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.     

Treatment with insulin glargine reduces asymptomatic hypoglycemia detected by continuous subcutaneous glucose monitoring in children and adolescents with type 1 diabetes

OBJECTIVE: Unsatisfactory basal insulin substitution may lead to asymptomatic hypoglycemia in children and adolescents with type 1 diabetes (T1D). To investigate the effects of multiple daily injections before and after changing to insulin glargine (IG), continuous glucose monitoring system (CGMS) data were used to analyze glycemic control and hypoglycemic episodes during the two different therapy regimens. METHODS: Basal insulin therapy was changed to one daily injection of IG in 30 pediatric patients with T1D (14 boys and 16 girls; age 4.5-18.3 yr, median 14.2 yr; diabetes duration 0.5-15.6 yr, median 4.6 yr) having elevated fasting glucose or recurrent hypoglycemia despite treatment with multiple injection therapy (basal insulin: two to four injections of neutral protamine Hagedorn (NPH) and/or zinc lente insulin). Ambulatory CGMS was applied before and 6-8 wk after treatment change. Frequency of hypoglycemic and hyperglycemic episodes, glucose area under the curve (AUC), and time below 60 mg/dL and above 180 mg/dL, respectively, were calculated from CGMS data during the day (8:00-22:00 hours) and at night (22:00-8:00 hours). RESULTS: Nocturnal hypoglycemia was detected by CGMS in 20 patients before and in 12 patients after the change to IG (p = .039), whereas both, the number of nocturnal and diurnal hypoglycemic episodes, decreased not significantly from 41 to 36 (p = .758) and 48 to 28 (p = .055), respectively. AUC and time below 60 mg/dL as well as hemoglobin A1c (HbA1c) were not significantly different before and after the change to IG. CONCLUSION: Under treatment with IG, asymptomatic hypoglycemia was reduced without increase of HbA1c.     

Continuous glucose monitoring in children with type 1 diabetes: before and after insulin pump therapy

Abstract: Objective: The aim of continuous subcutaneous insulin infusion (CSII) therapy in patients with type 1 diabetes mellitus (T1DM) is to mimic as closely as possible the normal physiologic pattern seen in individuals without diabetes. This study was undertaken to determine the specific areas of improved glycemic control in subjects after initiation of insulin pump therapy and times where further improvement is needed. Research design and methods: Eight patients with T1DM (age 7.5–17 yr) wore the Continuous Glucose Monitoring System (CGMS) (Medtronic MiniMed, Northridge, CA, USA) for 3 d before and 3 months after initiation of insulin pump therapy. The CGMS, which measures inter‐ stitial glucose concentrations every 5 min for a 72‐h period, was used to evaluate glucose profiles. Patients entered 4–5 fingerstick blood glucose measurements daily into the sensor for calibration. Detailed logs of food intake, exercise, and hypoglycemic symptoms were also recorded. Results: Hemoglobin A1c (HbA1C) was reduced (p < 0.007) following 3 months of insulin pump therapy. Post‐CSII continuous glucose profiles demonstrated an overall improvement in hourly mean glucose over a 24‐h period (p < 0.001) as well as a reduction in the area under the curve for glucose (27 ± 4 prepump vs. 8.6 ± 1.4 mg/dL/d postpump, p < 0.004). This improvement was a result of an attenuation of the maximal postprandial glycemic excursions. Postbreakfast 349 ± 24 vs. 267 ± 16 mg/dL, p < 0.003; lunch 340 ± 16 vs. 217 ± 20 mg/dL, p < 0.003. Postdinner average similarly decreased after 3 months of CSII by 22%, p < 0.04. Conclusions: Pump therapy specifically improved the postprandial glucose excursions in children.     

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.     

Missed bolus doses: devastating for metabolic control in CSII-treated adolescents with type 1 diabetes

Objective: To investigate the management of continuous subcutaneous insulin infusion (CSII) in adolescents with type 1 diabetes including their administration of bolus doses and to study relationships between insulin omission and metabolic control, body mass index, daily frequency of self‐monitoring of blood glucose (SMBG) and bolus doses, health‐related quality of life (HRQOL), the burden of diabetes and treatment satisfaction. Methods: Ninety CSII‐treated (≥6 months) adolescents aged 12–18 yr, from four diabetes clinics in Sweden, participated in the study. The adolescents recorded their meal intake the previous day, which was compared with downloaded pump data, and the frequency of missed boluses was stated. Haemoglobin A1c (HbA1c) and diabetes‐related data were recorded. HRQOL and treatment satisfaction were measured with questionnaires. Results: Thirty‐eight per cent of the adolescents had missed >15% of the doses the previous day, those had higher HbA1c (7.8 ± 1.0 vs. 7.0 ± 1.2%, p = 0.001), took fewer daily boluses (3.8 ± 1.7 vs. 5.3 ± 1.7, p < 0.001) and SMBG (2.4 ± 1.8 vs. 3.6 ± 1.8, p = 0.003), were less satisfied with their treatment (4.8 vs. 5.3, scale 0–6, p = 0.029) and perceived the medical treatment more negatively (72.1 vs. 79.7, scale 0–100, p = 0.029). Multiple linear regression analysis showed that the variations in HbA1c could be explained by the frequency of bolus doses (p = 0.013) and SMBG per day (p < 0.0001) adjusted for duration and age (r² = 0.339, p < 0.0001). Conclusion: Insulin omission was common. Those who missed doses were less satisfied and perceived more impact with the treatment. The frequencies of daily boluses and SMBG were associated with metabolic control. Diabetes teams need strategies to guide adolescents on how to avoid insulin omission.     

The impact of physiological, therapeutic and psychosocial variables on glycemic control in youth with type 1 diabetes mellitus

OBJECTIVE: Intensive management of type 1 diabetes mellitus (DM1) in youth is challenging. We evaluated the relative impact of variables related to DM1 among groups of pre/early pubertal, midpubertal and postpubertal youths with DM1. METHODS: In this cross-sectional study of 153 youth with DM1, we ascertained Tanner stage, insulin dose and delivery modality (CSII vs MDI), daily blood glucose monitoring (BGM) frequency, and most recent hemoglobin A1c (HbA1c). We collected questionnaires from patients and their parents on diabetes-specific family conflict and family involvement in diabetes management tasks. We assessed predictors of glycemic control according to pubertal status. RESULTS: Insulin doses increased between pre/ early puberty and midpuberty (p <0.0001); daily BGM frequency (p = 0.02) and family involvement for DM management (p <0.001) were lowest in the postpubertal group. HbA1c was similar among all three puberty groups (8.4+/-1.4). Lower levels of child-reported DM-specific family conflict, more frequent BGM, and CSII use were significantly associated with lower HbA1c (R2 = 0.20, p <0.001). CONCLUSION: Although glycemic control was not significantly worse in midpubertal and post-pubertal patients, family involvement for DM management and adherence to BGM were lower in late adolescence. Interventions to optimize glycemic control may include minimizing DM-specific conflict, increasing BGM frequency, and implementing CSII use.     

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.     

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.     

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.     

Poor adherence to integral daily tasks limits the efficacy of CSII in youth

O'Connell MA, Donath S, Cameron FJ. Poor adherence to integral daily tasks limits the efficacy of CSII in youth. Introduction/Aims: Many young people experience improved glycemia with continuous subcutaneous insulin infusion (CSII) regimens; however, sustained glycemic benefit eludes a significant proportion. Our aims were to assess adherence to recommended CSII‐related behaviors in a representative pediatric cohort and to identify potentially modifiable behaviors that impact on HbA1c in youth. Research Design and Methods: Data uploaded from insulin pump devices of 100 youth with type 1 diabetes were analyzed. Results: Ability to translate recommended behaviors into daily self‐management varied widely in youth. Mean bolus frequency was 6.1/d; however, 69/100 entered <4 blood glucose levels (BGL)/d. HbA1c decreased by 0.2% for each additional BGL (p = 0.001) and bolus event (p < 0.001) per day. Prandial insulin omission was common and associated with significantly increased HbA1c. On average, if breakfast insulin was missed ≥4 times per fortnight, HbA1c increased 1.0% (p < 0.001). If one or more days per fortnight with ≤2 food boluses/d were recorded, then HbA1c increased 0.8% (p = 0.001). Increasing age and duration of CSII correlated with poorer adherence to recommended behaviors. Conclusions: Glycemic advantage obtained with CSII regimens is closely related to the manner in which CSII is employed. Poor adherence to integral CSII‐related tasks is frequently encountered in adolescents and limits the efficacy of CSII in these youth.     

The interrelationships of glycemic control measures: HbA1c, glycated albumin, fructosamine, 1,5-anhydroglucitrol, and continuous glucose monitoring

Beck R, Steffes M, Xing D, Ruedy K, Mauras N, Wilson DM, Kollman C, the Diabetes Research in Children Network (DirecNet) Study Group. The interrelationships of glycemic control measures: HbA1c, glycated albumin, fructosamine, 1,5‐anhydroglucitrol, and continuous glucose monitoring. Objectives: To describe the interrelationships of glycemic control measures: hemoglobin A1c (HbA1c), glycated albumin, fructosamine, 1,5‐anhydroglucitrol (1,5‐AG), and continuous glucose monitoring (CGM) in children and adolescents with type 1 diabetes. Methods: In total, 26 subjects of age 4–17 had HbA1c measurement followed within 14 d by three laboratory measures of glycemia and the collection of CGM glucose data (N = 21). Results: Glycated albumin and fructosamine levels had a higher correlation with each other than with HbA1c. The correlation of 1,5‐AG with HbA1c was lower (absolute r value = 0.25). All four measures had a similar degree of correlation with CGM‐measured mean glucose (absolute r value = 0.50–0.56) and with hyperglycemic area under the curve (AUC) at 180 mg/dL (0.50–0.60). Conclusion: Each of the four measures (i.e., HbA1c, glycated albumin, fructosamine, and 1,5‐AG) had a similar correlation with mean glucose and hyperglycemic AUC‐180. 1,5‐AG did not correlate with hyperglycemic AUC‐180 better than did HbA1c.     

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.     

Life with continuous subcutaneous insulin infusion (CSII) therapy: child and parental perspectives and predictors of metabolic control

Abstract: Objective: The purpose of this study was twofold (i): to evaluate metabolic control in patients receiving CSII therapy in a routine pediatric diabetes clinic by describing reasons for initiating therapy and daily management issues, including needle fear; and (ii) to assess the change in parental involvement and anxiety once their child initiated CSII therapy. Research design and methods: The study included 52 subjects (aged 7.6–23.6 yr) from a general pediatric diabetes clinic. Management issues were defined as diet, exercise, home blood glucose monitoring (HBGM) frequency, and self/staff assessment of needle fear. Characteristics were analyzed both according to a 0.5% change in HbA1c status (decreased vs. stable vs. increased) compared with pre‐CSII therapy, and final HbA1c achieved (≤ 8.1 vs. > 8.1%). Results: The primary recommendation source for CSII use was most often the physician/diabetes team (48.1%), followed by a combination of the former with a personal referral source (32.7%). The most common reason (71.2%) for CSII initiation was a combination of wanting to achieve better metabolic control, dislike of insulin injections, and/or increased flexibility in daily living. Over one‐quarter (26.9%) of subjects were identified as being needle‐fearful, and this characteristic was predictive of final metabolic control (3/25 subjects ≤ 8.1% vs. 11/27 subjects > 8.1%, p = 0.03). On CSII therapy, dietary carbohydrate consistency was highly variable, and most subjects (65.3%) exclusively used an insulin to carbohydrate ratio for insulin bolus dosage calculation. The most common adjustment strategy (63.5%) for exercise was a combination of decreasing the insulin basal rate, disconnecting the pump, and/or eating extra carbohydrates. For the total cohort, the frequency of HBGM significantly increased on CSII therapy (4.31–4.85 tests/day, p = 0.02). Females did not have a significant change in HBGM frequency, while the youngest subjects had the highest HBGM frequency. Parental involvement and anxiety primarily stayed the same or decreased, regardless of the child's age (≤ 18 vs. > 18 yr) or metabolic control. Conclusions: Analyses of the various characteristics identified only needle fearfulness as being predictive of poor metabolic control. Interestingly, poor control with CSII therapy did not result in a significant increase in parental involvement and/or anxiety.     

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.     

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.     

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.     

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.     

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目的应用动态血糖监测系统(CGMS)观察1型糖尿病患儿血糖控制情况,寻找评价和改善血糖控制的方法。方法收集复旦大学附属儿科医院2003年10月至2004年6月内分泌科门诊随访的儿童1型糖尿病患者28例,男16例,女12例,年龄(13.1±4.5)岁,病程(5.5±3.4)年,其中21例采用每天多次胰岛素注射(MDI),另7例使用胰岛素泵连续胰岛素输注(CSII)治疗。动态监测血糖3d,同时指尖血糖监测≥4次/d。结果(1)研究对象体重指数(BMI)为(19.4±3.0)kg/m2,糖化血红蛋白(HbA1c)为(8.4±1.6)%。CSII组HbA1c(8.2±1.0)%,MDI组HbA1c(8.5±1.8)%,差异有显著性意义(P<0.05);(2)CGMS发现22例77次餐后2h高血糖,CSII组4例(57.1%),每例出现1次,MDI组18例(85.7%),每例出现(4.1±2.5)次,差异显著(P<0.01);(3)CGMS发现17例79次低血糖,持续时间(76.6±92.8)min,而指尖血糖监测仅发现19次低血糖;白天低血糖持续时间(41.5±39.1)min,夜间(112.4±117.1)min,夜间低血糖持续时间显著长于白天(P<0.01)。(4)HbA1c≤8%组餐后高血糖发生率低于HbA1c>8%组(P<0.05),而低血糖的发生率显著升高(P<0.01)。结论1型糖尿病患儿多数存在低血糖和餐后高血糖;动态血糖监测系统是发现血糖异常波动的有效工具。动态血糖监测对指导1型糖尿病治疗,调整胰岛素剂量,从而改善血糖控制有着重要的临床意义。     

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.