1. 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.
- Author
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Ruiz-de-Adana MS, Dominguez-Lopez ME, Gonzalez-Molero I, Machado A, Martin V, Cardona I, de-la-Higuera M, Tapia MJ, Soriguer F, Anarte MT, and Rojo-Martínez G
- Subjects
- Adolescent, Adult, Aged, Blood Glucose analysis, Blood Glucose Self-Monitoring, Diabetes Complications epidemiology, Diabetes Complications prevention & control, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 psychology, Drug Administration Schedule, Female, Glycated Hemoglobin analysis, Humans, Hypoglycemia chemically induced, Hypoglycemia prevention & control, Hypoglycemic Agents adverse effects, Hypoglycemic Agents therapeutic use, Infusions, Subcutaneous, Injections, Subcutaneous, Insulin Glargine adverse effects, Insulin Glargine therapeutic use, Insulin Lispro adverse effects, Insulin Lispro therapeutic use, Male, Meals, Middle Aged, Quality of Life, Treatment Outcome, Young Adult, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents administration & dosage, Insulin Glargine administration & dosage, Insulin Lispro administration & dosage
- 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., (Copyright © 2015 Elsevier España, S.L.U. All rights reserved.)
- Published
- 2016
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