Sophie Guilmin-Crépon1,2,3,4, Jean-Claude Carel1,5,4, Julien Schroedt2,3, Véronique Sulmont6, Anne-Sophie Salmon7, Claire Le Tallec8, Régis Coutant9, Fabienne Dalla-Vale10, Chantal Stuckens11, Hélène Bony-Trifunovic12, Hélène Crosnier13, François Kurtz14, Florentia Kaguelidou3, Anaïs Le Jeannic3,15, Isabelle Durand-Zaleski3,15, Nathalie Couque16, Corinne Alberti2,3,4, Nadia Tubiana-Rufi1,4. 1. Pediatric Endocrinology and Diabetology Department and Centre de Référence des Maladies Endocriniennes Rares de la Croissance, CHU Robert Debré, AP-HP, Paris, France. 2. Unit of Clinical Epidemiology, CHU Robert Debré, APHP, Paris, France. 3. Inserm, UMR-S 1123 ECEVE and CIC-EC 1426, Paris, France. 4. University Paris Diderot, Sorbonne Paris Cité, Paris, France. 5. Inserm, PROTECT, Université Paris Diderot, Paris, France. 6. Diabetology Unit, Alpes Leman Hospital, Annemasse, France. 7. Pediatric Unit, American Memorial Hospital, CHU Reims, Reims, France. 8. Pediatric Diabetology Unit, Children's Hospital, CHU Toulouse, Toulouse, France. 9. Pediatric Endocrinology and Diabetology Department, CHU Angers, Angers, France. 10. Pediatric Unit, Arnaud de Villeneuve Children's Hospital, CHU Montpellier, Montpellier, France. 11. Pediatric Unit, Jeanne de Flandre Hospital, CHU Lille, Lille, France. 12. Pediatric Unit, CHU Amiens, Amiens, France. 13. Pediatric Unit, Poissy Saint-Germain-en-Laye Hospital, Poissy, France. 14. Pediatric Unit, Saint Avold Hospital, Saint-Avold, France. 15. Health Economics Clinical Research Platform (URCEco), APHP, Paris, France. 16. Department of Molecular Biochemistry, CHU Robert Debré, APHP, Paris, France.
Abstract
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 hemoglobinA1c (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.
RCT Entities:
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.