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Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial.
Pediatr Diabetes. 2006 Jun; 7(3):159-64.PD

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).

CONCLUSION

CGMS use may improve metabolic control in children with T1DM without increasing the risk for hypoglycemia.

Authors+Show Affiliations

Department of Pediatrics, The University of North Carolina at Chapel Hill, NC 27599-7039, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

16787523

Citation

Lagarde, William H., et al. "Continuous Subcutaneous Glucose Monitoring in Children With Type 1 Diabetes Mellitus: a Single-blind, Randomized, Controlled Trial." Pediatric Diabetes, vol. 7, no. 3, 2006, pp. 159-64.
Lagarde WH, Barrows FP, Davenport ML, et al. Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial. Pediatr Diabetes. 2006;7(3):159-64.
Lagarde, W. H., Barrows, F. P., Davenport, M. L., Kang, M., Guess, H. A., & Calikoglu, A. S. (2006). Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial. Pediatric Diabetes, 7(3), 159-64.
Lagarde WH, et al. Continuous Subcutaneous Glucose Monitoring in Children With Type 1 Diabetes Mellitus: a Single-blind, Randomized, Controlled Trial. Pediatr Diabetes. 2006;7(3):159-64. PubMed PMID: 16787523.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial. AU - Lagarde,William H, AU - Barrows,Frank P, AU - Davenport,Marsha L, AU - Kang,Minsun, AU - Guess,Harry A, AU - Calikoglu,Ali S, PY - 2006/6/22/pubmed PY - 2006/12/9/medline PY - 2006/6/22/entrez SP - 159 EP - 64 JF - Pediatric diabetes JO - Pediatr Diabetes VL - 7 IS - 3 N2 - 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). CONCLUSION: CGMS use may improve metabolic control in children with T1DM without increasing the risk for hypoglycemia. SN - 1399-543X UR - https://www.unboundmedicine.com/medline/citation/16787523/Continuous_subcutaneous_glucose_monitoring_in_children_with_type_1_diabetes_mellitus:_a_single_blind_randomized_controlled_trial_ L2 - https://doi.org/10.1111/j.1399-543X.2006.00162.x DB - PRIME DP - Unbound Medicine ER -