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Comparison between a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) using continuous glucose monitoring in metabolically optimized type 1 diabetes patients: A randomized open-labelled parallel study.
Med Clin (Barc) 2016; 146(6):239-46MC

Abstract

BACKGROUND AND OBJECTIVE

Advantages of continuous subcutaneous insulin infusion (CSII) over multiple daily injections with glargine (MDI/G) are still uncertain. We compared CSII vs. MDI/G therapy in unselected patients with type 1 diabetes using continuous glucose monitoring (CGSM). The primary end-points were glycaemic control and quality of life (QOL).

METHODS

A total of 45 patients with long-term diabetes and mean HbA1c values of 8.6±1.8% (70.5±15.4mmol/mol), previously treated with MDI/NPH, were switched to MDI/G for 6 months and then, unfulfilling therapy CSII indication, were randomly assigned to CSII or MDI/G for another six months. We evaluated QOL (EsDqol) and glycaemic control by measuring HbA1c levels, rate of hypoglycaemia, ketoacidosis and CGSM data.

RESULTS

After the first phase (MDI/NPH to MDI/G) there was a significant improvement in total EsDQOL (99.72±18.38 vs. 92.07±17.65; p<0.028), a 0.5% decrease in HbA1c values (8.4±1.2 vs. 7.9±0.7% [68±9.7 vs. 63±5.5mmol/mol]; p<0.032), an improvement in glycaemic variability (standard deviation 66.9±14 vs. 59.4±16mg/dl; p<0.05), a decrease in insulin requirements (0.87±0.29 vs. 0.80±0.25U/kg; p<0.049), a decrease in number of severe hypoglycaemia episodes (0.44±0.9 vs. 0.05±0.2; p<0.014), and an increase in periods of normoglycaemia measured with CGSM (15.8±10.9% vs. 23±18.4%; p<0.003). Six months after randomization, significant improvements were seen in the HbA1c (7.9±0.7 vs. 7±0.6% [63±5.5 vs. 53±4.5mmol/mol]; p<0.001) and EsQOL (91.66±22 vs. 84.53±1.63; p<0.045) only in the CSII group. The HbA1c value was significantly lower when compared with the MDI/G group (CSII 7±0.6% [53±4.5mmol/mol] vs. MDI/G 7.6±0.9% [59.6±7.7mmol/mol]; p<0.03).

CONCLUSIONS

Intensive insulin therapy with CSII vs. MDI/G was associated with better levels of HbA1c in patients with long-term type 1 diabetes.

Authors+Show Affiliations

Diabetes Centre, Department of Endocrinology and Nutrition, General University Hospital of Malaga, Spain; CIBERDEM (Carlos III Health Institute), Malaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.Diabetes Centre, Department of Endocrinology and Nutrition, General University Hospital of Malaga, Spain; CIBERDEM (Carlos III Health Institute), Malaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.Diabetes Centre, Department of Endocrinology and Nutrition, General University Hospital of Malaga, Spain; CIBERDEM (Carlos III Health Institute), Malaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain. Electronic address: inmagonzalezmolero@hotmail.com.Department of Personality, Assessment and Psychological Treatment, Faculty of Psychology, University of Malaga, Malaga, Spain.Diabetes Centre, Department of Endocrinology and Nutrition, General University Hospital of Malaga, Spain.Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.Department of Endocrinology, Clinical Universitary of Navarra, Pamplona, Navarra, Spain.Diabetes Centre, Department of Endocrinology and Nutrition, General University Hospital of Malaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.Diabetes Centre, Department of Endocrinology and Nutrition, General University Hospital of Malaga, Spain; CIBERDEM (Carlos III Health Institute), Malaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.Department of Personality, Assessment and Psychological Treatment, Faculty of Psychology, University of Malaga, Malaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.Diabetes Centre, Department of Endocrinology and Nutrition, General University Hospital of Malaga, Spain; CIBERDEM (Carlos III Health Institute), Malaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26656958

Citation

Ruiz-de-Adana, María Soledad, et al. "Comparison Between a Multiple Daily Insulin Injection Regimen (basal Once-daily Glargine Plus Mealtime Lispro) and Continuous Subcutaneous Insulin Infusion (lispro) Using Continuous Glucose Monitoring in Metabolically Optimized Type 1 Diabetes Patients: a Randomized Open-labelled Parallel Study." Medicina Clinica, vol. 146, no. 6, 2016, pp. 239-46.
Ruiz-de-Adana MS, Dominguez-Lopez ME, Gonzalez-Molero I, et al. Comparison between a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) using continuous glucose monitoring in metabolically optimized type 1 diabetes patients: A randomized open-labelled parallel study. Med Clin (Barc). 2016;146(6):239-46.
Ruiz-de-Adana, M. S., Dominguez-Lopez, M. E., Gonzalez-Molero, I., Machado, A., Martin, V., Cardona, I., ... Rojo-Martínez, G. (2016). Comparison between a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) using continuous glucose monitoring in metabolically optimized type 1 diabetes patients: A randomized open-labelled parallel study. Medicina Clinica, 146(6), pp. 239-46. doi:10.1016/j.medcli.2015.09.020.
Ruiz-de-Adana MS, et al. Comparison Between a Multiple Daily Insulin Injection Regimen (basal Once-daily Glargine Plus Mealtime Lispro) and Continuous Subcutaneous Insulin Infusion (lispro) Using Continuous Glucose Monitoring in Metabolically Optimized Type 1 Diabetes Patients: a Randomized Open-labelled Parallel Study. Med Clin (Barc). 2016 Mar 18;146(6):239-46. PubMed PMID: 26656958.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison between a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) using continuous glucose monitoring in metabolically optimized type 1 diabetes patients: A randomized open-labelled parallel study. AU - Ruiz-de-Adana,María Soledad, AU - Dominguez-Lopez,Marta-Elena, AU - Gonzalez-Molero,Inmaculada, AU - Machado,Alberto, AU - Martin,Victor, AU - Cardona,Isabel, AU - de-la-Higuera,Magdalena, AU - Tapia,María-José, AU - Soriguer,Federico, AU - Anarte,María Teresa, AU - Rojo-Martínez,Gemma, Y1 - 2015/12/04/ PY - 2015/05/26/received PY - 2015/08/25/revised PY - 2015/09/03/accepted PY - 2015/12/15/entrez PY - 2015/12/15/pubmed PY - 2016/12/24/medline KW - CSII KW - Diabetes tipo 1 KW - ISCI KW - MDI KW - Type 1 diabetes SP - 239 EP - 46 JF - Medicina clinica JO - Med Clin (Barc) VL - 146 IS - 6 N2 - BACKGROUND AND OBJECTIVE: Advantages of continuous subcutaneous insulin infusion (CSII) over multiple daily injections with glargine (MDI/G) are still uncertain. We compared CSII vs. MDI/G therapy in unselected patients with type 1 diabetes using continuous glucose monitoring (CGSM). The primary end-points were glycaemic control and quality of life (QOL). METHODS: A total of 45 patients with long-term diabetes and mean HbA1c values of 8.6±1.8% (70.5±15.4mmol/mol), previously treated with MDI/NPH, were switched to MDI/G for 6 months and then, unfulfilling therapy CSII indication, were randomly assigned to CSII or MDI/G for another six months. We evaluated QOL (EsDqol) and glycaemic control by measuring HbA1c levels, rate of hypoglycaemia, ketoacidosis and CGSM data. RESULTS: After the first phase (MDI/NPH to MDI/G) there was a significant improvement in total EsDQOL (99.72±18.38 vs. 92.07±17.65; p<0.028), a 0.5% decrease in HbA1c values (8.4±1.2 vs. 7.9±0.7% [68±9.7 vs. 63±5.5mmol/mol]; p<0.032), an improvement in glycaemic variability (standard deviation 66.9±14 vs. 59.4±16mg/dl; p<0.05), a decrease in insulin requirements (0.87±0.29 vs. 0.80±0.25U/kg; p<0.049), a decrease in number of severe hypoglycaemia episodes (0.44±0.9 vs. 0.05±0.2; p<0.014), and an increase in periods of normoglycaemia measured with CGSM (15.8±10.9% vs. 23±18.4%; p<0.003). Six months after randomization, significant improvements were seen in the HbA1c (7.9±0.7 vs. 7±0.6% [63±5.5 vs. 53±4.5mmol/mol]; p<0.001) and EsQOL (91.66±22 vs. 84.53±1.63; p<0.045) only in the CSII group. The HbA1c value was significantly lower when compared with the MDI/G group (CSII 7±0.6% [53±4.5mmol/mol] vs. MDI/G 7.6±0.9% [59.6±7.7mmol/mol]; p<0.03). CONCLUSIONS: Intensive insulin therapy with CSII vs. MDI/G was associated with better levels of HbA1c in patients with long-term type 1 diabetes. SN - 1578-8989 UR - https://www.unboundmedicine.com/medline/citation/26656958/Comparison_between_a_multiple_daily_insulin_injection_regimen__basal_once_daily_glargine_plus_mealtime_lispro__and_continuous_subcutaneous_insulin_infusion__lispro__using_continuous_glucose_monitoring_in_metabolically_optimized_type_1_diabetes_patients:_A_randomized_open_labelled_parallel_study_ L2 - http://www.elsevier.es/en/linksolver/ft/pii/S0025-7753(15)00571-0 DB - PRIME DP - Unbound Medicine ER -