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More info
You can access this
clinical trial
if you have
Type 1 Diabetes Mellitus With Hypoglycemia, Impaired Awareness of Hypoglycemia or Type1diabetes
and you are
over 18
years old
-
The phase for this study is not defined.
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The purpose

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). 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.

Provided treatments

  • Device: Dexcom G5 Continuous Glucose Monitor
  • Device: Abbott Freestyle Libre
Tris trial is registered with FDA with number: NCT03028220. The sponsor of the trial is Imperial College London and it is looking for 40 volunteers for the current phase.
Official trial title:
Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous