To (1) evaluate the efficacy of OptimAAPP, a smartphone insulin dose calculator for carbohydrate, fat, and protein in managing glycaemia compared with carbohydrate counting in adolescents and adults with type 1 diabetes using flexible multiple daily injection therapy (MDI, ≥4 injections/day) and (2) assess user acceptability of OptimAAPP. In this free-living trial, participants aged 12-50 years were randomised to use carbohydrate counting or OptimAAPP for meal insulin dose calculation for 3 months, then use the alternate method for 3 months. The primary outcome, time-in-range (3.9-10.0 mmol/L) was measured in weeks 3-4 of each arm using continuous glucose monitoring. The acceptability of OptimAAPP was assessed at end intervention using a purpose-designed questionnaire. An intention-to-treat analysis of 41 participants, mean age 28 ± 12 years and HbA1c 56 ± 10 mmol/mol (7.3 ± 0.9%) found no significant difference in glycaemic outcomes when using OptimAAPP compared with carbohydrate counting including time-in-range (70.5 vs. 67.6%, p = 0.102), above range (24.5% vs. 28.0%, p = 0.068), below range (4.9% vs. 4.4%, p = 0.318), and coefficient of variation (32.2% vs. 33.3%, p = 0.136). There was no severe hypoglycaemia. Participants reported that OptimAAPP was easy to use (79%), and they were confident in giving the recommended doses (82%). Barriers to use were the small food database and the time associated with food entry. In adolescents and adults using flexible MDI therapy, OptimAAPP use did not produce glycaemic outcomes that were significantly different from carbohydrate counting. Participant views of OptimAAPP indicate a high level of acceptability. Increasing the size of the food database will likely enhance the user experience.
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