The impact of continuous subcutaneous insulin infusion on health-related quality of life in children and adolescents with type 1 diabetes

AIM: To study the impact of continuous subcutaneous insulin infusion (CSII) therapy on health-related quality of life in children and adolescents with type 1 diabetes. METHODS: 31 children and adolescents with poorly regulated type 1 diabetes (mean HbA1c 10.4%, SD 1.8), mean age 14.4 (1.5) y (range 9.7-17.1) and mean diabetes duration of 6.8 (3.2) y (range 1.3-14.6) were consecutively assigned to CSII therapy. Data for generic (CHQ-CF87) and diabetes-specific quality of life (DQOL) were obtained before initiating pump therapy and twice during 15 mo of treatment. HbA1c, BMI and episodes of severe hypoglycaemia and ketoacidosis were recorded over 15 mo prior to and 15 mo during pump therapy. RESULTS: Analysis showed improvements on the family activity scale (p=0.041) and change in health score (p=0.042) (CHQ-CF87). Mean HbA1c decreased from 10.4% (1.8) to 9.0% (0.9) after 3 mo, increasing to 9.6% (1.2) after 15 mo. The number of overweight and obese children increased from 4 and 2 before CSII, to 6 and 3 after 15 mo (IOTF criteria). There was a reduction in severe hypoglycaemia episodes from 43.8 to 5.2 per 100 patient years, but no change in ketoacidosis episodes. CONCLUSION: The degree of limitation experienced by families due to adolescents' general health and well-being was significantly reduced. Expected improvement in metabolic control and frequency of severe hypoglycaemia was observed.     

A randomized, controlled study of insulin pump therapy in diabetic preschoolers

OBJECTIVE: To compare glycemic control, safety, and parental satisfaction in preschool-aged diabetic children randomized to treatment either with continuous subcutaneous insulin infusion (CSII) or intensive insulin injection therapy. STUDY DESIGN: This clinical trial enrolled 42 patients <5 years of age who had been diagnosed with diabetes for at least 12 months. Children were randomly assigned to CSII (n = 21) or intensive insulin injection therapy (n = 21). Hemoglobin A1c (HbA1c) level was measured at baseline, 3, and 6 months. Secondary outcomes included severe hypoglycemic events, meter-detected hypoglycemia, blood sugar variability, body mass index (BMI), and satisfaction with therapy. RESULTS: Thirty-seven patients completed 6 months of therapy. There was a significant decrease in HbA1c during the study period for both groups (from 8.9% +/- 0.6% to 8.6% +/- 0.6% at 3- and 6-month visits). At 3 months, children using pumps had a significantly lower HbA1c than the injection group (8.4% vs 8.8%); however, by 6 months the two groups were similar (8.5% vs 8.7%). No differences in pre-meal blood sugar variabilities were seen between groups. Children on pumps had increases in the number of meter-detected episodes of hypoglycemia. Pump therapy was safe and well tolerated. No episodes of ketoacidosis occurred in either group, whereas one hypoglycemic seizure occurred in each group. Parents reported satisfaction with CSII, with 95% of families continuing on CSII beyond the 6-month study period. CONCLUSION: Pump therapy in preschool-aged children was not associated with clinically significant differences in glycemic control as compared with intensive injection therapy. The rationale for initiating CSII in this age group should be based on patient selection and lifestyle preference.     

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.     

Insulin requirement in preschoolers treated with insulin pumps at the onset of type 1 diabetes mellitus

The aim: The aim of this study is to analyze changes in the basal insulin requirement in preschoolers treated with insulin pump at the onset of T1DM, using system to calculate meal time insulin.
Methods: 58 children (31 girls) under 6 years (mean age 3.3 ± 1.5 years) initiated on insulin pump therapy within 2 months after recognition of T1DM and treated at least for 1 year were analyzed during a follow-up period of 165 patient-years. Data was collected every 6 months: HbA1c, BMI SDS, diabetic ketoacidosis, severe hypoglycaemia, total daily insulin dose (TDD) and basal insulin.
Results: Basal insulin rose from 10% in the third month and did not exceed 30% of TDD after 12 months (p<0.0001). In the third month, 46% of children were without basal insulin; this group included significantly older children (3.7 ± 1.4 vs. 2.8 ± 1.4 years; p = 0.01), which had lower TDD (0.33 ± 0.18 vs. 0.54 ± 0.23u/kg/d; p = 0.0007) than children with basal insulin. HbA1c persisted ≤7.3%.
Conclusion: In preschool children initiated on CSII therapy at the time of T1DM diagnosis the first year of treatment is critical for altering the basal insulin dose. Preschoolers with TDD lower than 0.5U/kg/d may not require basal insulin. Moreover, basal insulin did not exceed 30% of TDD in the first years after T1DM onset.     

Long-term use of continuous subcutaneous insulin infusion compared with multiple daily injections of glargine in pediatric patients

BACKGROUND: Studies comparing continuous subcutaneous insulin infusion (CSII) and glargine in pediatric patients are scarce and cover only 1 year follow up. Although short-term results are favorable for CSII, there is no clear evidence whether this therapy leads to a sustained improvement of glycemic control. OBJECTIVE: To evaluate long-term effects and safety of CSII versus multiple daily injections (MDI) of glargine over 2 years of treatment in children and adolescents. PATIENTS AND METHODS: 32 patients (aged 12.5 +/- 2.4 years; 19 females) with intensively treated type 1 diabetes mellitus were eligible. They were divided into two groups, virtually identical at study entry: eight on CSII and 24 on MDI of glargine. Variables at 0, 6, 12, 18 and 24 months were compared between groups by two-sided Mann-Whitney and Fisher tests. RESULTS: No significant differences were found between groups (CSII vs MDI) throughout the study period. At 24 months hemoglobin A1c was 7.70 +/- 0.64% vs 7.54 +/- 0.74% (p = 0.8); body mass index SDS was 0.33 +/- 0.74 vs 0.40 +/- 1.01 (p = 0.9); total daily insulin requirements were 0.95 +/- 0.10 vs 1.05 +/- 0.18 U/kg (p = 0.4), incidence of severe hypoglycemia was 0.00 +/- 0.00 vs 0.04 +/- 0.14 episodes/patient/year (p = 0.8); and incidence of ketoacidosis was 0.20 +/- 0.27 vs 0.04 +/- 0.14 episodes/patient/year (p = 0.2). CONCLUSION: CSII and MDI with glargine are equally effective and safe in pediatric patients at 2-year follow-up.     

A cross-sectional international survey of continuous subcutaneous insulin infusion in 377 children and adolescents with type 1 diabetes mellitus from 10 countries

OBJECTIVE: To document current practices using continuous subcutaneous insulin infusion (CSII) by downloading electronically the 90-d pump data held within the pump memory and relating that to clinical data from children and adolescents in different pediatric diabetes centers from Europe and Israel. METHODS: Data of patients (1-18 yr) treated with CSII in 23 centers from nine European countries and Israel were recorded with the encapture software (PEC International, Frankfurt, Germany). The number of patients who participated was 377 (48% female; mean diabetes duration +/- SD: 6.8 +/- 3.7 yr; age: 12.9 +/- 3.8 yr, preschool n = 33; prepubertal n = 95; adolescent n = 249; CSII duration: 1.6 +/- 1.2 yr; local HbA1c: 8.1 +/- 1.2%). RESULTS: The total insulin dose was lower than previously reported for injection therapy (0.79 +/- 0.20 U/kg/d). Covariance coefficient of daily total insulin was high in all age groups (adolescents 19 +/- 9%, prepubertal 18 +/- 8 and preschool 17 +/- 8). The distribution of basal insulin infusion rates over 24 hr (48 +/- 12% of total dose) varied significantly between centers and age groups. The number of boluses per day (7 +/- 3) was not significantly different between the age groups (average daily bolus amount: 0.42 +/- 0.16 U/kg). The rate of severe hypoglycemia (coma/convulsions) was 12.4 episodes per 100 patient-years and the number of diabetes-related hospital days was 124 per 100 patient-years. DISCUSSION: Pediatric CSII patients show a high variability in their insulin therapy. This relates both to age-dependent differences in the distribution of basal insulin as to the age-independent day-to-day variation in prandial insulin.     

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.     

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.     

Continuous subcutaneous insulin infusion in children and adolescents with diabetes mellitus: decreased HbA1c with low risk of hypoglycemia

AIM: To evaluate blood glucose and HbA1c levels, insulin dosage, hypoglycemia rate and body mass index (BMI) at baseline, and at 3 and 6 months after initiation of continuous subcutaneous insulin infusion (CSII) in children and youth with type 1 diabetes mellitus (DM). METHODS: A 6-month trial of pump therapy was carried out in 40 patients with type 1 DM and one with cystic fibrosis (CF) induced DM (25 males), aged 4-25 years (mean 13.5 +/- 4.2 [SD]; 4-8 years, n = 6; 8-10 years, n = 8; 10-12 years, n = 4; 12-15 years, n = 11; >15 years, n = 12). RESULTS: HbA1c was significantly reduced from 9.5 +/- 1.7% to 8.6 +/- 1.2% at 3 months (p < 0.03), and at 6 months 8.8 +/- 1.5% (p < 0.05). The mean daily values of blood glucose, as well as individual mean values of blood glucose at fasting and before lunch, also exhibited a significant reduction (p < 0.05) at 3 and 6 months. There was a significant reduction in the number of hypoglycemic events (level of plasma glucose <3.3 mmol/l, calculated as number of events per patient/30 days) at 3 months (6.5 +/- 5.5 vs 2.8 +/- 3.3; p = 0.02) and at 6 months (6.5 +/- 5.5 vs 3.5 +/- 3.0; p = 0.04). The insulin requirement dropped by 27.2% (1.03 +/- 0.30 U/kg/day before starting CSII; 0.75 +/- 020 U/kg/day on insulin pump therapy onset; 0.76 +/- 0.18 U/kg/day at 3 months; 0.75 +/- 0.21 U/kg/day at 6 months). During the follow-up 0.10 events of diabetic ketoacidosis/patient/year were recorded. The patients exhibited no increase in BMI during the 6 months of follow-up. CONCLUSION: CSII was safe and effective in improving short- and medium-term metabolic control in young adults, adolescents and younger children with DM.     

Assessment of glycemic control by continuous glucose monitoring system in 50 children with type 1 diabetes starting on insulin pump therapy

OBJECTIVE: To report experience with a continuous glucose monitoring system (CGMS) and to identify factors influencing glycemic control in a large cohort of children and adolescents with type 1 diabetes and change to insulin pump therapy via continuous subcutaneous insulin infusion (CSII). RESEARCH DESIGN and METHODS: In 50 patients [21 boys, 29 girls; median age 12.6 yr (range: 1.3-16.4 yr); diabetes duration 5.0 yr (0.2-13.3)], hemoglobin A1c (HbA1c) and ambulatory CGMS were performed before and 6 wk after starting CSII. Average glucose concentration per 24 h, during day and night time as well as number of excursions, duration, and area under the curve (AUC) of glucose values above 180 mg/dL and below 60 mg/dL were calculated from CGMS data. Simultaneously, metabolic control was documented by standardized self-monitoring of blood glucose (SMBG). RESULTS: In the total cohort, HbA1c improved from 8.1 +/- 1.2% at baseline to 7.7 +/- 0.9% after 6 wk of CSII (p <0.001). This effect was more distinct in boys (8.0 +/- 1.4 vs. 7.5 +/- 1.1%, p=0.007) than in girls (8.1 +/- 1.1 vs. 7.8 +/- 0.7%, p=0.039) as well as in patients with poor glycemic control (HbA1c >8.0%) at baseline (8.9 +/- 0.6 vs. 8.1 +/- 0.8%, p <0.001) and in those older than 12 yr (8.2 +/- 1.2 vs. 7.7 +/- 1.0%, p <0.001). At 6 wk of CSII, the values of glucose average per 24 h, AUC and time above 180 mg/dL, particularly during the day, improved. HbA1c was correlated with AUC above 180 mg/dL (r=0.742, p <0.001) and CGMS average glucose per 24 h (r=0.628, p=0.002), but to a lesser extent with SMBG values (r=0.418, p=0.054). CONCLUSION: With the change to CSII, HbA1c improved significantly after 6 wk of therapy. CGMS usage provided additional information about glycemic control in these patients.     

Continuous subcutaneous insulin infusion in the treatment of children and adolescents with type 1 diabetes mellitus

Continuous subcutaneous insulin infusion (CSII) with a portable insulin pump has been used for several years in the treatment of adult patients with diabetes mellitus (DM). This treatment, however, has rarely been utilised in children and adolescents. We studied the use of CSII in 16 children and adolescents with type 1 DM at Tampere and Kuopio University Hospitals between 1992 and 1997. The longest treatment periods are more than 4 years. The reasons for switching to CSII treatment and the goals achieved were evaluated. Glycaemic control before and during CSII treatment and the occurrence of hypoglycaemia and ketoacidosis were analysed. Compared with conventional insulin treatment, improved glycaemic control and a reduced frequency of hypoglycaemic events were achieved with CSII in those with particularly poor initial metabolic control (HbA1c >10.0%). The overall satisfaction with pump therapy was high in both patients and their families. According to our experience, CSII may be of benefit, especially in young infants with type 1 DM, but also in affected adolescents with unacceptable glycaemic control.     

Continuous subcutaneous insulin infusion in toddlers and children with type 1 diabetes mellitus is safe and effective

OBJECTIVE: The aim of this study was to investigate the safety and efficacy of continuous subcutaneous insulin infusion (CSII) for type 1 diabetes mellitus (T1DM) in toddlers and children. RESEARCH DESIGN AND METHODS: Seventy children who began CSII at the age of 12 yr or younger (youngest 2 yr old) and who were maintained on CSII for at least 6 months were studied by a retrospective chart review. A pre- or postintervention comparison approach was used to assess the impact of CSII on the measured variables. The control period was defined as 1 yr prior to beginning CSII. Charts were reviewed for hemoglobin A1c (HbA1c) reports of severe hypoglycemia, diabetic ketoacidosis (DKA), height and weight, and range of blood glucoses reported at each visit. Mean values for HbA1c, body mass index (BMI) z-score, and range of blood glucose were computed for each subject over all pre-CSII visits, and again over all post-CSII visits. RESULTS: The mean HbA1c decreased significantly during CSII [7.8 +/- 0.8% pre-CSII vs. 7.3 +/- 0.7% on CSII, p < 0.0001]. Hypoglycemic episodes decreased with CSII in the 10- to 12-yr-old group (p < 0.02) and demonstrated a strong trend (mean of 0.46-0.22 events per patient year, p < 0.06) overall. Two episodes of DKA occurred in the CSII period and none in the control period (p = NS). BMI z-scores increased to 0.21 in the 5- to 9-yr-age group (p < 0.008) and averaged 0.13 overall. The range of blood glucoses decreased during CSII (p < 0.005) in the middle and oldest age groups. CONCLUSIONS: This study supports CSII as a safe and effective alternative to managing T1DM, with no increase in hypoglycemia and a trend to improve control, even in the youngest patients.     

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.     

Adverse events in intensively treated children and adolescents with type 1 diabetes

The main objective of this study was to examine the relation between adverse events and degree of metabolic control and multiple-dose treatment. A total of 139 children, aged between 1 and 18 y, prospectively registered severe hypoglycaemia with or without unconsciousness, as well as hospitalized ketoacidosis, during 1994-95. Treatment from onset was multiple-dose insulin (> 95% > or = 4 doses) combined with intense training and psychosocial support. Median HbA1c was 6.9% (ref. 3.6-5.4%). The incidence of severe hypoglycaemia with unconsciousness was 0.17 events per patient-year, having decreased from the 1970s to the 1990s, parallel to a change from 1-2 to > or = 4 doses per day. There was no correlation or association to the year mean HbA1c for severe hypoglycaemia. Severe hypoglycaemic episodes in 1995 correlated to severe hypoglycaemic episodes in 1994 (r=0.38; p<0.0001). Severe hypoglycaemia with unconsciousness increased during the spring season, and according to case records the assumed causes were mainly mistakes with insulin, food and exercise. Ketoacidosis was rare: 0.015 episodes per patient-year. We conclude that multiple-dose insulin therapy from the very onset of diabetes, combined with adequate self-control, active problem-based training and psycho-social support, may limit severe hypoglycaemia and ketoacidosis. Strategies aimed at minimizing severe hypoglycaemia without compromising metabolic control need to be evaluated.     

Treatment of Danish adolescent diabetic patients with CSII - a matched study to MDI.

OBJECTIVE: To compare two intensified insulin therapy regimens - continuous subcutaneous insulin infusion (CSII) against multiple daily insulin injection (MDI) - in Danish adolescents examined in a prospective, matched controlled study design. RESEARCH DESIGN AND METHODS: Thirty type 1 diabetic adolescents at CSII and 26 matched MDI controls were included in this open intention-to-treat study. Actrapid was used in both groups. Before study entry, all participants followed a brush-up course in order to minimize study effect. At each visit, the following parameters were recorded: hemoglobin A1c (HbA1c), insulin dose, weight, number of hypoglycemic and diabetic ketoacidosis (DKA) events, and the time resources used. At entry and exit of the study, diet registration and validated quality-of-life (QoL) questionnaires were filled by the participants. RESULTS: A non-significant decline in HbA1c was seen in both groups (p = 0.468); HbA1c decreased from 9.5 to 8.9% and from 9.7 to 9.5% in the CSII and MDI group, respectively. The insulin dose and the number of severe hypoglycemic events per patient were lower (non-significant) in the CSII group. Both groups showed increased body mass index - highest in the CSII group - and mild to moderate DKA episodes were only seen among CSII users. No differences could be demonstrated within the QoL or diet registrations. CONCLUSIONS: CSII treatment is beneficial as an intensified insulin therapy for selected type 1 diabetic patients and both MDI and CSII can be offered by the professional diabetes team to better tailor therapy. In future, there is a strong need to identify the characteristics of responders to CSII treatment in order to increase the efficacy and safety of CSII treatment.     

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.     

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.     

Treatment of Danish adolescent diabetic patients with CSII – a matched study to MDI

Objective:  To compare two intensified insulin therapy regimens – continuous subcutaneous insulin infusion (CSII) against multiple daily insulin injection (MDI) – in Danish adolescents examined in a prospective, matched controlled study design.
Research design and methods:  Thirty type 1 diabetic adolescents at CSII and 26 matched MDI controls were included in this open intention-to-treat study. Actrapid was used in both groups. Before study entry, all participants followed a brush-up course in order to minimize study effect. At each visit, the following parameters were recorded: hemoglobin A1c (HbA1c), insulin dose, weight, number of hypoglycemic and diabetic ketoacidosis (DKA) events, and the time resources used. At entry and exit of the study, diet registration and validated quality-of-life (QoL) questionnaires were filled by the participants.
Results:  A non-significant decline in HbA1c was seen in both groups (p = 0.468); HbA1c decreased from 9.5 to 8.9% and from 9.7 to 9.5% in the CSII and MDI group, respectively. The insulin dose and the number of severe hypoglycemic events per patient were lower (non-significant) in the CSII group. Both groups showed increased body mass index – highest in the CSII group – and mild to moderate DKA episodes were only seen among CSII users. No differences could be demonstrated within the QoL or diet registrations.
Conclusions:  CSII treatment is beneficial as an intensified insulin therapy for selected type 1 diabetic patients and both MDI and CSII can be offered by the professional diabetes team to better tailor therapy. In future, there is a strong need to identify the characteristics of responders to CSII treatment in order to increase the efficacy and safety of CSII treatment.     

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.     

How well are we doing? – Metabolic control in patients with diabetes

OBJECTIVE: To compare the present level of metabolic control in children and adolescents with insulin-dependent diabetes mellitus (IDDM) attending Brisbane paediatric diabetes clinics with published overseas data. METHODOLOGY: Blood HbA1c concentrations, population characteristics, current treatment practices and short-term complications were recorded in all patients, aged 19 years and under, attending the diabetes clinics of the two Brisbane Children's Hospitals or the private practice of one of the authors (MJT) in the first quarter of 1998. RESULTS: Two hundred and sixty-eight patients were assessed (M/F 142/126). Ages ranged from 1 to 19 years (mean 11. 2 years); duration of IDDM was 0-16 years (mean 4.4 years); and 141 (53%) were pubertal. Of those aged less than 13 years, only 4% had more than two injections daily. Insulin doses (U/kg/day) rose with increasing age. Larger doses were required in regimens involving more than two injections per day than those involving one to two injections per day. Ketoacidosis or severe hypoglycaemia in the last 3 months were reported in eight (2.7%) and 17 (6.3%) of patients, respectively. Mean HbA1c (+/- SD) was 8.6 +/- 1.4% (range 5.2-14.0%), with 33% of children having a HbA1c concentration < 8%. HbA1c concentrations were significantly related (P < 0.05) to insulin dose and to duration of diabetes, but not to severe hypoglycaemia, ketoacidosis, age, frequency of injections, or number of clinic visits per year. Mean HbA1c concentration was significantly higher (P < 0.05) in those children in puberty (8.7 +/- 1.5%) than in those not in puberty (8.5 +/- 1.2%). CONCLUSION: Only 33% of patients had a HbA1C concentration less than 8% and 6.3% had a severe hypoglycaemic episode in the 3 months. These results are similar to published overseas data.