Psychological impact of continuous subcutaneous insulin infusion pump therapy in non-selected newly diagnosed insulin dependent (type 1) diabetic children: evaluation after two years of therapy

Thirty type 1 (insulin dependent) diabetic children were treated from diagnosis onwards in a random order (using a table of random permutations) with either continuous subcutaneous insulin infusion pump therapy (CSII), or with conventional injection therapy (CT). After two years of therapy psychosocial measurements were obtained of fifteen CSII children (8 boys, 7 girls; mean age: 12+/-4 years) and thirteen CT children (6 boys, 7 girls; mean age: 10+/-4 years) and their parents. Two families of the CT group refused to participate. The examination consisted of six tests (for the children: junior dutch personality test, WISC-R intelligence test, family relation test, diabetes questionnaire; for the parents: family interaction scale and assessment of acceptance scale). Parents (and pediatricians) rated CSII children higher on compliance and better on metabolic control. Acceptance of diabetes, physical and psychological condition was rated equally by parents and doctors. Except for the diabetes questionnaire, the children of the two groups scored not significantly different. The CSII group expressed significantly less physical complaints and physical restrictions. CSII children showed a tendency to score higher on recalcitrance compared with CT children. How adequate this coping of CSII children may be, is discussed.     

Continuous subcutaneous insulin infusion (CSII) in inpatient setting: unmet needs and the proposal of a CSII unit

Continuous subcutaneous insulin infusion (CSII) represents an increasingly popular method of treating diabetes. Patients with diabetes are often hospitalized, and current data indicate that inpatient hyperglycemia results in poorer outcomes. When patients on insulin pump therapy require hospitalization, practitioners caring for them face the issue of how to manage the inpatient care of these patients. We believe that patients using insulin pumps can safely have their therapy transitioned when hospitalized. Moreover, CSII during hospitalization should be regarded not only as a fundamental tool in patients already on insulin pump therapy, but also as an effective method to obtain euglycemia, in critically ill patients. However, a standard policy on CSII use during hospitalization is still lacking, and literature data are inconclusive about the benefits of insulin pump on glycemic homeostasis, in hospitalized patients. We suggest that a CSII unit should be activated inside the hospital, in order to increase compliance with required procedures and to properly address the unmet needs of CSII in inpatient setting.     

Insulin Pump Therapy in Childhood Diabetes Mellitus

The current goals for the therapy of children and adolescents with type 1 diabetes mellitus are to achieve near-normal glycemia, minimize the risk of severe hypoglycemia, limit excessive weight gain while achieving adequate growth, improve quality of life for both the patients and their families, and delay or prevent vascular complications. Insulin pump therapy provides a treatment option that can significantly aid in achieving all of these goals across all age ranges of pediatric patients. Continuous subcutaneous insulin infusion (CSII) pump therapy can provide greater flexibility in the timing of meals and snacks, has programmable basal rates to optimize overnight glycemic control, can reduce the risk of exercise-induced hypoglycemia, and enhances the ability of the patient and the family members to achieve acceptable diabetes control. In pediatric patients, CSII has been shown to reduce both glycosylated hemoglobin levels and the frequency of severe hypoglycemia without increasing the risk of diabetic ketoacidosis. The effectiveness of CSII, improvements in pump technology, and the availability of very rapid-acting insulin analogs have fueled a dramatic increase in the use of this therapy. This review presents practical guidelines for the selection of patients, initiation of treatment and patient education, as well as guidelines for use while exercising and at school. Keys to the success of CSII are to have a multidisciplinary team of clinicians who are expert in the care of children with diabetes, and patients and families who are able to carry out the tasks of intensive treatment, including self-monitoring of blood glucose levels, carbohydrate counting, and infusion pump management. Patients and parents need to be able to recognize and treat hypoglycemia, and prevent the development of ketoacidosis. School personnel need to be involved in the treatment plan and individual algorithms developed for periods of extra exercise and activity. The recent introduction of methods for continuous glucose monitoring provides a new means to optimize the basal and bolus capabilities of CSII and offers hope for the development of a feedback-controlled artificial pancreas.     

Basal insulin supplementation in Type 1 diabetic children: a long-term comparative observational study between continuous subcutaneous insulin infusion and glargine insulin

No long-term data are available on the efficacy of glargine insulin in comparison with continuous sc insulin infusion (CSII) in children and adolescents affected by Type 1 diabetes (T1D). Our aim was to compare the 2-yr efficacy of the 2 insulin approaches, in order to know how to best supply basal insulin in these patients. Thirty-six 9 to 18-yr-old consecutive children with at least 3 yr previous T1D diagnosis were enrolled. As part of routine clinical care, the patients consecutively changed their previous insulin scheme (isophane insulin at bedtime and human regular insulin at meals) and were randomly selected in order to receive either multiple daily injections (MDI) treatment with once-daily glargine and human regular insulin at meals, or CSII with aspart or lispro insulin. Both groups showed a significant decrease in glycosylated hemoglobin (HbA1c) values during the 1st year of therapy, though only in the CSII treated children was the decrease also observed during the 2nd year. The overall insulin requirement significantly decreased only in the CSII group and exclusively during the 1st year, while no significant differences were observed concerning body mass index SD score, severe hypoglycemic episodes and basal insulin supplementation. The work illustrates the first long-term study comparing the efficacy of CSII to MDI using glargine as basal insulin in children. Only with CSII were better HbA1c values obtained for prolonged periods of time, so that CSII might be considered the gold standard of intensive insulin therapy also for long-term follow-ups.     

An overview of so far published analyses comparating the effectiveness of the treatment with insulin pump and multiple daily injections in type 1 diabetes mellitus

The paper brings an overview of published systematic reviews and meta-analyses concerning the evaluation of the effectiveness of the treatment with insulin pump (CSII) in comparison with multiple daily injections (MDI) in type 1 diabetes mellitus. According to found works CSII leads to slightly lower levels of glycosylated hemoglobin (HbA1c) in patients with type 1 diabetes mellitus against MDI. The levels of HbA1c and the variability of glycaemia during the day on MDI before an initiation of CSII should serve for the prediction of an effect of CSII in particular patient. Type 1 diabetics on CSII have less often hypoglycaemia, higher flexibility of their daily regime and thus higher satisfaction with their treatment against MDI. The daily doses of insulin decrease. The weight of patients is the same or slightly higher after the initiation of CSII. There were not enough information for the assesment of the frequency of adverse reactions. It is necessary to educate each patient not only how to manipulate the particular insulin pump, but also about general recommendations for the treatment of diabetes and the application of insulin.     

Continuous subcutaneous insulin infusion versus multiple daily insulin injections in patients with diabetes mellitus: systematic review and meta-analysis

Aims We compared the effects of continuous subcutaneous insulin infusion (CSII) with those of multiple daily insulin (MDI) injections on glycaemic control, risk of hypoglycaemic episodes, insulin requirements and adverse events in type 1 and type 2 diabetes mellitus. Methods The electronic databases MEDLINE, EMBASE and CENTRAL were systematically searched for randomised controlled trials up to March 2007. A systematic review and meta-analysis were performed. Results Overall, 22 studies were included (17 on type 1 diabetes mellitus, two on type 2 diabetes mellitus, three on children). With regard to adults with type 1 diabetes mellitus, our meta-analysis found a between-treatment difference of −0.4% HbA_1c (six studies) in favour of CSII therapy. Available median rates of mild or overall hypoglycaemic events were comparable between the different interventions (1.9 [0.9–3.1] [CSII] vs 1.7 [1.1–3.3] [MDI] events per patient per week). Total daily insulin requirements were lower with CSII than with MDI therapy. In patients with type 2 diabetes mellitus, CSII and MDI treatment showed no statistically significant difference for HbA_1c. The incidence of mild hypoglycaemic events was comparable between the treatment groups. In adolescents with type 1 diabetes mellitus, glycated haemoglobin and insulin requirements were significantly lower in the CSII groups; no data were available on hypoglycaemic events. The only study performed in younger children did not provide enough data for conclusive inferences. No overall conclusions were possible for severe hypoglycaemia and adverse events for any of the different patient groups due to rareness of such events, different definitions and insufficient reporting. Conclusions/interpretation CSII therapy in adults and adolescents with type 1 diabetes mellitus resulted in a greater reduction of glycated haemoglobin, in adult patients without a higher rate of hypoglycaemia. No beneficial effect of CSII therapy could be detected for patients with type 2 diabetes mellitus. Electronic supplementary material The online version of this article (doi:) contains supplementary material, which is available to authorised users.     

Management of diabetes mellitus: is the pump mightier than the pen?

Continuous subcutaneous insulin infusion (CSII, or insulin pump therapy) reduces HbA1c levels and hypoglycaemia in patients with type 1 diabetes mellitus (T1DM) compared with multiple daily insulin injections (MDI). The greatest reduction in HbA(1c) levels with CSII occurs in patients with the worst glycaemic control; therefore, the most appropriate and cost-effective use of CSII in adults with T1DM is in those who have continued, elevated HbA(1c) levels or disabling hypoglycaemic episodes with MDI (including the use of long-acting insulin analogues and structured patient education). The disadvantages of CSII include higher costs than MDI and the risk of ketosis in the event of pump failure. In children with T1DM, CSII may be used when MDI is considered impractical or inappropriate. Pumps are not generally recommended for patients with type 2 diabetes mellitus but may improve control in some subgroups. A new generation of smaller insulin infusion pumps with an integrated cannula, called patch pumps, could improve uptake of CSII in general. The important clinical question is not whether CSII is more efficacious than MDI in general adult T1DM, but whether CSII further improves glycaemic control when this control continues to be poor with MDI, and evidence exists that in most cases it does.     

An observational study comparing continuous subcutaneous insulin infusion (CSII) and insulin glargine in children with type 1 diabetes

OBJECTIVE: The advantages of continuous subcutaneous insulin infusion (CSII) or insulin glargine have been demonstrated both in adult and paediatric diabetic patients; however, as no data comparing these two approaches during childhood are available, we have examined the efficacy of these two intensive approaches. RESEARCH DESIGN AND METHODS: We retrospectively evaluated data from 36 diabetic children, who had changed their previous insulin regimen [with isophane insulin (NPH) at bedtime] because of HbA1c levels >8.0%. Twenty patients underwent CSII, while the other 16 (significantly younger for age) started insulin glargine at bedtime. RESULTS: At 6 and 12 months, CSII-treated patients showed a significant reduction in HbA1c values from 8.5 +/- 1.8 to 7.4 +/- 1.1% and to 7.6 +/- 1.2%, respectively. The insulin requirement significantly decreased from 0.93 +/- 0.2 IU/kg to 0.73 +/- 0.2 IU/kg of body weight and to 0.74 +/- 0.15 IU/kg of body weight, respectively, while no significant differences were observed for BMI SDS, fructosamine and severe hypoglycaemic events. The patients treated with glargine showed a small decline in HbA1c values from 8.9 +/- 1.7 to 8.3 +/- 0.9% (not significant) in the first 6 months of treatment and to 8.2 +/- 0.9% after 12 months. CONCLUSION: The basal insulin supplementation can be supplied effectively in children with type 1 diabetes by either CSII or insulin glargine. As previously reported for adults, it is confirmed that CSII is the best current intensive approach aimed to the improvement of glycaemic control.     

Recent advances in treatment of youth with Type 1 diabetes: better care through technology.

While treatment of Type 1 diabetes mellitus (T1DM) in children and adolescents is especially difficult, recent technological advances have provided new therapeutic options to clinicians and patients. The urgency to achieve strict diabetes control and the introduction of new and improved insulin pumps have been accompanied by a marked increase in use of continuous subcutaneous insulin infusion (CSII) therapy in youth with diabetes. Results of clinical outcome studies indicate that CSII provides a safe and effective alternative to multiple daily injection (MDI) therapy, even when employed in a regular clinic setting in a large number of children. The safety and efficacy of CSII is further enhanced by the introduction of lispro and aspart insulin. The sharper peaks and shorter duration of action of these very rapid-acting insulin analogues provides a means to achieve better control of post-prandial hyperglycaemia with less late post-prandial and nocturnal hypoglycaemia. Glargine insulin, a soluble and essentially peakless long-acting insulin analogue, may provide a better basal insulin for MDI regimens, but there are limited published data with this agent in children with T1DM. A number of systems for pulmonary delivery of insulin are in development and preliminary results of Phase III studies have been promising. Like CSII, inhaled insulin allows the child to take bolus insulin doses before each meal without having to take a premeal injection. A major obstacle to effective treatment is that self-monitoring of three to four blood glucose levels a day often misses the marked glycaemic excursions that characterize T1DM in young patients. On the other hand, new continuous glucose sensing systems provide a wealth of data that can be used to optimize basal and bolus therapy, regardless of how insulin is administered. Even more important, we may finally be at the threshold of development of a practically applicable artificial pancreas.     

Is insulin pump therapy effective in Type 1 diabetes?

There continues to be uncertainty about the effectiveness in Type 1 diabetes of insulin pump therapy (continuous subcutaneous insulin infusion, CSII) vs. multiple daily insulin injections (MDI). This narrative review discusses the reasons for this uncertainty, summarizes the current evidence base for CSII and suggests some future research needs. There are difficulties in interpreting trials of CSII because effectiveness varies widely due to factors such as differing baseline control, suboptimal use of best CSII practices, and psychological factors, for example, high external locus of control, non‐adherence and lack of motivation. Many summary meta‐analyses are also misleading because of poor trial selection (e.g. short duration, obsolete pumps, low baseline rate of hypoglycaemia) and reliance on mean effect size for decision‐making. Both MDI and CSII can achieve strict glycaemic control without hypoglycaemia in some people with Type 1 diabetes, especially those who are motivated and have undergone structured diabetes education, and with high levels of ongoing input from healthcare professionals. CSII is particularly effective in those people with Type 1 diabetes who have not achieved target HbA_1c levels without disabling hypoglycaemia using best attempts with MDI, and here there can be valuable and substantial improvement. Insulin pumps are safe, effective and accepted when used in newly diagnosed diabetes, particularly in children, where MDI may not be practicable. Future research needs include more studies on mortality associated with insulin pumps where registry data have suggested lower rates vs. MDI; and psychological strategies to improve non‐adherence and suboptimal glycaemic outcomes on CSII.     

The renaissance of insulin pump treatment in childhood type 1 diabetes

Current goals for the treatment of children and adolescents with type 1 diabetes mellitus include achieving near-normal blood sugar levels, minimizing the risk of hypoglycemia, optimizing quality of life, and preventing or delaying long-term microvascular and macrovascular complications. Continuous subcutaneous insulin infusion (CSII), or insulin pump therapy, provides a treatment option that can assist in the attainment of all of these goals in all ages of children. In pediatric patients, CSII has been demonstrated to reduce both glycosylated hemoglobin levels and frequency of severe hypoglycemia, without sacrifices in safety, quality of life, or weight gain, particularly in conjunction with the use of new insulin analogs and improvements in pump technology. Clinical studies of safety and efficacy of CSII in children are reviewed, as well as criteria for patient selection and practical considerations using pump therapy in youth with T1DM. Supported by grants from the National Institute of Health (K12 DK063709, T32 DK063703 and RR 00125), the Juvenile Diabetes Research Foundation, and the Stephen I. Morse Pediatric Diabetes Research Fund.     

Age-related differences in metabolic response to continuous subcutaneous insulin infusion in pre-pubertal and pubertal children with Type 1 diabetes mellitus

The aim of this study was to evaluate clinical and metabolic data in a cohort of Type 1 diabetes (T1DM) children before and after 2 yr of continuous s.c. insulin infusion (CSII). Forty seven T1DM patients were subdivided into two groups: Group A (20 pre-pubertal children, mean age 7.43+/-3.19 yr); Group B (27 pubertal adolescents, mean age 14.47+/-1.91 yr). No statistically significant differences in body mass index (BMI) occurred in either groups after starting CSII or during follow-up. The frequency of mild-hypoglycemias significantly declined during pump therapy only in Group A (p<0.05). Both pre-pubertal and pubertal patients required a significant reduction in their total insulin requirement after 12 and 24 months of CSII. The total percentage of daily insulin doses delivered as basal rates was similar in both groups and was negatively associated (beta=-2.956, p=0.05) with glycosylated hemoglobin (HbA1c) values. No significant correlation was found between the percentage of the basal insulin rate and the number of daily boluses. Differences in timing of the highest insulin requirement were observed between the two groups. Group A had a higher insulin basal rate late in the evening (20:00-24:00 h), while Group B had a higher insulin requirement early in the morning (03:00-07:00 h). The HbA1c levels significantly improved in Group A after 6-12 and 24 months of CSII. In Group B a reduction of HbA1c values was observed only after 6 months of pump therapy (p=0.05). CSII is an effective therapy for all ages but different metabolic requirements should also be taken into account.     

Case study: contrasting challenges of insulin pump therapy in a toddler and adolescent with type 1 diabetes

PURPOSE: To describe the challenges and outcomes of continuous subcutaneous insulin infusion (CSII) pump therapy in a toddler and adolescent with type 1 diabetes. Insight into patient-family aspects motivating pump use is provided. METHODS: Two cases treated at the Pediatric Diabetes Clinic at Yale University. RESULTS: Upon parental request, CSII was initiated to improve glycemic control in a 4-year-old boy (case 1) with unpredictable food intake. During 68 months of CSII therapy, hemoglobin A1C levels averaged 6.3% +/- 0.6%. Severe hypoglycemic episodes ceased 36 months ago, and occasional postprandial hyperglycemia during early school years was corrected with school nurses' reminders about premeal insulin bolus doses. Currently 9.5 years old, he independently manages all his insulin injections with parental assistance only to change the catheter site. Case 2 is a girl who was nearly 12 years of age when diagnosed with type 1 diabetes. Initially managed with daily injections, hypoglycemic episodes were interfering with her physically active lifestyle. At age 13 years, she elected CSII therapy, and glycemic control improved. Temporarily erratic in the immediate period pre- and postmenarche, metabolic control has since stabilized. At 15 years old, she successfully manages her diabetes independently. CONCLUSIONS: To optimize glycemic control, CSII can be initiated and used effectively, both in children of all ages and in adolescents with type 1 diabetes. CSII may be ideal therapy for toddlers, with no apparent lower age boundary for initiating CSII; however, the parenting challenges and requirements for supportive education differ between toddlers and adolescents. When disease and pump management are appropriately individualized, CSII therapy can help children with diabetes achieve and sustain glycemic control. Lifestyle flexibility, quality-of-life improvement, and independence can thus begin early in childhood and be maintained throughout young adulthood.     

Continuous subcutaneous insulin infusion (CSII) in children with type 1 diabetes

Recent studies have shown that continuous subcutaneous insulin infusion (CSII), or insulin pump therapy, provides a treatment option that can assist in the attainment of current goals of treatment in children and adolescents with type 1 diabetes (T1DM). In pediatric patients, CSII has been demonstrated to reduce both glycosylated hemoglobin levels and frequency of severe hypoglycemia, without sacrifices in safety, quality of life, or excessive weight gain, particularly in conjunction with the use of new insulin analogs and improvements in pump technology. Clinical studies of safety and efficacy of CSII in children are reviewed.     

Insulinpumpentherapie in der Pädiatrie

In Germany, continuous subcutaneous insulin infusion (CSII) has been firmly established as an intensive insulin regimen for paediatric and adolescent patients with diabetes mellitus. The individually programmable basal rate and the option of triggering a meal bolus without a painful injection permit an almost physiologic insulin substitution. This allows for near-normal metabolic control with no increased risk of adverse effects. Compared with other age groups, young children aged newborn to less than 5 years constitute the highest percentage of pump users. Because of their low insulin dose requirements and their high insulin sensitivity, the CSII options are particularly advantageous for them; for example, their rate of severe hypoglycaemia is significantly reduced. To initiate CSII treatment, a clear indication must be defined, the patient must accept the pump treatment, and the patient and his or her family need specific pump education.     

Changes in Insulin Requirements From the Onset of Continuous Subcutaneous Insulin Infusion (CSII) Until Optimization of Glycemic Control

The aim was to evaluate changes in insulin requirements from onset of continuous subcutaneous insulin infusion (CSII) until glucose optimization in type 1 diabetes and to determine patient characteristics to be considered when CSII is implemented. We retrospectively analyzed 74 type 1 diabetic patients over a follow-up of 5 months after starting CSII. Patients without a decrease in HbA1c levels at the end of follow-up were excluded. We compared total daily doses (TDD), basal/bolus distribution, basal diurnal/nocturnal proportion, number of basal segments, and HbA1c levels in relation to sex, age, body mass index (BMI), diabetes duration, and indication for CSII. At follow-up, HbA1c decreased by 0.75%, TDD decreased by 18%, basal rate was 60% of TDD, and diurnal basal rate was 60% of total basal rate. Insulin requirements were higher in males and in obese patients. Female patients and patients with longer diabetes duration showed a higher percentage of basal insulin. The number of basal segments was 4.9 ± 2.9. Basal requirements were higher in the second half of the nocturnal period. The dawn phenomenon was more relevant in men. Improvements in glycemic control were more marked in younger patients, in patients with higher HbA1c, in patients using more basal segments, and in patients initiating CSII for glucose control before pregnancy. Sex, diabetes duration, and BMI should be considered when initiating CSII. Our findings may help clinicians in clinical decision making regarding CSII therapy.     

Continuous subcutaneous insulin infusion with short-acting insulin analogues or human regular insulin: efficacy, safety, quality of life, and cost-effectiveness

Portable insulin infusion devices are effective and safe insulin delivery systems for managing diabetes mellitus, especially type 1 diabetes. Rapidly absorbed insulin analogues, such as insulin lispro or insulin aspart, may offer an advantage over regular human insulin for insulin pumps. Several open-label randomised crossover trials demonstrated that continuous subcutaneous insulin infusion (CSII) with insulin lispro provided a better control of postprandial hyperglycaemia and a slightly but significantly lower glycated haemoglobin level, with lower daily insulin requirement and similar or even less hypoglycaemic episodes. A CSII study comparing insulin lispro and insulin aspart demonstrated similar results with the two analogues, and better results than those with regular insulin. Because these analogues have a quicker onset and a shorter duration of action than regular insulin, one might expect an earlier and greater metabolic deterioration in case of CSII interruption, but a more rapid correction of metabolic abnormalities after insulin boluses when reactivating the pump. These expectations were confirmed in randomised protocols comparing the metabolic changes occurring during and after CSII interruption of various durations when the pump infused either insulin lispro or regular insulin. The extra cost resulting from the use of CSII and insulin analogues in diabetes management should be compensated for by better metabolic control and quality of life. In conclusion, CSII delivering fast-acting insulin analogues may be considered as one of the best methods to replace insulin in a physiological manner by mimicking meal and basal insulin requirements, without higher risk of hypoglycaemia or ketoacidosis in well-educated diabetic patients.     

Continuous subcutaneous insulin infusion in patients with diabetes mellitus

During the last quarter of a century continuous subcutaneous insulin infusion (CSII) with external portable insulin pumps has been increasingly used in selected type 1 diabetic subjects and also in some patients with type 2 diabetes mellitus. The treatment of diabetes mellitus with insulin pumps has become more and more popular and accepted by diabetic patients as well as by medical professionals worldwide. Published trials have shown that, in most patients, mean blood glucose concentration and glycated hemoglobin (HbA1c) percentages are either slightly lower or similar on CSII versus an optimized therapy with multiple daily insulin injections. Hypoglycemic episodes seem to be less frequent and ketoacidoses occur at a comparable rate to that during intensive injection therapy. Moreover, nocturnal glycemic control can be improved with insulin pumps, and automatic basal rate changes help to minimize a prebreakfast blood glucose increase (often called 'the dawn phenomenon'). For many patients, CSII provides greater flexibility in timing of meals with the result of better quality of life and higher treatment satisfaction. However, despite these promising data, and although many patients with diabetes mellitus with well-defined clinical problems are likely to benefit substantially from CSII, either in respect to glycemic control, acute complications or quality of life and treatment satisfaction, we are still far away from reaching'dream diabetes management', the fully automatic closed-loop system. Presently, the most difficult problem concerns not the design of an 'optimal' insulin pump, but rather the development of a system which is able to provide continuous and reliable blood glucose monitoring. Hence, because this problem has not been solved with maximum satisfaction, the development of a feedback-controlled 'artificial pancreas' is one of the main goals in diabetes management in the new millennium.     

Insulin Kinetics in Type I Diabetic Patients Treated by Continuous Intraperitoneal Insulin Infusion: Influence of Anti-insulin Antibodies

Continuous intraperitoneal insulin infusion (CIPII) is a promising therapy of patients with Type 1 (insulin-dependent) diabetes mellitus (IDDM), since it improves metabolic control and decreases frequency of severe hypoglycaemia. This could be due to more appropriate insulin kinetics. Our aim, therefore, was to compare plasma free insulin levels achieved in patients with Type 1 diabetes chronically treated with CSII or CIPII. Furthermore, as anti-insulin antibodies increase with this treatment, we wanted to assess their influence upon insulin kinetics. Plasma free insulin profiles were obtained during the night and then after the bolus for breakfast and the bolus for lunch in 11 patients with Type 1 diabetes treated successively by CSII and CIPII. In another group of 16 patients with long-term Type 1 diabetes, treated by CIPII, we examined the influence of anti-insulin antibody level on insulin kinetics after a bolus. During the night, plasma free insulin levels were lower with CIPII than with CSII (12:00 am: 10.1 ± 1.7 vs 18.5 ± 2.6 mU l⁻¹; 4:00 am: 9.1 ± 2 vs 15 ± 3 mU l⁻¹), p < 0.01. After the bolus, CIPII lead to an earlier (1h vs 3h) and higher (25.8 ± 3.3 vs 18 ± 2.7, p < 0.05) plasma free insulin peak than CSII. With CIPII, the return to baseline level was observed within 3 h. Conversely, during CSII, insulin levels did not return to baseline until the next meal. After the bolus, high insulin-antibody levels were associated with a reduced maximal value of plasma free insulin peak. Taken together, these findings suggest that CIPII provides plasma free insulin profiles which are much closer to physiology than CSII. This could explain the lower rate of severe hypoglycaemia observed with this type of treatment. But in long-term CIPII treated patients with high anti-insulin antibody level, insulin profile could be moderately modified. This emphasizes the need for a less immunogenic insulin preparation.