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Prevention of Severe Hypoglycemia in Type 1 Diabetes

NCT00360984 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2006-08-07

No results posted yet for this study

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

Interventions

DRUG

insulin glargine

DEVICE

continuous subcutaneous insulin infusion

Sponsors & Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER

  • Newcastle Primary Care Trust

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • Medtronic

    collaborator INDUSTRY

  • Newcastle University

    lead OTHER

Principal Investigators

  • James AM Shaw, MD; PhD · Newcastle University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Completion
2004-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00360984 on ClinicalTrials.gov