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
AbstractIntroductionGlycemic 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).MethodsThis 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.ResultsParticipants (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).ConclusionFlash 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.Trial registrationClinicalTrials.gov identifier: NCT02082184.FundingAbbott Diabetes Care.
Diabetes Therapy