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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous

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

Intervention / Treatment
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* Device: Dexcom G5 Continuous Glucose Monitor
* Device: Abbott Freestyle Libre


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real time continuous glucose monitoring<br>Use of Dexcom G5 continuous glucose monitoring | Device: Dexcom G5 Continuous Glucose Monitor<br>* Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values<br>|
| Active Comparator: Flash glucose monitoring<br>Use of Abbott FreeStyle Libre flash glucose monitoring | Device: Abbott Freestyle Libre<br>* Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Hypoglycemia