NCT03028220

Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data

Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Type 1 Diabetes Mellitus With Hypoglycemia
• Impaired Awareness of Hypoglycemia
• Type1diabetes

Interventions

Type	Name	Description
DEVICE	Dexcom G5 Continuous Glucose Monitor	Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values
DEVICE	Abbott Freestyle Libre	Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-02-01
• Completion: 2017-08-01
• First posted: 2017-01-23
• Last updated: 2019-11-13
• Results posted: 2019-04-16