Prevention of Severe Hypoglycemia in Type 1 Diabetes
Status:
Completed
Trial end date:
2004-09-01
Target enrollment:
Participant gender:
Summary
Severe hypoglycaemia leading to collapse without warning is one of the most-feared
complications for those with Type 1 diabetes. The aim of this study is to determine whether
detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous
insulin regime or continuous insulin regime can restore hypoglycaemia awareness in Type 1
diabetes. Following a 6-day continuous subcutaneous monitor glucose profile, participants
will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current
insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia;
or continuous subcutaneous insulin infusion. Symptomatic experience and severity of
hypoglycaemia, pattern of hypoglycaemia on glucose profiling and, in selected individuals,
response to hyperinsulinaemic hypoglycaemic clamp, will be compared over a 6 month period. It
is envisaged that successful prevention of hypoglycaemia by one or more interventions may
reverse altered hypoglycaemia awareness and prevent further episodes of severe hypoglycaemia.
Phase:
Phase 4
Details
Lead Sponsor:
Newcastle University
Collaborators:
Medtronic Newcastle Primary Care Trust Newcastle-upon-Tyne Hospitals NHS Trust Sanofi