title: Frequent insulin dosage adjustments based on glucose readings alone are sufficient for a safe and effective therapy.
abstract: OBJECTIVE
  Frequent dosage adjustments are necessary to achieve effective insulin therapy. However, a controversy surrounds the pertinent clinical parameters required to make effective and safe insulin titrations. We hypothesize that glucose readings are sufficient to adjust insulin dosage provided that it is done on a weekly basis.
  
  
  METHODS
  In a prospective pilot study, we recruited 14 subjects with suboptimally controlled insulin-treated Type-2 and Type-1 diabetes. Subjects were treated with basal-bolus insulin therapy that was titrated weekly for 12 weeks. Dosage adjustments were made by the study Endocrinologist by reviewing subjects' glucose readings, exclusively based on logsheets and contingent upon the approval of the on-site study team. To corroborate that the glucose readings were sufficient for making dosage adjustments, we used software to process only glucose readings and recommend insulin dosage adjustments. The recommendations made by the software were retrospectively compared to the ones made by the study Endocrinologist.
  
  
  RESULTS
  All N=568 recommendations were approved by the study team and in 99.3% of the cases the recommendations were clinically similar to the ones made by the software. No hazardous disagreements were found. The mean A1C improved from 9.8% (± 2.0) to 7.9% (± 1.3) (p=0.001) in 12 weeks and the weekly mean glucose progressively improved from 220.3 mg/dl (± 51.9) to 151.5 mg/dl (± 19.2) (p<0.0001). The frequency of minor hypoglycemia was 22.7 per patient-year in subjects with Type-2 diabetes and 42.7 in the subjects with Type-1 diabetes. No severe hypoglycemic events occurred.
  
  
  CONCLUSIONS
  Glucose readings are sufficient to adjust insulin therapy in a safe and effective manner, when adjustments are made on a weekly basis. Thus, dedicated software may help adjust insulin dosage between clinic visits.
authors.affiliation: Hygieia, Inc., Ann Arbor, MI, USA.
authors.forename: Eran
authors.initials: E
authors.lastname: Bashan
authors.forename: Israel
authors.initials: I
authors.lastname: Hodish
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis* / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods; D003920:Diabetes Mellitus / Q000097:blood* / Q000188:drug therapy* / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D054796:Drug Dosage Calculations; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011932:Reading; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin