Is there an optimal strategy for real-time continuous glucose monitoring in pediatrics? A 12-month French multi-center, prospective, controlled randomized trial (Start-In!)
| Autor: | N. Tubiana-Rufi, V. Sulmont, Julien Schroedt, Jean-Claude Carel, Fabienne Dalla-Vale, Sophie Guilmin-Crepon, Isabelle Durand-Zaleski, Hélène Crosnier, Claire Le Tallec, Corinne Alberti, Hélène Bony-Trifunovic, Florentia Kaguelidou, Anaïs Le Jeannic, Anne-Sophie Salmon, Nathalie Couque, Régis Coutant, François Kurtz, Chantal Stuckens |
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| Rok vydání: | 2018 |
| Předmět: |
Blood Glucose
Male Pediatrics medicine.medical_specialty Time Factors endocrine system diseases Adolescent Endocrinology Diabetes and Metabolism medicine.medical_treatment 030209 endocrinology & metabolism Hypoglycemia law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Multicenter trial Internal Medicine medicine Humans 030212 general & internal medicine Child Type 1 diabetes Continuous glucose monitoring business.industry Insulin Blood Glucose Self-Monitoring nutritional and metabolic diseases medicine.disease Prognosis Medical insurance Diabetes Mellitus Type 1 Equipment and Supplies Child Preschool Pediatrics Perinatology and Child Health Calibration Population study Female France business |
| Zdroj: | Pediatric diabetes. 20(3) |
| ISSN: | 1399-5448 0094-9221 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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