self; Sanofi. Speaker's Bureau; Spouse/Partner; Eli Lilly and Company, IPCA LABORATORIES, Novo Nordisk A/S, MSD PHARMACEUTICALS PVT. LTD., Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca. M.C. Kothari: None. A.F. Shaikh: None. N. Wadhwa: None.
Use of Continuous Glucose Monitoring Data for Defining Glucose Control in Insulin-Treated Patients
Authors: TOTOMIROVA TZVETELINA , DASKALOVA IVONA , ARNAUDOVA MILA 
Published: June 2018

Glycated haemoglobin (HbA1c) and self-monitoring of blood glucose (SMBG) are usually used to define glucose control in diabetic patients, but in many cases they are insufficient to present overall control. Continuous Glucose Monitoring (CGM) is used for adjustment of insulin doses but derived data could help to define glucose control. We assess the use of CGM data for defining control in subgroup of patients treated with insulin. We studied 75 diabetic patients (43 men, 32 women; age 55.23±8.99 years, disease duration 12.84±7.02 years) - 33 with type 2 diabetes on pre-mixed insulin, 21 with type 2 on multiple insulin injection (MII), 21 with type 1 on MMI. Patients did multiple daily blood glucose measurements of fasting and prandial blood glucose for three month period. HbA1c was measured and CGM by using iProTM for seven days was performed at the end of this period. Based on HbA1c assessment 36.36% of patients on premixed insulin, 19.05% of type 2 patients on MII and 9.52% of type 1 patients on MII were with good control. After estimation of results from SMBG these percentage were respectively 28.14%, 12.11%, 4.51%. CGM defined 27.27% of patients on premixed insulin, 23.80% of type 2 patients on MII and 2.38% of type 1 patients on MII as well controlled. In addition CGM gave information about insulin excursion - they were with no significant difference in the three groups (17.09±7.01, p=0.231). CGM was more informative than SMBG in presenting hypoglycemic episode (p=0.01) including night hypoglycemia and especially their duration (p=0.001). No difference was found in different groups with no dependence on type of diabetes or insulin regimen. Nevertheless of short observed period CGM data could give much information about overall glucose control that is comparable to three month blood glucose measurement and are better than other methods in estimating hypoglycemic episodes. Performing of CGM should be included in recommendations for assessment of glucose control.

Disclosure
T. Totomirova: None. I. Daskalova: None. M. Arnaudova: None.
Safety of Microdose Dexamethasone Acetate in the Eversense Long-Term Implantable Continuous Glucose Monitoring System
Authors: KELLEY E. L. , HARIDAS HARITHA , LORENZ CARRIE 
Published: June 2018

Background: Dexamethasone (DEX) is used in a variety of implantable medical devices to decrease inflammation and improve outcomes. The implantable Eversense® CGM System (Senseonics, Inc.) includes a silicone collar which slowly releases DEX acetate throughout the lifetime of the sensor. Studies were performed to characterize the potential user risk to dexamethasone acetate exposure.
Methods: Clinical trial subjects underwent frequent blood sampling for analysis of plasma DEX levels. Chemical testing of 90-day sensor explants was used to measure residual DEX content. Finally, a post market clinical follow-up study (PMCF) is currently ongoing which monitors the rate of serious device-related, procedure-related, or drug (DEX) related adverse events through approximately 24 months.
Results: In two trials (N=161, 86 with 2 sensors, 75 with 1 sensor), blood tests were performed to the 2 ng/mL level with no detectable plasma DEX. In a third trial (N=35), the limit of detection was reduced to 0.050 ng/mL. Blood samples from 8 patients inserted with one sensor had no measurable DEX plasma levels. Among 27 patients inserted with two sensors, the highest level of DEX detected was 0.114 ng/mL on day 2 post-insertion. All samples were below the detectable limit by day 8. Literature review states at plasma levels &lt; 1 ng/mL no systemic effect occurs. Testing of sensor explants determined that 0.3 mg of DEX is eluted over 90 days. No adverse events related to exposure to DEX have been reported to date in the PMCF
Conclusions: Dexamethasone acetate, which was selected to reduce the inflammatory response of the implantable sensor, was found to be safe. Plasma DEX levels after extended use are well below the concentration necessary for a pharmacological response, demonstrating safety of the Eversense Sensor with regard to clinical adverse effects attributable to chronic DEX exposure and that this risk should not grow over time.

Disclosure
E.L. Kelley: Employee; Self; Senseonics. H. Haridas: Employee; Self; Senseonics. C. Lorenz: Employee; Self; Senseonics.
Real-World Data from the MiniMed™ 670G System Commercial Launch
Authors: AGRAWAL PRATIK , STONE MICHAEL , GOPALAKRISHNAN SHWETA , FOGEL CATHERINE , LEE SCOTT W. , KAUFMAN FRANCINE R. 
Published: June 2018

The Medtronic MiniMed™ 670G hybrid closed-loop system with SmartGuard™ technology, which automatically adjusts basal insulin delivery, was released for commercial use in the U.S. in March 2017. Data from the first 13,9patients to use the system are reported.
MiniMed™ 670G data from patients who voluntarily uploaded to CareLink™ Personal software, from 3/17/17 to 12/14/17, were de-identified and analyzed if there were ≥7 days of sensor wear. Comparisons of glycemic metrics between 258,415 patient-days in the initial open-loop Manual Mode and 724,220 patient-days after starting closed-loop Auto Mode were made. Data were compared for patients 7-13 years, 14-21 years, 22-60 years, and ≥60 years.
The Table shows glycemic metrics, including time in target range (TIR, 70-180mg/dL), during Manual Mode and after Auto Mode start for all users and by age group. Children and teens had lower baseline TIR and more hyperglycemia in Manual Mode vs. adults, but a similar magnitude of improvement when in Auto Mode. Older adults had the most optimal glycemia with Auto Mode. TIR was higher in patients with greater time in Auto Mode. For those in Auto Mode 50-59% of the time, mean TIR was 65%; for Auto Mode 60-80% of the time, TIR was 68%; and for Auto Mode &gt;80% of the time, TIR was 74%.
Overall, data from the commercial launch of the MiniMed™ 670G system mirrored the pivotal trial1 results for all ages and showed an increase in TIR with less hypoglycemia and hyperglycemia.
All Patients7-13 years14-21 years22-60 years≥ 60 yearsManual ModeAfter Auto Mode startManual ModeAfter Auto Mode startManual ModeAfter Auto Mode startManual ModeAfter Auto Mode startManual ModeAfter Auto Mode startPatients, N13,906479126293781946Auto Mode Use, %-80.05%-77.58%-66.07%-80.89%-84.95%Mean SG, mg/dL163.53154.87183.44163.44179.55166.98161.50153.55156.91150.38SD SG, mg/dL54.2251.0463.1560.5563.0560.2953.3550.0649.9447.22Percentage of time in SG range, mg/dL&lt;500.38%0.31%0.22%0.25%0.38%0.37%0.41%0.33%0.29%0.22%&lt;540.60%0.49%0.36%0.40%0.59%0.57%0.64%0.51%0.47%0.36%&lt;702.59%2.05%1.71%2.03%2.42%2.21%2.77%2.12%2.21%1.76%70-18063.16%71.35%52.31%64.86%53.49%62.68%64.12%72.13%68.27%75.26%&gt;18034.24%26.60%45.98%33.11%44.09%35.11%33.11%25.75%29.52%22.98%&gt;2509.58%6.18%17.22%10.37%16.49%11.42%8.79%5.53%6.69%4.55%&gt;3003.22%1.86%6.94%3.73%6.57%4.34%2.82%1.53%1.91%1.20%

Disclosure
P. Agrawal: None. M. Stone: None. S. Gopalakrishnan: Employee; Self; Medtronic. C. Fogel: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.
Automatic Tuning of CIR and ISF with the Adaptive Bolus Calculator (ABC) Approach Is Safe and Reliable—Results from a Hybrid In Silico Evaluation
Authors: REITERER FLORIAN , RE LUIGI DEL 
Published: June 2018

Introduction: T1DM patients usually determine their bolus insulin requirements using a patient and daytime specific carbohydrate to insulin ratio (CIR) and insulin sensitivity factor (ISF). These factors are tuned by the patients themselves with assistance of their MDs. Recently, the Adaptive Bolus Calculator (ABC) method has been proposed for the automatic tuning of CIRs and ISFs based on data that is routinely collected by T1DM patients.
Methods: Data from a recent clinical trial with 12 patients are used for evaluating the ABC method. CIR and ISF values are identified using the ABC method based on the first 6 days of the data, whereas the 7th day is used for the evaluation. The effect of the estimated CIRs and ISFs on the glycemic outcomes is simulated using a deviation based method. The simulation outcomes are compared to the outcomes obtained with the clinically used settings (in the figure below abbreviated as CUS) that the patients employed on the previous 6 days for calculating their bolus insulin needs.
Results: The CIRs and ISFs estimated by the ABC approach lead in average to a 6.8% reduction for time in hypoglycemia (BG&lt;70 mg/dl) as compared to the clinically used CIR/ISF settings (avg. time in hypoglycemia: from 9.8% to 3.0%, p&lt;0.01). Time in hyperglycemia (BG&gt;180 mg/dl) on the other hand increases only slightly (avg. time in hyperglycemia: 10.9% vs. 9.3%, p=0.08).

Disclosure
F. Reiterer: None. L. del Re: None.
Intradermal Administration Improves the Kinetics of Faster-Acting Fiasp® Insulin
Authors: RANAMUKHA SAHAN , MANSOOR IMAN , FENG KIMBERLEY , STOEBER BORIS , WEHBE MOHAMED , CLAIR RORY ST , PICHE CLAUDE , MOREAU JEAN-PIERRE 
Published: June 2018

Fiasp® (insulin aspart, Novo Nordisk) is a faster-acting injectable insulin formulation that is administered subcutaneously (SC) for blood glucose management. We hypothesized that intradermal (ID) administration could improve the pharmacokinetic profile of Fiasp® when compared to traditional SC injection.
Herein, we describe a simple, scalable and cost-effective hollow microneedle platform to evaluate the effects of ID administration on Fiasp® pharmacokinetics. Three groups of 8 rats received 1 IU/kg by SC injection or by ID injection using either a single or quadruple microneedle projection design. Blood was collected from 5-240 mins post-injection and assayed for insulin (ELISA, Crystal Chem) and blood glucose (hand-held glucometer) concentrations.
The results (below) show that plasma insulin levels were comparable for all groups with mean values ranging from 464 to 480 µU/mL. Yet, the peak plasma concentrations were 1.5-3-fold earlier for rats treated using the microneedle designs. This preliminary data suggests that ID injection of Fiasp® using these novel hollow microneedle designs results in faster absorption and thereby could lead to a more rapid onset of action.

Disclosure
S. Ranamukha: None. I. Mansoor: Stock/Shareholder; Self; Microdermics. K. Feng: Employee; Self; Microdermics Inc. B. Stoeber: Other Relationship; Self; Microdermics Inc.. M. Wehbe: None. R. St Clair: Employee; Self; Microdermics Inc. C. Piche: Employee; Self; Locemia Solutions. Stock/Shareholder; Self; Locemia Solutions. Consultant; Self; Microdermics Inc. Stock/Shareholder; Self; Diasome Pharmaceuticals, Inc., Bigfoot Biomedical. J. Moreau: Consultant; Self; Microdermics.
Glucose Control Using a Standard vs. an Enhanced Hybrid Closed-Loop System—A Pilot Study
Authors: PALDUS BARBORA , LEE MELISSA H. , JONES HANNAH , MCAULEY SYBIL A. , HORSBURGH JODIE C. , ROEM KERRYN L. , WARD GLENN , MACISAAC RICHARD , COHEN NEALE , COLMAN PETER G. , JENKINS ALICIA , O'NEAL DAVID N. 
Published: June 2018

Background: Hybrid closed loop (HCL) insulin delivery with the Medtronic MiniMed 670G system is safe and effective in improving glycemia for people with type 1 diabetes (T1D).
Aims: To compare glucose control, CL exits and alarm frequency with standard HCL vs. enhanced HCL (eHCL) systems.
Methods: Pump experienced adults with T1D (n=11; 9 women; mean[SD] age: 51[15]Y; HbA1c 7.5[1.0]%) were assigned in random order HCL and eHCL for 1 week each in a supervised live-in setting. eHCL incorporated enhanced bolus reminders and iterative changes broadening glucose and insulin delivery parameters permitting persistence in CL. For both HCL and eHCL insulin delivery was by a Medtronic pump with identical interventions (missed bolus, exercise, high GI and high fat meals), insulin action times and insulin-carbohydrate ratios implemented. The primary outcome was CGM time in target range.
Results: eHCL resulted in fewer CL alerts and exits. Time in target and mean glucose favored eHCL but did not reach significance (Table). No episodes of severe hypoglycemia or ketoacidosis occurred.
Conclusions: Iterative changes to the Medtronic HCL system resulted in trends towards improved glycemia, fewer CL exits and alerts without compromising safety, despite multiple food and exercise challenges during the study periods. Longer term studies at home are required to confirm these findings.
Table: All results are Mean (SD); *NS= Not Significant.HCL (n=11)eHCL (n=11)pInsulin DeliveryTotal daily insulin (units/day)44 (18)47 (24)NS*Daily basal (%)55 (8)55 (7)NS*Daily bolus (%)45 (8)45 (7)NS*Daily insulin to carbohydrate ratio9.6 (3.1)9.6 (3.1)NS*Insulin action time (hrs)3.7 (0.6)3.7 (0.6)NS*Glucose Metrics% time in 70-180mg/dL69 (11)74 (10)0.16Mean sensor glucose (mg/dL)160 (13)151 (11)0.091Time &lt;70mg/dL (%)1.9 (2.4)1.2 (1.2)0.42Time &lt;50mg/dL (%)0.4 (0.5)0.2 (0.3)0.21Time&gt;180mg/dL (%)29 (11)24 (9)0.37Time &gt;250mg/dL (%)7.3 (5.6)6.1 (4.7)0.48Algorithm related Alerts and Dropout Alerts (n/week)8.6 (5.8)3.9 (2.8)0.01CL exits (n/week)3.5 (3.1)0 (0)0.004

Disclosure
B. Paldus: None. M.H. Lee: None. H. Jones: None. S.A. McAuley: Research Support; Self; JDRF. Speaker's Bureau; Self; Novo Nordisk Inc., Australian Diabetes Society. J.C. Horsburgh: None. K.L. Roem: None. G. Ward: None. R. MacIsaac: None. N. Cohen: None. P.G. Colman: None. A. Jenkins: Research Support; Self; Medtronic, Mylan, Sanofi-Aventis. D.N. O'Neal: Research Support; Self; Medtronic MiniMed, Inc.. Advisory Panel; Self; Medtronic MiniMed, Inc.. Speaker's Bureau; Self; Medtronic MiniMed, Inc.. Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Research Support; Self; Sanofi.