bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effects of Basal Doses of Insulin Treatment in Type 1 Diabetes Evaluated by Continuous Glucose Monitoring on Glucose Variability
Authors: PROIETTI ADRIAN E. , DAGHERO ANDREA V. , PANEI NICOLAS , SCAPUZZI MARIA L. , JOKIEL ANDREA E. , GLESIAS MARIA LAURA , VELAZQUEZ JULIETA , NOGUEIRA JUAN P. 
Published: June 2018

Background: This study compared the effects of insulin glargine and insulin detemir or degludec on glucose variability with CGM technology in real-life condition of patients with T1D.
Methods: This was a paralell trial in 81 T1D patients: 27 men and 51 women, with an average age of 31.33 years, and hemoglobin A1c (HbA1c) level of 8.4%. 56 patients were treated with glargine and 25 with detemir/degludec. The primary end point was the coefficient of variation (CV) of blood glucose. Secondary end points included HbA1c, mean amplitude of glycemic excursions (MAGE) and total doses of basal insulin and rapid analogs.
Results: insulin degludec/detemir was not different to insulin glargine with respect to CV (39.42±7.64 vs. 40.37±7.38, p=0.95) and HbA1c (8.03±1.42 vs. 8.47±1.68, p=0.26). There were also no significant differences between treatment groups with respect to MAGE (305.77±7.50 vs. 300.83±10.64, p=0.71) and rapids analogs (17.92±1.34 vs. 17.50±1.88, p=0.85). Only significantly higher doses were found with insulin detemir/degludec vs. insulin glargine (33.30±5.60 vs. 21.70±1.53, p=0.01). In multiple regression analyses, the total dose of basal insulin was the only parameter positively associated with levels of HbA1c (p = 0.01).
Conclusion: the increased doses of insulin determir/degludec related to insulin glargine do not lead to a better metabolic control regarding CV or HbA1c levels.

Disclosure
A.E. Proietti: None. A.V. Daghero: None. N. Panei: None. M.L. Scapuzzi: None. A.E. Jokiel: None. M. Iglesias: None. J. Velazquez: None. J.P. Nogueira: None.
Flash Glucose Monitoring in Children–One-Year Experience
Authors: MESSAAOUI ANISSA , TENOUTASSE SYLVIE , CRENIER LAURENT 
Published: June 2018

Aims: To characterize the use of Flash Glucose Monitoring (FGM) in type 1 diabetic patients in a pediatric hospital one year after reimbursement by the public health insurance in Belgium.
Methods: This retrospective study included all type 1 diabetic children and adolescents who switched to FGM with specific education in our center and for whom A1c, FGM data, and severe hypoglycemic records were available.
Results: On the 334 subjects (aged 4-20 years) included, 56 (16.8%) refused to use FGM. At baseline, users were younger [median (IQR)] (13.6 (10.9-16.3) vs. 15.2 (12.2-17.5) years; p=0.012) and performed more SMBG tests (4.3 (3.8-5.0) vs. 4.1 (3.5-4.4) per day; p=0.008) than non-users. During follow-up, FGM users increased glucose monitoring from 4.3 (3.8-5.0) to 7.0 (5.0-10.0) time per day (p=0.011) while severe hypoglycemic events decreased from 6.8% to 0.9% (p=0.011). At the end of follow-up (12.7 (11.9-13.5) months), there were less severe hypoglycemic events in FGM users than in non-users (0.9% vs. 8.9%; p=0.026) but no difference in A1c. In multivariate analysis, ΔA1c during follow-up was independently related to A1c at baseline (R=0.419; p&lt;0.001) for FGM users, and negatively with the frequency of glucose scans (R=0.160; p&lt;0.001).
Conclusions: FGM is well accepted in our pediatric population and decreased the risk of severe hypoglycemic events, without changing A1c after one-year follow-up in youth with good glycemic control at baseline.

Disclosure
A. Messaaoui: None. S. Tenoutasse: None. L. Crenier: None.
Noninvasive Tissue Glucose Prediction in Patients with Type 1 Diabetes
Authors: PFÜTZNER ANDREAS , DEMIRCIK FILIZ , LIER ALEXANDER , RAMLJAK SANJA 
Published: June 2018

Background: Pain-free assessment of the glucose information required for treatment monitoring is one of the most desired unmet medical needs in insulin treated patients with type 1 diabetes. TensorTip CoG, is a non-invasive tissue glucose monitoring device (NI-CoG) with an additional built-in invasive glucose meter (Inv-CoG), which operates based on optical methods in the near-infrared and visible wavelength range. Here we report about the results obtained from type 1 patients in the course of two clinical studies.
Methods: The data from 6 patients with type 1 diabetes (3 male/3 female, age: 43±16 years, HbA1c: 8.0±0.5%), who had participated in a standard meal study experiment, and the results from 29 type 1 patients, who had participated in a system accuracy evaluation in accordance with ISO15197:2015 (13 male/16 female, age: 42±14 years, HbA1c: 7.5±0.5%) were combined for this analysis.
Results: The meal study patients (n = 66 data points) and the ISO study patients (n = 29) showed good agreement of the NI-CoG predicted tissue glucose with the capillary reference method (YSI Stat2300 plus). Mean absolute relative difference (values &gt;100 mg/dL) was calculated to be 13.3% (mean absolute difference for values&lt;100 mg/dL: 16 mg/dL). The consensus error grid (version for type 1 diabetes) revealed 78% of the data points to be in zone A (B: 18%, C: 4%). Zone C values were only observed in patients without proper device calibration over the entire measurement range of the device.
Conclusions: The results of this new non-invasive glucose prediction device are encouraging for routine use in patients with type type 1 diabetes. This non-invasive technology has reached an accuracy level for glucose prediction that is comparable to the results published for needle sensors working for flash or continuous glucose monitoring.

Disclosure
A. Pfützner: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Lifecare. Speaker's Bureau; Self; Berlin-Chemie AG. Research Support; Self; Boehringer Ingelheim GmbH. F. Demircik: None. A. Lier: None. S. Ramljak: None.
Unique Digital Care Interactions of Diabetes Patients with Remote Health Coach through Apollo Sugar App to Achieve Positive Glycemic Control Outcomes
Authors: SHAH SANJIV , MEHROTRA RABINDER NATH , DAS SAMBIT , ERUKULAPATI RAVI S. , REDDY SURYA P. , JAYAPRAKASHSAI JANA , DASH KALPANA , JAGANMOHAN BALAJI , AYYAGARI USHA , TIPPISETTY SUREKHA , KOLUKULA VAMSI K. , JOSHI SHASHANK 
Published: June 2018

Aim: To evaluate the quality and meaningful interactions of patients with type 2 diabetes mellitus (T2DM) with health coach through Apollo Sugar App and its effects on clinical outcomes.
Methods: Apollo Sugar Clinics is a pan-India chain of state of art, integrated care network of diabetes specialty clinics. The current analysis includes digital data of health interactions captured through a novel, unique and well-designed Apollo Sugar App. of great utility value. These live health interactions were between Sugar health coaches and 10,000 patients with T2DM, registered at Apollo Sugar Clinics who downloaded the Apollo Sugar App from Google Play store for the last 6 months. Meaningful health interactions with health coach were identified in 317 patients which were categorized into medication, diet, exercise, and self-monitoring blood glucose (SMBG). Descriptive statistics was applied to analyze the data, to assess clinical outcomes.
Results: A total of 10800 health interactions were captured, of which 2000 quality interactions were categorized as meaningful interactions. Among these interactions 29% on diet, 21% on exercise, 19% on medication change, 4% on insulin dose, 2% on hypoglycemia and 25% on meaningful use of SMBG data. SMBG was performed &gt;2times/week by 65% of study population. Pre-meal and post-meal SMBG target were achieved in 35% and 24% of patients, respectively. 28% achieved control reductions in &lt;2 weeks and no hypoglycemic episodes occurred in any of the patients. There was a considerable reduction in mean HbA1c (-0.7%), fasting plasma glucose (-41.5mg/dL) and post-prandial glucose (-100.7mg/dL) at 3 months follow-up.
Conclusions: The current analysis indicates that patient interactions with health coach through an Apollo Sugar app is a modern improved method of behavioral and clinical care, to achieve long term continuity of care for change in outcome of hard end points.

Disclosure
S. Shah: None. R. Mehrotra: None. S. Das: None. R.S. Erukulapati: None. S.P. Reddy: None. J. Jayaprakashsai: None. K. Dash: None. B. Jaganmohan: None. U. Ayyagari: None. S. Tippisetty: None. V.K. Kolukula: None. S. Joshi: None.
Impact of a Noninvasive Blood Glucose Device on Glycemic Control and Daily Routine Measurement Aspects—Results of a Pilot Study
Authors: PFÜTZNER ANDREAS , LIER ALEXANDER , RAMLJAK SANJA , DEMIRCIK FILIZ 
Published: June 2018

Regular blood glucose self-testing is considered to be the most painful procedure during daily treatment routine for patients with diabetes mellitus. This pilot study was undertaken to evaluate the performance of TensorTip CoG, a non-invasive glucose monitoring device (NI-CoG, CNOGA Medical, Israel) on glycemic control and daily measurement aspects in patients with type 1 and type 2 diabetes.
The study was performed with 6 type 1 patients (T1D: 3 male/3 female, age: 43±16 years, HbA1c: 8.0±0.5%), and 15 type 2 patients (T2D: 8 male/7 female, 62±6 years, 7.2±1.3%). The participants used the NI-CoG device at home after an initial standardized meal experiment to evaluate device performance in comparison to a standard reference method (YSI Stat2300 plus). In addition, HbA1c was assessed and a treatment satisfaction questionnaire was completed after a period of three months of home use.
During the meal experiment, NI-CoG showed good accuracy (mean bias: 15.3%; consensus error grid: 100% in zones A and B). A trend for HbA1c improvement was seen in both groups over 3 months (T1D: -0.22%, T2D: -0.1%, n.s.). Patients reported to measure more frequently, and to feel more comfortable with the non-invasive measurement procedure. Use of the device in the study initiated the general desire to switch to the new device also for daily routine use.
The non-invasive TensorTip device was shown to increase the frequency of glucose testing and to have a positive impact on patients' perception of the measurement procedure. There was also an initial trend for improvements of glycemic control within the first three months of use in this pilot study.

Disclosure
A. Pfützner: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Lifecare. Speaker's Bureau; Self; Berlin-Chemie AG. Research Support; Self; Boehringer Ingelheim GmbH. A. Lier: None. S. Ramljak: None. F. Demircik: None.
The MiniMed™ 670G Hybrid Closed-Loop (HCL) System and Patient-Reported Outcomes Concerning Quality of Life Measures
Authors: GOPALAKRISHNAN SHWETA , FOGEL CATHERINE , MUECKLER JOHN 
Published: June 2018

Patient-reported outcomes are important in assessing the impact of new diabetes therapies on patient perceptions of quality of life (QoL). The QoL of patients using the Medtronic MiniMed™ 670G HCL system with SmartGuard™ technology, released for commercial use in March 2017, was examined. MiniMed™ 670G HCL system users (n=198) completed the validated Diabetes-39 (D-39) questionnaire prior to starting HCL system therapy and at 3-4 months post start. QoL was evaluated on a 7-point scale (1=Not Affected at All to 7=Extremely Affected) across 5 categories: energy and mobility, diabetes control, anxiety and worry, social burden, and sexual functioning. Paired t-test was used to compare the mean score for each attribute, and a two-tailed t-test determined statistical significance from baseline to 3-4 months after MiniMed™ 670G system use. All patients had responses indicating a positive experience after use of the system in Auto Mode. For all 5 categories, 160/198 patients (81%) experienced an outcome in the positive direction. The Table shows the top 10 criteria in which statistically significant improvement was observed. In addition to the previously reported improvements in glycemic control,1 these findings suggest that the MiniMed™ 670G system improves multiple domains in self-reported QoL measures, and particularly those concerning adherence to diabetes management.

Disclosure
S. Gopalakrishnan: Employee; Self; Medtronic. C. Fogel: Employee; Self; Medtronic. J. Mueckler: Employee; Self; Medtronic MiniMed, Inc..
Open Artificial Pancreas System Reduced Hypoglycemia and Improved Glycemic Control in Patients with Type 1 Diabetes
Authors: CHOI SOO BONG , HONG EUN SHIL , NOH YUN HEE 
Published: June 2018

Background and Aims: Artificial pancreas combines continuous glucose monitoring (CGM) with insulin pump by using a control algorithm to direct insulin delivery. Although several control algorithms have been developed, the control algorithms are beyond reach of most of diabetic patients in need. The Open Artificial Pancreas System project (openAPS) is an open control algorithm for artificial pancreas, which is available worldwide in type 1 diabetes (T1D). Here, we present several interesting clinical experiences using openAPS.
Materials and Methods: Twenty T1D patients using openAPS, CGM (Dexcom G4®), and insulin pump (Sooil, Dana R®) were studied. Normal glycemic range was set as 80∼180 mg/dl.
Results: Mean age was 11.9 ± 6.9 years and 10 patients were male. Median openAPS duration was 180 (30-240) days. By the use of openAPS, CGM analysis showed significant decrease in A1C (6.8 ± 1.0% to 6.3 ± 0.7%, p&lt;0.001), increase in percent time in normal glycemic range (70.1 ± 16.4% to 83.3 ± 10.1%, p&lt;0.001), decrease in percent time in high glycemic range (24.7 ± 16.5% to 13.3 ± 9.4%, p&lt;0.001), and decrease in percent time in low glycemic range (5.1 ± 3.3% to 3.4 ± 2.3%, p= 0.004), respectively. There was no significant side effect due to using openAPS.
Conclusion: Open artificial pancreas system reduced hypoglycemia and improved glycemic control in patients with T1D.

Disclosure
S. Choi: Stock/Shareholder; Self; SOOIL Developments Co., Ltd.. E. Hong: None. Y. Noh: None.
Basal Rate Delivery of Different Insulin Pumps—An Accuracy Evaluation
Authors: FRECKMANN GUIDO , KAMECKE ULRIKE , WALDENMAIER DELIA , HAUG CORNELIA , ZIEGLER RALPH 
Published: June 2018

Continuous subcutaneous insulin infusion is a common therapy for patients with type 1 diabetes, involving the continuous delivery of fast-acting insulin according to preset basal rates. The standard EN 60601-2-24 describes test settings and procedures for the evaluation of infusion pumps in general; however, no acceptance criteria relating to insulin delivery accuracy are stipulated. Most manufacturers specify a basal rate accuracy of ±5%, at least for larger basal rates.
In this study, the accuracy of different insulin pumps was evaluated in an experimental setting based on EN 60601-2-24. The insulin pumps Accu-Chek® Insight, Accu-Chek® Spirit Combo, Animas® Vibe®, MiniMed® 640G, Paradigm® Veo™ and mylife™ OmniPod® were tested with different infusion sets (IIS). Evaluations were based on the determination of weight increase of a water-filled, oil-covered beaker placed on an electronic balance into which insulin was delivered by the pumps. Pumps were installed outside of the balance with the infusion set or a steel pipe (for the patch pump), respectively, connected to the beaker. After priming, a basal rate of 1.0 U/h was run for 72 h while weight increases were recorded. Each combination of insulin pump and IIS was tested 9 times. The total delivery as well as mean delivery over 1-h windows was calculated.
The total weight increase for all pumps was slightly higher than expected for the programmed basal rate (+0.3% to +2.1%), but within the range specified by the manufacturers. During the first 24h, larger deviations between the measured and expected delivery were recorded. For 8 of 10 systems, more than 95% of 1-h windows were within ±15% of the weight increase expected with the preset basal rate.
Using a basal rate of 1.0 U/h, all tested systems showed minor deviations when analyzing a period of 72 h; however, stability during the run time, i.e., variation from hour to hour, differed considerably between the tested systems. This might be important with regard to the clinical use of insulin pumps.

Disclosure
G. Freckmann: Speaker's Bureau; Self; Ascensia Diabetes Care. Research Support; Self; Ascensia Diabetes Care. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Abbott, Novo Nordisk Inc.. Consultant; Self; Sensile Medical AG. Speaker's Bureau; Self; Ypsomed AG. U. Kamecke: None. D. Waldenmaier: None. C. Haug: None. R. Ziegler: Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Novo Nordisk A/S. Other Relationship; Self; Sanofi-Aventis. Speaker's Bureau; Self; Animas Corporation.
Effect of Medicare (CMS) Insulin Pump Policies in T1D
Authors: ARGENTO NICHOLAS B. , LIU JINGWEN , HICKEY AILEEN , GAUTSCHI ELDA , MCAULIFFE-FOGARTY ALICIA H. 
Published: June 2018

CMS has numerous requirements for insulin pump coverage and obtaining disposable supplies. T1D Exchange surveyed 241 adult T1D patients who had been on a pump with CMS coverage for at least 6 mo on their experience. Median age 67, 64% women, 93% white, 16% on disability, median T1D duration 42 y, median pump use 15 y, mean A1c 7.0%, 82% on pump before starting CMS, 95% current pump users. Of those starting a pump while on CMS, 50% reported challenges, most commonly cost of the supplies (29%) or the pump (24%). Issues with obtaining supplies reported in 57.5%, the most common problems being delays releasing supplies (29%), difficulty getting paperwork completed (23.5%), and seeing an HCP face to face every 90 days (18%). When asked if they had changed pump behaviors because of possible or actual supply delays, 39% answered yes. Most common responses: leaving site in place &gt;3 days (64%), explicitly to reduce cost (33%), reused pump supplies (34%), used injections to supplement pump (23%), or temporarily stopped pump (17%). Responses to a question about any adverse effects of these actions are shown in Table.
On their experience with CMS compared to prior insurance, a minority thought it was somewhat (4%) or much (6%) better; 31% about the same; 28% found it somewhat worse, and 31% found it much worse.
Conclusion: current CMS pump policies cause increased adverse pump behaviors and outcomes in T1D, and CMS is perceived negatively compared to prior insurers by 59% of respondents.Adverse outcomes from changes in pump related actions, n=88QuestionfrequencypercentQuestionfrequencypercentNone2122.8Hospitalization66.5Higher blood sugar3740.2More hypoglycemia1516.3Infection at site1314.1Increased anxiety or frustration3942.4Pain or irritation3032.6Required emergency pump supply shipment1718.5More scarring2527.2Needed emergency supplies from local source1314.1More erratic blood sugar4245.7Other11.1Diabetic Ketoacidosis88.7No change needed22.2

Disclosure
N.B. Argento: Speaker's Bureau; Self; Dexcom, Inc., Novo Nordisk Inc.. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Unomedical a/s, T1D Exchange. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Senseonics. Consultant; Self; Intuity Medical. J. Liu: None. A. Hickey: None. E. Gautschi: None. A.H. McAuliffe-Fogarty: Advisory Panel; Self; Novo Nordisk Inc..
CSII Use in Hospitalized Patients—Adherence to Policy and Safety of Use
Authors: YANG KATHERINE , ATEYA MOHAMMAD B. , GIANCHANDANI ROMA 
Published: June 2018

Continuous subcutaneous insulin infusion (CSII) therapy is routinely used in diabetes management for patients expecting to use their insulin pumps during hospitalizations. For hospital personnel, this is unfamiliar and complex technology, which necessitates implementing policies and guidelines for standardizing CSII use in the inpatient setting. This study aims to examine adherence to an institutional CSII policy and safety glucometrics for hospitalized patients using CSII. We performed an IRB-exempt retrospective review of CSII user records from January to June 2017. Policy adherence was evaluated for appropriate provider and nurse order set use and documentation in the electronic medical record. 81 patients with 111 admissions on CSII were evaluated. Mean age was 42±16.9 years, 62% were female and 82.7% had type 1 diabetes. Median LOS was 5 days for 788 total patient days, HgbA1c 8.3 ± 1.78, and baseline admission blood glucose (BG) was 175 mg/dL. CSII was continued in 62% of admissions with 12.6% discontinuing use due to medical and surgical contraindications. Overall adherence to the policy was high with documented endocrinology consultations in 100%, provider specified basal rates in 96%, specified bolus doses in 92%, specified correction doses in 83%, specified target BG in 90%, and nurse documented verified doses on the MAR in 93%. Nurse documentation of CSII in the Lines/Drains/Airways flowsheets was 16%. Hypoglycemia (BG&lt;70mg/dL), severe hypoglycemia (BG&lt;40 mg/dL), and uncontrolled hyperglycemia (BG&gt;299mg/dL) were present in 10%, 0.8%, and 10.5% of patient days, respectively. Rates of DKA in CSII users was 0.9%. Policy adherence was effectively achieved for CSII use in hospitals. Rates of hypoglycemia and uncontrolled hyperglycemia were high with very low incidence of severe hypoglycemia or DKA episodes. These results suggest that CSII is possible to safely continue in hospitalized patients, but future studies are necessary to determine how to modify pump rates and optimize glycemic control.

Disclosure
K. Yang: None. M.B. Ateya: Stock/Shareholder; Self; AbbVie Inc.. R. Gianchandani: None.