Prevention of Severe Hypoglycemia in Type 1 Diabetes - Full Text View

Sponsors and Collaborators:	University of Newcastle Newcastle-upon-Tyne Hospitals NHS Trust Newcastle Primary Care Trust Sanofi-Aventis Medtronic
Information provided by:	University of Newcastle
ClinicalTrials.gov Identifier:	NCT00360984

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 IV

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by University of Newcastle:

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:

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
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
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, Tyne and Wear
Newcastle Diabetes Centre
Newcastle, Tyne and Wear, United Kingdom, NE4 6BE

Sponsors and Collaborators

University of Newcastle

Newcastle-upon-Tyne Hospitals NHS Trust

Newcastle Primary Care Trust

Sanofi-Aventis

Medtronic

Investigators

Principal Investigator:

James AM Shaw, MD; PhD

University of Newcastle

More Information

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

Keywords provided by University of Newcastle:

CSII
insulin analog
severe hypoglycaemia

altered hypoglycaemia awareness
diabetes quality of life
CGMS

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Glargine
Diabetes Mellitus
Quality of Life

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009