Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360984
Status:
COMPLETED
Last Update Posted:
2006-08-07
First Post:
2006-08-04
Brief Title:
Prevention of Severe Hypoglycemia in Type 1 Diabetes
Sponsor:
Newcastle University
Organization:
Newcastle University
Study Overview
Official Title:
Can Hypoglycaemia Awareness Be Restored in Individuals With Type 1 Diabetes and Severe Hypoglycaemia Employing Optimised Subcutaneous Insulin Regime or Continuous Subcutaneous Insulin Infusion Pump
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The unifying objective of the proposed unblinded randomized prospective study is to determine whether hypoglycaemia awareness in Type 1 diabetes can be restored by rigorous avoidance of hypoglycaemia addressed by one of the following interventions
1 A non-targeted approach whereby pre-prandial glycaemic targets are raised from 45-7mmolL to 72-83mmolL and hypoglycaemia is rigorously avoided without specific alterations in subcutaneous insulin regime5
2 Optimisation of subcutaneous insulin regime employing pre-prandial short-acting insulin analogue in combination with once daily insulin Glargine targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles
3 Insulin delivery by external pump continuous subcutaneous insulin infusion targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles
1 A non-targeted approach whereby pre-prandial glycaemic targets are raised from 45-7mmolL to 72-83mmolL and hypoglycaemia is rigorously avoided without specific alterations in subcutaneous insulin regime5
2 Optimisation of subcutaneous insulin regime employing pre-prandial short-acting insulin analogue in combination with once daily insulin Glargine targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles
3 Insulin delivery by external pump continuous subcutaneous insulin infusion targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None