Aim: To compare safety (immunogenicity) and efficacy of a biosimilar insulin GP-Lis25 and a reference insulin Ly-Lis25 (Humalog Mix 25) in Type 2 diabetes mellitus (T2D) patients. Materials & methods: This randomized open-label, 26-week clinical trial enrolled 210 T2D patients, randomized 1:1 to twice-daily GP-Lis25 or Ly-Lis25. The primary end point was immune response at 26th week. Noninferiority margin for HbA1c was 0.4%. Results: Immune response frequency was similar in GP-Lis25 and Ly-Lis25 groups both at week 12 (p = 0.651) and 26 (p = 0.164). The difference of HbA1c change at week 26 was (95% CI) 0.01 (-0.27–0.28)%. Fasting plasma glucose, seven-point glucose profile and insulin dose were similar between groups. Safety did not differ between groups. Conclusion: GP-Lis25 and Ly-Lis25 demonstrated similar safety and efficacy. ClincalTrials.gov identifier: NCT04023344 .

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There are several models of T2DM remission after bariatric surgery (ABCD, DiaRem, DRS), but none of them includes insulin resistance. Moreover these models are not suitable for early prediction of T2DM remission (within several months after surgery). Methods: We included 42 patients with T2DM and morbid obesity (BMI 42.3 [38.9; 48.1] kg/m2) after bariatric surgery (16 pts after restrictive procedures and 26 pts after bypass surgery). Insulin resistance was measured by hyperinsulienic euglycaemic test with M-index estimation (mg/kg/min) and HOMA-IR before the surgery. Glycaemia normalization was assessed by self-monitoring of blood glucose (FPG < 110 mg/dl (6.1 mmol/l) and postprandial PG < 140 mg/dl (7.8 mmol/l) in 1 month after surgery) as well as HbA1c < 6.0% (42 mmol/mol) in 3 months after surgery. ROC-curve identified insulin resistance predictive value of blood glucose normalization after bariatric surgery. Statistical analysis was performed using SPSS v.23.0. Results: All patients had severe insulin resistance at baseline (median M-index before surgery 1.535 mg/kg/min, HOMA-IR 10.0). Within 1 month after surgery 7 patients (16,7%) reached blood glucose normalization, within 3 months - 22 patients (52,4%), within 6 months - 31 patient (73,8%), in 12 months - 35 patients (83,3%). ROC-analysis showed that M-index within 1st month after surgery was predictive of blood glucose normalization; insulin resistance cut-off value was 1.876 mg/kg/min (Youden’s index). HOMA-IR and M-index in 3, 6 and 12 months after surgery didn’t predict glycaemia normalization. Conclusion: Baseline insulin resistance value defined as M-index > 1.876 mg/kg/min can be used to predict early blood glucose normalization within 1 month after bariatric surgery. Disclosure I. Sklyanik: None. E. Shestakova: Employee; Spouse/Partner; AstraZeneca. Speaker’s Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novartis Pharma K.K., Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. I. Stafeev: None. S. Michurina: None. A. Karmadonov: None. A.V. Vorotnikov: None. K. Yahyaev: None. A. Yurasov: None. M. Menshikov: None. A. Mayorov: Speaker’s Bureau; Self; Abbott, LifeScan, Inc., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis. Y.V. Parfyonova: None. M.V. Shestakova: None. Funding Russian Science Foundation (17-15-01435)

The article represents the review of issues of self-monitoring of blood glucose (SMBG) in diabetes treatment. The therapeutic purposes are considered when carrying out SMBG before and after the meals, accepted in Russia, providing an individualization depending on age, existence of severe complications and the risk of hypoglycemia. SMBG frequency is presented at various options of the antidiabetic therapy. The value of carrying out SMBG for the patient and the doctor is discussed. The principles of the work photometric and electrochemical glucometers are given. Issues of accuracy of blood glucose measuring accepted by the International organization for standardization for the systems of SMBG are presented. The reasons of errors to the system evaluation of blood glucose are connected with incorrect hand washing, improper coding of test strips, external conditions (altitude, temperature, humidity), hematocrit, acidosis, hyperlipidemia, concentration of oxygen in blood, exogenous interfering substances (some medicines). The structure and rules of maintaining the diary as the main way of the storage of results of SMBG are presented. Data of the international and Russian studies on an assessment of efficiency of SMBG are shown. The SMBG new methods are discussed in the section on continuous glucose monitoring.

1 ФГБУ Национальный медицинский исследовательский центр эндокринологии Минздрава России, Москва, Россия 2 Университет Бергена, Берген, Норвегия ОБОСНОВАНИЕ. Аутоиммунный полигландулярный синдром 1 типа (АПС 1 типа) -редкое наследственное аутоиммунное заболевание, возникающее в результате мутаций в гене аутоиммунного регулятора (AIRE) и характеризующееся полиорганной дисфункцией. Сахарный диабет (СД) является одним из компонентов этого заболевания. ЦЕЛЬ.Определение частоты СД среди пациентов с АПС 1 типа в России, выявление клинических и иммунологических особенностей его течения.МЕТОДЫ. В исследование были включены 113 пациентов с АПС 1 типа, 16 человек из которых имели нарушения углеводного обмена. Исследование антител к глутаматдекарбоксилазе (GAD), цинковому транспортеру-8 (ZnT8), тирозинфосфатазе (IA2), инсулину (IAA) и островковым клеткам поджелудочной железы (ICA) было проведено 30 пациентам с АПС 1 типа без СД и 11 пациентам с АПС 1 типа и СД. Исследование уровня антител проводилось при помощи иммуноферментного анализа. РЕЗУЛЬТАТЫ.Частота СД в группе пациентов с АПС 1 типа в России составила 14,1% (16/113). Медленно-прогрессирующее течение СД имели 19% пациентов (3/16). При исследовании отмечено, что методы исследования антител к IAA и ICA обладают низкой специфичностью и чувствительностью для диагностики СД при АПС 1 типа. Методы исследования антител к IA2 и ZnT8 обладают высокой специфичностью (100% и 97%), но низкой чувствительностью (42% и 33,3%). Метод определения антител к GAD менее специфичен (70%), а чувствительность его также низкая (58,3%). ЗАКЛЮЧЕНИЕ.Частота СД у пациентов с АПС 1 типа в России высокая по сравнению с данными авторов из других стран. Около 20% пациентов с АПС 1 типа и СД в России имеют медленно-прогрессирующее течение. Наибольшей специфичностью по отношению к СД у пациентов с АПС 1 типа обладают антитела к IA2 и ZnT8, однако чувствительность их низкая.КЛЮЧЕВЫЕ СЛОВА: аутоиммунный полигландулярный синдром 1 BACKGROUND. Autoimmune polyglandular syndrome type 1 (APS type 1) is a rare inherited autoimmune disease caused by mutations in AIRE gene (autoimmune regulator) and characterized by list of components. Diabetes mellitus (DM) can be one of components of this disease. AIMS.To show frequency of DM in patients with APS type 1 in Russia, to describe clinical and immunological aspects of DM in patients with APS type 1 MATERIALS AND METHODS. 113 patients have been enrolled in the study, 16 of them had DM (15/16) or impaired glucose tolerance (1/16). Antibodies against glutamate decarboxylase, tyrosine phosphatase, zinc transporter-8, insulin and β-cells of pancreas were investigated in 30 patients with APS type 1 without DM and in 11 patients with APS type 1 and DM. ELISA test was used for detection autoantibodies. RESULTS.Frequency of DM in patients with APS type 1 in Russia is 14.1% (16/113). Some patients had slow-progressive DM -19%(3/16). Antibodies against insulin and β-cells were not specific and also were not sensitive markers for DM in APS type 1.Примечания: IAA -антитела к ин...