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Is there an optimal strategy for real-time continuous glucose monitoring in pediatrics? A 12-month French
Sophie Guilmin-Crépon1,2,3,4, Jean-Claude Carel1,5,4, Julien Schroedt2,3
1Pediatric Endocrinology and Diabetology Department and Centre de Référence des Maladies Endocriniennes Rares de la Croissance, CHU Robert Debré, AP-HP, Paris, France.
Insights
Real-time continuous glucose monitoring (RT-CGM) strategies showed no difference in HbA1c for type 1 diabetes in children. Three months of RT-CGM use reduced severe hypoglycemia, confirming feasibility and highlighting educational needs.
Area of Science:
- Pediatric Endocrinology
- Metabolic Diseases
- Biomedical Engineering
Background:
- Type 1 diabetes management in children and adolescents requires effective glucose monitoring.
- Real-time continuous glucose monitoring (RT-CGM) offers potential benefits but optimal long-term strategies are unclear.
- Understanding the comparative efficacy of different RT-CGM usage patterns is crucial for clinical practice.
Purpose of the Study:
- To compare the efficacy of three distinct RT-CGM strategies over 12 months in pediatric patients with type 1 diabetes.
- To evaluate the impact of RT-CGM on glycemic control (HbA1c) and acute metabolic events.
- To assess patient satisfaction, hypoglycemia rates, and associated costs with different RT-CGM protocols.
Main Methods:
- A randomized, controlled, prospective trial involving 151 children and adolescents (2-17 years) with type 1 diabetes.
- Patients initially used RT-CGM for 3 months, then were randomized to: self-monitoring of blood glucose, continuous RT-CGM (80% time), or discontinuous RT-CGM (40% time).
- Primary outcome was HbA1c change from 3 to 12 months; secondary outcomes included metabolic events, hypoglycemia, satisfaction, and cost.
Main Results:
- No significant differences in HbA1c levels were observed among the three RT-CGM groups over the 12-month study period.
- The rate of severe hypoglycemia significantly decreased across the entire study population after 3 months of RT-CGM use.
- Consistent device use and good tolerance were reported by subjects, irrespective of age or insulin regimen; full-time RT-CGM cost €2629 per patient over 3 months.
Conclusions:
- None of the evaluated long-term RT-CGM strategies demonstrated superiority in improving HbA1c levels for pediatric type 1 diabetes.
- Short-term RT-CGM use (3 months) effectively reduced severe hypoglycemia rates.
- The study confirms the feasibility of long-term RT-CGM use and underscores the necessity for enhanced educational support for patients and caregivers.
Aim:
To compare the efficacy of three strategies for real-time continuous glucose monitoring (RT-CGM) over 12 months in children and adolescents with type 1 diabetes.
Methods:
A French multicenter trial (NCT00949221) with a randomized, controlled, prospective, open, and parallel-group design was conducted. After 3 months of RT-CGM, patients were allocated to one of three groups: return to self-monitoring of blood glucose, continuous CGM (80% of the time), or discontinuous CGM (40% of the time). The primary outcome was hemoglobin A1c (HbA1c) levels from 3 to 12 months. The secondary outcomes were acute metabolic events, hypoglycemia, satisfaction with CGM and cost.
Results:
We included 151 subjects, aged 2 to 17 years, with a mean HbA1c level of 8.5% (SD0.7; 69 mmol/mol). The longitudinal change in HbA1c levels was similar in all three groups, at 3, 6, 9 and 12 months. The medical secondary endpoints did not differ between groups. The rate of severe hypoglycemia was significantly lower than that for the pretreatment year for the entire study population. Subjects reported consistent use and good tolerance of the device, regardless of age or insulin treatment. The use of full-time RT-CGM for 3 months costs the national medical insurance system €2629 per patient.
Conclusion:
None of the three long-term RT-CGM strategies evaluated in pediatric type 1 diabetes was superior to the others in terms of HbA1c levels. CGM-use for 3 months decreased rates of severe hypoglycemia. Our results confirm the feasibility of long-term RT-CGM-use and the need to improve educational support for patients and caregivers.
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