Using Novel Flash Glucose-Sensing Technology Reduces Hypoglycemia in Individuals with Type 1

Poster at the Meeting

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JAN BOLINDER, RAMIRO ANTUNA, NEL GEELHOED-DUIJVESTIJN, STEPHAN MATTHAEI, RAIMUND WEITGASSER, Stockholm, Sweden, Madrid, Spain, The Hague, Netherlands, Quakenbrück, Germany, Salzburg, Austria

Background

Hypoglycemia is a barrier to intensive insulin therapy and influences quality of life. We assessed the impact of new sensor technology on hypoglycemia compared to conventional self-monitoring of blood glucose (SMBG). 241 subjects with well controlled type 1 diabetes (T1DM), [HbA1c 6.74±0.56% (50.1±6.1 mmol/mol), age 43.7±13.9 years and average duration of diabetes 22±12 years (mean±SD)] were recruited into a 6 month European study (23 sites). The control group (n=121) used capillary glucose-testing (FreeStyle Lite™) and the intervention group (n=120) used sensor glucose data (FreeStyle Libre™ Flash Glucose Monitoring System) for self-management. 

Results

At 6 months, the time in hypoglycemia <70 mg/dL (primary outcome) was significantly reduced by 38.0% [mean difference -1.24±0.239 hours per day (mean±SE); p<0.0001]. Time <40 mg/dL was reduced by 65.3%; (p=0.0003). Reductions were evident both during day and night with nocturnal hypoglycemia <70 mg/dL reduced by 39.8%; (p<0.0001). Time in hyperglycemia (>240 mg/dL) was significantly reduced by -0.37±0.163 hours per day (p=0.0247) and time in range (70-180 mg/dL) was significantly increased by 1.0±0.30 hours per day (p=0.0006). There were no differences in mean glucose or HbA1c. Using FreeStyle Libre™, scanning frequency averaged 15.1 per day, whereas SMBG tests dropped from a median of 5.4 (baseline) to 0.1 per day. In the control group, SMBG remained unchanged at 5.6 per day. Ten subjects experienced 13 device related AEs, e.g., allergy, itching, rash, erythema and edema (6 severe, 4 moderate, 3 mild), with 5 subjects withdrawing due to the event. Treatment satisfaction (DTSQ, DQoL), perception of hyperglycemia (DTSQ) and quality of life (total score for DQoL) were significantly improved. 

Conclusion

It is concluded that well controlled T1DM subjects using novel flash glucose monitoring technology reduced time in hypoglycemia without deterioration of HbA1c and reported improvements in quality of life.

POSTER ABSTRACT MARD COMPARISON

Standardized Evaluation of Three Continuous Glucose Monitoring Systems under Routine Clinical ConditionsView session detail

Author Block: JULIA K. MADER, MARTIN HAJNSEK, FELIX ABERER, MARKUS RUMPLER, SABINE ZENZ, ADELHEID PUFFING, HESHAM EL-SAYED, THOMAS AUGUSTIN, FRANK SINNER, THOMAS R. PIEBER, Graz, Austria

Continuous glucose monitoring (CGM) has become an essential tool in diabetes management. In order to use CGM for treatment decisions, CGM systems have to be reliable over a wide range of glycemia as well as in situations with rapidly changing glucose levels. In this monocentric study we evaluated the performance of 3 commercially available CGM systems (Abbott Libre, Dexcom G4 Platinum, Medtronic Enlite) in 12 type 1 diabetic subjects (age 33 ± 11 y, 42% women, BMI 22.5 ± 2.4 kg/m2, diabetes duration 17 ± 12 y, HbA1c 7.6 ± 1.1%) over a period of 12 hours. Routine clinical conditions were mimicked by meal and exercise tests. The sensors were inserted 24 hours prior to the test in parallel and were calibrated according to manufacturers’ instructions. Reference plasma glucose samples were taken every 5 minutes throughout the study and measured with Super GL analyzer. Glucose measurement accuracy was determined for each CGM system according to ISO 15197: 2013 guideline (±15%; ±15 mg/dL for glucose <100 mg/dL).

The systems fulfilled these criteria as follows: 73.1% (Abbott), 56.1% (Dexcom) and 52.0% (Medtronic). Additional accuracy metrics are indicated in Table 1.

In summary, the Abbott sensor showed superior performance based on all accuracy metrics applied in this study. All sensors were less accurate during hypoglycemia. Future CGM generations need to be improved regarding accuracy in the low glucose range.

Continuous Glucose Monitor PerformanceAbbott (n=462)Dexcom (n=540)Medtronic (n=502)Overall Mean Absolute Relative Difference (MARD)13.22 ± 10.8716.75 ± 12.3121.36 ± 17.60MARD <70 mg/dL14.61 ± 10.3423.77 ± 15.6626.86 ± 20.02MARD 70-≤180 mg/dL13.68 ± 11.5316.34 ± 11.6420.94 ± 15.34MARD >180 mg/dL10.09 ± 7.9311.56 ± 7.2417.15 ± 21.85Parkes Error Grid Zone A (%)85.7183.5271.12Parkes Error Grid Zone B (%)14.2915.7427.49Parkes Error Grid Zone C (%)00.741.39