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Prevention of Severe Hypoglycemia in Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle Primary Care Trust
Sanofi
Medtronic
Information provided by:
Newcastle University
ClinicalTrials.gov Identifier:
NCT00360984
First received: August 4, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Drug: insulin glargine
Device: continuous subcutaneous insulin infusion
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Newcastle University:

Primary Outcome Measures:
  • prevention of severe hypoglycemia

Secondary Outcome Measures:
  • incidence of mild symptomatic hypoglycemia
  • HbA1C
  • Continuous Subcutaneous Glucose Monitoring System profiles
  • Altered Hypoglycemia Awareness survey
  • Hypoglycemia Fear Survey
  • Diabetes Quality Of Life of questionnaires.

Estimated Enrollment: 21
Study Start Date: May 2003
Estimated Study Completion Date: September 2004
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

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360984

Locations
United Kingdom
Newcastle Diabetes Centre
Newcastle, Tyne and Wear, United Kingdom, NE4 6BE
Sponsors and Collaborators
Newcastle University
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle Primary Care Trust
Sanofi
Medtronic
Investigators
Principal Investigator: James AM Shaw, MD; PhD Newcastle University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00360984     History of Changes
Other Study ID Numbers: 4044
Study First Received: August 4, 2006
Last Updated: August 4, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Newcastle University:
CSII
insulin analog
severe hypoglycaemia
 altered hypoglycaemia awareness
diabetes quality of life
CGMS

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013