Months Of Continuous Subcutaneous Insulin Infusion Research Articles

Glucose Variability Assessed by Low Blood Glucose Index Is Predictive of Hypoglycemic Events in Patients With Type 1 Diabetes Switched to Pump Therapy

OBJECTIVETo determine whether subgroups of type 1 diabetic patients with different glucose variability indices respond differently to continuous subcutaneous insulin infusion (CSII) in terms of reduced hypoglycemic events.RESEARCH DESIGN AND METHODSWe studied 50 adults with long-standing type 1 diabetes switched to CSII because of persistently high A1C or frequent hypoglycemia despite well-managed intensive basal-bolus therapy. We compared A1C, hypoglycemic events, and glucose variability from self-monitoring of blood glucose profiles at baseline and after 6 months of CSII. Regression analysis was performed to identify predictors of response.RESULTSIn multivariate analysis, baseline low blood glucose index (LBGI) was the best independent predictor of hypoglycemia outcome on CSII (R2 = 0.195, P = 0.0013). An ROC curve analysis demonstrated a sensitivity of 70.8% (95% CI 48.9–87.4) and specificity of 73.1% (52.2–88.4) by using the LBGI cutoff of 3.34 as predictor of reduction of hypoglycemia on CSII. By grouping patients by LBGI tertiles, we found a 23.3% reduction in hypoglycemic events (<60 mg/dL [3.3 mmol/L]) in the third tertile (range 4.18–9.34) without change in A1C (P < 0.05). Conversely, the first tertile (range 0.62–2.05) demonstrated the greatest A1C reduction, −0.99% (P = 0.00001), but with increasing hypoglycemia.CONCLUSIONSBaseline LBGI predicts the outcome of type 1 diabetic patients who switch to CSII in terms of hypoglycemia.

Insulin Therapy with Personal Insulin Pumps and Early Angiopathy in Children with Type 1 Diabetes Mellitus

Objective. Assessment of the effect of a treatment method change from multiple daily insulin injection (MDI) to continuous subcutaneous insulin infusion (CSII) on the development of early angiopathy in children with T1DM with or without retinopathy. Methods. The study pump group involved 32 diabetic children aged 14.8, with the initial HbA1c level of 8.3%, previously treated by MDI. The patients were examined before pump insertion and after 3 and 6 months of CSII. We assessed HbA1c level, carotid artery intima-media thickness (c-IMT), and flow-mediated dilatation (FMD) of the brachial artery. The pump group was compared to a group of eight teenagers with diagnosed nonproliferative retinopathy, treated with MDI. Results. HbA1c in the entire group was found to improve in the second and in the third examination. During 6 months of CSII, FMD increased and IMT decreased. Retinopathic adolescents had significantly thicker IMT and lower FMD compared to baseline results of the pump group. Treatment intensification in the retinopathy-free children enhanced these differences. Conclusions. CSII is associated with lower IMT and higher FMD. Whether on the long-run CSII is superior to MDI to delay the occurrence of diabetes late complications remains to be explained.

The impact of continuous subcutaneous insulin infusion and multiple daily injections of insulin on glucose variability in older adults with type 2 diabetes

AimsTo determine whether continuous subcutaneous insulin infusion (CSII) or multiple daily injections of insulin (MDI) are associated with improved glycemic variability. MethodsType 2 diabetic patients ≥60 years of age were randomized to 12 months of CSII (n=53) or MDI (n=54) therapy. Patients were asked to complete monthly eight-point self-monitored glucose profiles (n=78) and continuous glucose monitoring systems (CGMS) for up to 72 h at Months 0, 6, and 12 (n=77). Within-day mean glucose, standard deviation (SD), range, pre- and post-prandial glucose, M value, and mean amplitude of glycemic excursions (MAGE) were calculated from eight-point profiles. Mean glucose, SD, range, area under the curve (AUC) high (>180 mg/dl) and AUC-low (<70 mg/dl) were calculated from CGMS. Mixed model analyses of variance were used to examine the associations between treatment, time, and the study outcomes, adjusting for any effects of sex. ResultsWith the use of the eight-point profiles, CSII and MDI groups did not differ with respect to mean glucose, mean pre-prandial and post-prandial glucose, SD, range, M value, or MAGE. With the CGMS data, there were no significant between-group differences in measures of mean glucose, range, SD, AUC-high, or AUC-low. In both treatment groups, all measures improved over time (P<.0001) except for AUC-low (P=.68) which did not change. There were treatment-by-time interactions when considering the CGMS range (P=.04) and AUC-high (P=.001), but no significant differences were found at individual time points. ConclusionsGlucose variability improved equally with CSII and MDI treatment in older patients with type 2 diabetes.

Sustained Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Subjects with Recurrent Non-Severe and Severe Hypoglycemia and Hypoglycemia Unawareness: A Pilot Study

This study evaluated the effect of CSII on hypoglycemia awareness and on glucose profile in type 1 diabetes (T1D) subjects with repeated non-severe or severe hypoglycemia (NS or SH, respectively). We included subjects (1) older than 18 years, (2) with T1D duration of >5 years, (3) on multiple doses of insulin, and (4) without micro- or macrovascular complications and more than four NS events per week (in the last 8 weeks) and more than two SH events (in the last 2 years). NS/SH episodes and hypoglycemia awareness were evaluated. A 72-h continuous glucose monitoring (CGM) was performed before continuous subcutaneous insulin infusion (CSII). A hypoglycemia-induced test was used to evaluate each patient's symptoms in euglycemia/hypoglycemia. Quality of life (QoL) was also evaluated. After 6, 12, and 24 months, all the subjects were reevaluated. Twenty subjects were included (34.0 +/- 7.5 years old, 12 women, A1c 6.7 +/- 1.1%, 16.2 +/- 6.6 years of diabetes' duration). At baseline, 19 out of 20 subjects displayed hypoglycemia unawareness, which diminished significantly during the follow-up (3 out of 20). NH episodes per week diminished from 5.40 +/- 2.09 at baseline to 2.75 +/- 1.74 at the end of the follow-up (P < 0.001). SH episodes fell from 1.25 +/- 0.44 per subject-year to 0.05 +/- 0.22 after 24 months (P < 0.001). Hemoglobin A1c remained unaltered. With CGM, the percentage of values within 70-180 mg/dL increased (53.2 +/- 11.0% to 60.3 +/- 17.1%, P = 0.13), and the percentage of values <70 mg/dL decreased (13.7 +/- 9.4% to 9.1 +/- 5.2%, P = 0.07), after 24 months. Mean amplitude of glycemic excursions diminished after 24 months of CSII (136 +/- 28 mg/dL to 115 +/- 19 mg/dL; P < 0.02). An improvement in all the aspects of QoL was observed. The basal alteration in symptom response to an induced hypoglycemia improved after 24 months of initiating CSII leading to a response indistiguishable from that observed in a control group of subjects with T1D without repeated NH and SH. CSII prevents hypoglycemic episodes, improves hypoglycemia awareness, and ameliorates glycemic profile in T1D subjects with repeated NS/SH. Its use is also associated with an improvement in diabetes QoL.

Reduction of Glycosylated Hemoglobin Following 6 Months of Continuous Subcutaneous Insulin Infusion in an Indian Population with Type 2 Diabetes

The standard treatment regimen for insulin-dependent type 2 diabetes is multiple daily injections (MDI) of insulin, but continuous subcutaneous insulin infusion (CSII) with an insulin pump offers more flexibility and the possibility of a reduced total daily insulin dose. Few studies have investigated CSII for type 2 diabetes, and none has focused on an Asian Indian population. Subjects with type 2 diabetes who were previously using MDI were switched to CSII. Glycosylated hemoglobin (HbA1c), body weight, and total daily insulin dose were recorded at baseline (MDI) and after 6 months of CSII. Subjects were also asked to rate their satisfaction with CSII and the treatment's interference in their daily activities after 6 months. A total of 46 subjects received CSII. Mean HbA1c was reduced by 0.5% after 6 months. This outcome was statistically significant (P < 0.0063; 95% confidence interval, 0.161-0.921%). There was no statistically significant change in body weight or total insulin daily dose. Subjects reported high satisfaction with CSII and low interference with daily activities. Six months of CSII in Asian Indian subjects with type 2 diabetes resulted in a statistically and clinically significant change in HbA1c.

Efficacy of continuous subcutaneous insulin infusion in Type 1 diabetes: a 2‐year perspective using the established criteria for funding from a National Health Service

To determine the 2-year efficacy of continuous subcutaneous insulin infusion (CSII) following the current established criteria for funding of a National Health Service. Longitudinal, prospective, observational unicentre study. Included in the study were 153 Type 1 diabetes (T1D) subjects, previously treated with multiple daily injections (MDI) of insulin, in whom CSII was started in accordance with the criteria for reimbursement of the Catalan National Health Service. At baseline, we recorded data on age, gender, duration of the disease, body mass index (BMI), insulin dose and indications for CSII. Glycated haemoglobin (HbA(1c)) and the frequency of hypoglycaemic events were used to assess glycaemic control. Quality of life was assessed using three different self-report questionnaires. After 24 months, these same items were remeasured in all subjects. Serious adverse events and injection-site complications were also recorded. In 96% of subjects, CSII indication included less than optimal glycaemic control using MDI. HbA(1c) fell from 7.9 +/- 1.3 to 7.3 +/- 1.1% (P < or = 0.001) after 24 months of CSII. Insulin requirements were significantly lower at the end of follow-up (0.55 +/- 0.21 U/kg body weight) in comparison with before use of CSII (0.70 +/- 0.20, P < or = 0.001). BMI increased from 24.0 +/- 3.1 to 24.4 +/- 3.2 kg/m(2) after 24 months (P < or = 0.025). The rate of episodes of diabetic ketoacidosis per year remained unchanged. Mild and severe hypoglycaemic episodes were significantly reduced. The scores in all subsets of the Diabetes Quality-of-Life (DQoL) questionnaire significantly improved after 24 months of CSII. CSII, commenced according to the criteria for a nationally funded clinical programme, improves glycaemic control and quality-of-life outcomes with fewer hypoglycaemic episodes in T1D subjects previously conventionally treated with MDI.

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

To evaluate the safety and efficacy of continuous subcutaneous insulin infusion (CSII) in children under 7 years of age. 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. 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. In the youngest children, CSII therapy lowers HbA1c values and provides sustained metabolic control without increases in hypoglycaemia or ketoacidosis episodes.

Persistence of Benefits of Continuous Subcutaneous Insulin Infusion in Very Young Children With Type 1 Diabetes: A Follow-up Report

Use of continuous subcutaneous insulin infusion (CSII) has increased dramatically in recent years, and pump therapy has been shown to be a safe and effective alternative to multiple daily injections in adults and older pediatric patients with type 1 diabetes. Its use in very young children, however, has been limited, although this group might be expected to benefit the most from CSII. The objective of this study was to analyze the CSII efficacy and safety data in very young children with type 1 diabetes from our Diabetes Clinic database. Glycosylated hemoglobin (HbA1c), severe hypoglycemia (SH), and ketoacidosis (DKA) in the year before CSII were compared with corresponding values during pump treatment in all children who started CSII before age 7. Sixty-five children (mean age: 4.5 y at CSII initiation; range: 1.4-6.9 years; 28 girls; 3 black, 1 Hispanic) were analyzed for >162 patient-years of follow-up. Mean HbA(1c) (7.4 +/- 1.0 prepump) decreased to 7.0 +/- 0.9 after 12 months of CSII and continued to improve even after 4 years on CSII. The rate of SH was reduced by 53% (from 78 to 37/100 patient-years). Children who received daytime care from paid caregivers (n = 26) experienced significant reductions in HbA1c and hypoglycemia frequency. There were no episodes of DKA requiring emergency treatment in the year before CSII and 4 episodes (4 per 100 patient-years) after transition to pump. CSII is a durable and effective means of optimizing glycemic control in very young patients with type 1 diabetes and may be superior to multiple daily injections in minimizing the risk of severe hypoglycemia in this age group. Employment of paid caregivers does not preclude safe and effective use of CSII.

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.

Comparison of Continuous Subcutaneous Insulin Infusion and Multiple Daily Injection Regimens in Children With Type 1 Diabetes: A Randomized Open Crossover Trial

To compare the efficacy and feasibility of continuous subcutaneous insulin infusion (CSII) with multiple daily insulin injections (MDI) in children with type 1 diabetes. The study sample included 23 children (10 males) aged 9.4 to 13.9 years with type 1 diabetes. An open randomized crossover design was used to compare 3.5 months of CSII to 3.5 months of MDI therapy for the following variables: diabetic control, incidence of adverse events, daily insulin requirement, body mass index standard deviation scores, treatment satisfaction, and quality of life. The changes in HbA(1c) and fructoseamine values were similar in the 2 arms over time. At the end of the study, mean HbA(1c) level measured 8.05 +/- 0.78%. There were no differences between the treatment modes in frequency of symptomatic hypoglycemic or hyperglycemic events. There was 1 event of severe hypoglycemia during pump therapy and 3 during MDI, yielding a rate of 0.26 events per patient-year. There were no episodes of diabetic ketoacidosis. Body mass index standard deviation scores decreased during CSII and increased during MDI, as did mean insulin dose. Patients expressed a higher treatment satisfaction from CSII than MDI, although there was no difference in quality of life between the 2 modes. Intensive insulin therapy by either insulin pump or MDI is safe in children and young adolescents with type 1 diabetes, with similar diabetes control and a very low rate of adverse events. We suggest that both modes be available to the diabetic team to better tailor therapy.

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

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. All patients < or = 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. 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). 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.

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.

The effect of continuous subcutaneous insulin infusion on insulin binding to erythrocytes in diabetes mellitus

The effect of continuous subcutaneous insulin infusion (CSII) on glycaemic control and insulin binding to erythrocytes was studied in six diabetic patients. A marked improvement in blood glucose control during CSII was observed in these patients previously on conventional therapy. Specific 125I-insulin binding to erythrocytes of the diabetics before the institution of CSII was significantly lower than that of age-, weight- and sex-matched nondiabetic subjects, 6.5 +/- 0.1% vs. 9.8 +/- 0.3% (P less than 0.05). After 4-6 months of CSII, insulin binding was restored to normal levels. This normalization in insulin binding to erythrocytes of patients on CSII was due to a 35% increase in active binding sites, together with a small change in binding affinity.