Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301 Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Introduction Although CGM is essential in the management of diabetes, the benefit of standard CGM in the paediatric population remains uncertain This study aimed to demonstrate non-inferiority of the FreeStyle Libre™ Flash Glucose Monitoring System in determining the time in target range compared with SMBG in young patients with type 1 diabetes CGM, continuous glucose monitoring; SMBG, self-monitoring of blood glucose Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Screening and enrolment Study design Prospective, open-label study conducted at 10 European diabetes centres (ClinicalTrials.gov record: NCT02821117) Sensor glucose data reports and glycaemic control* reviewed with a healthcare professional Patients (aged 4–17 yrs) with T1D (disease duration ≥1 yr); receiving current insulin regimen for ≥2 mo. using SMBG (≥2 times/day) Days -14 -7 14 28 42 56 Screening and enrolment Baseline period Treatment period Flash glucose monitoring system worn in masked mode and scanned at every finger prick test and at least 8 hourly thereafter Flash glucose monitoring system unmasked and patients used the sensor data for insulin titration and self management as per the device label SMBG, self-monitoring of blood glucose; T1D, type 1 diabetes *generated at the clinic using system software Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Outcomes The primary outcome was the equivalence (non-inferiority) of time in glucose range (70–180 mg/dL) between the final 14 days of treatment phase and SMBG (baseline phase) Secondary outcomes included: Hyperglycaemic and hypoglycaemic events Time in hyperglycaemia and hypoglycaemia HbA1c Frequency of glucose monitoring Total daily insulin dose BMI, body mass index; HbA1c, glycated haemoglobin; SMBG, self-monitoring of blood glucose Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Participants Of 76 enrolled participants, 75 were included in the full analysis set The per protocol analysis included 66 participants Five participants deviated from the study protocol Four participants did not complete the study Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Baseline characteristics Participants (n=76) Age, years 10.3 ± 4.0 Male, n (%) 35 (46.1%) BMI, kg/m2 19.5 ± 3.9 HbA1c, mmol/mol 62.9 ± 11.1 HbA1c, % 7.9 ± 1.0 Duration of diabetes, years 5.4 ± 3.7 Values are presented as mean ± standard deviation unless stated otherwise BMI, body mass index; HbA1c, glycated haemoglobin Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Primary endpoint The lower confidence limit for change in time in range (70–180 mg/dL) exceeded the non-inferiority margin, −1.2 h/d, demonstrating non-inferiority Moreover, time in range improved by 1.0 h/d from 10.1±3.0 at baseline to 11.1±3.2 h/d at study end (p=0.006) Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Time in glucose range or hyperglycaemia ** ** Time (hours/day) ** * Glucose 70–180 mg/dL Glucose >180 mg/dL Glucose >240 mg/dL Glucose >300 mg/dL *p<0.05 vs baseline; **p<0.01 vs baseline Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Time in hypoglycaemia Time (hours/day) Glucose <70 mg/dL Glucose Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Other secondary glucose endpoints HbA1c significantly decreased from 62.9±11.2 mmol/mol (7.9±1.0%) at baseline to 58.5±9.8 mmol/mol (7.5±0.9%) after 8 weeks (p<0.0001) Change from baseline in mean glucose, blood glucose risk index, and high blood glucose index were −10±30 mg/dL (p=0.005), −1.6±4.9 mg/dL (p=0.005), and −1.8±5.3 mg/dL (p=0.004) Mean daily frequency of glucose monitoring reduced from 7.7±2.5 at baseline to 1.6±1.9 Unmasked device use and self-reported total daily insulin dose increased from baseline by 4% (from 35.8±25.6 to 37.2±25.6 units, p<0.001) Insulin pump upload data (n=38) showed more variation in the change between participants, resulting in an overall (71 participants) 3% change (p=0.24) HbA1c, glycated haemoglobin Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Patient reported outcomes The DTSQ (parent version) score for caregivers (n=70) demonstrated an improvement in overall satisfaction with treatment (p<0.0001) and perceived diabetes control (p<0.0001) The DTSQ (teen version) score for teenagers (≥13 years) demonstrated an improvement in overall satisfaction with treatment (p<0.0001) DTSQ, Diabetes Treatment Satisfaction Questionnaire Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Adverse events No serious AEs related to severe hypoglycaemia hyperglycaemia or diabetic ketoacidosis were reported The main device-related AEs included: Mild dry flaky skin (n=1), dry yellow/white collection (n=1), and non-itchy redness (n=1) Symptoms (n=96 by 42 participants, all mild or moderate) for sensor insertion (bleeding, pain, induration, and bruising) and wear (erythema, itching, rash, and infection; resolved without treatment) Moderate erythema at the site of wearing the sensor which led to treatment discontinuation; resolved without treatment (n=1) AEs, adverse events Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301

Conclusions The use of the FreeStyle LibreTM Flash Glucose Monitoring was associated with significant and safe improvements in time in glucose range, HBA1c, and treatment satisfaction compared with SMBG only in children with type 1 diabetes SMBG, self-monitoring of blood glucose Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301