Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus With Hypoglycemia
- Sponsor
- Imperial College London
- Enrollment
- 40
- Primary Endpoint
- % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
Time Frame: 10 weeks
Percentage time spent in hypoglycaemia (\<3.3mmol/L, 60mg/dL) change from baseline
Secondary Outcomes
- % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)(10 weeks)
- Severe Hypoglycaemia(8 weeks)
- % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)(10 weeks)
- % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)(10 weeks)
- Hypoglycemia(8 weeks)
- Glucose Variability Measured by CONGA(8 weeks)
- % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)(10 weeks)
- % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)(10 weeks)
- Changes in Glucose Variability Measured(8 weeks)
- % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)(10 weeks)
- Glucose Variability Measured by MAGE(8 weeks)