Clinical trial NCT00360984: Prevention of Severe Hypoglycemia in Type 1 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: CSII
insulin analog
severe hypoglycaemia
altered hypoglycaemia awareness
diabetes quality of life
CGMS
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Newcastle Primary Care Trust
name: Sanofi
name: Medtronic
First posted: 2006-08-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 4.5-7mmol/L to 7.2-8.3mmol/L 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

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes
* recurrent severe hypoglycemia within the preceding 6 months
* attending the Newcastle Diabetes Centre

Exclusion Criteria:

* previous use of rapid- and long-acting insulin analogs used in an multiple daily insulin injection regimen
* previous use of continuous subcutaneous insulin infusion pump
* alcohol or drug abuse
* seizures unrelated to hypoglycemia.

Primary outcomes:
measure: prevention of severe hypoglycemia
Secondary outcomes:
measure: incidence of mild symptomatic hypoglycemia
measure: HbA1C
measure: Continuous Subcutaneous Glucose Monitoring System profiles
measure: Altered Hypoglycemia Awareness survey
measure: Hypoglycemia Fear Survey
measure: Diabetes Quality Of Life of questionnaires.
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Newcastle Diabetes Centre
state: Tyne and Wear
Study officials:
affiliation: Newcastle University
name: James AM Shaw, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: