Prevention of Severe Hypoglycemia in Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360984
• Other study ID #: 4044
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2006
• Last updated: August 4, 2006
• Start date: May 2003
• Est. completion date: September 2004

Study information

• Verified date: July 2006
• Source: Newcastle University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus

Intervention

Drug:
• insulin glargine

Device:
• continuous subcutaneous insulin infusion

Locations

Country	Name	City	State
United Kingdom	Newcastle Diabetes Centre	Newcastle	Tyne and Wear

Sponsors (5)

Lead Sponsor	Collaborator
Newcastle University	Medtronic, Newcastle Primary Care Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Sanofi

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of severe hypoglycemia
Secondary	incidence of mild symptomatic hypoglycemia
Secondary	HbA1C
Secondary	Continuous Subcutaneous Glucose Monitoring System profiles
Secondary	Altered Hypoglycemia Awareness survey
Secondary	Hypoglycemia Fear Survey
Secondary	Diabetes Quality Of Life of questionnaires.