title: Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial.
abstract: BACKGROUND
  Tight glycemic control delays the long-term complications of type 1 diabetes mellitus (T1DM) but increases the risk for hypoglycemia. The continuous glucose-monitoring system (CGMS) provides blood glucose (BG) readings every 5 min, and its accuracy and reliability has been established in adults. However, there are limited data on its efficacy and safety in children. The purpose of this study was to determine if CGMS use improves metabolic control in children with T1DM.
  
  
  METHODS
  Twenty-seven children (12 male) with T1DM participated in this single-blind, randomized, controlled trial. Participants (age: 11.4 +/- 3.7 (mean +/- SD) yr, range: 7-17 yr) were randomized to an intervention group (n = 18) or a control group (n = 9). Both groups wore the CGMS for 72-h periods at 0, 2, and 4 months. Adjustments in therapy for the intervention group were based on both CGMS and self-monitoring of BG (SMBG) data, while only SMBG data were used for the control group. Hemoglobin A1c (HbA1c) was determined at 0, 2, 4, and 6 months. The change in HbA1c from 0 to 6 months (HbA1c(Delta1-4)) and mean daily area under the CGMS curve for glucose <70 mg/dL area under the curve (AUC(<70)) were compared between groups.
  
  
  RESULTS
  At study entry, HbA1c levels were similar in the intervention and control groups (8.4 +/- 0.98 and 8.8 +/- 0.86%, respectively; p = 0.12) but were significantly lower in the intervention group compared with the control group at study completion (7.8 +/- 0.88 and 8.6 +/- 0.95%, respectively; p = 0.02). The decrease in HbA1c of 0.61 +/- 0.68% in the intervention group was statistically significant (p = 0.03), whereas the decrease in HbA1c of 0.28 +/- 0.78% in the control group was not. Nonetheless, the differences in HbA1c(Delta1-4) between groups did not reach statistical significance (p = 0.13). There was no statistically significant difference in AUC(<70) between study groups (p = 0.18).
  
  
  CONCLUSIONS
  CGMS use may improve metabolic control in children with T1DM without increasing the risk for hypoglycemia.
authors.affiliation: Department of Pediatrics, The University of North Carolina at Chapel Hill, NC 27599-7039, USA.
authors.forename: William H
authors.initials: WH
authors.lastname: Lagarde
authors.forename: Frank P
authors.initials: FP
authors.lastname: Barrows
authors.forename: Marsha L
authors.initials: ML
authors.lastname: Davenport
authors.forename: Minsun
authors.initials: M
authors.lastname: Kang
authors.forename: Harry A
authors.initials: HA
authors.lastname: Guess
authors.forename: Ali S
authors.initials: AS
authors.lastname: Calikoglu
mesh_terms: D000293:Adolescent; D019540:Area Under Curve; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods*; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000175:diagnosis; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007003:Hypoglycemia / Q000517:prevention & control*; D008297:Male; D016037:Single-Blind Method
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin