Effect of prandial treatment timing adjustment, based on continuous glucose monitoring, in patients with type 2 diabetes uncontrolled with once‐daily basal insulin: A randomized, phase IV study

Abstract

AimsTo 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 MethodsThis 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.ResultsA 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).ConclusionUsing 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.

Impact of technology on glycaemic control in type 2 diabetes: A meta‐analysis of randomized trials on continuous glucose monitoring and continuous subcutaneous insulin infusion

“…The results of the present study are similar to those of a recent meta‐analysis which also included restrospective CGM and observational studies . Conversely, a meta‐analysis that only included randomized trials estimated an effect of real‐time CGM on HbA1c greater than that assessed in the present analysis; however, this latter analysis included one trial in which CGM was used intermittently for a short time, and it did not include another trial that was published after the end of the study search . Available data are insufficient, however, to draw clear conclusions on the effect of CGM on hypoglycaemic risk and on quality of life; notably, no increase in hypoglycaemic risk was observed despite a reduction in HbA1c.…”

“…Two studies reported that CGM and SMBG did not differ for total insulin dose; however, one of those two studies did not report complete data, thus preventing a formal meta‐analysis. In addition, in another trial, no difference was observed in basal or bolus insulin dose.…”

“…No study not already identified on Medline or www.clinicaltrials.gov was retrieved through manual searching of references. The number of trials on CSII, CGM and FGM fulfilling the inclusion criteria was six, [9][10][11][12][13][14] five [15][16][17][18][19][20] and one, 21 respectively. All the trials had been published, except for one, the results of which were partly disclosed on the www.clinicaltrials.…”

“…The overall quality of trials was fair. Although all studies were open-label, allocation concealment was not clearly described in some trials, 9,11,13,15,18 and a risk of attrition bias 13,[16][17][18] could not be excluded in some other studies ( Figure S2). All studies had a Jadad score > 3.…”

“…Despite the potentially wide number of people with type 2 diabetes on basal–bolus insulin, available evidence on the efficacy and safety of CSII and CGM/FGM in this population is relatively poor. In fact, our search retrieved only six trials on CSII and six on either CGM or FGM …”