Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes (original) (raw)

2015, Pediatric Diabetes

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Abstract

Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes Thalange N, Deeb L, Iotova V, Kawamura T, Klingensmith G, Philotheou A, Silverstein J, Tumini S, Ocampo Francisco A-M, Kinduryte O, Danne T. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatric Diabetes 2015: 16: 164-176.

Insulin degludec/insulin aspart combination for the treatment of type 1 and type 2 diabetes

Vascular Health and Risk Management, 2014

Glycemic control remains the major therapeutic objective to prevent or delay the onset and progression of complications related to diabetes mellitus. Insulin therapy represents a cornerstone in the treatment of diabetes and has been used widely for achieving glycemic goals. Nevertheless, a large portion of the population with diabetes does not meet the internationally agreed glycemic targets. Moreover, insulin treatment, especially if intensive, may be associated with emergency room visits and hospitalization due to hypoglycemic events. Therefore, fear of hypoglycemia or hypoglycemic events represents the main barriers to the attainment of glycemic targets. The burden associated with multiple daily injections also remains a significant obstacle to initiating and maintaining insulin therapy. The most attractive insulin treatment approach should meet the patients' preference, rather than demanding patients to change or adapt their lifestyle. Insulin degludec/insulin aspart (IDegAsp) is a new combination, formulated with ultra-long-acting insulin degludec and rapid-acting insulin aspart, with peculiar pharmacological features, clinical efficacy, safety, and tolerability. IDegAsp provides similar, noninferior glycemic control to a standard basal-bolus regimen in patients with type 1 diabetes mellitus, with additional benefits of significantly lower episodes of hypoglycemia (particularly nocturnal) and fewer daily insulin injections. Moreover, although treatment strategy and patients' viewpoint are different in type 1 and type 2 diabetes, trial results suggest that IDegAsp may be an appropriate and reasonable option for initiating insulin therapy in patients with type 2 diabetes inadequately controlled on maximal doses of conventional oral agents. This paper will discuss the role of IDegAsp combination as a novel treatment option in diabetic patients.

Real-world efficacy and safety of insulin degludec with mealtime rapid-acting insulin in type 1 diabetes in Indian pediatric population

International Journal of Pediatric Endocrinology, 2018

Background: Insulin Degludec (IDeg) is a new ultra-long-acting basal insulin that has not been yet evaluated in Indian pediatric population. We aim to evaluate the efficacy and safety of IDeg as basal-bolus therapy in Indian pediatric patients affected by type 1 diabetes mellitus (T1DM). Methods: A total of 30 pediatric and adolescent patients (17 boys, 13 girls; 22 were pre-pubertal) with T1DM who were on IDeg once daily participated in the study. All the patients received IDeg for at least 26 weeks along with rapid-acting mealtime insulin and their pre-and post-baseline characteristics (anthropometric data (BMI), age, duration of diabetes), metabolic (HbA1C), insulin requirement (unit/kg body weight per day) and number of hypoglycemia episodes were recorded along with the daily self-monitoring of blood glucose. Results: There was a significant decline in HbA1c, FPG and bolus insulin dose from baseline to 26 weeks in the overall population (HbA1c: 9.

Clinical use of the co-formulation of insulin degludec and insulin aspart

International Journal of Clinical Practice, 2016

He has conducted clinical trials for Novo Nordisk, Sanofi, MSD and Boehringer Ingelheim. M. Tambascia has received honoraria for lectures, travel support and consultancy services from pharmaceutical companies manufacturing diabetes treatments, including Novo Nordisk, Merck Sharp Domme, AstraZeneca, Sanofi, Eli Lilly, Takeda and Boehringer Ingelheim. J. Tibaldi has acted as a consultant to and received speaker honoraria from Novo Nordisk, and is on the speakers' bureau for AstraZeneca and Merck. J.S. Christiansen has served on advisory boards and speaker panels for Novo Nordisk.

Overview of Clinical Trial Program and Applicability of Insulin Degludec/Insulin Aspart in Diabetes Management

The Journal of the Association of Physicians of India, 2015

Insulin degludec/insulin aspart (IDegAsp) is the first soluble coformulation combining a long-acting insulin degludec (IDeg) and rapid-acting insulin aspart (IAsp). In patients with uncontrolled type 2 diabetes (T2DM) previously treated with insulins, IDegAsp twice daily effectively improves glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) levels with fewer hypoglycaemic episodes versus premix insulins. Further, insulin initiation with IDegAsp once daily provides superior long-term glycaemic control compared to insulin glargine with similar FPG and insulin doses, and numerically lower rates of overall and nocturnal hypoglycaemia. In patients with type 1 diabetes mellitus (T1DM), IDegAsp once daily and IAsp at remaining meals provides more convenient three injection regimen per day over conventional 4-5 injections based basal-bolus therapy. IDegAsp is an appropriate and reasonable option for intensifying insulin therapy in patients with T2DM and a relatively less complex...

Switching From Glargine to Degludec: The Effect on Metabolic Control and Safety During 1-Year of Real Clinical Practice in Children and Adolescents With Type 1 Diabetes

Frontiers in Endocrinology, 2018

Background/Objective: Insulin degludec (IDeg) is an ultra-long-acting analog with less daily variability compared to other basal insulins. In this retrospective study we examined 1-year efficacy and safety of IDeg in youth with type 1 diabetes (T1D). Subjects/Methods: Thirty-seven patients [11.7 ± 4.22 years; T1D duration 4.97 ± 3.63 years; once-daily glargine (IGlar) by at least 1 year] were switched to once-daily IDeg because of glycosylated hemoglobin (HbA1c) >7.5% and/or reported physical pain at IGlar injection. Changes in HbA1c, 30-day mean fasting plasma glucose (mean FPG), daily insulin dose, and severe hypoglycemia rates were collected at basal insulin switch (T0), 3-months (T1), 6-months (T2), and 12-months (T3) after IDeg was started. Results: In patients with HbA1c >7.5% at T0 we found a decrease in HbA1c values (%) from 8.46 ± 0.53 to 7.89 ± 0.72 at T1 (p = 0.008) and 7.97 ± 0.89 at T2 (p = 0.035). At T3, 38.9% of patients had HbA1c ≤7.5%. Mean FPG levels significantly decreased at T2 (p = 0.043). In the overall study population, we documented an increase in IDeg dose (+12.5% at T3; p < 0.001) and a decrease in mealtime insulin dose (−11.6% at T3; p = 0.001) after switch. HbA1c levels were unchanged. No episode of severe hypoglycemia was reported. Conclusions: Our data in children and adolescents with T1D suggest that IDeg dose should be increased by 12% and mealtime insulin doses should be lowered by 11% for patients who previously received IGlar. IDeg might be considered useful and well tolerated and it seems to improve the glycemic control compared to IGlar, mainly in patients with poor glycemic control.

A Review of Insulin Degludec/Insulin Aspart: Pharmacokinetic and Pharmacodynamic Properties and Their Implications in Clinical Use

Clinical Pharmacokinetics, 2016

Insulin degludec/insulin aspart (IDegAsp; 70 % IDeg and 30 % IAsp) is a soluble combination of two individual insulin analogues in one product, designed to provide mealtime glycaemic control due to the IAsp component and basal glucose-lowering effect from the IDeg component. The pharmacokinetic and pharmacodynamic characteristics of IDegAsp have been investigated in a series of clinical pharmacology studies with generally comparable designs, methodologies and patient inclusion/ exclusion criteria. The glucose-lowering effect profile of IDegAsp during once-daily dosing at steady state shows distinct and clearly separated action from the prandial and basal components of IDegAsp. The IAsp component provides rapid onset and peak glucose-lowering effect followed by a flat glucose-lowering effect lasting beyond 30 h due to IDeg. During twice-daily dosing, the distinct peak effect and the flat basal effect are retained following each dose. The pharmacological properties of IDegAsp are maintained in the elderly, children, adolescents, Japanese patients and those with hepatic or renal impairment. The potential clinical benefits associated with the pharmacological properties of IDegAsp have been verified in phase III clinical trials comparing IDegAsp with three other currently available treatment options: premixed insulin, basal-bolus regimens and basal-only therapy. IDegAsp shows favourable clinical benefits compared with biphasic insulin aspart 30 and is a viable alternative to basal-bolus and basal-only therapy. This review presents the results from clinical pharmacology studies conducted with IDegAsp to date, and extrapolates these results to clinical use of IDegAsp in the context of findings from the IDegAsp clinical therapeutic studies. Key Points There is a clinical need for an insulin combination that can offer both basal and mealtime insulin coverage in one injection in patients with diabetes. Insulin degludec/insulin aspart (IDegAsp; 70 % IDeg and 30 % IAsp) provides rapid onset and peak glucose-lowering effect due to the bolus IAsp component, as well as a flat and long-lasting glucoselowering effect from the basal IDeg component, during both once-and twice-daily dosing across several different patient populations. Due to its pharmacological properties, IDegAsp is superior to premixed formulations and may also be an alternative to basal-only and basal-bolus therapy.

Insulin Degludec Aspart: The First Co-formulation of Insulin Analogues

Diabetes therapy : research, treatment and education of diabetes and related disorders, 2014

Insulin degludec/insulin aspart (IDegAsp) is the first soluble co-formulation which combines two insulin analogues, and provides effective basal and prandial glycemic coverage. It has been assessed as basal insulin in type 2 diabetes mellitus (T2DM), and as part of basal-bolus regime in both type 1 diabetes mellitus and T2DM. Insulin degludec has also been assessed as flexibly administered basal insulin in terms of time of administration. This review discusses data pertaining to the efficacy, safety, tolerability, and clinical potential of IDegAsp. The discussion includes comparisons of IDegAsp with basal as well as premixed insulin.

The Rate of Hyperglycemia and Ketosis With Insulin Degludec-Based Treatment Compared With Insulin Detemir in Pediatric Patients With Type 1 Diabetes: An Analysis of Data From Two Randomized Trials

Pediatric Diabetes

Background: Historically, data on the rate of hyperglycemia and ketosis have not been collected in clinical trials. However, it is clinically important to assess the rate of these events in children with type 1 diabetes (T1D). This question was addressed in two pediatric trials using insulin degludec (degludec). Objective: To assess the rate of hyperglycemia and ketosis in two-phase 3b trials investigating degludec (Study 1) and degludec with insulin aspart (IDegAsp [Study 2]) vs insulin detemir (IDet). Subjects: Patients (aged 1-17 years inclusive) with T1D treated with insulin for ≥3 months. Methods: Study 1: patients were randomized to degludec once daily (OD) or IDet OD/twice daily (BID) for 26 weeks, followed by a 26-week extension phase. Study 2: patients were randomized to IDegAsp OD or IDet OD/BID for 16 weeks. Bolus mealtime IAsp was included in both studies. In Study 1, hyperglycemia was recorded if plasma glucose (PG) was >11.1 mmol/L, with ketone measurement required with significant hyperglycemia (>14.0 mmol/L). In Study 2, hyperglycemia was recorded with PG >14.0 mmol/L where the subject looked/felt ill, with ketone measurement also required in these hyperglycemic patients. In this post hoc analysis, the hyperglycemia threshold was 14.0 mmol/L for uniformity. Results: Despite similar rates of hyperglycemia with degludec/IDegAsp compared with IDet, the rates of ketosis were lower with degludec/IDegAsp. Conclusions: These trials, the first to systematically collect data on ketosis in pediatric patients with T1D, demonstrate the potential of degludec/IDegAsp to reduce rates of metabolic decompensation, compared with IDet. K E Y W O R D S hyperglycemia, insulin degludec/insulin aspart, insulin detemir, ketosis, type 1 diabetes 1 | INTRODUCTION Control of hyperglycemia is a key focus of diabetes management and insulin is the mainstay of treatment for type 1 diabetes (T1D). Insulin deficiency leads to hyperglycemia and elevated ketones (ketosis) and, if not managed correctly, progresses to diabetic ketoacidosis (DKA). The

Patient safety and minimizing risk with insulin administration - role of insulin degludec

Drug, healthcare and patient safety, 2014

Diabetes is a lifelong condition requiring ongoing medical care and patient self-management. Exogenous insulin therapy is essential in type 1 diabetes and becomes a necessity in patients with longstanding type 2 diabetes who fail to achieve optimal control with lifestyle modification, oral agents, and glucagon-like peptide 1-based therapy. One of the risks that hinders insulin use is hypoglycemia. Optimal insulin therapy should therefore minimize the risk of hypoglycemia while improving glycemic control. Insulin degludec (IDeg) is a novel basal insulin that, following subcutaneous injection, assembles into a depot of soluble multihexamer chains. These subsequently release IDeg monomers that are absorbed at a slow and steady rate into the circulation, with the terminal half-life of IDeg being ~25 hours. Thus, it requires only once-daily dosing unlike other basal insulin preparations that often require twice-daily dosing. Despite its long half-life, once-daily IDeg does not cause accu...

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Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial

Pediatric Diabetes

Funding information Novo Nordisk Background: Insulin degludec/insulin aspart (IDegAsp) is a fixed soluble co-formulation of basal and bolus insulin. Objective: To evaluate efficacy and safety of IDegAsp in pediatric patients with type 1 diabetes (T1D). Subjects: Children and adolescents (aged 1 to <18 years) with T1D. Methods: A 16-week, phase 3b, treat-to-target, parallel-group, open-label, non-inferiority trial was conducted at 63 sites in 14 countries from October 2013 to November 2014. Patients were randomized 1:1 (age stratified: 1-<6 years; 6-<12 years; 12-<18 years) to IDegAsp once daily (OD) plus insulin aspart (IAsp) for remaining meals (IDegAsp + IAsp), or IDet OD or twice daily plus mealtime IAsp (IDet + IAsp). The primary end-point was HbA1c change from baseline at week 16. Results: A total of 362 participants were randomized to IDegAsp + IAsp (n = 182) or IDet + IAsp (n = 180). HbA1c decreased from baseline to week 16 by 0.3% in both groups (estimated treatment difference: −0.04%-points [−0.23; 0.15] 95%CI (−0.45 mmol/mol [−2.51; 1.60] 95%CI), confirming non-inferiority. There were no significant differences between treatment groups in fasting or self-measured plasma glucose. Confirmed hypoglycemia rates did not significantly differ between groups. There was a significant reduction in basal and total insulin dose with IDe-gAsp + IAsp vs IDet + IAsp (post hoc analysis). Mean number of injections/day was 3.6 and 4.9 with IDegAsp + IAsp and IDet + IAsp, respectively (post hoc analysis). A non-significant higher rate of severe hypoglycemia was observed with IDegAsp + IAsp vs IDet + IAsp. The most frequent adverse events in both groups were hypoglycemia, headache, and nasopharyngitis. Conclusions: IDegAsp + IAsp was non-inferior to IDet + IAsp regarding HbA1c, had similar hypoglycemia rates and required fewer injections.

Efficacy of the Novel Degludec/Aspart Insulin Co-formulation in Children and Adolescents with Type 1 Diabetes: A Real-life Experience with 1-year IDeg/Asp Therapy in Poorly Controlled and Non-compliant Patients

Journal of Clinical Research in Pediatric Endocrinology

What is already known on this topic? Achieving optimal metabolic control can be extremely challenging in some children and adolescents with type 1 diabetes (T1DM). Adherence to multiple insulin injections is poor in a subgroup of those children leading to frequent hospitalizations with ketoacidosis (DKA). Degludec/Aspart co-formulation (70%IDeg+30%IAsp-IDegAsp) can be beneficial in challenging cases with poor glycemic control and acute complications of diabetes by providing the longer-duration of basal insulin with simplified basal-bolus treatment in 3 injections instead of 4-5 injections. What this study adds? The real-life experience demonstrates that IDegAsp is non-inferior to classic basal-bolus regimen regarding to glycemic control in children with T1DM. Simplified basal-bolus regimen with IDegAsp could be an alternative in patients with frequent hypoglycemia and DKA attacks, who have poor compliance with 4-5 injections per day.

Use of Insulin Degludec/Insulin Aspart in the Management of Diabetes Mellitus: Expert Panel Recommendations on Appropriate Practice Patterns

Frontiers in Endocrinology

Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec (IDeg), which provides long-lasting basal insulin coverage, and insulin aspart (IAsp), which targets post-prandial glucose. This expert panel aimed to provide a practical and implementable guidance document to assist clinicians in prescribing IDegAsp in the diabetes management with respect to different patient populations including children and adults with type 1 diabetes (T1D) or type 2 diabetes (T2D) as well as pregnant, elderly and hospitalized patients and varying practice patterns (insulin-naive, insulin-treated, switching from basal, basal bolus and premix regimens). The experts recommended that IDegAsp can be used in insulin-naive T2D patients with poor glycemic control (HbA1c >8.5%) despite optimal oral antidiabetic drugs (OADs) as well as in insulin-treated T2D patients by switching from basal insulin, basal-bolus therapy or premixed insulins in relation to lower risk of nocturn...

Initiating insulin therapy in children and adolescents with type 1 diabetes mellitus

Indian journal of endocrinology and metabolism, 2015

The primary clinical goals to be achieved with insulin initiation are elimination of ketosis and hyperglycemia with prevention of chronic complications. Insulin therapy is the mainstay in management of type 1 diabetes, which should be aimed at achieving good glycemic control, with achievement of hemoglobin A1c (HbA1c) <7.5%, pre-meal self-monitored blood glucose (SMBG) of 90-130 mg/dL, bed time SMBG of 100-140 mg/dL, mean blood glucose level of 120-160 mg/dL and no ketonuria. Two classes of insulin are available for use in T1DM viz. bolus/prandial insulins (rapid-acting insulins and short-acting insulins) and basal insulins (intermediate-acting insulin and long-acting insulin). Insulin glargine and glulisine can be used in children above 6 years, lispro in children above 3 years and detemir and aspart in children above 2 years. The caution for hypoglycemia should be exercised while prescribing them. Degludec is currently not approved for pediatric use. The initial insulin regimen...

Long-term safety and efficacy of insulin degludec in the management of type 2 diabetes

Diabetes, metabolic syndrome and obesity : targets and therapy, 2015

Insulin degludec (IDeg) is a novel antiglycemic agent belonging to the therapeutic class of ultra-long duration basal insulin analogs. Its half-life and duration of action are 25 hours and 42 hours, respectively. This pharmacodynamic profile leads to a strict dosing schedule, ie, IDeg is injected at the same time each day to ensure optimal biological action and consistent glycemic control. According to the literature, IDeg provides glycemic control and nocturnal hypoglycemia reduction comparable with other long-acting analogs in type 2 diabetes mellitus. The risk of severe hypoglycemic episodes seems also to be reduced when using IDeg therapy; however, long-term follow-up is warranted for monitoring of possible but relatively infrequent adverse events. IDeg is also available in combination with aspart insulin and with liraglutide. The above preparations have been approved by the European Medicines Agency and other national health authorities. In 2012, the US Food and Drug Administra...

Ultralong Analogue Insulin Degludec in Type 1 Diabetes : Reduction of Hypoglycemic Events

2021

Long-acting insulins analogues are related with the reduction of hypoglycemic events. Objective: Ultralong-acting insulin analog Degludec (IDeg) in type 1 diabetic patients (T1D) previously treated with Glargine (U100) with severes hypoglycemic events and poor metabolic control. Patients and Method: 230 T1D patients were followed for 18 months, average 34 years old and 14 years of the diabetes diagnosed. Hypoglycemias, biochemical parameters and insulin requirements were analyzed in a period of 18 months. All the patients were on a basal bolus regimen with IDeg as basal adjusted fortnightly, and ultra-fast bolus insulin pre-meals three times a daily. Results: At 3 months fasting glycemia decreased from 253 mg/dl to 180 mg/dl; at 6 months 156 mg/dl; at 12 months151 mg/dl and at 18 months 150 mg/dl. Glycated hemoglobin (HbA1c) initially 10.6%, decreased at 3 months to 8.7% at 6 months 8.3% at 12 months 9.0%, at 18 months 9.0%. All these results were statistically significant p < 0....

Twice-daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin-naïve adults with Type 2 diabetes

Diabetic Medicine, 2015

Aim To evaluate the efficacy and safety of twice-daily insulin degludec/insulin aspart vs. twice-daily biphasic insulin aspart 30 in people with Type 2 diabetes mellitus who were na€ ıve to insulin. Methods In this 26-week, multinational, open-label, controlled, two-arm, parallel-group, treat-to-target trial, participants [mean (AE SD) age 58.9 (AE8.9) years, duration of diabetes 9.5 (AE5.9) years, HbA 1c 68 (AE8.7) mmol/mol or 8.4 (AE0.8)% and BMI 31.2 (AE4.2) kg/m 2) were randomized (1:1) to insulin degludec/insulin aspart (n = 197) or biphasic insulin aspart 30 (n = 197), administered with breakfast and the main evening meal, titrated to a self-monitored plasma glucose target > 3.9 and ≤ 5.0 mmol/l. Results The mean HbA 1c was reduced to 49 mmol/mol (6.6%) with insulin degludec/insulin aspart and 48 mmol/mol (6.5%) with biphasic insulin aspart 30. Insulin degludec/insulin aspart achieved the prespecified non-inferiority margin (estimated treatment difference 0.02%; 95% CI À0.12, 0.17). Insulin degludec/insulin aspart was superior in lowering fasting plasma glucose (estimated treatment difference À1.00 mmol/l; 95% CI À1.4, À0.6; P < 0.001) and reducing overall and nocturnal confirmed hypoglycaemia at a similar overall insulin dose compared with biphasic insulin aspart 30. Similar proportions of participants in each arm experienced severe hypoglycaemia. Adverse events were equally distributed. Conclusions Consistent with previous findings, insulin degludec/insulin aspart twice daily effectively improved longterm glycaemic control, with superior reductions in FPG, and significantly less overall and nocturnal confirmed hypoglycaemia compared with biphasic insulin aspart 30 in people with Type 2 diabetes who were insulin-na€ ıve.

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Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial

Pediatric Diabetes

Comparison of Second-Generation Basal Insulin Analogs: A Review of the Evidence from Continuous Glucose Monitoring

Diabetes Technology & Therapeutics

Many people with insulin-treated diabetes continue to experience inadequate glycemic control and a high incidence of hypoglycemic events, despite improvements in therapeutic strategies. While glycated hemoglobin (HbA 1c) is currently recognized as the gold-standard for assessing glycemic control, the measure reflects mean blood glucose levels over a period of time, does not inform on acute glycemic deviations, and can be unreliable in certain populations. Continuous glucose monitoring (CGM) facilitates the acquisition of blood glucose data around the clock and, importantly, predicts and/or captures acute hyper-and hypoglycemic episodes. In light of the recent publication of the Time in Range (TIR) International Consensus Group report on key CGM metrics, we performed a review of current CGM evidence for second-generation basal insulins in both people with type 1 and type 2 diabetes. The identified studies highlight the varied CGM-related metrics used to assess basal insulins, which complicate comparisons. Furthermore, all studies had small sample sizes and typically were of short duration, which may account for the lack of statistically significant between-treatment differences observed. Differences were seen in the titration approaches used and the settings in which participants were observed. These results highlight the need for further studies of secondgeneration basal insulin analogs that are designed to capture the standard metrics proposed by the TIR consensus group, with additional consideration given to sample size and study duration.

Switching From Glargine to Degludec: The Effect on Metabolic Control and Safety During 1-Year of Real Clinical Practice in Children and Adolescents With Type 1 Diabetes

Frontiers in Endocrinology, 2018

Real-world efficacy and safety of insulin degludec with mealtime rapid-acting insulin in type 1 diabetes in Indian pediatric population

International Journal of Pediatric Endocrinology, 2018

Diabetes mellitus type 1 in childhood

Diabetes mellitus, 2020

Аналоги инсулина-форма инсулина, в которой произведены некоторые изменения в молекуле человеческого инсулина. Аналог действует так же, как инсулин, но с фармакокинетическими/фармакодинамическими различиями, которые могут иметь преимущества Базальный режим-введение инсулина помпой в автоматическом режиме с заданной пользователем скоростью (постоянной или изменяющейся в течение суток) Болюсы инсулина-дискретно вводимые пользователем инсулиновой помпы дозы инсулина, необходимые для поддержания гликемии после еды и для коррекции гипергликемии Вариабельность гликемии-показатель частоты, продолжительности и амплитуды изменений уровня глюкозы в крови за определенный период времени Гипергликемия-уровень глюкозы в крови выше нормальных значений Гипогликемия-уровень глюкозы в крови ниже нормальных значений Гликемия-концентрация глюкозы в крови Гликированный гемоглобин-показатель, который отражает средний уровень глюкозы в крови за последние 2-3 месяца Инсулин-гормон, в физиологических условиях секретируемый бета-клетками поджелудочной железы и регулирующий уровень глюкозы в крови, стимулируя поглощение глюкозы тканями Инсулиновая помпа-устройство для непрерывной подкожной инфузии инсулина Инфузионная система-одноразовый комплект медицинских изделий, через который осуществляется инфузия инсулина, состоящий из резервуара для инсулина, устанавливаемой подкожно канюли (тефлоновой или стальной), а также катетера, связывающего резервуар и канюлю Липодистрофия-патологическое изменение жировой ткани в местах инъекций инсулина Помповая инсулинотерапия-способ инсулинотерапии, осуществляемый путем непрерывной подкожной инфузии инсулина с помощью инсулиновой помпы Прандиальный инсулин-инсулин короткого действия, вводимый на прием пищи Калькулятор болюса-математический алгоритм, позволяющий помпе рассчитать дозу болюса на еду и/или коррекцию гликемии, исходя из введенных пользователем показателей (количество углеводов в пище, гликемия) и на основе предустановленных индивидуальных коэффициентов (углеводный коэффициент, чувствительность к инсулину, целевая гликемия, время действия инсулина и др.) Хлебная единица-способ оценки количества углеводов в пище. Одна хлебная единица эквивалентна 10-12 г раммам углеводов Шприц-ручка-устройство для инъекций инсулина

A 26-week, randomized trial of insulin detemir versus NPH insulin in children and adolescents with type 2 diabetes (iDEAt2)

European Journal of Pediatrics, 2018

There are limited studies evaluating the safety and efficacy of treatments in young people with type 2 diabetes (T2D). This study compared the efficacy and safety of insulin detemir versus neutral protamine Hagedorn (NPH) insulin, both in combination with metformin and lifestyle intervention, in children and adolescents with T2D. This randomized, open-label, phase 3 trial recruited patients (n = 42) aged 10-17 years diagnosed with T2D already receiving metformin ± other oral antidiabetic drugs ± basal insulin. Patients were randomized (1:1) to receive either insulin detemir or NPH insulin, both with the maximum tolerated dose of metformin, and lifestyle intervention, over 26 weeks. Enrollment terminated prematurely after 17 months due to a very slow recruitment rate (12% of the target met). After 26 weeks, the observed mean HbA 1c value had decreased by 0.61% points in the insulin detemir group vs. 0.84% points in the NPH insulin group. The rate of symptomatic blood glucose-confirmed hypoglycemic episodes was 0.4 episodes/patient-year of exposure (PYE) for insulin detemir vs. 1.1 episodes/PYE for NPH insulin.

Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes (original) (raw)

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