title: Development and validation of a computer application to aid the physician's decision-making process at the start of and during treatment with insulin in type 2 diabetes: a randomized and controlled trial.
abstract: BACKGROUND
  Achieving optimum blood glucose control in patients with type 2 diabetes mellitus (T2DM) is difficult. Some primary care physicians (PCPs) delay the start of insulin use because of the uncertainty in intensifying insulin therapy. The objective was to develop and validate a computer application (CA) that helps PCPs to make decisions about insulin therapy in order to achieve a significant improvement in glycated hemoglobin (HbA1c).
  
  
  METHODS
  This was a cluster-randomized clinical trial. Fourteen primary care centers (PCCs) in Madrid with 66 PCPs and 697 T2DM patients on insulin therapy were randomly divided into two groups of seven PCCs each. In the intervention group, seven PCCs included 39 PCPs and 365 T2DM patients on insulin therapy. These PCPs were free to use the CA. A further seven PCCs were assigned to the control group with 27 PCPs and 332 T2DM patients on insulin therapy. The control group did not use the CA. The duration of the trial was 18 months to validate the CA. The outcome was a change in HbA1c from baseline.
  
  
  RESULTS
  In the intervention group, the final HbA1c was 7.19% (standard deviation [SD] ± 0.93), with a difference from the start of -0.69% (p = .001). In the control group, it was 7.71% (SD ± 1.37), with a difference from the start of -0.09% (p not significant).
  
  
  CONCLUSIONS
  This CA helps to improve HbA1c figures of T2DM patients with insulin when it is used by PCPs to make decisions when starting, continuing, or changing insulin and its dosage.
authors: Centro de Salud Pozuelo 1, Pozuelo de Alarcón, Madrid, Spain. asaenzcalvo@telefonica.net
authors: Antonio
authors: A
authors: Sáenz
authors: Miguel
authors: M
authors: Brito
authors: Ignacio
authors: I
authors: Morón
authors: Amalia
authors: A
authors: Torralba
authors: Elena
authors: E
authors: García-Sanz
authors: Jesus
authors: J
authors: Redondo
mesh_terms: D000368:Aged; D000465:Algorithms; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D020000:Decision Support Systems, Clinical; D003661:Decision Support Techniques; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004360:Drug Therapy, Computer-Assisted; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011320:Primary Health Care; D015203:Reproducibility of Results; D012984:Software; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human