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.     

A 2-yr national population study of pediatric ketoacidosis in Sweden: predisposing conditions and insulin pump use

Abstract:  The aim was to investigate triggering factors and insulin pump usage (continuous subcutaneous insulin infusion, CSII) at diabetic ketoacidosis (DKA). Data from 1999 and 2000 were collected retrospectively from Sweden. In 1999 and 2000, 7.4 and 11.0%, respectively, of children with diabetes used CSII. One hundred and forty-two episodes of DKA (pH < 7.30) were identified in 115 children (DKA at onset not included). Their hemoglobin A1c (HbA1c) was 10.1 ± 2.0%, age 14.6 ± 3.1 yr (range 1.5–19.9 yr), and diabetes duration 6.6 ± 3.5 yr (range 0.4–17.7 yr). Fourteen persons (seven girls) had more than one episode of DKA. Reported causes of DKA were missed insulin doses (48.6%), gastroenteritis (14.1%), technical pump problems (12.7%), infection (13.4%), social problems (1.4%), unknown (5.6%), and not stated (4.2%). Alcohol was involved in eight episodes and drugs in one. Thirty of 115 patients (19 girls) used insulin pumps. The overall DKA incidence was 1.4/100 patient years in 1999 and 1.7/100 patient years in 2000. For insulin pump users, the DKA incidence was 3.2/100 patient years in 1999 and 3.6/100 patient years in 2000. HbA1c at DKA admission was lower for CSII users than patients who used injections (9.1 ± 1.5 vs. 10.8 ± 2.2%, p < 0.01), but pH and age did not differ. CSII had been used for 6 months (median) before the DKA episode. In conclusion, the DKA frequency in CSII users was approximately twice that of patients who used injections. Seventy-seven percent of the episodes occurred within 1 yr after CSII start. The high number of events reported to be caused by gastroenteritis is alarming because this may reflect a misinterpretation of DKA symptoms.     

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.     

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.     

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.     

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.     

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...     

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.     

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.     

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.     

Multinational study in children and adolescents with newly diagnosed type 1 diabetes: association of age,ketoacidosis, HLA status,and autoantibodies on residual beta‐cell function and glycemic control 12 months after diagnosis

HB Mortensen, PGF Swift, RW Holl, P Hougaard, L Hansen, H Bjoerndalen, CE de Beaufort, M Knip. Multinational study in children and adolescents with newly diagnosed type 1 diabetes: association of age, ketoacidosis, HLA status, and autoantibodies on residual beta‐cell function and glycemic control 12 months after diagnosis. Objective: To identify predictors of residual beta‐cell function and glycemic control during the first 12 months after the diagnosis of type 1 diabetes (T1D). Subjects and Methods: Clinical information and blood samples were collected from 275 children. HbA1c, antibodies, HLA typing and mixed meal‐stimulated C‐peptide levels 1, 6, and 12 months after diagnosis were analyzed centrally. Results: Mean age at diagnosis was 9.1 yr. DKA with standard bicarbonate <15 mmol/L was associated with significantly poorer residual beta‐cell function 1 (p = 0.004) and 12 months (p = 0.0003) after diagnosis. At 12 months, the decline in stimulated C‐peptide levels compared with the levels at 1 month was 69% in the youngest age group and 50% in patients 10 yr and above (p < 0.001). Stimulated C‐peptide at 12 months was predicted by younger age (p < 0.02) and bicarbonate levels at diagnosis (p = 0.005), and by stimulated C‐peptide (p < 0.0001), postmeal blood glucose (p = 0.0004), insulin antibodies (IA; p = 0.02) and glutamic acid decarboxylase antibodies (GADA; p = 0.0004) at 1 month. HbA1c at 12 months was predicted by HbA1c at diagnosis (p < 0.0001), GADA at 1 month (p = 0.01), and non‐white Caucasian ethnicity (p = 0.002). Conclusions: Younger age, ketoacidosis at diagnosis, and IA and GADA 1 month after diagnosis were the strongest explanatory factors for residual beta‐cell function at 12 months. Glycemic control at 12 months was influenced predominantly by ethnicity, HbA1c at diagnosis, and GADA at 1 month.     

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.     

Hypoglycemia and ketoacidosis with insulin pump therapy in children and adolescents

Abstract:  This review deals with the two most serious side effects encountered with insulin pump therapy, severe hypoglycemia and diabetic ketoacidosis (DKA). Although clinical follow-up studies reported decreased rates of severe hypoglycemia, randomized studies have not confirmed this, showing no difference between the pump and injection groups. Less-severe hypoglycemia (mild/moderate/symptomatic hypoglycemia) was found to be more common with pump use. Some patients have inadvertently dosed or overdosed while awake or during sleep, causing fatal outcome in rare cases. Population-based or retrospective clinical studies reported a low rate of DKA in pump users that was still a higher rate than those using injection therapy, at least in some countries. In research settings and for patients with good compliance and adequate family support, the risk of DKA seems lower; many short-term studies report no DKA at all, possibly due to the increased attention given to participants. The use of continuous subcutaneous insulin infusion (CSII) seems to decrease the risk in patients who had recurrent DKA before pump start. Most episodes of DKA occur early after pump start, suggesting a learning curve occurs in all new forms of treatment. Increased teaching and awareness programs are vital to prevent severe hypoglycemia and DKA in children and adolescents using insulin pumps.     

Lower HbA1c after 1 year, in children with type 1 diabetes treated with insulin glargine vs. NPH insulin from diagnosis: a retrospective study

Salemyr J, Bang P, Örtqvist E. Lower HbA1c after 1 year, in children with type 1 diabetes treated with insulin glargine vs. NPH insulin from diagnosis: a retrospective study. Objective: Insulin glargine offers sustained insulin delivery for 24 h. Change to glargine treatment consistently results in lower fasting glucose and fewer hypoglycemic episodes in children with type 1 diabetes compared to continuation of NPH, although glargine has not been shown to improve HbA1c in randomized trials. Studies comparing glargine and NPH in multiple injection therapy in children treated from diagnosis of type 1 diabetes are lacking. Methods: HbA1c and insulin requirement were compared in a retrospective study of children (7–17 yr of age) with type 1 diabetes treated from diagnosis with basal insulin glargine (n = 49) or NPH (n = 49) in a multiple injection therapy (MIT) regimen with a rapid‐acting insulin analogue. Patients were followed every third month for 1 yr. HbA1c, insulin dose, and weight data were retrieved. Results: HbA1c (mean ± SD) was lower at 3–5 months (5.5 ± 0.89 vs. 6.2 ± 0.89%, p < 0.05) and 6–9 months (5.6 ± 1.14 vs. 6.6 ± 0.99%; p < 0.001) in glargine treated. After 12 months, HbA1c was significantly lower in glargine treated (6.3 ± 1.56 vs. 7.1 ± 1.28; p < 0.01). Reported total insulin doses were similar at nadir (0.5 U/kg BW × 24 h), but significantly lower at 12 months in glargine treated (0.64 ± 0.23 vs. 0.86 ± 0.3 U/kg BW × 24 h; p < 0.001). Conclusions: HbA1c 1 yr from diagnosis was lower in children treated with glargine from start as compared with those on NPH. This observation should be viewed in the light of a significantly lower dose of total daily insulin in the glargine 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.     

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.     

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.     

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.     

Effect of Carelink, an internet-based insulin pump monitoring system, on glycemic control in rural and urban children with type 1 diabetes mellitus

Objective:  To determine whether use of the internet-based insulin pump monitoring system, Carelink, improved glycemic control in rural and urban children treated with insulin pump therapy.
Research design:  We reviewed records of 94 children treated with insulin pump therapy between the years 2004 and 2007 and compared glycemic control, diabetes self-care measures, frequency of clinic visits, and geographic location associated with Carelink use.
Results:  Carelink users showed improvement in hemoglobin A1c (HbA1c) levels [8.0 ± 0.1 (SE) vs. 7.7 ± 0.1 (SE), p = 0.002]. Carelink users uploaded pump and glucometer data 2.2 ± 1.8 (SD) times per month over 0.8 ± 0.4 (SD) yr. Patients who had no access to carelink software and were followed in a conventional manner showed no change in HbA1c levels [8.0 ± 0.2 (SE) vs. 8.1 ± 0.2 (SE), p = 0.17] during the study period. Carelink non-users, defined as patients who had Carelink access but did not use it, had a higher HbA1c level at the start of the study and did not change over the study period [8.9 ± 0.2 (SE) vs. 9.0 ± 0.3 (SE), p = 0.82]. Rural Carelink users showed improvement in HbA1c levels following Carelink use [7.9 ± 0.2 (SE) vs. 7.4 ± 0.2 (SE), p = 0.001], yet had significantly fewer clinic visits per year compared with urban patients [2.8 ± 0.2 (SE) vs. 3.5 ± 0.1 (SE), p = 0.001].
Conclusion:  Use of the Carelink system was associated with improved glycemic control in children with type 1 diabetes on insulin pump therapy.