TY - JOUR
T1 - Effect of prandial treatment timing adjustment, based on continuous glucose monitoring, in patients with type 2 diabetes uncontrolled with once-daily basal insulin
T2 - A randomized, phase IV study
AU - Ilany, Jacob
AU - Bhandari, Hamad
AU - Nabriski, Dan
AU - Toledano, Yoel
AU - Konvalina, Noa
AU - Cohen, Ohad
N1 - Publisher Copyright:
© 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
PY - 2018/5
Y1 - 2018/5
N2 - Aims: To evaluate the glycaemic control achieved by prandial once-daily insulin glulisine injection timing adjustment, based on a continuous glucose monitoring sensor, in comparison to once-daily insulin glulisine injection before breakfast in patients with type 2 diabetes who are uncontrolled with once-daily basal insulin glargine. Materials and Methods: This was a 24-week open-label, randomized, controlled, multicentre trial. At the end of an 8-week period of basal insulin optimization, patients with HbA1c ≥ 7.5% and FPG < 130 mg/dL were randomized (1:1) to either arm A (no sensor) or arm B (sensor) to receive 16-week intensified prandial glulisine treatment. Patients in arm A received pre-breakfast glulisine, and patients in arm B received glulisine before the meal with the highest glucose elevation based on sensor data. The primary outcome was mean HbA1c at week 24 and secondary outcomes included rates of hypoglycaemic events and insulin dosage. Results: A total of 121 patients were randomized to arm A (n = 61) or arm B (n = 60). There was no difference in mean HbA1c at week 24 between arms A and B (8.5% ± 1.2% vs 8.4% ± 1.0%; P =.66). The prandial insulin glulisine dosage for arm A and arm B was 9.3 and 10.1 units, respectively (P =.39). The frequency of hypoglycaemic events did not differ between study arms (36.1% vs 51.7%; P =.08). Conclusion: Using a CGM sensor to identify the meal with the highest glucose excursion and adjusting the timing of prandial insulin treatment did not show any advantage in terms of glycaemic control or safety in our patients.
AB - Aims: To evaluate the glycaemic control achieved by prandial once-daily insulin glulisine injection timing adjustment, based on a continuous glucose monitoring sensor, in comparison to once-daily insulin glulisine injection before breakfast in patients with type 2 diabetes who are uncontrolled with once-daily basal insulin glargine. Materials and Methods: This was a 24-week open-label, randomized, controlled, multicentre trial. At the end of an 8-week period of basal insulin optimization, patients with HbA1c ≥ 7.5% and FPG < 130 mg/dL were randomized (1:1) to either arm A (no sensor) or arm B (sensor) to receive 16-week intensified prandial glulisine treatment. Patients in arm A received pre-breakfast glulisine, and patients in arm B received glulisine before the meal with the highest glucose elevation based on sensor data. The primary outcome was mean HbA1c at week 24 and secondary outcomes included rates of hypoglycaemic events and insulin dosage. Results: A total of 121 patients were randomized to arm A (n = 61) or arm B (n = 60). There was no difference in mean HbA1c at week 24 between arms A and B (8.5% ± 1.2% vs 8.4% ± 1.0%; P =.66). The prandial insulin glulisine dosage for arm A and arm B was 9.3 and 10.1 units, respectively (P =.39). The frequency of hypoglycaemic events did not differ between study arms (36.1% vs 51.7%; P =.08). Conclusion: Using a CGM sensor to identify the meal with the highest glucose excursion and adjusting the timing of prandial insulin treatment did not show any advantage in terms of glycaemic control or safety in our patients.
KW - basal insulin
KW - clinical trial
KW - continuous glucose monitoring (CGM)
KW - insulin therapy
UR - http://www.scopus.com/inward/record.url?scp=85043374102&partnerID=8YFLogxK
U2 - 10.1111/dom.13214
DO - 10.1111/dom.13214
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C2 - 29316176
AN - SCOPUS:85043374102
SN - 1462-8902
VL - 20
SP - 1186
EP - 1192
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
IS - 5
ER -