title: 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.
abstract: 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.affiliation: 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.
authors.forename: María Soledad
authors.initials: MS
authors.lastname: Ruiz-de-Adana
authors.affiliation: 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.
authors.forename: Marta-Elena
authors.initials: ME
authors.lastname: Dominguez-Lopez
authors.affiliation: 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.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Gonzalez-Molero
authors.affiliation: Department of Personality, Assessment and Psychological Treatment, Faculty of Psychology, University of Malaga, Malaga, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Machado
authors.affiliation: Diabetes Centre, Department of Endocrinology and Nutrition, General University Hospital of Malaga, Spain.
authors.forename: Victor
authors.initials: V
authors.lastname: Martin
authors.affiliation: Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.
authors.forename: Isabel
authors.initials: I
authors.lastname: Cardona
authors.affiliation: Department of Endocrinology, Clinical Universitary of Navarra, Pamplona, Navarra, Spain.
authors.forename: Magdalena
authors.initials: M
authors.lastname: de-la-Higuera
authors.affiliation: Diabetes Centre, Department of Endocrinology and Nutrition, General University Hospital of Malaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.
authors.forename: María-José
authors.initials: MJ
authors.lastname: Tapia
authors.affiliation: 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.
authors.forename: Federico
authors.initials: F
authors.lastname: Soriguer
authors.affiliation: Department of Personality, Assessment and Psychological Treatment, Faculty of Psychology, University of Malaga, Malaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.
authors.forename: María Teresa
authors.initials: MT
authors.lastname: Anarte
authors.affiliation: 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.
authors.forename: Gemma
authors.initials: G
authors.lastname: Rojo-Martínez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring; D048909:Diabetes Complications / Q000453:epidemiology / Q000517:prevention & control; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy* / Q000523:psychology; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D055104:Infusions, Subcutaneous; D007279:Injections, Subcutaneous; D000069036:Insulin Glargine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D061268:Insulin Lispro / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D062407:Meals; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D061268:Insulin Lispro
keywords: CSII; Diabetes tipo 1; ISCI; MDI; Type 1 diabetes