ABSTRACT
Abstract Diabetes during pregnancy has been linked to unfavorable maternal-fetal outcomes. Human insulins are the first drug of choice because of the proven safety in their use. However, there are still questions about the use of insulin analogs during pregnancy. The objective of the present study was to determine the effectiveness of insulin analogs compared withhuman insulin in the treatment of pregnant women with diabetes througha systematic review withmeta-analysis. The search comprised the period since the inception of each database until July 2017, and the following databases were used:MEDLINE, CINAHL, EMBASE, ISIWeb of Science, LILACS, Scopus, SIGLE andGoogle Scholar.We have selected 29 original articles: 11 were randomized clinical trials and 18 were observational studies.We have explored data from 6,382 participants. All of the articles were classified as having an intermediate to high risk of bias. The variable that showed favorable results for the use of insulin analogs was gestational age, with a mean difference of - 0.26 (95 % confidence interval [CI]: 0.03-0.49; p = 0.02), but with significant heterogeneity (Higgins test [I2] = 38%; chi-squared test [χ2] = 16.24; degree of freedom [DF] = 10; p = 0.09). This result, in the clinical practice, does not compromise the fetal well-being, since all babies were born at term. There was publication bias in the gestational age and neonatal weight variables. To date, the evidence analyzed has a moderate-to-high risk of bias and does not allow the conclusion that insulin analogs are more effective when compared with human insulin to treat diabetic pregnant women.
Resumo Diabetes durante a gestação tem sido relacionado a desfechos materno-fetais desfavoráveis. As insulinas humanas são a primeira escolha medicamentosa, devido à comprovada segurança no seu uso. Entretanto, ainda há questionamentos sobre o uso dos análogos da insulina na gestação. O objetivo do presente estudo foi determinar a efetividade dos análogos da insulina comparados às insulinas humanas no tratamento de gestantes com diabetes por meio de uma revisão sistemática com metanálise. A busca compreendeu desde o início de cada base de dados até julho de 2017, e foi realizada nos seguintes bancos de dados: MEDLINE, CINAHL, EMBASE, ISI Web of Science, LILACS, Scopus, SIGLE e Google Scholar. Selecionamos 29 artigos originais, sendo 11 ensaios clínicos randomizados e 18 estudos observacionais. Exploramos dados de 6.382 participantes. Todos os artigos foram classificados como sendo de intermediário a alto risco de viés. A variável que demonstrou resultado favorável ao uso dos análogos da insulina foi idade gestacional, com uma diferençamédia de - 0.26 (95% índice de confiança [IC]: 0.03-0.49; p = 0.02), porém com heterogeneidade significativa (teste de Higgins [I2] = 38%; teste do qui quadrado [χ2] =16.24; graus de liberdade [GL] =10; p = 0.09). Esse resultado, na prática clínica, não compromete o bem-estar fetal, uma vez que todos os bebês nasceram a termo. Houve viés de publicação nas variáveis idade gestacional e peso neonatal. Até o momento, as evidências analisadas possuem um risco de viés moderado a elevado e não permitem concluir que os análogos da insulina sejam mais efetivos em comparação às insulinas humanas para tratar gestantes diabéticas.
Subject(s)
Humans , Female , Pregnancy , Diabetes, Gestational/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Prenatal Care/methods , Birth Weight , Fetal Macrosomia/etiology , Randomized Controlled Trials as Topic , Abortion, Spontaneous/etiology , Gestational Age , Treatment Outcome , Observational Studies as Topic , Insulin Aspart/therapeutic use , Insulin Lispro/therapeutic use , Insulin Glargine/therapeutic use , Hypoglycemia/chemically induced , Insulin/analogs & derivativesABSTRACT
ABSTRACT Human insulin is provided by the Brazilian Public Health System (BPHS) for the treatment of diabetes, however, legal proceedings to acquire insulin analogs have burdened the BPHS health system. The aim of this study was to perform a cost-effectiveness analysis to compare insulin analogs and human insulins. This is a pharmacoeconomic study of cost-effectiveness. The direct medical cost related to insulin extracted from the Ministry of Health drug price list was considered. The clinical results, i.e. reduction in glycated hemoglobin (HbA1c), were extracted by meta-analysis. Different scenarios were structured to measure the uncertainties regarding the costs and reduction in HbA1c. Decision tree was developed for sensitivity of Incremental Cost Effectiveness Ratio (ICER). A total of fifteen scenarios were structured. Given the best-case scenario for the insulin analogs, the insulins aspart, lispro, glargine and detemir showed an ICER of R$ 1,768.59; R$ 3,308.54; R$ 11,718.75 and R$ 2,685.22, respectively. In all scenarios in which the minimum effectiveness was proposed, lispro, glargine and detemir were dominant strategies. Sensitivity analysis showed that the aspart had R$ 3,066.98 [95 % CI: 2339.22; 4418.53] and detemir had R$ 6,163.97 [95% CI: 3919.29; 11401.57] for incremental costs. We concluded there was evidence that the insulin aspart is the most cost-effective.
Subject(s)
Cost-Benefit Analysis/statistics & numerical data , Insulin, Long-Acting/analysis , Insulins/analysis , Insulin, Short-Acting/analysis , Unified Health System/statistics & numerical data , Glycated Hemoglobin , Costs and Cost Analysis , Diabetes Mellitus/drug therapy , Insulin Aspart/analysis , Insulin Detemir , Insulin/supply & distributionABSTRACT
Allergic reaction to insulin is uncommon since the introduction of human recombinant insulin preparations and is more rare in pregnant than non-pregnant females due to altered immune reaction during pregnancy. Herein, we report two cases of allergic reaction to insulin in gestational diabetes that were successfully managed. One case was a 33-year-old female using isophane-neutral protamine Hagedorn human insulin and insulin lispro. She experienced dyspnea, cough, urticaria and itching sensation at the sites of insulin injection immediately after insulin administration. We discontinued insulin therapy and started oral hypoglycemic agents with metformin and glibenclamide. The other case was a 32-year-old female using insulin lispro and insulin detemer. She experienced pruritus and burning sensation and multiple nodules at the sites of insulin injection. We changed the insulin from insulin lispro to insulin aspart. Assessments including immunoglobulin E (IgE), IgG, eosinophil, insulin antibody level and skin biopsy were performed. In the two cases, the symptoms were resolved after changing the insulin to oral agents or other insulin preparations. We report two cases of allergic reaction to human insulin in gestational diabetes due to its rarity.
Subject(s)
Adult , Female , Humans , Pregnancy , Biopsy , Burns , Cough , Diabetes, Gestational , Dyspnea , Eosinophils , Glyburide , Hypersensitivity , Hypersensitivity, Immediate , Hypoglycemic Agents , Immunoglobulin E , Immunoglobulin G , Immunoglobulins , Insulin Aspart , Insulin Lispro , Insulin , Metformin , Pruritus , Sensation , Skin , UrticariaABSTRACT
OBJECTIVE: To evaluate the safety, effectiveness and health-related quality of life (HRQoL) parameters of A1chieve study participants in the Philippine cohort, who were treated with BIAsp 30.METHODOLOGY: A1chieve is a non-interventional, six-month, observational study of 66,726 people with type 2 diabetes mellitus (T2DM), including both insulin users and non-insulin users, started on insulin detemir, insulin aspart, or BIAsp 30 in 28 countries across four continents. The present study evaluates the safety, effectiveness and HRQoL in 1,252 subjects from the Philippine cohort of the A1chieve study who were treated with BIAsp 30.RESULTS: At baseline, the mean age, duration of diabetes and mean BMI were found to be 55.5±11.7 years, 7.2 ± 5.6 years and 25.4 ± 5.3 kg/m2, respectively. Seventy-eight percent (78%) of subjects were insulin naïve and 22% were prior insulin users. At baseline, glycemic control was poor (HbA1c = 9.9%) in the entire cohort. Overall there was a 2.7% reduction in mean HbA1c and 44.2% subjects achieved the HbA1c target of CONCLUSION: BIAsp 30 is safe and efficacious for initiating and intensifying insulin therapy for Filipino T2DM patients.
Subject(s)
Humans , Male , Female , Middle Aged , Adult , Insulin Aspart , Insulin , Diabetes Mellitus, Type 2 , Glycated Hemoglobin , Cholesterol, LDL , Triglycerides , Insulin, IsophaneABSTRACT
<p><b>OBJECTIVE</b>To observe the therapeutic effect and safety of vildagliptin combined with insulin aspart injection in elderly patients with type 2 diabetes.</p><p><b>METHODS</b>Sixty-six elderly patients with type 2 diabetes who had poor blood glucose control with insulin aspart injection were divided into two groups to have additional Vildagliptin (50 mg, twice daily, n=36, observation group) or Acarbose (50 mg, three times a day, n=30, control group). Blood glucose (including FBG and 2hPG), HbA1C, fasting c-peptide, postprandial c-peptide, BMI and GFR were observed after 12 weeks.</p><p><b>RESULTS</b>In the observation group, FBG, 2hPG and HbA1C decreased significantly (P<0.05), fasting and postprandial c-peptide increased (P<0.05), and BMI and GFR showed no obvious changes (P>0.05). In the control group, 2hPG and HbA1C were significant lowered (P<0.05) but FBG, fasting and postprandial c-peptide, BMI or GFR showed no changes (P>0.05). Compared with those in the control group, FBG in the observation group showed a significant reduction (P<0.05), but no significant differences were found in 2hPG, HbA1C, BMI or GFR (P>0.05). No hypoglycemia occurred in the two groups during the treatment.</p><p><b>CONCLUSION</b>Vildagliptin with insulin aapart injection has equivalent effect with Acarbose combined with insulin aspart injection in decreasing 2hPG and HbA1C without increasing the body weight or the risk to hypoglycemia or causing lowered GFR. Vildagliptin has better effect in decreasing FBG and improving the function of the islet cells.</p>
Subject(s)
Aged , Humans , Adamantane , Therapeutic Uses , Blood Glucose , Diabetes Mellitus, Type 2 , Drug Therapy , Glycated Hemoglobin , Metabolism , Hypoglycemic Agents , Therapeutic Uses , Injections , Insulin Aspart , Therapeutic Uses , Nitriles , Therapeutic Uses , Pyrrolidines , Therapeutic UsesABSTRACT
<p><b>BACKGROUND</b>The effectiveness and safety of initiating biphasic insulin aspart 30 in patients who were poorly controlled on oral glucose-lowering drugs were studied in randomized controlled trials, while results from clinical practice remain limited. This subgroup analysis was to provide such findings from a large-scale non-interventional study.</p><p><b>METHODS</b>A1chieve was a multinational, prospective, open-label, non-interventional, 24-week study in patients with type 2 diabetes initiating insulin analogues in 28 countries across Asia, Africa, Europe, and Latin America. After physician had taken the decision to use this insulin, any patient with type 2 diabetes who was not treated with or who had started the study insulin within 4 weeks before inclusion was eligible. Patients were treated with study insulin alone or in combination with oral glucose-lowering drugs. Data on adverse drug reactions, hypoglycemia and glycemic control were collected at baseline, week 12 and 24. This is a report of a Chinese subgroup analysis from the A1chieve study.</p><p><b>RESULTS</b>Totally, 4 100 patients constituted this subgroup. No serious adverse drug reactions were reported. Rates of total, major, nocturnal hypoglycemic events (events/patient per year) were 1.47, 0.10, 0.31 at baseline and 1.35, 0.00, 0.22 at week 24, respectively. Glycemic control was improved as measured by hemoglobin A1c (mean 9.3% to 7.0%, reduction -2.3%), fasting plasma glucose (mean 10.2 to 6.8 mmol/L, reduction -3.5 mmol/L) and postprandial plasma glucose (mean 14.4 to 8.8 mmol/L, reduction -5.6 mmol/L), all P < 0.001. Change in mean body weight was +0.3 kg (P < 0.001).</p><p><b>CONCLUSION</b>In this subgroup analysis of the A1chieve study, biphasic insulin aspart 30 improved glycemic control with low risk of hypoglycemia.</p>
Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Administration, Oral , Biphasic Insulins , Therapeutic Uses , Blood Glucose , Diabetes Mellitus, Type 2 , Blood , Drug Therapy , Glycated Hemoglobin , Metabolism , Hypoglycemic Agents , Therapeutic Uses , Insulin Aspart , Therapeutic Uses , Insulin, Isophane , Therapeutic Uses , Prospective StudiesABSTRACT
Verificaram-se características radiográficas do posicionamento da falange distal em relação ao estojo córneo em equinos da raça Crioula e correlacionaram-se tais achados com sinais de obesidade e concentrações plasmáticas de insulina. Consideraram-se dois grupos com base no escore da condição corporal (ECC). A média de idade entre os grupos foi de 9,2±5,8 anos em indivíduos normais (ECC 5-7) e de 10,3±3,7 anos em obesos (ECC 8-9). Diferenças estatísticas entre grupos ocorreram para valores de peso, perímetro torácico, escore da condição corporal, escore da crista do pescoço, comprimento do pescoço, circunferência do pescoço em três regiões referentes a 25%, 50% e 75% do comprimento do pescoço e entre o posicionamento da falange distal em relação ao estojo córneo. O ângulo formado entre as superfícies dorsais de falange distal e casco (ângulo de rotação) correlacionou-se estatisticamente com ECC (r = 0,30; P=0,02) e com peso e perímetro torácico (r = 0,50; P<0,01). Quanto à concentração de insulina plasmática, foram encontradas correlações positivas com ECP (r = 0,40; P<0,01) e com ângulo de rotação (r = 0,23; P = 0,08), e correlação negativa com idade (r = -0,42; P<0,01). Em oito animais (27%) o ângulo de rotação foi maior que 2 graus; destes, 25% eram normais e 75%, obesos (P<0,05). Aparentemente, em equinos da raça Crioula, características morfométricas no casco diferiram dos padrões internacionais obtidos de outras raças. A obesidade interferiu na relação espacial da falange distal com o estojo córneo, indicando que os animais obesos dessa raça são mais propensos a desenvolver laminite.
The radiographic relationship of the distal phalanx with the hoof capsule was verified in Creole breed horses and these findings correlated with signs of obesity and insulin blood levels. Horses were divided in two groups based on their body score condition (ECC). The average age was 9.2±5.8 years in normal (ECC 5-7) and 10.3±3.7 years in the obese group (ECC 8-9). Statistical differences between groups (P<0.05) were detected for values of weight, thoracic girth, body score condition, neck score (ECP), neck length, neck circumference into three regions based on 25% (P25), 50% (P50) and 75% (P75) of the length of the neck and phalanx and hoof capsule relationship. The angle between the dorsal aspects of distal phalanx and hoof wall (rotation angle) statistically correlated with ECC (r = 0.30; P=0.02) and with weight and thoracic girth (r = 0.50; P<0.01). Plasma insulin concentrations positively correlated with ECP (r = 0.40, P <0.01) and rotation angle (r = 0.23, P = 0.08) and negatively with age (r = -0.42, P <.01). In eight animals (27%) rotation angle was greater than 2 degrees, of which 25% were normal and obese 75% (P <0.05). Apparently in Creole horses, morphometric characteristics of the hoof differ from international standards obtained from other breeds. Obesity interfered with the spatial relationship of the distal phalanx with the hoof capsule, indicating that obese animals of this breed are more likely to develop laminitis.
Subject(s)
Animals , Insulin Aspart , Obesity/complications , Horses/classificationABSTRACT
BACKGROUND: The purpose of this study was to evaluate change in glycosylated hemoglobin (HbA1c), side effects, and quality of life (QOL) after a 16-week treatment period with Biphasic insulin aspart 30/70 (BIasp30) in patients with type 2 diabetes mellitus (T2DM) who had been suboptimally controlled with oral antidiabetic drugs (OADs). METHODS: The study consisted of a 4-week titration period when concurrent OAD(s) were replaced with BIasp30 and followed by a 12-week maintenance period. All patients completed the Diabetes Treatment Satisfaction Questionnaire at the beginning and the end of the trial. Hypoglycemic episodes were recorded by the patient throughout the trial. RESULTS: Sixty patients were included, of whom 55 patients (92%) completed the full 16-week treatment period. Seven-point blood glucose was significantly improved as compared with the baseline, except for the postlunch blood glucose level. HbA1c at the end of period was significantly improved from 9.2% to 8.2% (P<0.001). Eleven percent (n=6) of patients achieved HbA1c values < or =6.5% and 22% (n=12) of patients achieved <7.0%. There were 3.4 episodes/patients-year of minor hypoglycemia and 0.05 episodes/patients-year of major hypoglycemia. QOL showed significant changes only in the acceptability of high blood glucose category (P=0.003). CONCLUSION: Treatment with once or twice daily BIasp30 may be an option for the patients with T2DM suboptimally controlled with OADs in Korea. However, considering the low number of patients achieving the HbA1c target and the high postlunch blood glucose levels, additional management with another modality may be required for optimal control.
Subject(s)
Humans , Biphasic Insulins , Blood Glucose , Diabetes Mellitus, Type 2 , Glycated Hemoglobin , Hypoglycemia , Hypoglycemic Agents , Insulin Aspart , Insulin, Isophane , Korea , Quality of LifeABSTRACT
BACKGROUND: A1chieve(R) was a noninterventional study evaluating the clinical safety and efficacy of biphasic insulin aspart 30, insulin detemir, and insulin aspart. METHODS: Korean type 2 diabetes patients who have not been treated with the study insulin or have started it within 4 weeks before enrollment were eligible for the study. The patient selection and the choice of regimen were at the discretion of the physician. The safety and efficacy information was collected from the subjects at baseline, week 12, and week 24. The number of serious adverse drug reactions (SADRs) was the primary endpoint. The changes of clinical diabetic markers at week 12 and/or at week 24 compared to baseline were the secondary endpoints. RESULTS: Out of 4,058 exposed patients, 3,003 completed the study. During the study period, three SADRs were reported in three patients (0.1%). No major hypoglycemic episodes were observed and the rate of minor hypoglycemic episodes marginally decreased during 24 weeks (from 2.77 to 2.42 events per patient-year). The overall quality of life score improved (from 66.7+/-15.9 to 72.5+/-13.5) while the mean body weight was slightly increased (0.6+/-3.0 kg). The 24-week reductions in glycated hemoglobin, fasting plasma glucose and postprandial plasma glucose were 1.6%+/-2.2%, 2.5+/-4.7 mmol/L, and 4.0+/-6.4 mmol/L, respectively. CONCLUSION: The studied regimens showed improvements in glycemic control with low incidence of SADRs, including no incidence of major hypoglycemic episodes in Korean patients with type 2 diabetes.
Subject(s)
Humans , Biphasic Insulins , Body Weight , Diabetes Mellitus, Type 2 , Drug-Related Side Effects and Adverse Reactions , Fasting , Glucose , Hemoglobins , Incidence , Insulin , Insulin Aspart , Insulin, Isophane , Insulin, Long-Acting , Patient Selection , Plasma , Quality of Life , Republic of Korea , Treatment Outcome , Insulin DetemirABSTRACT
Background & objectives: Conventionally, biphasic human insulin (30/70, BHI) is used twice daily for the management of patients with diabetes. However, this regimen is suboptimal to control post-lunch and/ or pre-dinner hyperglycaemia in some patients. This study was undertaken to compare the efficacy and safety of thrice-daily biphasic human insulin (30/70, BHI) versus basal detemir and bolus aspart (BB) in patients with poorly controlled type 2 diabetes mellitus (T2DM). Methods: In this open labelled randomized pilot study, 50 patients with uncontrolled T2DM on twicedaily BHI and insulin sensitizers were randomized either to BHI thrice-daily or BB regimen. HbA1c, six point plasma glucose profile, increment in insulin dose, weight gain, hypoglycaemic episodes and cost were compared between the two treatment groups at the end of 12 wk. Results: Mean HbAlc (±SD) decreased from 9.0±0.9 per cent at randomization to 7.9±0.8 per cent in BHI (P<0.001) and from 9.4±1.3 to 8.2±1.0 per cent in BB regimen (P<0.001) after 12 wk of treatment. The mean (±SEM) weight gain in patients in the BHI regimen was 1.5±0.33 kg compared to 1.4±0.34 kg in the BB regimen. Insulin dose increment at 12 wk was significantly more in the BB regimen 0.46±0.32 U/ kg/day compared to 0.15±0.21 U/kg/day in the BHI regimen (P<0.001). The incidence of major as well as minor hypoglycaemic episodes was not different in both the regimen. The BB regimen was more expensive than the BHI regimen (P<0.001). Interpretation & conclusions: The thrice daily biphasic human insulin regimen is non-inferior to the basal bolus insulin analogue regimen in terms efficacy and safety in patients with poorly controlled T2DM. However, these data require further substantiation in large long term prospective studies.
Subject(s)
Adult , Biphasic Insulins/administration & dosage , Blood Glucose , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/pathology , Drug Administration Schedule , Female , Glycated Hemoglobin/analysis , Humans , Hyperglycemia/pathology , Hypoglycemic Agents/administration & dosage , Insulin Aspart/administration & dosage , Insulin, Long-Acting/administration & dosage , Male , Middle Aged , Pilot Projects , Treatment Outcome , Weight GainABSTRACT
<p><b>BACKGROUND</b>The clinical importance of glycaemic control in patients with diabetes has been well established. This study aimed to explore twice-daily biphasic insulin aspart 30 (BIAsp 30) for insulin initiation in patients with type 2 diabetes mellitus (T2DM) who had poor glycaemic control with human insulins (HIs). We use data from a Chinese cohort of the PRESENT study.</p><p><b>METHODS</b>In the 3-month study, Chinese subjects with T2DM started insulin therapy with BIAsp 30 in routine care. Glycaemic control was measured by glycosylated hemoglobin (HbA(1C)), fasting plasma glucose (FPG) and posting plasma glucose (PPG). The safety assessment included hypoglycaemia and other adverse events.</p><p><b>RESULTS</b>A total of 1989 subjects previously treated with His were switched to BIAsp 30 for 3-month treatment. Mean HbA(1C), FPG and PPG were significantly improved after the therapy. The overall rate of hypoglycaemia decreased at the end of the trial except for the patients previously treated with long-acting insulin. Most of the events were minor and diurnal hypoglycaemia. Only one serious adverse drug reaction (SADR), a local hypersensitivity, was reported. The majority of the patients (> or = 96.7%) and physicians (> or = 84.7%) were either satisfied or very satisfied with the treatment using BIAsp 30 compared with previous HI therapy.</p><p><b>CONCLUSION</b>The BIAsp 30 treatment improved both glycaemic control and patients' satisfaction without increasing hypoglycaemia in T2DM subjects inadequately controlled by His.</p>
Subject(s)
Adult , Female , Humans , Male , Middle Aged , Biphasic Insulins , Diabetes Mellitus, Type 2 , Drug Therapy , Metabolism , Glycated Hemoglobin , Insulin , Pharmacology , Therapeutic Uses , Insulin Aspart , Insulin, Isophane , Prospective Studies , Treatment OutcomeABSTRACT
<p><b>BACKGROUND</b>Subcutaneous absorption is accelerated by the monomeric conformation of insulin Aspart, which provides good glycemic control with a lower risk of hypoglycemia and less body weight increase. In the present study we investigated the efficacy and safety of a rapid-acting human insulin analogue (insulin Aspart) delivered with continuous subcutaneous insulin infusion (CSII) into Chinese diabetic patients.</p><p><b>METHODS</b>A total of 21 patients with type 1 or type 2 diabetes were recruited for the 2-way cross-over, open-labeled trial, and then randomized to Group A (n = 10, treated with insulin Aspart) or Group B (n = 11, treated with Novolin R). Insulin Aspart and Novolin R were administered by CSII. Capillary glucose concentrations were measured at 8 time points, pre-prandial and postprandial, bedtime (10 pm), midnight (2 am) every day during the treatment.</p><p><b>RESULTS</b>The average capillary glucose profiles for the day were much better controlled in Group A than in Group B (P < 0.01). The blood glucose levels were particularly better controlled in Group A than in Group B at pre-breakfast ((6.72 +/- 1.24) mmol/L vs (7.84 +/- 1.58) mmol/L, P = 0.014), post-breakfast ((8.96 +/- 2.41) mmol/L vs (11.70 +/- 3.11) mmol/L, P = 0.0028), post-supper ((8.15 +/- 2.10) mmol/L vs (10.07 +/- 2.36) mmol/L, P = 0.008), bed time ((7.73 +/- 1.72) mmol/L vs (9.39 +/- 2.05) mmol/L, P = 0.007) and midnight ((6.32 +/- 1.16) mmol/L vs (7.48 +/- 1.36) mmol/L, P = 0.0049). There was no significant difference in the frequency of hypoglycemic episodes between the two groups.</p><p><b>CONCLUSION</b>Insulin Aspart results in better control of blood glucose levels than regular human insulin (Novolin R) in diabetic patients during delivery by CSII.</p>