Continuous Glucose Monitoring–Guided Insulin Adjustment in Children and Adolescents on Near-Physiological Insulin Regimens

Abstract

OBJECTIVE -This randomized controlled trial assesses the effect on glycemic control of continuous glucose monitoring system (CGMS)-guided insulin therapy adjustment in young people with type 1 diabetes on intensive diabetes treatment regimens with continuous subcutaneous insulin infusion (CSII) or glargine.RESEARCH DESIGN AND METHODS -Pediatric subjects were recruited if they had an HbA 1c (A1C) Ͻ10% and had been on CSII or glargine for at least 3 months. Thirty-six subjects were randomized to insulin adjustment on the basis of 72 h of CGMS every 3 weeks or intermittent self-monitoring of blood glucose (SMBG) for 3 months. A1C and fructosamine were measured at baseline and 6 and 12 weeks. Follow-up A1C was measured at 6 months. Mean baseline A1C was 8.2% (n ϭ 19) in the CGMS group and 7.9% (n ϭ 17) in the control group.RESULTS -There was a significant improvement in A1C from baseline values in both groups, but there was no difference in the degree of improvement in A1C at 12 weeks between the CGMS (Ϫ0.4% [95% CI Ϫ0.7 to Ϫ0.1]) and the control group (Ϫ0.4% [Ϫ0.8 to 0.2]). In the CGMS group, improved A1C was at the cost of increased duration of hypoglycemia.CONCLUSIONS -CGMS is no more useful than intermittent fingerstick SMBG and frequent review in improving diabetes control in reasonably well-controlled patients on nearphysiological insulin regimens when used in an outpatient clinic setting.

Continuous Glucose Monitoring System in children with type 1 diabetes mellitus: a systematic review and meta-analysis

“…Table 1 summarises characteristics of the included trials. Five RCTs involving 131 participants met our predefined inclusion criteria [15][16][17][18][19]; the remaining 20 studies were excluded [7,[11][12][13][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]. Table 2 summarises the characteristics of excluded trials, including reasons for exclusion.…”

“…All included trials were small, one-centre studies; two of them were performed in Europe [15,16], two in the USA [17,19] and one in Australia [18]. Three of the included trials [17][18][19] had parallel-group design and two others [15,16] were crossover.…”

“…Three of the included trials [17][18][19] had parallel-group design and two others [15,16] were crossover. There was considerable clinical heterogeneity among the trials with regard to the children's age, diabetes duration, frequency of CGMS use and insulin adjustments.…”

“…Depending on the trial, patients had to wear CGMS: every 5 days [17], every 2 weeks [16], every 3 weeks [18], every 2 months [19] or once during a 3 month period [15]. We also found significant differences in the frequency of insulin changes: >11 times during 1 month (experimental group only) [17], every 3 weeks [18], every 6 weeks [16] and every 2 months [19]. Follow-up periods extended up to 3 months in three trials [15][16][17] and up to 6 months in the other two trials [18,19].…”

“…Yet, these values differed from the summarised results presented by the authors. In another study [18], standard deviations of HbA 1c changes were obtained from 95% CIs, using the formula: SD=√N×(upper limit−lower limit)/3.92 [14]. Two trials [15,16] did not report data on standard deviations of changes in HbA 1c .…”