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

Not Applicable

Completed

• Conditions: Impaired Awareness of Hypoglycemia; Type1diabetes; Type 1 Diabetes Mellitus With Hypoglycemia
• Interventions: Device: Dexcom G5 Continuous Glucose Monitor; Device: Abbott Freestyle Libre

• Registration Number: NCT03028220
• Lead Sponsor: Imperial College London

Brief 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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-23
• Primary Completion: 2017-02
• Study Completion: 2017-08
• Results First Submitted: 2018-08-10
• Results First Submitted QC: 2019-04-12
• Results First Posted: 2019-04-16
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adults over 18 years of age
• Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200 pmol/L
• Severe hypoglycaemic event in the last 12 months requiring third party assistance OR a Gold Score ≥ 4
• Type 1 diabetes for greater than 3 years
• On an intensified multiple dose insulin injection regimen for > 6 months (MDI)
• Previous type 1 diabetes structured education (either group or 1:1)

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Exclusion Criteria

• Use of CGM or Libre device within the last 6 months (except short periods of diagnostic blinded use under clinic supervision)
• Use of regular paracetamol
• Pregnant or planning pregnancy
• Breastfeeding
• Enrolled in other clinical trials, except at the discretion of the chief investigator
• Have active malignancy or under investigation for malignancy
• Severe visual impairment
• Reduced manual dexterity
• Unable to participate due to other factors, as assessed by the Chief Investigators

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real time continuous glucose monitoring	Dexcom G5 Continuous Glucose Monitor	Use of Dexcom G5 continuous glucose monitoring
Flash glucose monitoring	Abbott Freestyle Libre	Use of Abbott FreeStyle Libre flash glucose monitoring

Primary Outcome Measures

Name	Time	Method
% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)	10 weeks	Percentage time spent in hypoglycaemia (\<3.3mmol/L, 60mg/dL) change from baseline

Secondary Outcome Measures

Name	Time	Method
Severe Hypoglycaemia	8 weeks	Number of participants with episodes of severe hypoglycaemia
% Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)	10 weeks	Percentage time spent in hyperglycaemia (\>10mmol/L, 180mg/dL) change in baseline to endpoint
% Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)	10 weeks	Percentage time spent in hypoglycaemia (\<3.9mmol/L, 70mg/dL) change in baseline to endpint
Hypoglycemia	8 weeks	Number of participants with hypoglycemic excursions
Glucose Variability Measured by CONGA	8 weeks	Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)
% Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)	10 weeks	Percentage time spent in hypoglycaemia (\<2.8mmol/L, 50mg/dL) change from baseline
% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)	10 weeks	Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint
% Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)	10 weeks	% time spent in hyperglycaemia (\>15mmol/L, 270mg/dL) change in baseline to endpoint
Changes in Glucose Variability Measured	8 weeks	Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1
% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)	10 weeks	Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint
Glucose Variability Measured by MAGE	8 weeks	Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)