Prevention of recurrent severe hypoglycaemia: optimised multiple daily insulin injection (MDI) versus continuous subcutaneous insulin infusion (CSII) with or without adjunctive real-time continuous glucose monitoring

Not Applicable

Completed

• Conditions: Type 1 diabetes mellitus; Nutritional, Metabolic, Endocrine; Insulin-dependent diabetes mellitus

• Registration Number: ISRCTN52164803
• Lead Sponsor: ewcastle Upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2012 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/23237320 protocol 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24130355 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29661916 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36538062/ results (added 30/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-18
• Study Completion: 2013-08-31
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female patients aged 18 - 74 years
2. Established type 1 diabetes mellitus (C peptide negative)
3. Experienced impaired hypoglycaemia awareness and, or at least one episode of severe hypoglycaemia as defined as by the American Diabetes Association in the previous 12 months
4. Willing to undergo intensive insulin therapy including the use of CSII (insulin pump)
5. Willing to monitor home blood glucose levels at least four times daily
6. Willing to monitor and record signs and symptoms of hypoglycaemia

Exclusion Criteria

1. Not willing to consider insulin pump therapy
2. Unable to use the technology such as real time glucose monitoring

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Restoration of hypoglycaemia awareness as determined by quantitative questionnaire analysis.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Difference in rates of mild symptomatic hypoglycaemia as measured by home blood glucose diaries at 6 months and intermediate study visits<br> 2. Difference in duration of biochemical hypoglycaemia determined by 7-day continuous glucose monitoring system (CGMS) at 6 months and intermediate study visits<br> 3. Difference in HbA1c at 6 months and intermediate study visits<br> 4. Difference in rates weekly 8-point glucose profiles<br>