Prevention of Severe Hypoglycemia in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00360984
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : August 7, 2006
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle Primary Care Trust
Information provided by:
Newcastle University

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.

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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2003
Estimated Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. prevention of severe hypoglycemia

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00360984

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
Principal Investigator: James AM Shaw, MD; PhD Newcastle University Identifier: NCT00360984     History of Changes
Other Study ID Numbers: 4044
First Posted: August 7, 2006    Key Record Dates
Last Update Posted: August 7, 2006
Last Verified: July 2006

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

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