Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes

Abstract

Introduction: Published evaluations of sensor glucose monitoring use in insulin treated type 2 diabetes are limited. The aim of this study was to assess the impact of flash glucose-sensing technology as a replacement for self-monitoring of blood glucose (SMBG) over a 12-month period in participants with type 2 diabetes who were on intensive insulin therapy.

Methods: An open-label, randomized, controlled study in adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers aimed at assessing flash glucose sensing technology was conducted. Participants (N = 224) were randomized (1:2 respectively) to a control group (n = 75) that used SMBG (FreeStyle Lite™) or to an intervention group (n = 149) which used sensor glucose data (FreeStyle Libre™ Flash Glucose Monitoring System) for self-management over 6 months. All intervention group participants who completed the 6-month treatment phase continued into an additional 6-month open-access phase.

Results: A total of 139 intervention participants completed the 6-month treatment phase and continued into the open-access phase. At 12 months (end of open-access period), time in hypoglycemia [sensor glucose <3.9 mmol/L (70 mg/dL)] was reduced by 50% compared to baseline [-0.70 ± 1.85/24 h (mean ± standard deviation); p = 0.0002]. Nocturnal hypoglycemia [2300 to 0600 hours, <3.9 mmol/L (70 mg/dL)] was reduced by 52%; p = 0.0002. There was no change in time in range [sensor glucose 3.9-10.0 mmol/L (70-180 mg/dL)]. SMBG testing fell from a mean of 3.9 (median 3.9) times/day at baseline to 0.2 (0.0), with an average frequency of sensor scanning of 7.1 (5.7) times/day at 12 months, and mean sensor utilization was 83.6 ± 13.8% (median 88.3%) during the open-access phase. During this 6-month extension period no device-related serious adverse events were reported. Nine participants reported 16 instances of device-related adverse events (e.g. infection, allergy) and 28 participants (20.1%) experienced 134 occurrences of anticipated skin symptoms/sensor-insertion events expected with device use (e.g. erythema, itching and rash).

Conclusion: The use of flash glucose-sensing technology for glycemic management in individuals with type 2 diabetes treated by intensive insulin therapy over 12 months was associated with a sustained reduction in hypoglycemia and safely and effectively replaced SMBG.

Trial registration: ClinicalTrials.gov identifier, NCT02082184.

Keywords: Flash sensor glucose technology; Glucose monitoring; Insulin; Type 2 diabetes.

Fig. 1

Trial profile. ITT Intention to treat

Fig. 2

Difference from baseline for time in range and hypoglycemia measures at 12 months. Rescaled confidence intervals are confidence intervals for the difference from baseline expressed as a percentage of the baseline mean

Fig. 3

Summaries of all glycemic measures during the day (0600–2300) (a) and during the night (2300–0600) (b). Difference from baseline for glycemic measures at 12 months post-baseline. Rescaled confidence intervals are confidence intervals for the difference from baseline expressed as a percentage of the baseline mean

Fig. 4

Blood glucose monitoring tests and sensor scans frequency per day by study period. BGM Blood glucose monitoring

Fig. 5

Summaries of glycemic measures for participants aged <65 years (a) and aged ≥65 years (b). Difference from baseline for glycemic measures at 12 months. Rescaled confidence intervals are confidence intervals for the difference from baseline expressed as a percentage of the baseline mean

Fig. 6

Significantly reduced time in hypoglycemia is observed as soon as sensor glucose results can be utilized by the participants at the end of the baseline phase and is sustained for 12 months