Continuous glucose monitoring-guided insulin adjustment in children and adolescents on near-physiological insulin regimens - A randomized controlled trial

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 I 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) < 10% 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 AIC was measured at 6 months. Mean baseline A1C was 8.2% (n = 19) in the CGMS group and 7.9% (n = 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 AIC at 12 weeks between the CGMS (-0.4% [95% CI -0.7 to -0.1]) and the control group (-0.4% [-0.8 to 0.2]). In the CGMS group, improved AIC 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 near-physiological insulin regimens when used in an outpatient clinic setting.