Prevention of Severe Hypoglycemia in Type 1 Diabetes

NCT00360984 | Completed Phase 4

• 1 other identifier: 4044
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

CSII; insulin analog; severe hypoglycaemia; altered hypoglycaemia awareness; diabetes quality of life; CGMS

Outcome Measures

Primary Outcomes (1)

• prevention of severe hypoglycemia

Secondary Outcomes (6)

• incidence of mild symptomatic hypoglycemia

• HbA1C

• Continuous Subcutaneous Glucose Monitoring System profiles

• Altered Hypoglycemia Awareness survey

• Hypoglycemia Fear Survey

Interventions

insulin glargine DRUG

continuous subcutaneous insulin infusion DEVICE

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newcastle University: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• Newcastle Primary Care Trust: collaborator
• Sanofi: collaborator
• Medtronic: collaborator

Study Sites (1)

Newcastle Diabetes Centre

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• James AM Shaw, MD; PhD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 7, 2006
• Study Start: May 1, 2003
• Study Completion: September 1, 2004
• Last Updated: August 7, 2006

Record last verified: 2006-07

Locations

GB (1)