title: Randomized Trial of Long-Acting Insulin Glargine Titration Web Tool (LTHome) Versus Enhanced Usual Therapy of Glargine Titration (INNOVATE Trial).
abstract: Basal insulin titration in the real world is often unsuccessful. LTHome, a web tool, applies a rules engine-based algorithm providing insulin titration advice directly to the patient.
  
  
  
  This pilot, randomized trial evaluates basal insulin glargine titration by LTHome compared to enhanced usual therapy ([EUT]-diabetes education program) over 12 weeks. Important inclusion criteria: 18-75 years, type 2 diabetes, computer literacy, and HbA1c >7.0%. Trial protocol was approved by ethics board.
  
  
  
  We randomized 139 subjects. The achievement of primary composite outcome (four out of seven fasting plasma glucose [FPG] within 5-7.2 mmol/L + mean for three consecutive FPG within 5-7.2 mmol/L + no severe hypoglycemia) was 15% in LTHome versus 41% in EUT (noninferiority not met, P-value = 0.92). Other outcomes were similar between the LTHome and EUT arms: alternate composite outcome achievement (last five FPG mean within the range of 5-7.2 mmol/L + no hypoglycemia, 47% and 51%, P = 0.73); A1c reduction (-1.0% and -1.1%, P = 0.66); proportion achieving A1c ≤7% (14% and 20%, P = 0.36); and hypoglycemia incidence (31% and 37%, P = 0.4), respectively. Patient satisfaction score improvements were greater in LTHome versus EUT (change in fear of hypoglycemia score P = 0.04 and change in diabetes distress score P = 0.04). The mean number of additional healthcare provider visits was 0.13 for LTHome and 1.22 for EUT (P < 0.01).
  
  
  
  INNOVATE trial suggests clinical utility of LTHome compared to EUT in real-life settings. Further research is needed to evaluate the efficacy and safety of automated insulin titration algorithms.
authors.affiliation: 1 LMC Diabetes & Endocrinology , Toronto, Canada .|2 Leadership Sinai Centre for Diabetes, Mount Sinai Hospital , Toronto, Canada .
authors.forename: Harpreet S
authors.initials: HS
authors.lastname: Bajaj
authors.affiliation: 1 LMC Diabetes & Endocrinology , Toronto, Canada .
authors.forename: Karri
authors.initials: K
authors.lastname: Venn
authors.affiliation: 3 Health Quality Ontario , Toronto, Canada .
authors.forename: Chenglin
authors.initials: C
authors.lastname: Ye
authors.affiliation: 1 LMC Diabetes & Endocrinology , Toronto, Canada .
authors.forename: Ronnie
authors.initials: R
authors.lastname: Aronson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000008:administration & dosage / Q000627:therapeutic use*; D020407:Internet; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012648:Self Care / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine