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

A randomized controlled trial

¹ Institute of Endocrinology and Diabetes, The Children’s Hospital at Westmead, Westmead, NSW, Australia
² Centre for Clinical Epidemiology and Biostatistics, University of Newcastle, Newcastle, Australia
³ National Centre for Epidemiology and Population Health, Australian National University, Canberra, Australia

Address correspondence and reprint requests to Kylie Yates, MBBS, FRACP, Institute of EndocrinologyDiabetes, The Children’s Hospital, Westmead, Locked Bag 4001, Westmead, NSW 2145, Australia. E-mail: kyliey{at}chw.edu.au

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) <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 A1C 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 A1C 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 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 near-physiological insulin regimens when used in an outpatient clinic setting.

Abbreviations: BGL, blood glucose level • CGMS, continuous glucose monitoring system • CSII, continuous subcutaneous insulin infusion • MDI, multiple daily doses of insulin • SMBG, self-monitoring of blood glucose

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