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

Type1diabetes Clinical Trial

— IHART-CGM  

Official title:

Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028220
• Other study ID #: 15HH2875
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)	Percentage time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) change from baseline	10 weeks
Secondary	% Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)	Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline	10 weeks
Secondary	% Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)	Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) change in baseline to endpint	10 weeks
Secondary	% 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	10 weeks
Secondary	% 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	10 weeks
Secondary	% Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)	Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint	10 weeks
Secondary	% Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)	% time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint	10 weeks
Secondary	Hypoglycemia	Number of participants with hypoglycemic excursions	8 weeks
Secondary	Severe Hypoglycaemia	Number of participants with episodes of severe hypoglycaemia	8 weeks
Secondary	Changes in Glucose Variability Measured	Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1	8 weeks
Secondary	Glucose Variability Measured by MAGE	Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)	8 weeks
Secondary	Glucose Variability Measured by CONGA	Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)	8 weeks