Long-Term Use of Continuous Subcutaneous Insulin Infusion Compared with Multiple Daily Injections of Glargine in Pediatric Patients

Abstract

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 Ai c 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).

Clinical effectiveness and cost-effectiveness of continuous subcutaneous insulin infusion for diabetes: systematic review and economic evaluation

“…Pickup et al (2006) 139 reported that 37% of CSII subjects and 13% of MDI ones achieved HbA 1c < 7%; for a target of < 8%, the proportions were 73% and 30%. Radermecker et al (2005) 143 noted that of 95 patients on CSII, only five reached HbA 1c of 7% or less; most (66) 167 (n = 8) the increases of 0.01% and 0.08%, respectively, were neither clinically or statistically significant. The statistical significance level was not reported in Variety of reasons for discontinuing pumpusually multiple reasons; including, dislike or difficulty with needle insertion (n = 3), insurance difficulties (n = 2), trouble keeping the infusion site clean (n = 2), tape not adhering (n = 2) and general dislike of the pump (n = 2) Reasons for discontinuing: major problems (n = 8, DKA, insulin omission); diabetes burnout (n = 8); minor problems (n = 6, infusion site problems), body image concerns (n = 4); concerns about weight gain (n = 3) 3.8 years 159 (n = 12), where the increase was 0.6%.…”

“…Among adults and mixed age groups, planning for pregnancy or during pregnancy [140][141][142][143] 164 minimum duration of diabetes 167,168 and daily insulin requirement of more than 0.75 units/kg. 167 One study reported that patients were excluded if in the honeymoon phase.…”

“…[Cersosimo et al 2002, 169 Pickup et al 138 and Garcia-Garcia et al)]. 167,168 Several studies described intensive training/ education of participants and their families. 101,140,144,146,147,152,[154][155][156][157][158][159][160][161][162][164][165][166][170][171][172][173][174] Some training programmes included the use of a dummy saline pump.…”

“…149,151,152,155,158,160,[166][167][168]171,173 One study 167 had no SH before or after going on pumps. Of the remaining 10 studies, the overall rate ratios varied from 0.12 to 0.80.…”

Prevention of Hypoglycemia While Achieving Good Glycemic Control in Type 1 Diabetes

“…In the era of soluble long-acting analogs, MDI is no longer inferior to CSII in terms of A1C and frequency of hypoglycemia (73)(74)(75)(76). CSII has the theoretical advantage of lower variability compared with MDI, but so far this has been difficult to prove.…”