title: Long-term improvement of metabolic control without increased risk of hypoglycaemia by intensive insulin regimens in type 1 diabetes patients treated in a regular clinical setting.
abstract: OBJECTIVE
  To evaluate if intensive insulin regimen with multiple daily injections (MDI) is successful for treating type 1 diabetes patients over a long period of time in a regular clinical setting.
  
  
  METHODS
  This is a prospective, observational seven-year study. Fifty-nine (35 male) type 1 diabetic patients with bad metabolic control (HbA1c> or =9%), aged 31.9 years, range 18-47 were included in the present study. All of them had had at least 5 years of diabetes duration after diagnosis and showed negative responses of serum C-peptide to a standard breakfast. The main control variables are: Metabolic control measured by serum HbA1c values (values < 6.2 % was the treatment objective) and the frequency of hypoglycaemic episodes (episodes/patient-month).
  
  
  RESULTS
  Significant decreases in mean+/-SD HbA1c values in this group of patients were observed from the first year of follow-up, with the mean values being: 7.5+/-1.5%, 7.2+/-1.8%, 7.6+/-1.6%, 7.1+/-1.7%, 7+/-1.4, 6.6+/-1.6% and 6.8+/-1.4% for the first, second, third, fourth, fifth, sixth and seventh years of follow-up respectively. Sixteen %, 27.5%, 15.7%, 33.3%, 28.6%, 42% and 33% of the patients reached the treatment objective (HbA1c values<6.2%) for each year of follow-up. Throughout the study period the rate of severe hypoglycaemia (episodes/patient-year) was 0.32+/-0.2 which was not significantly different compared with the value of 0.28+/-0.1 observed the year before the study began. Similarly frequencies of mild/moderate hypoglycaemia episodes (episodes/patient-month) varies between 16.5+/-4 and 21.7+/-5, which are not significantly different from the value of 17.7+/-6 observed the year before the study began.
  
  
  CONCLUSIONS
  Long-term improvement in metabolic control was observed in this group of type 1 diabetes patients with previous bad control, during treatment in a regular clinical setting. A considerable percentage of type 1 diabetic patients with MDI reached the treatment objective in every year of follow-up. Furthermore improvement in metabolic control is not associated with significantly increased frequency of hypoglycaemia episodes.
authors.affiliation: Department of Endocrinology, University of Vigo, Vigo, Spain.
authors.forename: L F
authors.initials: LF
authors.lastname: Pérez Méndez
authors.forename: E
authors.initials: E
authors.lastname: Alvarez-García
authors.forename: P
authors.initials: P
authors.lastname: Alvarez-Vázquez
authors.forename: E
authors.initials: E
authors.lastname: Hervás
authors.forename: A
authors.initials: A
authors.lastname: Casterás
authors.forename: L
authors.initials: L
authors.lastname: Fajar
authors.forename: R V
authors.initials: RV
authors.lastname: García-Mayor
mesh_terms: D000328:Adult; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology; D007328:Insulin / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D006442:Glycated Hemoglobin; D007328:Insulin