A randomized prospective study of insulin pump vs. insulin injection therapy in very young children with type 1 diabetes: 12-month glycemic, BMI, and neurocognitive outcomes

Objective:  To compare glycemic control, body mass index (BMI), neurocognitive function, and parenting stress for preschool-aged diabetic children randomized to treatment either with continuous subcutaneous insulin infusion (CSII) or with intensive insulin injection therapy (IIT).
Methods:  Children <5 yr of age diagnosed with type 1 diabetes mellitus for at least 12 months were randomized to either CSII (n = 21) or IIT (n = 21) for 6 months. After 6 months, the IIT group began CSII therapy and the CSII group continued on pumps. Hemoglobin A1c (HbA1c) and BMI percent were collected at baseline, 3, 6, 9, and 12 months. Neurocognitive assessments (Developmental Test of Visual–Motor Integration and Stanford–Binet Intelligence Scale: Fourth Edition) were administered to children, and parenting and child behavior assessments (Parenting Stress Index and Child Behavior Checklist) were completed by parents and at baseline, 6, and 12 months.
Results:  Thirty-five children completed the study. Mean HbA1c decreased significantly over the study period (8.9% ± 0.6 vs. 8.5% ± 0.7, p = 0.006). Initiation of CSII resulted in an HbA1c decrease of 0.4% after 3 months (p = 0.002); however, in the CSII first group, the HbA1c at 12 months was not significantly different from study start (8.8% ± 0.6 vs. 8.5% ± 0.6; p = 0.4). There were no significant changes in BMI%, neurocognitive, parenting, and child behavior measures between groups.
Conclusion:  Initiation of CSII vs. continuing IIT does not significantly influence HbA1c, BMI, neurocognitive, or parenting stress parameters in a research study setting.     

Use of Continuous Insulin Infusion Pumps in Young Children With Type 1 Diabetes: A Systematic Review

IntroductionAlthough insulin pump therapy has been successful in adults and adolescents, its use has been limited in young children because of perceived risk of severe or frequent hypoglycemia. The purpose of this review is to evaluate the safety and efficacy of continuous subcutaneous insulin infusion (CSII) in young children with type 1 diabetes.MethodsWe searched Medline, PubMed, and CINAHL for clinical trials comparing multiple-dose injection therapy to CSII therapy in children 6 years of age or younger who were diagnosed with type 1 diabetes at least 6 months prior to study. Primary outcome measures were glycosylated hemoglobin (HbA1c) and hypoglycemic episodes. Other outcomes of interest were quality of life and parental satisfaction.ResultsMost studies showed significant improvements in HbA1c and trends of decreased hypoglycemia. Quality of life improved in most CSII groups. Parental satisfaction with therapy was evidenced by continuation of CSII after study completion.DiscussionCurrent evidence indicates CSII is a safe and effective method of insulin delivery in young children. When parents are highly motivated, CSII should be offered as a mode of insulin delivery for this age group.     

Insulin pumps in pediatric routine care improve long-term metabolic control without increasing the risk of hypoglycemia

Although continuous subcutaneous insulin infusion (CSII) has been used in pediatric practice for >20 yr, the technique is not widely used in many countries. The aim of this non-randomized population-based study was to evaluate CSII in routine pediatric care. In a 1-yr cross-sectional evaluation, 27/89 patients (30.3%, age 7-21 yr) used pumps (two during the night only), the others 4-6 injections/day. In patients with >2 yr of diabetes, pump users had higher HbA1c (8.9+/-1.0 vs. 8.2+/-1.6%, p=0.04), less insulin/24 h (0.9+/-0.1 vs. 1.0+/-0.2 U/kg, p=0.002), and longer diabetes duration (p=0.02). The higher HbA1c is explained by 67% of pump patients having high HbA1c (>8.5%) as the major indication for CSII. The overall incidence of severe hypoglycemia was 31.5/100 patient years, 40.3 for injection therapy, and 11.1 for pump therapy (p=not significant). The incidence of severe hypoglycemia with unconsciousness was 12.9/100 patient years and with seizures 9.7 for injection therapy, whereas no children on pumps experienced these complications during the cross-sectional study year. We had no admissions for ketoacidosis in either group during this year. The pump patients were followed for 5 yr after pump start. Two stopped using the pump after 2 and 3 yr. For the patients with high HbA1c as indication, mean HbA1c the year before pump was 9.5%. Mean HbA1c during the first year with pump was lowered to 8.9% (p=0.019), the second year 8.6% (p=0.017), the third year 8.6 (p=0.012), the fourth year 8.7 (p=0.062), and the fifth year 8.9% (p=0.28). We found six cases of ketoacidosis corresponding to 4.7/100 patient years. In conclusion, we found a long-term lowering of HbA1c after starting CSII in a pediatric population, decreased frequency of severe hypoglycemia, and a low risk of ketoacidosis.     

Risk and benefits of continuous subcutaneous insulin infusion (CSII) treatment in school children and adolescents

Abstract:  Continuous subcutaneous insulin infusion (CSII) therapy with technically advanced modern insulin pumps is a treatment option enabling patients and multidisciplinary diabetes teams to achieve all current goals for the treatment of children and adolescents with type 1 diabetes mellitus (T1DM): near-normoglycemia, low rate of hypoglycemia, preventing or delaying long-term complications and increasing quality of life. Clinical studies demonstrate that CSII therapy reduces glycosylated hemoglobin A1c (HbA1c) with a concomitant decrease in the rate of hypoglycemic events, without excessive weight gain and with an increase of patients' treatment satisfaction in all pediatric age groups. With the development of continuous glucose sensing coupled with an insulin pump, patients can hope for an ever-increasing technological support for the management of insulin therapy in the foreseeable future.     

Insulinpumpentherapie und kontinuierliche Glukosemessung

Intensive insulin treatment has continuously increased in the last 15?years for the treatment of type-1 diabetes in children and adolescents. Especially continuous subcutaneous insulin infusion (CSII) is now an established treatment option in all pediatric age groups. In very young children (<?6?years), more than two-thirds of patients are using CSII. With CSII better glycemic control and quality of life, but less severe hypoglycemia appeared compared with multiple daily injection (MDI) therapy. The use of continuous glucose monitoring (CGM) is also increasing in pediatric patients. CGM is mostly applied for several days for diagnostic reasons and to optimize therapy. Sensor augmented pump therapy is recommended when used on a nearly daily basis. CGM can be an additional tool to optimize glycemic control and maintaining target HbA1c levels, while limiting the risk of hypoglycemic events.     

Ambulatory treatment of diabetes in children by continuous subcutaneous infusion of insulin using a portable pump

Six diabetic children, aged 2 to 4 years, were selected for continuous subcutaneous insulin infusion (SCII) therapy using a portable pump, because of unstable glycemic control. Under previous conventional insulin therapy, they experienced both chronic hyperglycemia (mean: 2.10 +/- 0.07 milligrams, HbA1 C: 9.02 +/- 0.2%) and frequent or severe hypoglycemic manifestations. Reduction of both glycemic level: 1.08 +/- 0.04 milligrams (p less than 0.01) and instability: M index 0.76 +/- 0.2 vs 5.5 +/- 1.4 (p less than 0.01) was obtained the first week after CSII therapy was started. The metabolic improvement was maintained over 5 to 9 months of ambulatory CSII therapy: HbA1 C decreased down to 7.6 +/- 0.6% (p less than 0.05), while hypoglycemic episodes became rare. The portable insulin delivery system was well tolerated both physically and psychologically by 5/6 of the children and their families.     

Mixing rapid-acting insulin analogues with insulin glargine in children with type 1 diabetes mellitus

OBJECTIVE: To determine whether mixing insulin glargine (IG) with a rapid-acting insulin (RAI) analogue in the same syringe had any deleterious effects on glycemic control in children with type 1 diabetes mellitus. STUDY DESIGN: Data from 55 children mixing the IG with a RAI analogue was collected for 6 months before and 6 months after the insulin mixing began. Data from a control group of 55 children not mixing the insulins was collected at similar intervals. Parameters evaluated included hemoglobin A1c (HbA1c) values, number of non-severe and severe hypoglycemic events, number of diabetic ketoacidosis (DKA) events, and blood glucose distribution patterns. RESULTS: After 6 months of study, HbA1c values were equivalent for the control and test groups (8.54+/-1.14 vs 8.61+/-1.14, respectively; P=1.0000). Percentages of blood glucose values in, above, and below the target range did not vary significantly in the groups. There were no significant differences in the groups in the occurrence of non-severe or severe hypoglycemic events or of DKA events. CONCLUSION: There were no significant differences in glycemic control between children who mixed IG in the same syringe with a RAI analogue compared with children who took separate injections.     

Insulin pump treatment in children and adolescents with type 1 diabetes

Within children and adolescents with type 1 diabetes insulin pump treatment is of increasing interest. Frequency of insulin pump therapy shows a rapid and steep increase in toddlers and young children. Insulin pumps allow a close to physiologic insulin delivery due to basal rates programmed over 24 hours with circadian rhythms taken into account. Furthermore, another advantage of technical devices as insulin pumps is the application of extremely small amounts of insulin, as needed in very young children, with the possibility of titration of infusion rates down to 0.01E/h. Dawn Phenomenon and hypoglycemic events are main indications for insulin pump treatment in children and adolescents. A significant reduction of severe hypoglycemia, especially nocturnal hypoglycemia was shown, whereas a reduction of HbA1c and an improvement of metabolic control has been reported in short term and in some but not all long term studies. Ketoacidosis rate did not increase in insulin pump therapy. Complications due to continuous subcutaneous insulin infusion, like local infections and dermatological changes are frequent but were not associated with glycemic control and did not lead to discontinuation of insulin pump treatment. Pump discontinuation rate in general is low, varying from 1% in very young children up to 6% in pubertal adolescent girls. Insulin pump treatment was shown to be safe and efficient and the simplicity of handling the devices as well as an improvement of quality of life may explain the rapid increase of pump treatment in young children and adolescents with type 1 diabetes.     

Insulin pump use in young children in the T1D Exchange clinic registry is associated with lower hemoglobin A1c levels than injection therapy

Insulin delivery via injection and continuous subcutaneous insulin infusion (CSII) via insulin pump were compared in a cross‐sectional study (n = 669) and retrospective longitudinal study (n = 1904) of young children (<6 yr) with type 1 diabetes (T1D) participating in the T1D Exchange clinic registry. Use of CSII correlated with longer T1D duration (p < 0.001), higher parental education (p < 0.001), and annual household income (p < 0.006) but not with race/ethnicity. Wide variation in pump use was observed among T1D Exchange centers even after adjusting for these factors, suggesting that prescriber preference is a substantial determinant of CSII use. Hemoglobin A1c (HbA1c) was lower in pump vs. injection users (7.9 vs. 8.5%, adjusted p < 0.001) in the cross‐sectional study. In the longitudinal study, HbA1c decreased after initiation of CSII by 0.2%, on average (p < 0.001). Frequency of a severe hypoglycemia (SH) event did not differ in pump vs. injection users (p = 0.2). Frequency of ≥1 parent‐reported diabetic ketoacidosis (DKA) event in the prior year was greater in pump users than injection users (10 vs. 8%, p = 0.04). No differences between pump and injection users were observed for clinic‐reported DKA events. Children below 6 yr have many unique metabolic characteristics, feeding behaviors, and care needs compared with older children and adolescents. These data support the use of insulin pumps in this youngest age group, and suggest that metabolic control may be improved without increasing the frequency of SH, but care should be taken as to the possibly increased risk of DKA.     

Continuous subcutaneous insulin infusion benefits quality of life in preschool-age children with type 1 diabetes mellitus

OBJECTIVE: To compare medical, nutritional, and psychosocial outcomes of continuous subcutaneous insulin infusion (CSII) therapy and multiple daily insulin injections (MDI) in preschoolers with type 1 diabetes mellitus (T1DM) in a randomized controlled trial. STUDY DESIGN: Sixteen children (mean age 4.4 +/- 0.7 yr, range 3.1-5.3 yr) with T1DM were randomly assigned to CSII or MDI. Hemoglobin A1c (HbA1c) was measured monthly for 6 months. Glucose variability was measured at baseline and at 6 months using continuous blood glucose sensing. Quality of life, adverse events, and nutrition information were assessed. RESULTS: Parents of the CSII group reported a significant decrease in diabetes-related worry, while parents of the MDI group reported an increased frequency of stress associated with their child's medical care. Mean HbA1c levels from baseline (CSII 8.3 +/- 1.4%, MDI 8.0 +/- 0.8%) to 6 months (CSII 8.4 +/- 0.8%, MDI 8.2 +/- 0.4%) remained stable, and group differences were not significant. There were no significant group differences in duration of hypo- or hyperglycemic events or frequency of adverse events. CONCLUSION(S): For young children with T1DM, CSII therapy is comparable to MDI therapy with regard to glucose control but is associated with higher treatment satisfaction and improved quality of life.     

Initiation of insulin glargine in children and adolescents with type 1 diabetes

BACKGROUND: Glargine (Lantus) is a recently approved, long-acting insulin analog that is increasingly being used in children with diabetes. The aim of this retrospective chart review was to summarize our experience in starting glargine in children and adolescents with diabetes. SUBJECTS AND STUDY METHODS: We reviewed the medical records of 71 children with type 1 diabetes (29 boys and 42 girls) who initiated glargine therapy to improve glycemic control between 1 June 2001 and 30 June 2002. Data were collected for 6 months before and 6 months after adding glargine. RESULTS: Subjects' mean age [+/-standard deviation (SD)] at diagnosis of diabetes was 7.5 +/- 4.1 yr. Mean age at initiation of glargine therapy was 11.5 +/- 4.9 yr. The total daily long-acting insulin dose decreased by about 20% after initiating glargine therapy. There were no significant differences in hemoglobin A1c (HbA1c) and blood glucose control prior to and after initiating glargine therapy (HbA1c at baseline 8.9 +/- 1.6% and HbA1c after 6 months of glargine therapy was 8.9 +/- 1.5%). Overall, blood glucose concentrations did not differ significantly throughout the study. Patients who switched to glargine because of nocturnal hypoglycemia had a 65% decrease in nocturnal blood glucose reading less than 50 mg/dL. There were three seizures in the first week after initiating glargine therapy. CONCLUSION: This retrospective study suggests that glargine is at least as effective as other long-acting insulins but that care must be taken during the conversion process to avoid hypoglycemia.     

Use of a subcutaneous injection port to improve glycemic control in children with type 1 diabetes

Objective:  To determine if use of an injection port, the Insuflon™, would help to improve glycemic control in youth with type 1 diabetes (TID) who were in suboptimal glycemic control (hemoglobin A1c, HbA1c >8.0%).
Study design:  A three-arm randomized protocol was used to study the effects of the Insuflon (a subcutaneous injection port) vs. an alarmable blood glucose meter vs. a control group on glycemic control in 66 youth with T1D. All participants used insulin glargine™ as their basal insulin and the NovoPen^® Junior with insulin aspart™ as their rapid-acting insulin. Participants were randomized into control, alarm, or Insuflon groups. HbA1c levels were the primary outcome with values at baseline, 3, and 6 months.
Results:  Initial parameters were similar in the three groups. HbA1c values were significantly lower for youth who used the Insuflon than for the control group at 3 and 6 months (p = 0.025). The HbA1c values (in %) for youth using the Insuflon decreased significantly from 9.4 at screening to 8.7 at 3 months (p < 0.001) and 8.5 at 6 months (p < 0.001). There were no significant reductions (p ≥ 0.05) in the HbA1c values within the other two groups.
Conclusion:  The Insuflon injection port helps some youth with T1D to improve glycemic control.     

Sustained metabolic control and low rates of severe hypoglycaemic episodes in preschool diabetic children treated with continuous subcutaneous insulin infusion

AIM: To evaluate the safety and efficacy of continuous subcutaneous insulin infusion (CSII) in children under 7 years of age. METHODS: One hundred and ten children, aged 0.9-7 years, who had received CSII therapy for at least 6 months, were studied for 237 patient-years by a retrospective chart review. Charts were reviewed for glycosylated hemoglobin (HbA1c), severe hypoglycaemia (SH), ketoacidosis (DKA), height, weight and insulin requirement. In 69 cases (children aged 1.6-7 years) CSII was administered after at least 3 months of insulin therapy with pens. In this group, data from the year from before CSII administration were compared with values recorded during 1 year of CSII treatment. RESULTS: Mean HbA1c decreased from 7.8 +/- 0.9 before CSII to 7.5 +/- 1.0 after 6 and 12 months of pump therapy (p = 0.04). In the whole group, the mean HbA1c after 6 months of CSII was 7.5 +/- 1.0 and remained unchanged for up to 4 years of follow-up. Some episodes of SH--4.2 per 100 patient-years, and DKA--5.7 per 100 patient-years were recorded. No increase in BMI z-score occurred. CONCLUSIONS: In the youngest children, CSII therapy lowers HbA1c values and provides sustained metabolic control without increases in hypoglycaemia or ketoacidosis episodes.     

Changes in Glycemic Control and Quality of Life in Pediatric Type 1 Diabetics with Continuous Subcutaneous Insulin Infusion of Insulin Aspart Following Multiple Daily Injection Therapy

The efficacy of continuous subcutaneous insulin infusion (CSII) of the rapid-acting insulin analogue, insulin aspart, was evaluated in 26 patients with childhood-onset type 1 diabetes aged between 6 and 18 yr who had been on basal-bolus therapy (multiple daily injection (MDI) of regular human insulin or rapid-acting insulin and intermediate/long-acting insulin). The glycemic control in the patients was evaluated based on changes in the clinical parameters and the patient quality of life (QOL) was evaluated by using the insulin therapy-related QOL questionnaire. Twenty two patients continued CSII during the 6-mo study period. The mean HbA1c was 7.8 ± 1.8% at baseline and it decreased to 7.4 ± 0.8% at 6 mo after the start of the CSII. Overall, no decrease of the QOL post-CSII initiation was noted. The possible superiority of CSII as compared to MDI was suggested for patients who “eat out” or “have to look for an appropriate place for insulin injection.” Aside from an inadequate indwelling needle placement detected after the initiation of CSII in several patients, no adverse event associated with NovoRapid^® was seen. In conclusion, CSII of rapid-acting insulin appears to be a useful therapy for patients with childhood-onset type 1 diabetes.     

Frequency of SMBG correlates with HbA1c and acute complications in children and adolescents with type 1 diabetes

Ziegler R, Heidtmann B, Hilgard D, Hofer S, Rosenbauer J, Holl R; for the DPV‐Wiss‐Initiative. Frequency of SMBG correlates with HbA1c and acute complications in children and adolescents with type 1 diabetes. The aim of this study was to correlate the frequency of self‐monitoring of blood glucose (SMBG) to the quality of metabolic control as measured by hemoglobin A1c (HbA1c), the frequency of hypoglycemia and ketoacidosis, and to see whether the associations between SMBG and these outcomes are influenced by the patient's age or treatment regime. We analyzed data from the DPV‐Wiss‐database of 26 723 children and adolescents aged 0–18 yr with type 1 diabetes recorded during 1995–2006. Variables evaluated were gender, age at visit, diabetes duration, therapy regime, insulin dose, body mass index–standard deviation scores (BMI–SDS), HbA1c, rate of hypoglycemia, and ketoacidosis. In the youngest age group of children under the age of 6 yr, the frequency of SMBG was the highest compared with that in children aged 6–12 yr or children aged > 12 yr: 6.0/d vs. 5.3/d vs. 4.4/d (p < 0.001). Frequency of SMBG differed significantly also in the different groups of treatment (p < 0.001), but only for the continuous subcutaneous insulin infusion (CSII) group the frequency was considerably higher: 5.3/d (CSII) vs. 4.7/d (multiple daily injections) vs. 4.6/d (conventional therapy). Adjusted for age, gender, diabetes duration, year of treatment, insulin regimen, insulin dose, BMI‐SDS, and center difference, SMBG frequency was significantly associated with better metabolic control with a drop of HbA1c of 0.20% for one additional SMBG per day (p < 0.001). Increasing the SMBG frequency above 5/d did not result in further improvement of metabolic control. A higher frequency of SMBG measurements was related to better metabolic control. But only among adolescents aged > 12 yr, metabolic control (HbA1c) improved distinctively with two or more blood glucose measurements.     

Insulin pump therapy in toddlers and preschool children with type 1 diabetes mellitus

OBJECTIVE: To test whether glycemic control in young children could be achieved more effectively and safely by using continuous insulin infusions administered by insulin pumps. STUDY DESIGN: We analyzed the effects of pump therapy in nine toddlers in whom type 1 diabetes developed between the ages of 10 and 40 months. After a mean of 13.7 months of therapy with multiple daily injections, patients were treated with insulin pumps for periods ranging from 7 to 19 months (mean, 12.7 months). RESULTS: Before initiation of pump therapy, HbA1c levels averaged 9.5% +/- 0.4%, and patients had a mean of 0.52 episodes per month of severe hypoglycemia (uncontrolled shaking, inconsolable crying, disorientation, or seizures). After initiation of pump therapy, HbA1c levels declined to 7.9% +/- 0.3% (P <.001 vs prepump levels), and the incidence of severe hypoglycemia decreased to 0.09 episodes per month (P <.05). Normal linear growth and weight gain were maintained during pump therapy. There were no changes in the frequency of physician or emergency room visits for acute hyperglycemia or ketoacidosis. However, the frequency of parental contacts with health personnel declined by >80%, reflecting increasing parental confidence and independence in diabetic care. Subjective assessments revealed significant improvements in quality of life and high levels of satisfaction with pump therapy. CONCLUSIONS: Insulin pump therapy may provide an effective alternative for selected preschool children with type 1 diabetes.     

Benefits of continuous subcutaneous insulin infusion in children with type 1 diabetes

OBJECTIVE: To examine the effect of continuous subcutaneous insulin infusion (CSII) therapy on parameters affecting long-term outcome in type 1 diabetes.Study design Height, weight, body mass index, insulin dose, glycosylated hemoglobin (HbA(1C)), and blood glucose data from home meter downloads were collected prospectively for analysis in 51 children (age, 10.7+/-3.1 years, mean+/-SD) throughout the 12 months before and after introducing CSII. RESULTS: Before pump initiation, HbA(1C) was relatively stable, but it fell to 7.7+/-0.2% (P<.001) within 3 months of CSII and remained decreased (7.9+/-0.1%) at 12 months (P<.01). In contrast, weight standard deviation score increased before CSII (from 0.50+/-0.13 to 0.60+/-0.13, P<.05), but remained unchanged (0.61+/-0.11) in the year thereafter. Although severe hypoglycemia (<50 mg/dL) was reduced in the entire cohort, HbA(1C) improved primarily in young children and teenagers. Comparison of glycemic responders (HbA(1C) <7.5, or a decrease >1% on CSII, n=23) with nonresponders demonstrated no differences with respect to gender, socioeconomic status, weight standard deviation score, body mass index, initial HbA(1C), frequency of hypoglycemia, or number of education visits before CSII. CONCLUSION: Continuous subcutaneous insulin infusion is effective in lowering HbA(1C) and the occurrence of severe nocturnal hypoglycemia without excessive weight gain in most children with type 1 diabetes. HbA(1C) response to CSII is poorer in preadolescents than in young children or teenagers.     

Weight in adolescents with type 1 diabetes mellitus during continuous subcutaneous insulin infusion (CSII) therapy

Continuous subcutaneous insulin infusion (CSII) has become increasingly popular as a form of intensified insulin therapy in adolescents with type 1 diabetes mellitus (DM). One reported drawback was increased weight gain in adolescents after initiation of insulin pump therapy. In a prospective, longitudinal, non-randomized and case controlled study, we followed 12 adolescents (mean age 13.6 yr, 8 males, 4 females) from 6 months before the start of CSII to 12 months on CSII. These 12 adolescents with DM on CSII were matched for age, gender, HbA1c, duration of DM, and body mass index (BMI) with 12 adolescents who continued on multiple injection therapy (MIT). In addition, six of the 12 adolescents on CSII intended to control their weight by means of the insulin pump. These six vs six adolescents within the CSII group were further analyzed for weight development and eating habits. Clinical indications for CSII were dawn phenomenon, night-time hypoglycemia and patient request for more flexibility in DM management. All patients had been in satisfactory metabolic control on MIT. After 12 months of CSII, the daily insulin requirement remained significantly lower than 18 months before (0.79 +/- 0.11 vs 1.02 +/- 27 U/kg/d, p = 0.034) and number of daily meals was lower (4.1 +/- 0.9 vs 6.5 +/- 0.7, p = 0.006). Mean initial HbA1c was 7.4% in the MIT and CSII patients, and remained comparable between these two groups. BMI was not different between the CSII and MIT group over the entire study period. However, those adolescents on CSII who intended to control their weight by means of the insulin pump were able to achieve relative weight loss during the,first 6 months on CSII. Two patients of the CSII group had one severe hypoglycemic episode with loss of consciousness. In conclusion, CSII does not lead to weight gain by itself, but allows sufficient weight control without a negative effect on metabolic control. The general threat of weight gain in patients who switch to insulin pump therapy must be pointed out, and the role of eating habits and caloric content of food should play a central role in insulin pump educational programs.     

Optimal control of type 1 diabetes mellitus in youth receiving intensive treatment

OBJECTIVE: To investigate the impact of factors that might interfere with optimal glycemic control in youth with type 1 diabetes mellitus (T1DM) in the current era of intensive management, including the interplay of race/ethnicity and socioeconomic status (SES) on HbA1c levels. STUDY DESIGN: This study comprised a database review of all patients under age 18 years with T1DM for at least 6 months duration. Sex, age, race/ethnicity, duration of diabetes, mode of insulin administration (pump vs injection), body mass index, SES, and HbA1c level were recorded at each patient's most recent visit between January and September 2003. RESULTS: Mean HbA1c level for the 455 patients was 7.6% +/- 1.4%; only 31% of patients failed to meet the therapeutic goal of < 8.0%. Multiple linear regression analysis identified female sex (P = .02), older age (P = .001), longer duration of diabetes (P < .001), injection therapy (P < .001), and lower SES (P = .001) as significantly associated with higher HbA1c level. After adjustment for SES, race/ethnicity was not a determinant of HbA1c level. CONCLUSIONS: Low SES had a greater association with poor metabolic control than did race/ethnicity, which was not associated with differences in HbA1c level after controlling for SES. Most children were able to attain glycemic targets at least as good as the Diabetes Control and Complications Trial recommendations in a large clinical practice.     

Improved treatment satisfaction but no difference in metabolic control when using continuous subcutaneous insulin infusion vs. multiple daily injections in children at onset of type 1 diabetes mellitus

Objective: The aim of this study was to compare safety, metabolic control, and treatment satisfaction in children/adolescents at onset of type 1 diabetes mellitus who were treated with either continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). Research design and methods: Seventy‐two children/adolescents (7–17 yr of age) were enrolled in this open, randomized, parallel, multicenter study. Approximately half of the patients were treated with MDI (natural protamine hagedorn [NPH] insulin twice daily and rapid‐acting insulin three to –four times daily, n = 38) by pen, and the other half received CSII (n = 34). The patients were followed for 24 months with clinical visits at the entry of the study and after 1, 6, 12, and 24 months. During these visits, hemoglobin A1c, insulin doses, weight, and height were registered. Severe episodes of hypoglycemia and ketoacidosis as well as technical problems were recorded. In addition, the patients/parents answered the Diabetes Treatment Satisfaction Questionnaire. Results: There was no significant difference in metabolic control between the treatment groups. Treatment satisfaction was significantly higher in the group treated with CSII compared with the MDI group (p ≤ 0.01 at all screening visits). There were no episodes of ketoacidosis and there was no significant difference regarding severe hypoglycemia between the treatment groups. Conclusions: CSII treatment proved to be a safe therapy in children/adolescents followed for 24 months after onset of their diabetes. Treatment satisfaction was higher in the CSII group, although there was no difference in metabolic control compared with the MDI group.