title: Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial.
abstract: Aim. To analyze clinical effect of a novel approach to initiate sensor-augmented insulin pumps in type 1 diabetes mellitus (T1DM) patients through early real-time continuous glucose monitoring (RT-CGM) initiation.Methods. A 26-week pilot study with T1DM subjects randomized (1 : 1) to start RT-CGM three weeks before continuous subcutaneous insulin infusion (CGM pre-CSII) or adding RT-CGM three weeks after continuous subcutaneous insulin infusion (CGM post-CSII).Results. Twenty-two patients were enrolled with a mean age of 36.6 yr. (range 19-59 yr.) and T1DM duration of 16.8 ± 10.6 yr. Higher adherence in CGM pre-CSII patients was confirmed at study end (84.6 ± 11.1% versus 64.0 ± 25.4%;P= 0.01). The two intervention groups had similar HbA1creduction at study end of -0.6% (P= 0.9). Hypoglycemic event frequency reduction was observed from baseline to study end only in CGM pre-CSII group (mean difference in change, -6.3%; 95% confidence interval, -12.0 to -0.5;P= 0.04). Moreover, no severe hypoglycemia was detected among CGM pre-CSII subjects during the study follow-up (0.0 ± 0.0 events versus 0.63 ± 1.0 events;P= 0.03). CGM pre-CSII patients showed better satisfaction than CGM post-CSII patients at the end of the study (27.3 ± 9.3 versus 32.9 ± 7.2;P= 0.04).Conclusions. CGM pre-CSII is a novel approach to improve glycemic control and satisfaction in type 1 diabetes sensor-augmented pump treated patients.
authors.affiliation: Service of Endocrinology and Nutrition, Ciudad Real General University Hospital, SESCAM, Ciudad Real, Spain.
authors.forename: Jesus
authors.identifier: 0000-0002-9703-1094
authors.initials: J
authors.lastname: Moreno-Fernandez
authors.affiliation: Service of Endocrinology and Nutrition, La Mancha-Centro General Hospital, SESCAM, Alcázar de San Juan, Ciudad Real, Spain.
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Gómez
authors.affiliation: Service of Endocrinology and Nutrition, Reina Sofia University Hospital, Maimónedes Institute of Biomedical Research of Córdoba (IMIBIC), Córdoba, Spain.
authors.forename: Maria Ángeles
authors.initials: MÁ
authors.lastname: Gálvez Moreno
authors.affiliation: Maimónedes Institute of Biomedical Research of Córdoba (IMIBIC), University of Córdoba, CIBERObn, Córdoba, Spain.
authors.forename: Justo P
authors.initials: JP
authors.lastname: Castaño
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D007332:Insulin Infusion Systems; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin