Can an electronic glycaemic notebook associated with an insulin calculator improve HbA1c in diabetic patients on a multiple insulin injections regimen? A 26-week observational real-life study.

Background: Automated insulin calculators (AICs) with carbohydrate counting (CHC) have been shown to be effective in improving glycated haemoglobin (HbA1c) levels. By contrast, use of AICs without CHC, with predetermined prandial insulin doses modified according to a correction factor and modulated as a function of glycaemia, has not yet been investigated.

Methods: This comparative, retrospective, observational and non-randomized study took place over a 6-month period of routine clinical practice. It evaluated the use of Free-style InsuLinx® and Free-style Neo® Abbott Diabetes Care (AIC) in easy mode (no CHC). All patients performed a basal-prandial insulin dosing schedule, and were not educated as to how to determine carbohydrate intake. Changes in HbA1c and capillary blood glucose levels, insulin therapy, frequency of blood glucose tests and body weight were analyzed 6 months prior to inclusion (T-6), at the time of inclusion (T0) and 6 months later (T+6). From T-6 to T0 (period A), patients used a standard blood glucose meter and adjusted their insulin doses themselves, and from T0 to T+6 (period B), each patient was provided with an AIC on easy mode function.

Results: Of the 230 patients, 221 were retained at the end of the study (126 type 1 diabetes mellitus (T1DM) and 95 type 2 diabetes mellitus (T2DM)). At T-6, average (±standard error of mean) HbA1c level was 8.3 ± 0.1%; T1DM: 8.5 ± 0.1% and T2DM: 8.0 ± 0.1%, respectively. At T0, the average HbA1c level was 8.4 ± 0.1% (p = 0.02); T1DM: 8.5 ± 0.1% (ns) and T2DM: 8.2 ± 0.1% (p = 0.004). At T+6, with AIC in easy mode, average HbA1c level decreased significantly to 7.7 ± 0.1% (p < 0.0001); T1DM: 8.0 ± 0.1% (p < 0.0001) and T2DM: 7.5 ± 0.1% (p < 0.0001). At T+6, in all diabetics, blood glucose monitoring frequency increased by 0.4/day (p < 0.0001). Insulin correction amounted to 14% of changes in predetermined prandial insulin doses.

Conclusion: Routine clinical use of an AIC without CHC improved self-management of blood glucose and on average, decreased HbA1c levels by 0.52% in T1DM and 0.80% in T2DM after 6 months.