bluuebunny/crossref_metadata_2025 huggingface dataset:
Factors Associated with High Glycemic Variability Defined by Coefficient of Variation in Hypo-Prone Type 2 Diabetes
Authors: GOMEZ ANA MARIA
Published: June 2018

Objective: To determine clinical variables associated with high glucose variability (GV) evaluated by continuous glucose monitoring (CGM) in patients with type 2 diabetes (T2D) and high risk of hypoglycemia.

Methods: A observational study with retrospective cohort analysis of the data was done. We included patients with T2D and history of hypoglycemia as an indication of CGM. GV was calculated using different metrics. They were classified depending on the coefficient of variation (CV) in 2 groups (<30% and ≥30%). Hypoglycemia was defined as interstitial glucose levels lower than 54 mg/dL for at least 20 minutes. For possible association between clinical variables and the CV, we did a bivariate dichotomous logistic regression model, then for the construction of the multivariate model, all the variables were included.

Results: 148 patients were included, 52 patients had hypoglycemia (35.1%). 52.0% were classified in the group with CV ≥ 30%. Three variables presented statistically significant differences: BMI comparing overweight vs. normal (OR 0.35; IC 95%, 0.16-0.78, p 0.010) and obesity vs. normal BMI (OR 0.34; IC 95%, 0.14-0.82, p 0.017), duration of diabetes (OR 1.03; IC 95%, 1.00-1.07, p 0.047) and glomerular filtration rate (GFR) between 30-45 ml/min (OR 2.93; IC 95%, 1.06-8.06, p 0.037), in the bivariate analysis. Female gender (OR 2.14; IC 95%, 1.03-4.46, p 0.041), BMI comparing overweight vs. normal (OR 0.31; IC 95%, 0.13-0.73, p 0.007) and obesity vs. normal BMI (OR 0.22; IC 95%, 0.06-0.61, p 0.003), GFR between 30-45 ml/min (OR 3.92; IC 95%, 1.29-11.93, p 0.016) and diabetic neuropathy (OR 2.39; IC 95%, 1.07-5.32, p 0.033) presented statistically significant differences in the multivariate model.

Conclusion: this study suggested association between clinical variables such as female gender, normal BMI, GFR between 30-45 and diabetic neuropathy with high CV in hypo-prone T2D patients. However, these results should be confirmed with randomized clinical trials.

Disclosure

A. Gomez: Research Support; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Eli Lilly and Company, Medtronic, Novartis Pharmaceuticals Corporation. Research Support; Self; Abbott.
Short-Chain Fatty Acids Prevent Diabetic Nephropathy In Vivo and In Vitro
Authors: HUANG WEI , XU YONG , XU YOUHUA , ZHOU LUPING , GAO CHENLIN
Published: June 2018

Diabetic nephropathy (DN) is the leading cause of end-stage renal disease (ESRD). Over the past decade, the gut microbiota metabolites—short-chain fatty acids (SCFAs), have emerged as new therapeutic targets of systemic inflammatory diseases and kidney injury such as acute kidney injury (AKI) via GPRs-β-arrestins signaling pathway and histone deacetylase-inhibiting (HDACi) properties. However, it is unclear whether SCFAs might prevent DN. Therefore, we evaluated the role and mechanism of the three main SCFAs (acetate, propionate, and butyrate) in streptozotocin (STZ) and high-fat diet (HFD)-induced type 2 diabetes (T2D) and DN mouse model in vivo and in high glucose-induced mouse glomerular mesangial cells (GMCs) and human proximal renal tubular epithelia cells in vitro. Our results found that exogenous SCFAs administration, especially butyrate, protected from experimental T2D, preventing the renal dysfunction and inhibiting oxidative stress and NF-κB inflammatory signaling in vivo. The GPR43 expression decreased, however, β-arrestin-2 expression increased in both high glucose-stimulated renal intrinsic cells and in DN kidney tissue. We hypothesized that SCFAs-mediated GPR43-β-arrestin-2 signaling might modulate kidney injury. GPR43 was over-expressed or suppressed by transfection with a GPR43 expressing vector or siRNA-GPR43 respectively. Exogenous SCFAs-mediated the anti-oxidative stress and anti-inflammatory effects were significantly facilitated or imitated by over-expression GPR43 or GPR43 agonist, but which were inhibited by siRNA-GPR43. Specifically, co-IP revealed that butyrate regulated the interaction between I-κBα and β-arrestin-2 via GPR43. Overall, this is the first observation of the potential therapeutic role of SCFAs in DN, we demonstrated that SCFAs improved STZ and HFD-induced renal dysfunction and inhibited NF-κB activation through GPR43-β-arrestin-2 signaling, suggesting a likely mechanism for SCFAs-mediated therapeutic effect in DN.

Disclosure

W. Huang: None. Y. Xu: None. Y. Xu: None. L. Zhou: None. C. Gao: None.
A1C vs. Glucose Downloads—Which Is the Better Gold Standard?
Authors: PERLMAN JORDAN E. , ROSENBAUM JENNIFER L. , MCNULTY BRIDGET K. , HIRSCH IRL B.
Published: June 2018

Introduction: The ADAG Study Group defined the relationship between average blood glucose (AG) and A1C. They derived a linear equation valid across diabetes types and the complete spectrum of glucose control. This study aims to determine appropriate clinical use of the ADAG equation to substitute home glucose monitoring for A1C.

Methods: A retrospective chart review was performed of downloaded glucose data from patients prescribed insulin at the UW Diabetes Center between 1/2011-10/2017. Eligible charts required: 1) 2 weeks of fingerstick glucose (SMBG) data with >14 checks or 1 month of CGM with >14 complete days and, 2) an A1C measured within 1 month of the encounter. The SMBG and CGM means were obtained from downloads. The associated A1C was used to extrapolate AG via the ADAG equation. The downloaded data and A1C-derived averages were compared. The analysis was repeated excluding comorbidities known to impact A1C.

Results: The downloaded AG was within 15% of that predicted by ADAG in 68% of patients (N=537). This criterion was met by 65% of patients using SMBG (N=401) and 67% of those checking >1x/day (N=359). The percentage was not different in patients checking >3x/day (71%; N=189). For CGM data, 79% of AGs were within 15% of A1C projection (N=136). CGM had superior ADAG agreement compared to SMBG (p<0.01). After excluding comorbidities (N=209), 72% of AGs were within 15% of ADAG estimation. This was higher than when looking at comorbidities alone (57%, N=228, p<0.001). In CGM users (no comorbidities, N=72), 82% of AGs were within 15% of expected. CGM again had better ADAG agreement than SMBG (p<0.01). Diabetes type did not predict ADAG agreement in any population. Our data replicated the ADAG equation following exclusion of comorbidities.

Conclusion: For most patients, SMBG and CGM data provide an important confirmatory assessment of A1C. However, in over 40% with (and about 30% without) a comorbidity, home glucose data are discordant with A1C. For many, downloaded glucose data gives a better assessment of overall diabetes control.

Disclosure

J.E. Perlman: None. J.L. Rosenbaum: None. B.K. McNulty: None. I.B. Hirsch: Research Support; Self; Medtronic MiniMed, Inc.. Consultant; Self; Abbott, Bigfoot Biomedical, Roche Diabetes Care Health and Digital Solutions, ADOCIA.
Effectiveness and Tolerability of Vildagliptin plus Metformin Compared with Other Oral Dual Antidiabetes Agents in Different Baseline HbA1c Patients with Type 2 Diabetes—A Real-World Study (China PDS)
Authors: HU DAQING , HAN YING , CHEN LIXIAN , JIN HUI , YANG NAILONG , SHI XIAOYUN , LI QUANMIN , LIANG LINLANG , ZANG LI , LIU MINGMING , HE JAMES , MU YIMING
Published: June 2018

Background and Aim: China PDS aimed to investigate the real-world effectiveness and tolerability of vildagliptin plus metformin (VM) in patients with type 2 diabetes mellitus (T2DM), compared with other oral dual agents (OD). Here, we present the results of prespecified baseline HbA1c subgroups.

Materials and Methods: In China PDS, T2DM patients with poor glycemic control by monotherapy were assigned to either VM dual therapy or OD therapy according to local physician’s decision. In this subgroup study, patients were divided into three groups according to their baseline HbA1c levels (≤8%, 8-9%, >9%). The primary outcome was the proportion of patients with HbA1c<7% and without tolerability events (hypoglycemia, weight gain, or discontinuation due to gastrointestinal event) at 12th month. Secondary outcomes included mean changes in HbA1c from baseline to study endpoint and tolerability.

Results: In total, 7(312 in VM vs. 394 in OD) patients in HbA1c≤8% group, 332 (151 in VM vs. 181 in OD) patients in HbA1c 8-9% group, and 236 (141 in VM vs. 95 in OD) patients in HbA1c>9% group were enrolled. Compared with OD, significantly higher proportion of patients reached primary outcome with VM in HbA1c ≤8% group (57.4% vs. 38.3%, P<0.001), in HbA1c 8-9% group (39.7% vs. 26.0%, P=0.008), and in HbA1c>9% group (48.2% vs. 31.6%, P=0.011). The mean HbA1c changes from baseline to study endpoint in VM and OD were -0.61±0.932 and -0.32±0.874 (P<0.001) in HbA1c≤8% group, -1.37±1.072 and -0.97±1.169 (P<0.001) in HbA1c 8-9% group, and -2.71±1.392 and -2.39±1.4(P=0.305) in HbA1c>9% group. Compared with OD, VM resulted in less tolerability findings (HbA1c≤8%: 7.7% vs. 16.8%; HbA1c 8-9%: 2.6% vs. 9.4%; HbA1c>9%: 5.0% vs. 16.8%; P<0.for all).

Conclusion: In different baseline HbA1c groups, vildagliptin plus metformin dual therapy was associated with better glycemic control and good tolerability.

Disclosure

D. Hu: None. Y. Han: None. L. Chen: None. H. Jin: None. N. Yang: None. X. Shi: None. Q. Li: None. L. Liang: None. L. Zang: None. M. Liu: None. J. He: None. Y. Mu: None.
Serum Galectin-3 and All-Cause Mortality in Type 2 Diabetes
Authors: TAN KATHRYN C.B. , SHIU SAMMY , LAM JOANNE K.Y. , LEE ALAN C. , WONG YING
Published: June 2018

Background and Aims: Galectin-3, a member of the multifunctional galectin family, is ubiquitously expressed and acts a broad-spectrum biological response modifier. It is involved in tissue fibrosis, tumorigenesis, immunity and inflammatory response. It can also act as a receptor for advanced glycation end products. Recent evidence suggests that galectin-3 is associated with heart failure and with progression of nephropathy in type 2 diabetes. We have therefore evaluated whether serum galectin-3 level is associated with all-cause mortality in patients with type 2 diabetes.

Materials and Methods: Galectin-3 was measured in the baseline serum samples by ELISA in 1495 type 2 diabetic patients followed up in a teaching hospital specialist diabetes clinic. All-cause mortality was ascertained from hospital electronic medical records.

Results: The mean age of the subjects was 55.3 ± 9.9 years and 54% were male. During a median follow-up of 11 years, 169 subjects died from all causes, and baseline serum galectin-3 levels were significantly higher in subjects with a fatal outcome (9.86 ± 3.11 ng/ml vs. 8.15 ± 2.73, p<0.01). When galectin-3 was analyzed as quartiles, individuals in the third quartile [hazard ratio (HR) 2.0, 95% confidence interval (CI) 1.2-3.2, p<0.01] and the highest quartile (HR 3.9, 95% CI 2.6-6.0, p<0.01) had significantly elevated risk of a fatal outcome compared to those in the lowest quartile. Multivariable Cox regression analysis showed a significant association between serum galectin-3 level and all-cause mortality and the association remained significant even after adjustment for potential confounders including age, sex, body mass index, duration of diabetes, smoking, baseline HbA1c, systolic blood pressure, LDL and albuminuria status.

Conclusion: Elevated serum galectin-3 level was independently associated with all-cause mortality in patients with type 2 diabetes. Galectin-3 may potentially be useful as a predictor of adverse outcome.

Disclosure

K.C.B. Tan: None. S. Shiu: None. J.K.Y. Lam: None. A.C. Lee: None. Y. Wong: None.
Relationship between Frequency of Blood Glucose Testing and Reduction in HbA1c and Body Weight during Intensive Lifestyle Intervention in Patients with Type 2 Diabetes and Obesity
Authors: TOMAH SHAHEEN , MAHMOUD NOOR , MOTTALIB ADHAM , ALSIBAI KHALED , ASHRAFZADEH SAHAR , ELSEAIDY TAHA , HAMDY OSAMA
Published: June 2018

Self-monitoring of blood glucose (SMBG) is known to be valuable for proper diabetes management. However, the optimal frequency of SMBG has been debated. The aim of this study is to evaluate the relationship between frequency of SMBG and the degree of glycemic control and the magnitude of weight reduction in patients with type 2 diabetes (T2D) and obesity enrolled in an intensive lifestyle intervention (ILI).

We evaluated 36 patients with T2D and obesity (mean age 56±9 years, 56% female) enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program, a 12-week multidisciplinary ILI clinical program between May 2016 and December 2017. Participants were asked to test their blood glucose before each meal, at bed time, before and after exercise, occasionally postprandial and when needed. At baseline, average body weight was 105.7±20.9 kg, BMI 36±6 kg/m2, HbA1c 7.8±1.3%, and 41% of participants were treated with insulin. Based on their actual frequency of SMBG per day, participants were divided into tertiles. The lowest tertile tested on average 2.3±0.6 times/day (range: 1.1-2.9 times). The middle tertile tested on average 3.3±0.3 times/day (range: 3.0-3.9 times). The highest tertile tested on average 5.2±1 times/day (range: 4.0-7.7 times). HbA1c and body weight did not differ between tertiles at baseline.

At 12 weeks, HbA1c changed by -0.9±0.3% (p=0.01), -1.2±0.4% (p<0.01) and -1.7±0.5% (p=0.001) respectively from baseline. Body weight changed by -7.6±3.2 kg (-7.13%), -9.2±6.4 kg (-8.7%), and -10.6±4.1 kg (-9.9%) respectively from baseline (p<0.01 for all). The reduction in HbA1c and body weight was significantly better in the highest tertile of SMBG in comparison to the lowest tertile (p<0.for both).

In conclusion, patients with T2D and obesity who test their blood glucose more often during ILI achieve significantly better HbA1c reduction and significantly higher percentage of weight loss.

Disclosure

S. Tomah: None. N. Mahmoud: None. A. Mottalib: None. K. Alsibai: None. S. Ashrafzadeh: None. T. Elseaidy: None. O. Hamdy: Research Support; Self; Abbott. Advisory Panel; Self; AstraZeneca. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Healthimation, LLC.. Consultant; Self; Sanofi-Aventis.
Glycemic Parameters for Clinical Shifting to Glargine 300 U/mL (Gla-300) Basal-Plus/Basal-Bolus Insulin Therapies in Asian Patients with Poorly Controlled T2DM
Authors: LIN CHIA-HUNG
Published: June 2018

Aim: T2DM patients are shifted to long-acting insulin analogs when premixed insulin therapy becomes insufficient for individuals to achieve glycemic control. The objective of this study was to investigate glucose patterns from continuous glucose monitoring (CGM) for the clinical assignment of Asian T2DM patients with poor glucose control to Gla-300 basal-plus or Gla-300 basal-bolus therapy.

Method: 20 T2DM premixed insulin outpatients requiring therapy change were enrolled in the study. Based on clinical judgment during routine follow-up, patients were switched to Gla-300 basal-plus or Gla-300 basal-bolus therapy by clinicians. Adjustments were not made to patients’ diet or daily routines. Non-real time CGM was prospectively applied at baseline and one month after switching insulin therapy regimens. Mean fasting and postprandial glucose levels, glucose excursion markers, including mean amplitude of glucose excursion (MAGE) and standard deviation of plasma glucose (SDPG), estimated A1C from CGM and frequency of hypoglycemia were recorded for computer-assisted analysis.

Result: Baseline CGM data indicated that pre-meal (dinner) glucose levels (129 ± 33 vs. 204 ± 92 mg/dL, p=0.046), SDPG (52 ± 11 vs. 72 ± 21 mg/dL, p=0.029) and MAGE (119 ± 26 vs. 174 ± 32 mg/dL, p=0.038) were statistically lower in patients shifted to basal-plus therapy than those shifted to basal-bolus therapy. One month after initiating Gla-300-based insulin therapies, glucose excursion manifestations, estimated A1C levels and hypoglycemia occurrences were shown to decrease in both treatment groups; though without statistical significance between groups.

Conclusion: The baseline glucose excursion markers (i.e., SDPG and MAGE) as well as pre-dinner glucose levels are significant glycemic parameters that can be assessed for the clinical shifting of T2DM Asian patients from premixed insulin to Gla-300 based basal-plus or basal-bolus therapies.

Disclosure

C. Lin: None.
The Effect of Flash Glucose Monitoring on Glycemic Control in Patients with Type 1 Diabetes
Authors: DØRFLINGER GRY H. , ØSTERGAARD JAKOB A. , FISKER SANNE , KNUDSEN SOREN T. , HANSEN TROELS K.
Published: June 2018

Introduction: Freestyle Libre Flash glucose monitoring system is a new approach to self-monitoring of glucose. We investigated the effect on glycaemic control of applying this system in patients with type 1 diabetes in a real world clinical setting.

Materials and Methods: A total of 210 consecutive patients with type 1 diabetes were included in an observational study investigating the change in glycaemic control upon introducing Freestyle Libre Flash Glucose monitoring (FGM) system (Abbott Diabetes Care Ltd, Range Road Witney, Oxon OX29 OYL; UK). Hba1c was monitored prior to the application of FGM and every 3-4 months during a follow-up of between 3 and 15 months.

Results: HbA1C decreased significantly by 5 mmol/mol (IQR 10, P <0.0001) after 3 months as compared with baseline, where after HbA1c stabilized.

When subdividing patients according to baseline glycemic control (Hba1c <53 mmol/mol, 54-70 mmol/mol, >70 mmol/mol) at inclusion in the study, we found a significant decrease in Hba1c in two groups (54-70: 4 mmol/mol, P<0.0001, >70: 7 mmol/mol, P<0.0001) from baseline to 3 months.

Conclusion: In this observational study, we found a significant decrease in Hba1c- levels after the introduction of flash glucose monitoring in subjects with type 1 diabetes; this decrease was maintained throughout the 12-month study period.

Disclosure

G.H. Dørflinger: None. J.A. Østergaard: None. S. Fisker: Other Relationship; Self; Novo Nordisk A/S. S.T. Knudsen: Advisory Panel; Self; Novo Nordisk A/S, Merck & Co., Inc., Sanofi-Aventis, Eli Lilly and Company, Boehringer Ingelheim GmbH, AstraZeneca. Speaker's Bureau; Self; Merck & Co., Inc., Boehringer Ingelheim GmbH, AstraZeneca. T.K. Hansen: Advisory Panel; Self; Abbott, AstraZeneca, Novo Nordisk A/S. Research Support; Self; Novo Nordisk Foundation. Advisory Panel; Self; Merck Sharp & Dohme Corp..
Assessing Glucose Trend Accuracy with a Novel Continuous Glucose Monitoring System
Authors: JOHNSON TERRI , ZHANG XIAOHE , BALO ANDREW
Published: June 2018

In addition to point accuracy, continuous glucose monitoring (CGM) devices should be evaluated on trend accuracy to determine whether they provide accurate and timely tracking of glucose fluctuations. We evaluated trend accuracy in a study of the investigational G6 Factory-Calibrated System ("G6 FC", Dexcom), which provides real-time glucose measurements and trend indicators. A total of 76 subjects enrolled (49 children ages 6-17 years and 27 adults) at four U.S. clinical sites. 73 had type 1 diabetes. Participants attended 1 or 2 clinic sessions during which CGM readings were compared to reference venous YSI glucose obtained every 15 minutes. Trend accuracy was assessed using R-deviation, which computes the difference between “instantaneous” rates of glucose change for the CGM and the reference rate of glucose change. Approximately 94% of data had less than ±1 mg/dL/min difference from the reference rate of change (95% for adults vs. 93% for children). When YSI glucose values were falling rapidly (<-2 mg/dL/min), the G6 FC showed that glucose values were falling moderately to rapidly 83% of the time; when the glucose values were rising rapidly (>2 mg/dL/min), the G6 FC showed that glucose values were rising moderately to rapidly 91% of the time (Table). Accurate tracking of glucose trends with the novel G6 FC CGM system will provide additional assurance to the patients relying on these data for diabetes management decisions.G6 FC System's Concurrence on Rate of ChangeCGM Rate of Change (mg/dL/min)YSI Rate of Change (mg/dL/min)Matched Pairs (N)< -2[-2, -1)[-1, 0)[0, 1)[1, 2]>2< -245.0%37.5%17.5%0.0%0.0%0.0%40[-2, -1)3.6%59.5%33.6%2.9%0.4%0.0%274[-1, 1)0.2%3.9%57.2%34.8%3.6%0.3%2707[1, 2]0.0%0.8%1.6%36.2%50.2%11.3%257> 20.0%0.0%2.4%6.6%27.7%63.3%166Matched Pairs (N)33285165610542741423444

Disclosure

T. Johnson: Employee; Self; Dexcom, Inc. X. Zhang: Employee; Self; Dexcom, Inc. A. Balo: Employee; Self; Dexcom, Inc..
Beneficial Effect of Flash Glucose Monitoring Persists in a Two-Year Perspective—A Clinical Follow-Up Study of 334 Individuals with Type 1 Diabetes
Authors: LONDAHL MAGNUS , FAGHER KATARINA , KATZMAN PER , FILIPSSON KARIN
Published: June 2018

Short term follow-up studies indicate that use of Flash glucose monitoring (FGM) improves metabolic control in people with type 1 diabetes. Whether this effect persists is unknown.

The aim of this study was to evaluate long-term effects on HbA1c and treatment satisfaction in people with type 1 diabetes after introduction of FGM in a university hospital diabetes clinic. Treatment satisfaction was measured using DTSQs questionnaires at the one year follow-up. Of the first 334 patients who were introduced to FGM 80.5% were still users after 2 years, 8.7% changed to a CGM-system, 6.6% stopped due to skin reactions, 3.4% did not want to continue and 1.3% had died. Baseline HbA1c among continuers were 71.8±16.6 mmol/mol (8.7%). Compared to baseline, HbA1c was -8.3±9.8 mmol/mol after 1 year and 9.0±11.8 mmol/mol lower after 2 years. Self-estimated treatment satisfaction after 1 year was 2.44±0.74 (+3 to -3) and rating for continued FGM use was 2.87±0.33. Unacceptable high blood glucose was less often present (-0.6) as were unacceptable low blood glucose levels (-0.3).

Conclusions: Use of FGM adds clinical significant advantage to individuals with 1 diabetes in terms of HbA1c reduction and improved self-estimated treatment satisfaction also in a 2-year perspective.

Disclosure

M. Londahl: Speaker's Bureau; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company. Advisory Panel; Self; Amgen Inc.. Speaker's Bureau; Self; AstraZeneca, Novo Nordisk A/S. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; ReApplix AS. K. Fagher: Speaker's Bureau; Self; AstraZeneca, Sanofi, Novo Nordisk A/S, Merck Sharp & Dohme Corp.. P. Katzman: None. K. Filipsson: Speaker's Bureau; Self; Boehringer Ingelheim GmbH, Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Advisory Panel; Self; MSD K.K.. Speaker's Bureau; Self; Novo Nordisk A/S, Sanofi.
Hypoglycemia with Mealtime Fast-Acting Insulin Aspart vs. Insulin Aspart Across Two Large Type 1 Diabetes Trials
Authors: BLOCK CHRISTOPHE DE , CARLSON ANDERS , ROSE LUDGER , GONDOLF THEIS , GORST-RASMUSSEN ANDERS , LANE WENDY
Published: June 2018

Hypoglycemia is a ubiquitous challenge with insulin treatment in type 1 diabetes (T1D), with nocturnal episodes of particular concern. Severe (as defined by the ADA) or blood glucose-confirmed (<56 mg/dL [3.1 mmol/L]) hypoglycemia was investigated across two double-blind, treat-to-target, randomized trials assessing the efficacy and safety of mealtime fast-acting insulin aspart (FA) vs. insulin aspart (IAsp) by multiple daily injections in adults with T1D: a 52-week trial in combination with insulin detemir (onset 1; n=761), and a 26-week trial in combination with insulin degludec (onset 8; n=684). FA was confirmed to be non-inferior to IAsp regarding change from baseline in A1C in both trials, with a statistically significantly greater A1C reduction with FA in onset 1. Importantly, nocturnal hypoglycemia rates were consistently lower with FA vs. IAsp in both trials (pooled estimated treatment rate ratio [ETR] 0.84 [95% CI 0.72;0.98]; p=0.02) (Figure), while no significant difference was observed for overall (pooled ETR 0.94 [95% CI: 0.85;1.05]) and diurnal hypoglycemia (pooled ETR 0.96 [95% 0.86;1.07])(Figure) with some heterogeneity across trials.

In summary, analysis across two large trials supports the safety of mealtime FA, with lower rates of nocturnal hypoglycemia with FA vs. IAsp.

ClinicalTrials.gov: NCT01831765; NCT02500706.

Disclosure

C. De Block: None. A. Carlson: Advisory Panel; Self; Sanofi, Insulet Corporation. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Medtronic, Novo Nordisk A/S. L. Rose: Advisory Panel; Self; Novo Nordisk A/S. Consultant; Self; Member of Association of Statutory Health Insurance Physicians. T. Gondolf: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Chr. Hansen A/S. A. Gorst-Rasmussen: Employee; Self; Novo Nordisk A/S. W. Lane: Advisory Panel; Self; Novo Nordisk A/S, Insulet Corporation, Intarcia Therapeutics, Inc., Sanofi. Research Support; Self; Novo Nordisk A/S, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Sanofi, Dexcom, Inc.. Speaker's Bureau; Self; Novo Nordisk A/S, Insulet Corporation.
Patient Reported Outcomes (PRO) in a Study of Human Regular U-500 Insulin (U-500R) Delivered by Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injections (MDI) in Patients with T2D
Authors: PENG XIAOMEI , CHEN JIELING , FAN LUDI , ILAG LIZA , LY TRANG T. , JOHNSON JENNAL
Published: June 2018

Persons with T2D treated with U-500R have shown improved glycemic control. This prospective analysis evaluated the impact on PRO of U-500R delivered by CSII (using an investigational Omnipod U-500TM Insulin Management System) or MDI (using a U-100 syringe). In this 26-week (week), open-label, parallel trial, 420 patients treated with >200 units/day of insulin for T2D were randomized to CSII (n=209) or MDI (n=211) treatment groups. The Treatment-Related Impact Measure for Diabetes (TRIM-D) and Diabetes Device (TRIM-DD) questionnaires were assessed at baseline, week 14, and week 26. Results are shown in Table 1. TRIM-D scores (overall score and all 5 domain scores) and TRIM-DD overall score in both groups improved significantly from baseline to week 26 (p<0.05). At week 26, change in baseline score for the CSII group was significantly higher than the MDI group in all TRIM-D measures (p<0.05). At week 26, there were no significant differences in the change from baseline score between the CSII and MDI groups in TRIM-DD overall or its domains.

In summary, the U-500R CSII device scored significantly better than MDI in the perceived impact on diabetes treatment (TRIM-D) but not for diabetes device (TRIM-DD). PROs for diabetes treatment improved significantly from baseline to week 26 in patients treated with U-500R by either CSII or MDI.

Disclosure

X. Peng: Employee; Self; Eli Lilly and Company. J. Chen: None. L. Fan: Employee; Self; Eli Lilly and Company. L. Ilag: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. T.T. Ly: Employee; Self; Insulet Corporation. J. Johnson: Employee; Self; Eli Lilly and Company.
Postprandial Response in Children Using the MiniMed™ 670G System
Authors: GROSMAN BENYAMIN , ROY ANIRBAN , WU DI , PARIKH NEHA , LEE SCOTT W. , KAUFMAN FRANCINE R.
Published: June 2018

The Medtronic MiniMed™ 670G hybrid closed-loop (HCL) system was investigated in a multi-center pivotal trial conducted in 1T1D children aged 7-13 years. A 3-month at-home study phase with Auto Mode enabled followed the 2 week run-in phase in Manual Mode. The system improved overall glycemic control and minimized the percentage of time in hypoglycemia (≤70mg/dL, 3.9mmol/L). Several aspects of the postprandial response and sensor glucose (SG) values, during the run-in and study were compared. The maximum increase in SG (mg/dL) per 50 grams of carbohydrate (carb) in postprandial responses >3h; settling time, defined as the minutes for the postprandial response to settle back to <10mg/dL of the glycemic value at meal start; and the 3-h postprandial distribution of SG values were analyzed. Analyses were separated into 4-11am, 11am-4pm, and 4pm-4am periods. The median (IQR) for the postprandial maximum SG increase 4-11am was 91 (139) and 96 (136) mg/dL, p=0.34; for 11am-4pm was 86 (152) and 82 (141) mg/dL, p=0.66; and for 4pm-4am was 102(182) and 87.5 (166), p<0.001, for run-in and study, respectively. That for settling time for 4-11am was 192 (176) and 189 (158) min, p<0.001; for 11am-4am was 195.5 (213) and 191 (217) min, p=0.24; and for 4pm-4am was 295 (555) and 221 (447) min, p<0.001, respectively. That for 3-h postprandial SG values for 4-11am was 154 (106) and 150.5 (88) mg/dL, p=0.004; for 11am-4pm was 159.5 (104) and 153 (93) mg/dL, p<0.001; and for 4pm-4am was 163 (106) and 158 (89) mg/dL, p=0.001, respectively. The postprandial response in most of the tested outcomes between the study and run-in phase was significantly improved when the MiniMed™ 670G Auto Mode feature was enabled. For meals consumed between 4pm-4am, a reduction of 14.5 mg/dL was observed in the median maximum SG per 50 grams of carb. Furthermore, for meals consumed between 4pm-4am, settling time was reduced by 74 minutes. Overall, the HCL system reduced postprandial excursions and settling times throughout the day, while showing significant improvements 4pm-4am.

Disclosure

B. Grosman: Employee; Self; Medtronic. A. Roy: Employee; Self; Medtronic MiniMed, Inc.. D. Wu: None. N. Parikh: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.
Real-World Use of Hybrid Closed-Loop Therapy in Pediatric Patients with Type 1 Diabetes
Authors: BERGET CARI , MESSER LAUREL H. , PYLE LAURA , WESTFALL EMILY , FORLENZA GREGORY P. , DRISCOLL KIMBERLY A.
Published: June 2018

Objective: To describe the real world impact of the 670G Hybrid Closed Loop (HCL) system on glucose control in pediatric patients with type 1 diabetes (T1D).

Methods: Patients starting the 670G were recruited to participate in a 12-month observational study. Data on 670G use and glycemic outcomes were obtained from pump downloads and chart review as part of routine clinical care. Descriptive statistics are reported as medians (25th%ile, 75th%ile).

Results: Nineteen pediatric patients (14 y (11.7, 17.4); 53% F) with 32 days (26, 44) of 670G data were included. T1D duration was 7 years (3, 9) and HbA1C was 8.5% (7.9, 9.6). Patients spent 70% (35, 85) of each week in HCL. System exits from HCL mode (auto mode) to standard pump mode (manual mode) occurred 0.64 times/day (0.5, 1.05), primarily due to hyperglycemia. Sensor glucose time in target range (70-180 mg/dl) was 60% (50, 64) with 1% of sensor glucose values ≤70 mg/dl. Increased time spent in HCL was correlated with reduced mean sensor glucose and standard deviation of glucose, and increased time in target range (Table).

Conclusions: Youth using the 670G in clinical care were able to stay in HCL most of the time in the initial weeks of system use. HCL use may improve glucose control for pediatric patients with T1D. Data collection is ongoing and will elucidate the impact of the 670G on glycemic control longitudinally and describe patient use of the system in real-world conditions. Correlation of % time in HCL 'auto mode' with glucose variablesVariableSpearman Correlation Coefficientp-value% time sensor values 70-180 mg/dl0.670.002Mean sensor glucose value-0.600.007% time sensor <54 mg/dl-0.0490.84% time sensor values 54-69 mg/dl0.170.50% time sensor values >250 mg/dl-0.670.002Standard deviation of sensor glucose values-0.540.02

Disclosure

C. Berget: None. L.H. Messer: Other Relationship; Self; Medtronic MiniMed, Inc.. L. Pyle: None. E. Westfall: None. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc.. Research Support; Self; Medtronic, Tandem Diabetes Care, Inc., Insulet Corporation, Dexcom, Inc., Novo Nordisk Inc., Bigfoot Biomedical. K.A. Driscoll: None.
Insulin Pump Therapy—Patient and Provider Perceptions
Authors: PEREZ-NIEVES MAGALY , GAREY COLLEEN , FAN LUDI , MCAULIFFE-FOGARTY ALICIA H.
Published: June 2018

This study aimed to identify the benefits and challenges of insulin pump therapy from both the patient and provider perspective.

One hundred current multiple daily injection (MDI) users, including 31 former pump users, and 250 current pump users were recruited from myGlu.org, and 61 healthcare providers were recruited from T1D Exchange Clinic Network and American Association of Diabetes Educators to complete an online survey.

Reports of decreased HbA1Cs (A1C) after pump initiation differed significantly between patients and providers (p = .001); more former users reported their A1C increased compared to current users (p = .03). Significantly more current and MDI had recent A1Cs < 7.0% than former users (p = .005).

The most common reason patients reported stopping pump therapy was an increase in blood glucose; however, providers reported that the most common reason for patients to stop pump therapy was cost. Over 90% of current users were satisfied with their pump and providers report that 92% of their patients were satisfied with their pump; however, only 29% of former pump users reported that they were satisfied with their pump.

HCP’s perceptions of the patients’ experience with pumps differs from patients’ experience, which highlights the importance of patient-centered communication to understand an individual patient’s preferences, and challenges in managing diabetes to select an insulin treatment plan that meets both patient and HCP goals.

Disclosure

M. Perez-Nieves: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. C. Garey: None. L. Fan: Employee; Self; Eli Lilly and Company. A.H. McAuliffe-Fogarty: Advisory Panel; Self; Novo Nordisk Inc..
Achievement of Glycemic Targets when Switching from Basal-Bolus Therapy to V-Go for Insulin Delivery in Type 2 Diabetes
Authors: HUNDAL RIPU S. , KOWALYK STEPHAN , CASES JANE , AL-KARADSHEH AMER , WAKIM AMANDA P. , DOYLE MELISSA , SINK JOHN H. , SPENCE ADRIENNE , BREWER JAMIE L. , NIKKEL CARLA C.
Published: June 2018

Achieving A1C targets is a fundamental component of quality measures such as HEDIS and Star ratings. A typical basal-bolus insulin regimen requires 4 insulin injections a day. Adherence decreases as the number of injections increases and non-adherence to therapy is a primary reason for failure to achieve glycemic control. Less invasive options for insulin delivery may improve patient adherence leading to positive clinical outcomes. This multi-state retrospective analysis evaluated the achievement of glycemic targets compared to prior therapy in 186 patients switched from a basal-bolus regimen to a 24-hour wearable insulin delivery device (V-Go). At baseline, mean A1C was 9.1%, weight 219 lbs and insulin total daily dose (TDD) was 84 u/day across a mean of 4.3 injections/day. Forty-five percent of patients were poorly controlled (A1C > 9%) and less than 30% had achieved an A1C < 8% despite basal-bolus therapy. After 7 months of V-Go use, changes from baseline in A1C and TDD were significant (P<0.0001). Mean change (95% CI) in A1C was -1.02% (-1.24, -0.78) and TDD was reduced by 32% or 25 u/day (31, 19). Weight did not significantly change. Switching to V-Go, resulted in significant improvement to achievement of glycemic targets (90% increase in A1C values < 8% and 50% decrease in A1C values > 9%) compared to prior basal-bolus regimen, having positive implications on quality metrics.

Disclosure

R.S. Hundal: Speaker's Bureau; Self; Valeritas, Inc., Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Novo Nordisk Inc., Amarin Corporation, Eli Lilly and Company, Merck & Co., Inc. S. Kowalyk: Speaker's Bureau; Self; Valeritas, Inc.. J. Cases: None. A. Al-Karadsheh: None. A.P. Wakim: Speaker's Bureau; Self; Versartis, Inc.. Research Support; Self; Valeritas, Inc.. M. Doyle: None. J.H. Sink: Other Relationship; Self; Janssen Pharmaceuticals, Inc., valeritas. Speaker's Bureau; Self; Novo Nordisk Inc.. Consultant; Self; Becton, Dickinson and Company. A. Spence: None. J.L. Brewer: Speaker's Bureau; Self; Valeritas, Inc., Janssen Pharmaceuticals, Inc. C.C. Nikkel: Employee; Self; Valeritas, Inc.. Stock/Shareholder; Self; Valeritas, Inc..
Supramolecular Biomaterials as a Biomimetic Platform for Investigating Immunopathological Processes of Human Type 1 Diabetes
Authors: BECKER MATTHEW , SEROSKI DILLON , STIMPSON SCOTT , MATHEWS CLAYTON E. , HUDALLA GREG , PHELPS EDWARD A.
Published: June 2018

A major goal of type 1 diabetes (T1D) research is development of state-of-the-art devices that recreate the human islet microenvironment to help elucidate the molecular and cellular mechanisms of beta cell loss due to autoimmunity. We recently reported a novel synthetic biomaterial technology to form hydrogels from a pair of oppositely-charged peptides that co-assemble into a network of interpenetrating β-sheet nanofibers. Here, we explored the potential of this biomaterial, referred to as “CATCH” for Co-Assembly Tags based on Charge complementarity, to serve as a 3D microenvironment for studies of the islet—immune cell interface within the context of human T1D. Supramolecular CATCH hydrogels offer a number of key advantages for engineering islet biomimetic microenvironments: 1) they are fabricated via self-assembly at neutral pH and 37°C; 2) require no chemical reaction to form; and 3) are intrinsically capable of installing folded proteins or peptides via covalent fusion to one of the synthetic peptides sequences. In initial experiments, we established that CATCH hydrogels are cyto-compatible with human beta cells via encapsulation of BetaLox5 cells (βL5), an immortalized human beta cell line, by demonstrating strong viability (Calcein-AM/Ethidium homodimer-1 stain) of encapsulated βL5 at 3 and 24 hours after gelation similar to βL5 seeded on 2D surfaces. CATCH gels also showed promise as a viable platform for interrogating the engagement of autoreactive immune cells with human beta cells. Engineered CD8+ human T cell avatars expressing human T cell receptors for the islet antigen pre-proinsulin co-embedded into CATCH hydrogels with βL5 cells show strong beta cell killing in 3D by T cells over an 18-hour period (assessed via loss of TMRM staining of mitochondrial membrane potential). These initial successes are guiding our development of CATCH hydrogels for further detailed 3D studies of islet—immune cell interactions relevant to human T1D.

Disclosure

M. Becker: None. D. Seroski: None. S. Stimpson: None. C.E. Mathews: None. G. Hudalla: None. E.A. Phelps: None.
Closing the Loop with OpenAPS in People with Type 1 Diabetes—Experience from Italy
Authors: PROVENZANO VINCENZO , GUASTAMACCHIA EDOARDO , BRANCATO DAVIDE , CAPPIELLO GERARDO , MAIOLI ANTONIO , MANCINI RAFFAELE , CRISPINO GIUSEPPE , MONTE ARIELLA DE , TURCO SALVATORE , TONOLO GIANCARLO
Published: June 2018

Background: Since 2017, people with type 1 diabetes (T1D) in Italy began to use spontaneously an Artificial Pancreas Systems (APS) with off-label use of existing insulin pumps, continuous glucose monitors (CGM), and open source software (known as OpenAPS). Aim of this study is to understand if closing the loop with OpenAPS is effective to improve the glucose control in T1D diabetes.

Methods: We studied 30 people (male/female = 19/11; age = 35.9 years ± 12.52 DS) with T1D who shared and self-reported their data and experiences from using this system. All the people included in the study used a CGM Dexcom G5 and insulin pump Dana Diabecare R; the implementation of OpenAPS realized a so called hybrid closed loop system. Main outcomes were A1c and % of time into hypoglycemia (glycemia < 70 mg%, %TIHypo), before and 3 months after closing the loop. Secondary outcomes were % of time into hyperglycemia (glycemia > 180 mg%, %TIHyper) and time into range (glycemia between 70 and 180 mg%, TIR).

Results: We observed a significant decrease of A1c (from 7.17% ± 0.49 DS to 6.61% ± 0.47 DS; p < 0.05) and of %TIHypo (from 8.55% ± 5.81 DS to 2.48% ± 1.16 DS). We also observed a decrease of TIHyper and an increase of TIR, but the differences were not statistically significant. All patients were satisfied of OpenAPS use and only one patient dropped out, on advice of his diabetologist. No any serious adverse event was recorded (diabetic ketoacidosis, serious hypoglycemia).

Discussion and Conclusions: Closing the loop with OpenAPS in people with T1D is effective in decreasing A1c and %TIHypo, without any serious adverse event. Of note, these results were obtained with people who showed a good baseline metabolic control (A1c of 7.17%). However, we need to study OpenAPS implementation on a larger sample of people with T1D and with a more prolonged follow-up.

Disclosure

V. Provenzano: None. E. Guastamacchia: None. D. Brancato: None. G. Cappiello: None. A. Maioli: None. R. Mancini: None. G. Crispino: None. A. De Monte: None. S. Turco: None. G. Tonolo: None.
Real-World Data from the MiniMed™ 670G System Commercial Launch—The First 1,052 Patients Using the System for Three Months
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 was released for commercial use in the U.S. in March 2017. Sensor glucose (SG) and device utilization data from the initial open-loop Manual Mode and closed-loop Auto Mode periods were analyzed for the first 1052 patients and compared to those from the MiniMed™ 670G system pivotal trial1.

De-identified data voluntarily uploaded to CareLink™ Personal software, from 3/17/17 to 11/11/17, were evaluated monthly, for 3 months. Data for 12,758 patient-days in Manual Mode and 142,065 patient-days after Auto Mode start were compared to results of the MiniMed™ 670G pivotal trial (124 patients aged 14-75 years) conducted from 6/2/15 to 3/7/16.

The percentage of time in Auto Mode, after initiation, was >85% over the 3 months for the entire commercial cohort. The SG values across glucose ranges were comparable to pivotal trial data (Table).

These findings indicate that outcomes data for the first 1052 patients using the commercial MiniMed™ 670G system mirrored the pivotal trial outcomes. Further, the increased time in target range and decreased hypoglycemia and hyperglycemia were sustained over 3 months.

Pivotal TrialCommercial LaunchManual ModeAuto ModeManual ModeAuto Mode Month 1Auto Mode Month 2Auto Mode Month 3Patients, N1241241052105210521052Auto Mode Use, %-87.20-88.6086.7885.96Mean SG, mg/dL150.2150.78157.02149.84150.30150.75Percentage of time in SG range, mg/dL<500.850.520.380.300.320.33<541.330.780.600.460.500.52<705.472.952.652.072.212.2370-18067.1372.6167.3975.0074.3674.07>18027.424.4529.9622.9323.4323.70>2506.945.587.494.504.865.14

1. Garg SK, Weinzimer SA, Tamborlane WV, et al. Glucose outcomes with the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes.

Diabetes Technol Ther. 2017;19:155-163.

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.
Learning From Past Failures of Oral Insulin Trials
Authors: Michels Aaron W. , Gottlieb Peter A.
Published: June 2018

Very recently one of the largest type 1 diabetes prevention trials using daily administration of oral insulin or placebo was completed. After 9 years of study enrollment and follow-up, the randomized controlled trial failed to delay the onset of clinical type 1 diabetes, which was the primary end point. The unfortunate outcome follows the previous large-scale trial, the Diabetes Prevention Trial–Type 1 (DPT-1), which again failed to delay diabetes onset with oral insulin or low-dose subcutaneous insulin injections in a randomized controlled trial with relatives at risk for type 1 diabetes. These sobering results raise the important question, “Where does the type 1 diabetes prevention field move next?” In this Perspective, we advocate for a paradigm shift in which smaller mechanistic trials are conducted to define immune mechanisms and potentially identify treatment responders. The stage is set for these interventions in individuals at risk for type 1 diabetes as Type 1 Diabetes TrialNet has identified thousands of relatives with islet autoantibodies and general population screening for type 1 diabetes risk is under way. Mechanistic trials will allow for better trial design and patient selection based upon molecular markers prior to large randomized controlled trials, moving toward a personalized medicine approach for the prevention of type 1 diabetes.
Hypogonadotropic Hypogonadism in Men With Diabesity
Authors: Dhindsa Sandeep , Ghanim Husam , Batra Manav , Dandona Paresh
Published: June 2018

One-third of men with obesity or type 2 diabetes have subnormal free testosterone concentrations. The lower free testosterone concentrations are observed in obese men at all ages, including adolescents at completion of puberty. The gonadotropin concentrations in these males are inappropriately normal; thus, these patients have hypogonadotropic hypogonadism (HH). The causative mechanism of diabesity-induced HH is yet to be defined but is likely multifactorial. Decreased insulin and leptin signaling in the central nervous system are probably significant contributors. Contrary to popular belief, estrogen concentrations are lower in men with HH. Men with diabesity and HH have more fat mass and are more insulin resistant than eugonadal men. In addition, they have a high prevalence of anemia and higher mortality rates than eugonadal men. Testosterone replacement therapy results in a loss of fat mass, gain in lean mass, and increase in insulin sensitivity in men with diabesity and HH. This is accompanied by an increase in insulin-signaling genes in adipose tissue and a reduction in inflammatory mediators that interfere with insulin signaling. There is also an improvement in sexual symptoms, anemia, LDL cholesterol, and lipoprotein (a). However, testosterone therapy does not consistently affect HbA1c in men with diabetes. The effect of testosterone replacement on cardiovascular events or mortality in men with diabesity is not known and remains to be studied in prospective trials.
PASTEURIZED CANNED GOODS FROM COD AND SALMON WITH THE ADDITION OIL WITH OPTIMIZED COMPOSITE COMPOSITION
Authors: Petrova Kseniia Nikolaevna , Volchenko Vasiliy Igorevich , Grokhovskiy Vladimir Aleksandrovich , Kuranova Ludmila Kasimirovna
Published: June 2018

The regional market of sterilized canned fish of the Murmansk region has been investigated. Based on the study of consumer demands, it has been revealed that the quality is in the first place among the respondents; in the second is the presence of properties that allow positioning products as a "healthy food product"; and in the third - the price and manufacturer. The urgency of creation and advance on the food market of new types of pasteurized canned food is established. The analysis of consumer preferences on the range allowed to allocate two groups of canned food: natural and natural with addition of oil as potentially the most demanded by consumers and attractive for developers of technologies. The basic technological scheme of pasteurized canned fish from cod and salmon with addition of oil was developed. There has been worked out the most acceptable mode of pasteurization of canned "Cod and salmon with addition of oil" (packaged in a can № 2, net weight of the product is 160 g), determined the actual mortality of the regime, which was 111.0 cond. min. The composition of pasteurized canned food was optimized for two population groups: canned food of social orientation and of premium class. The rotatable composite plan of the second order for two factors has been applied at establishing optimum parameters of composite structure of canned food. As optimization parameters there were chosen: the level of quality according to organoleptic evaluation of pasteurized canned food in points (for premium canned food); the level of quality according to organoleptic evaluation and the cost of raw materials in rubles, determining the price availability of the product (for canned food for social purposes). Values of these optimum factors for production of social appointment are established: the ratio of salmon fillet and cod fillet made 26 and 74%, correspondingly; quantity of vegetable oil-14.5 g; for premium canned food-46 and 54% correspondingly; the mass of vegetable oil -13,5 g, respectively.