Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial

Introduction: Glycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG). Methods: This open-label randomized controlled study (ClinicalTrials. gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2: 1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction. Results: Participants (n=224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: -3.1 +/- 0.75 mmol/mol, [-0.29 +/- 0.07% (mean +/- SE)] and -3.4 +/- 1.04 mmol/mol (-0.31 +/- 0.09%) respectively; p = 0.8222. A difference was detected in participants aged < 65 years [-5.7 +/- 0.96 mmol/mol (-0.53 +/- 0.09%) and -2.2 +/- 1.31 mmol/mol (-0.20 +/- 0.12%), respectively; p = 0.0301]. Time in hypoglycemia < 3.9 mmol/L (70 mg/dL) reduced by 0.47 +/- 0.13 h/day [mean +/- SE (p = 0.0006)], and < 3.1 mmol/L (55 mg/dL) reduced by 0.22 +/- 0.07 h/day (p = 0.0014) for intervention participants compared with controls; reductions of 43% and 53%, respectively. SMBG frequency, similar at baseline, decreased in intervention participants from 3.8 +/- 1.4 tests/ day (mean +/- SD) to 0.3 +/- 0.7, remaining unchanged in controls. Treatment satisfaction was higher in intervention compared with controls (DTSQ 13.1 +/- 0.50 (mean +/- SE) and 9.0 +/- 0.72, respectively; p < 0.0001). No serious adverse events or severe hypoglycemic events were reported related to sensor data use. Forty-two serious events [16 (10.7%) intervention participants, 12 (16.0%) controls] were not device-related. Six intervention participants reported nine adverse events for sensor-wear reactions (two severe, six moderate, one mild). Conclusion: Flash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG.