IMPACT OF A COMBINED INVASIVE AND NON-INVASIVE GLUCOSE METER ON GLYCEMIC CONTROL IN PATIENTS WITH TYPE 1 AND TYPE 2 DIABETES MELLITUS

Session Name
GLUCOSE SENSORS
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:30 - 09:30
Presenter
  • Andreas Pfützner, Germany
Authors
  • Andreas Pfützner, Germany
  • Sarah Kent, United States of America
  • Irina Nayberg, United States of America
  • Filiz Demircik, Germany
  • David Klonoff, United States of America
  • Anke H. Pfützner, Germany
  • Ronald Brazg, United States of America

Abstract

Background and Aims

This study evaluated the TensorTip Combo glucose meter (CoG, CNOGA Medical, Cesarea, Israel), which measures blood glucose invasively (INV) and tissue glucose non-invasively (NI). The optical non-invasive device module is individually calibrated over a period of 3-4 days.

Methods

Standardized meal experiments were performed at baseline and endpoint (after three months of home use). During the meal experiments, glucose was assessed at 11 time-points resulting in 2729 comparator readings vs. the YSI Stat2300 reference method. A subgroup of patients used two devices analysis of precision. The statistical analysis included parameters of glycemic control (HbA1c, hypoglycemia etc.) and system accuracy (mean absolute relative difference; MARD and consensus error grid analysis; CEG).

Results

The study was performed with 88 patients (male/female: 43/45, type1/type2: 24/64, HbA1c: 7.4±1.0%; Ethnicities: 40 Caucasian, 19 African-American, 12 Hispanic, 14 Asian). The observed glucose range was 53.5-399 mg/dL. A positive NI-MARD and a negative NI-MARD of 5.1% and 11.5% were observed, respectively (total NI-MARD: 16.6%). 99.3 % of the NI-data-points were seen in zones A+B of the CEG. No differences were seen in the meal test results between baseline and endpoint. The frequency of use of the NI module increased significantly (baseline NI/INV measurement ratio: 1.04 vs. 2.62 at endpoint, p<0.001). HbA1c remained stable (endpoint: 7.5±1.1%, n.s.), while frequency of hypoglycemia (invasive readings <70 mg/dL) was substantially reduced by 54% (p<0.01).

Conclusions

Using the CoG for 3 months at home resulted in an increased measurement frequency, and in a major improvement of glycemic control in patients with both types of diabetes.

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