Prevention of Severe Hypoglycemia in Type 1 Diabetes
Launched by NEWCASTLE UNIVERSITY · Aug 4, 2006
Trial Information
Current as of July 22, 2025
Completed
Keywords
ClinConnect Summary
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 insu...
Gender
ALL
Eligibility 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.
About Newcastle University
Newcastle University is a leading research institution located in the United Kingdom, renowned for its commitment to advancing healthcare through innovative clinical trials and scientific research. The university's Clinical Trials Unit plays a pivotal role in the design, coordination, and execution of high-quality clinical studies, focusing on a wide range of therapeutic areas. With a multidisciplinary team of experts, Newcastle University fosters collaboration between academia, industry, and healthcare providers, ensuring that research findings translate into meaningful advancements in patient care. Its dedication to excellence and ethical standards positions Newcastle University as a trusted sponsor in the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Newcastle, Tyne And Wear, United Kingdom
Patients applied
Trial Officials
James AM Shaw, MD; PhD
Principal Investigator
Newcastle University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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