Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial

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 t...

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Main Authors: Jesus Moreno-Fernandez, Francisco Javier Gómez, Maria Ángeles Gálvez Moreno, Justo P. Castaño
Format: Article
Language:English
Published: Wiley 2016-01-01
Series:Journal of Diabetes Research
Online Access:http://dx.doi.org/10.1155/2016/4171789
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author Jesus Moreno-Fernandez
Francisco Javier Gómez
Maria Ángeles Gálvez Moreno
Justo P. Castaño
author_facet Jesus Moreno-Fernandez
Francisco Javier Gómez
Maria Ángeles Gálvez Moreno
Justo P. Castaño
author_sort Jesus Moreno-Fernandez
collection DOAJ
description 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 HbA1c reduction 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.
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spelling doaj-art-999dcc680b1c4baa86f8ccfeb9305d6a2025-08-20T02:10:19ZengWileyJournal of Diabetes Research2314-67452314-67532016-01-01201610.1155/2016/41717894171789Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled TrialJesus Moreno-Fernandez0Francisco Javier Gómez1Maria Ángeles Gálvez Moreno2Justo P. Castaño3Service of Endocrinology and Nutrition, Ciudad Real General University Hospital, SESCAM, Ciudad Real, SpainService of Endocrinology and Nutrition, La Mancha-Centro General Hospital, SESCAM, Alcázar de San Juan, Ciudad Real, SpainService of Endocrinology and Nutrition, Reina Sofia University Hospital, Maimónedes Institute of Biomedical Research of Córdoba (IMIBIC), Córdoba, SpainMaimónedes Institute of Biomedical Research of Córdoba (IMIBIC), University of Córdoba, CIBERObn, Córdoba, SpainAim. 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 HbA1c reduction 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.http://dx.doi.org/10.1155/2016/4171789
spellingShingle Jesus Moreno-Fernandez
Francisco Javier Gómez
Maria Ángeles Gálvez Moreno
Justo P. Castaño
Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial
Journal of Diabetes Research
title Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial
title_full Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial
title_fullStr Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial
title_full_unstemmed Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial
title_short Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial
title_sort clinical efficacy of two different methods to initiate sensor augmented insulin pumps a randomized controlled trial
url http://dx.doi.org/10.1155/2016/4171789
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