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REPLACE (Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in T2DM). Heak T et al, Oral presentation session 3 at the ATTD

Conclusions

Device safety

PROM Patient reported outcome measures

Study design

6 mån RCT T2DM with additional 6 month open access phase – initial 6 month data reported, 26 sites across France, Germany and the UK, HbA1c DCCT 7,5-12%, on intensive insulin therapy or CSII, regular blood glucose test users 10 tests or more per week

Intention to treat (ITT) set with 75 patients randomised to control group, 149 randomised to intervention group.

Study objective

Primary objective to evaluate effectiveness of the FreeStyle Libre device in T2DM

Secondary endpoints included

SMBG test frequency, quality of life, device safety 

FreeStyle Libre Glucose Monitoring system

On body factory calibrated, 14 day wear disposable sensor, providing on demand glucose data, measuring interstitial fluid glucose, designed to replace SMBG except

  1. / during times of rapidly changing glucose
  2. / when hypoglycemia or impending hypoglycemia is reported by the system
  3. / when symptoms do not match the system readings

Nyhetsinfo
www red DiabetologNytt 

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