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Effects of advanced carbohydrate counting guided by an automated bolus calculator in Type 1 diabetes mellitus (StenoABC): a 12-month, randomized clinical trial

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AIMS: 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.

METHODS: 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 HbA1c levels 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 HbA1c from baseline to 12 months.

RESULTS: 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 HbA1c was 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 HbA1c was 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 HbA1c reductions were significantly greater in the ABC group (P=0.033). No episodes of severe hypoglycaemia were reported.

CONCLUSIONS: People with Type 1 diabetes initiating advanced carbohydrate counting obtained significantly greater HbA1c reductions when guided by an automated bolus calculator. Parts of the StenoABC Study have previously been presented in abstract format [Hommel E, Schmidt S, Gribild M, Neergaard K, Almdal T, Nørgaard K. A randomized trial of training Type 1 diabetes patients in advanced carbohydrate counting with or without an automated bolus calculator. ADA Annual Meeting, Boston, 2015, and Hommel E, Schmidt S, Vistisen D, Gribhild M, Neergaard K, Almdal T, Nørgaard K. Effects of advanced carbohydrate counting guided by an automated bolus calculator in Type 1 diabetes (ABC): a 12-month, randomised clinical trial. EASD Annual Meeting, Stockholm, 2015 This article is protected by copyright. All rights reserved.

Original languageEnglish
JournalDiabetic Medicine
Volume34
Issue number5
Pages (from-to)708-715
ISSN0742-3071
DOIs
Publication statusPublished - 18 Apr 2017

ID: 49157654