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Effects of advanced carbohydrate counting guided by an automated bolus calculator in Type 1 diabetes mellitus (Steno ABC ): a 12‐month, randomized clinical trial
Author(s) -
Hommel E.,
Schmidt S.,
Vistisen D.,
Neergaard K.,
Gribhild M.,
Almdal T.,
Nørgaard K.
Publication year - 2017
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/dme.13275
Subject(s) - medicine , diabetes mellitus , randomized controlled trial , bolus (digestion) , type 2 diabetes , concomitant , carbohydrate , randomization , gastroenterology , endocrinology
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 HbA 1c 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 HbA 1c 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 HbA 1c 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 HbA 1c 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 HbA 1c 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 HbA 1c reductions when guided by an automated bolus calculator ( NCT 02084498).