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

• Use of FreeStyle Libre by subjects with T2DM was associated with reduced SMBG frequency of finger pricks by more than 92% and increased treatment satisfaction, suggesting a high level of confidence using sensor glucose data to support self-management of diabetes.
• Statistically significant 43,1% reduction in time spent in hypoglycemia <3,9 mmol/l.
• Test frequency decreased immediately on unmasked use of FreeStyle Libre by 92%, less need of conventional blood glucose test strips.
• 100% of  study participants choose to continue using FreeStyle Libre after completion of the 6 month study period.

Device safety

• No device related serious AEs were reported
• 91% of sensor insertion site signs and symtoms (SISS) were mild/moderate and all resolved without treatment.
• 50 subjects were reporting erythema, pain, itching, rash, bleeding, local edema, induration and bruising

PROM Patient reported outcome measures

• Diabetes Quality of Life (DQoL) questtionaire showed increased satisfaction for intervention versus vs control at the end of intervention
• -0,2 vs 0,00 p=0,0259
• Diabetes Treatment Satisfaction Questionnaire DTSQ showed increased overall treatment satisfaction for intervention versus control (13,1 +-0,5 vs 9,0 +-0,72, p<0,001)

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