title: Effects of advanced carbohydrate counting guided by an automated bolus calculator in Type 1 diabetes mellitus (StenoABC): a 12-month, randomized clinical trial.
abstract: To test whether concomitant use of an automated bolus calculator for people with Type 1 diabetes carrying out advanced carbohydrate counting would induce further improvements in metabolic control.
  
  
  
  We conducted a 12-month, randomized, parallel-group, open-label, single-centre, investigator-initiated clinical study. We enrolled advanced carbohydrate counting-naïve adults with Type 1 diabetes and HbA1clevels 64-100 mmol/mol (8.0-11.3%), who were receiving multiple daily insulin injection therapy. In a 1:1-ratio, participants were randomized to receive training in either advanced carbohydrate counting using mental calculations (MC group) or advanced carbohydrate counting using an automated bolus calculator (ABC group) during a 3.5-h group training course. For 12 months after training, participants attended a specialized diabetes centre quarterly. The primary outcome was change in HbA1cfrom baseline to 12 months.
  
  
  
  Between August 2012 and September 2013, 168 participants (96 men and 72 women) were recruited and randomly assigned to the MC group (n = 84) and the ABC group (n = 84). Drop-out rates were 23.8 and 21.4%, respectively (P = 0.712); 130 participants completed the study. The baseline HbA1cwas 75 ± 9 mmol/mol (9.0 ± 0.8%) in the MC group and 74 ± 8 mmol/mol (8.9 ± 0.7%) in the ABC group. At 12 months, change in HbA1cwas significant within both groups: MC group: -2 mmol/mol (95% CI -4 to -1) or -0.2% (95% CI -0.4 to -0.1; P = 0.017) and ABC group: -5 mmol/mol (95% CI -6 to -3) or -0.5% (95% CI -0.6 to -0.3; P < 0.0001), but HbA1creductions were significantly greater in the ABC group (P = 0.033). No episodes of severe hypoglycaemia were reported.
  
  
  
  People with Type 1 diabetes initiating advanced carbohydrate counting obtained significantly greater HbA1creductions when guided by an automated bolus calculator (NCT02084498).
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.
authors.forename: E
authors.initials: E
authors.lastname: Hommel
authors.affiliation: Department of Endocrinology, Hvidovre University Hospital, Hvidovre, Denmark.|Danish Diabetes Academy, Odense, Denmark.
authors.forename: S
authors.initials: S
authors.lastname: Schmidt
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.
authors.forename: D
authors.initials: D
authors.lastname: Vistisen
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.
authors.forename: K
authors.initials: K
authors.lastname: Neergaard
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Gribhild
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.|Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.
authors.forename: T
authors.initials: T
authors.lastname: Almdal
authors.affiliation: Department of Endocrinology, Hvidovre University Hospital, Hvidovre, Denmark.
authors.forename: K
authors.initials: K
authors.lastname: Nørgaard
mesh_terms: D000328:Adult; D001331:Automation; D001786:Blood Glucose / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000178:diet therapy*; D050528:Diet, Carbohydrate-Restricted; D004040:Dietary Carbohydrates / Q000008:administration & dosage* / Q000032:analysis*; D004435:Eating / Q000502:physiology; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008297:Male; D062407:Meals; D008875:Middle Aged; D010353:Patient Education as Topic
chemical_list: D001786:Blood Glucose; D004040:Dietary Carbohydrates; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human