Type 1 Diabetes Clinical Trial
Official title:
New Strategies for Automated Glycaemic Control: the Issue of Continuous Glucose Monitoring Accuracy Under Hypoglycaemic Conditions
Achieving near-normoglycaemia has been established as the main objective for most patients
with diabetes. However, it is well known that intensification of treatment is associated
with an increase in the frequency of hypoglycemia, especially in the context of insulin
therapy. The burden of hypoglycemia in terms of psychological implications, morbidity and
even mortality, explains why it has been defined as the main limiting factor to achievement
of good metabolic control.
Continuous subcutaneous glucose monitoring (CGM) devices have been claimed to be useful in
hypoglycemia detection/prevention, allowing theoretically for safer intensification of
therapy in diabetic patients. However, accuracy of CGM devices, especially in the
hypoglycemic range, raises some concerns. In fact, commercially available CGM devices
estimate plasma glucose from measurements in the interstitial fluid and not in plasma.
However, the relationship between plasma and interstitial glucose is not fully understood,
especially under dynamic conditions, and this may explain the poor CGM performance during
rapid changes in blood glucose and hypoglycemia.
In this project, the relationship between plasma and interstitial glucose will be evaluated
under conditions of normal glucose concentrations and hypoglycemia. Experiments will be
performed to assess the role, if any, of different plasma insulin concentrations on the
accuracy of CGM.
All the information obtained may be relevant to the improvement of the ability of CGM
devices to detect hypoglycemia and hypoglycemic risk.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science
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