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Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized,
William H Lagarde1, Frank P Barrows, Marsha L Davenport
1Department of Pediatrics, The University of North Carolina at Chapel Hill, NC 27599-7039, USA.
Insights
Continuous glucose-monitoring system (CGMS) use in children with type 1 diabetes mellitus (T1DM) may improve metabolic control. This study found CGMS improved glycemic control without increasing hypoglycemia risk in pediatric T1DM patients.
Area of Science:
- Pediatric Endocrinology
- Diabetes Technology
- Metabolic Control
Background:
- Tight glycemic control in type 1 diabetes mellitus (T1DM) reduces long-term complications but elevates hypoglycemia risk.
- Continuous glucose-monitoring systems (CGMS) offer frequent blood glucose (BG) readings, with established accuracy in adults.
- Limited data exist on CGMS efficacy and safety in pediatric populations.
Purpose of the Study:
- To evaluate the impact of CGMS on metabolic control in children with T1DM.
- To determine if CGMS use improves glycemic management in pediatric T1DM patients.
Main Methods:
- A single-blind, randomized controlled trial involving 27 children with T1DM (ages 7-17).
- Participants were randomized into an intervention group (CGMS + SMBG) or a control group (SMBG only).
- CGMS was used for 72-h periods at 0, 2, and 4 months, with HbA1c measured at 0, 2, 4, and 6 months.
Main Results:
- The intervention group showed a statistically significant decrease in HbA1c (0.61 +/- 0.68%, p=0.03) from baseline.
- While the intervention group had lower final HbA1c levels (7.8% vs 8.6%, p=0.02), the overall change between groups was not statistically significant (p=0.13).
- No significant differences in hypoglycemia (AUC(<70)) were observed between groups (p=0.18).
Conclusions:
- CGMS use shows potential for improving metabolic control in children with T1DM.
- The study suggests CGMS can be used safely in pediatric T1DM patients without increasing hypoglycemia risk.
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.
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