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.     

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.     

Multiple daily injections in young patients using the ezy-BICC bolus insulin calculation card, compared to mixed insulin and CSII

Objective: To describe the easy bolus insulin calculation card (ezy-BICC) approach to multiple daily injections and to compare in an observational study, the haemoglobin A1c (HbA1c) achieved while using ezy-BICC, mixed insulin injections and continuous subcutaneous insulin infusion (CSII).
Methods: HbA1c results from 7121 clinic visits by 573 patients aged 1–20 yr using the three methods between June 2000 and July 2008 were reviewed.
Results: For mixed insulin median, mean and SD HbA1c were 8.3%, 8.3%, 1.33, for ezy-BICC, 7.6%, 7.7%, 1.40, and for CSII, 7.6%, 7.8%, 1.31. HbA1c increases with age significantly more in those using CSII (p < 0.001). By regression, compared with mixed insulin HbA1c is 0.7% lower using ezy-BICC (p < 0.018) and 1.5% lower using CSII (p < 0.001). For patients using CSII compared with <6 yr, those 6–12 yr have HbA1c 0.7% higher (p < 0.001), 12–15 yr 1.0% higher (p < 0.001) and 15–20 yr 1.2% higher (p < 0.001). For subjects >12 yr, HbA1c is lower while using ezy-BICC than CSII. HbA1c increases 0.2% per yr following diagnosis for 2.8 yr. In those who change from mixed insulin to ezy-BICC after this time, the mean HbA1c is 0.5% lower by 9 months, 0.7% lower at 21 months and 0.6% lower at 24 months (p < 0.05).
Conclusions: The ezy-BICC system is inexpensive and convenient and allows patients to vary meal size. Subjects achieve lower HbA1c while using CSII and ezy-BICC MDI than with mixed insulin. Very young subjects achieve excellent HbA1c using CSII, but for 12 to 20 yr-old patients, ezy-BICC results in lower HbA1c than CSII for a lower cost.     

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.     

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.     

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.     

Benefits of an insulin dosage calculation device for adolescents with type 1 diabetes mellitus

OBJECTIVE: Multiple daily injection insulin regimens (MDI) and continuous subcutaneous insulin infusion (CSII) allow adolescents with type 1 diabetes mellitus (DM) meal flexibility, and may improve metabolic control. The insulin dosage calculations, however, involve ratios of insulin to carbohydrate and corrections for high blood glucose values, and are labor-intensive and prone to error. We evaluated the impact of an insulin dosage calculation device (IDC) on metabolic control, treatment satisfaction, regimen adherence and quality of life in adolescents using MDI or CSII. RESEARCH DESIGN AND METHODS: We conducted a randomized control trial using the IDC in 83 adolescents on MDI or CSII. At enrollment, patients received training on dosage calculation using either the IDC or conventional methods, and performed sample calculations. At enrollment, 6 months and 12 months, we recorded HbA1c and frequency of hypoglycemia, and patients completed questionnaires assessing treatment satisfaction, regimen adherence and quality of life. After 6 months, patients in the control group were also given the IDC. RESULTS: We observed a higher frequency of errors with conventional calculations (53-67% incorrect calculations) than with the IDC (25-32% incorrect). At 6 months, there was a trend toward improved HbA1c in the IDC group overall (9.3 vs 8.9, p = 0.07) and a significant improvement in the subset (42%) who used the IDC consistently (9.7 vs 8.8, p = 0.03). There was no change in HbA1c in the control group during this interval (9.0 vs 8.9, p = 0.90). During months 6-12, when both groups were combined, there was a significant increase in HbA1c in patients using the IDC inconsistently or not at all (8.9 vs 9.4, p = 0.005), but no change in HbA1c in those using the IDC consistently (9.1 vs 8.9, p = 0.57). Treatment satisfaction, adherence and quality of life improved throughout the study in both groups. CONCLUSIONS: Errors in calculation of insulin dosage by adolescents occur frequently. Consistent use of an insulin dosage calculation device may help to improve metabolic control in adolescents using MDI or CSII.     

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.     

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.     

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.     

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.     

Insulin pump therapy in pediatrics: a therapeutic alternative to safely lower HbA1c levels across all age groups

Abstract: Objective: To examine the efficacy and safety of using continuous subcutaneous insulin infusion (CSII) therapy in a large group of patients 18 months to 18 yr from a single pediatric diabetes program. Research design and methods: All patients ≤ 18 yr of age starting on CSII from 1 January 1997 to 31 March 2000 at the Yale Children's Diabetes Program were included. Clinical data were collected prospectively before and during pump treatment. HbA1c was the primary efficacy outcome and rates of diabetes‐related adverse events were the primary safety measures. Results: One hundred and sixty‐one children ranging in age from 18 months to 18 yr received CSII for an average of 32 ± 9 months when data collection was closed on 31 October 2001, including 26 preschoolers (< 7 yr), 76 school‐agers (7–11 yr) and 59 adolescents (12–18 yr). Mean HbA1c levels were 7.1% in the preschoolers, 7.8% in the school‐agers and 8.1% in the adolescents prior to the start of CSII. There was a significant and consistent reduction in mean HbA1c levels after 12 months of CSII (to 6.5% in preschoolers, 7.3% in school‐agers and 7.4% in adolescents, p < 0.02 vs. prepump) that was maintained at the most recent visit. Improved diabetes control was achieved with CSII without increasing daily insulin doses and in association with a decrease in the frequency of severe hypoglycemic events (p < 0.05 vs. prepump, all three age groups combined). Conclusions: CSII is an effective alternative to injection therapy in a large pediatric diabetes clinic setting. Even very young patients can utilize CSII to safely lower HbA1c levels.     

The effect of socioeconomic deprivation on efficacy of continuous subcutaneous insulin infusion: a retrospective paediatric case-controlled survey

We aimed to retrospectively evaluate the efficacy of continuous subcutaneous insulin infusion (CSII) therapy in relation to social deprivation in an urban paediatric type 1 diabetic population. Data were compared between 51 children on CSII therapy (mean age 11.2?years and duration of follow-up 1.9?years) and matched controls on multiple daily injection (MDI) therapy. Social deprivation was measured using the UK Office of National Statistics 2007 Index of Multiple Deprivation. Using linear mixed modelling analysis, lower HbA1c levels at 24?months were associated with CSII not MDI therapy (P?=?0.02), after adjustment for known variables. Children with the least educated parents showed a rise in HbA1c levels from baseline on MDI therapy (least versus most educated tertile; HbA1c change +0.5% [95% confidence interval ?0.1 to 1.1] versus 0% [?0.8 to 0.8]), whereas this was not observed in CSII therapy (least versus most educated tertile; HbA1c change ?0.3% [?0.7 to +0.1] versus ?0.2% [?0.7 to +0.3], P value for ANCOVA?=?0.02, after adjusting for income and employment). Conclusion: Parental educational deprivation was associated with a failure of MDI but not CSII therapy. These outcomes need confirmation by larger studies.     

儿童1型糖尿病胰岛素泵治疗长期随访的疗效观察

目的 比较1型糖尿病(T1DM)患儿应用持续皮下胰岛素输注(CSII)与每日多次皮下胰岛素注射(MDI)治疗对血糖控制的疗效差异.方法 回顾性收集91例应用CSII方式治疗1年以上T1DM患儿的临床资料,评估其糖化血红蛋白(HbA1C)水平、糖尿病酮症酸中毒(DKA)再发生情况,通过与75例应用MDI治疗的T1DM患儿...     

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.     

Use of insulin glargine in children under age 6 with type 1 diabetes

AIM: Children under 6 yr have the highest incidence of severe hypoglycemia (SH) and the greatest likelihood of brain damage from SH. The purpose of this study is to evaluate the use of insulin glargine (Lantus in children under age 6 with type 1 diabetes (T1D). METHODS: The electronic medical records were reviewed for patients under age 6 during the first 6 months of insulin glargine therapy and compared with age, sex, and duration of diabetes for matched control patients on neutral protamine Hagedorn (NPH) insulin. Data from 128 subjects (32 male pairs and 32 female pairs) were collected relating to the incidence of severe and non-severe hypoglycemic events, hemoglobin A1c (HbA1c) values, body mass index (BMI), and daily insulin dose. Additionally, parents were asked to complete a diabetes Quality of Life (QoL) survey. RESULTS: In the 6 months before the study period, the glargine group had 16 SH events compared with three in the 6 months post-glargine. The comparison (NPH) group had seven and six SH events in their respective 6-month periods. Nighttime SH events in the glargine group decreased from 12 prestudy events to one during the study period. The average daily insulin dose in the glargine group was higher than that in the NPH group (0.8+/- 0.2 vs. 0.7+/- 0.2 U/kg/day; p=0.03). The HbA1c values, BMI, and QoL responses were not significantly different between the two groups. CONCLUSIONS: SH was decreased, particularly at night (from 12 episodes to one), after the introduction of glargine in young children with T1D.     

Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial

BACKGROUND: Tight glycemic control delays the long-term complications of type 1 diabetes mellitus (T1DM) but increases the risk for hypoglycemia. The continuous glucose-monitoring system (CGMS) provides blood glucose (BG) readings every 5 min, and its accuracy and reliability has been established in adults. However, there are limited data on its efficacy and safety in children. The purpose of this study was to determine if CGMS use improves metabolic control in children with T1DM. METHODS: Twenty-seven children (12 male) with T1DM participated in this single-blind, randomized, controlled trial. Participants (age: 11.4 +/- 3.7 (mean +/- SD) yr, range: 7-17 yr) were randomized to an intervention group (n = 18) or a control group (n = 9). Both groups wore the CGMS for 72-h periods at 0, 2, and 4 months. Adjustments in therapy for the intervention group were based on both CGMS and self-monitoring of BG (SMBG) data, while only SMBG data were used for the control group. Hemoglobin A1c (HbA1c) was determined at 0, 2, 4, and 6 months. The change in HbA1c from 0 to 6 months (HbA1c(Delta1-4)) and mean daily area under the CGMS curve for glucose <70 mg/dL area under the curve (AUC(<70)) were compared between groups. RESULTS: At study entry, HbA1c levels were similar in the intervention and control groups (8.4 +/- 0.98 and 8.8 +/- 0.86%, respectively; p = 0.12) but were significantly lower in the intervention group compared with the control group at study completion (7.8 +/- 0.88 and 8.6 +/- 0.95%, respectively; p = 0.02). The decrease in HbA1c of 0.61 +/- 0.68% in the intervention group was statistically significant (p = 0.03), whereas the decrease in HbA1c of 0.28 +/- 0.78% in the control group was not. Nonetheless, the differences in HbA1c(Delta1-4) between groups did not reach statistical significance (p = 0.13). There was no statistically significant difference in AUC(<70) between study groups (p = 0.18). CONCLUSION: CGMS use may improve metabolic control in children with T1DM without increasing the risk for hypoglycemia.     

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.     

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.