This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia.
Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self monitoring of glucose levels is an important component of achieving and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can become less aware of it. This reduced aware of hypoglycaemia has significant risks including seizures, coma and even death, and has an impact on people's ability to drive and function. The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14 days and is non-adjunctive (does not require calibration to capillary blood glucose).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values
Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data
% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
Percentage time spent in hypoglycaemia (\<3.3mmol/L, 60mg/dL) change from baseline
Time frame: 10 weeks
% Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)
Percentage time spent in hypoglycaemia (\<2.8mmol/L, 50mg/dL) change from baseline
Time frame: 10 weeks
% Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)
Percentage time spent in hypoglycaemia (\<3.9mmol/L, 70mg/dL) change in baseline to endpint
Time frame: 10 weeks
% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint
Time frame: 10 weeks
% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)
Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint
Time frame: 10 weeks
% Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)
Percentage time spent in hyperglycaemia (\>10mmol/L, 180mg/dL) change in baseline to endpoint
Time frame: 10 weeks
% Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)
% time spent in hyperglycaemia (\>15mmol/L, 270mg/dL) change in baseline to endpoint
Time frame: 10 weeks
Hypoglycemia
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of participants with hypoglycemic excursions
Time frame: 8 weeks
Severe Hypoglycaemia
Number of participants with episodes of severe hypoglycaemia
Time frame: 8 weeks
Changes in Glucose Variability Measured
Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1
Time frame: 8 weeks
Glucose Variability Measured by MAGE
Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)
Time frame: 8 weeks
Glucose Variability Measured by CONGA
Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)
Time frame: 8 weeks