TITANIC version-1
Research type
Research Study
Full title
Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes (The TITANIC studies): a Case Cross-over Study
IRAS ID
217187
Contact name
Angus Forbes
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 0 months, 29 days
Research summary
This study will assess the impact of lipohypertrophy(LH) on glucose variability in adults with type 1 diabetes. LH is a condition that occurs with repeated exposure to insulin at injection sites, resulting in the development of subcutaneous fatty lumps that impede the absorption of insulin. This can lead to glucose variability, with high and low levels of glucose, resulting in increased risk of diabetes complications, hypoglycaemia and patient distress. Therefore, this study aims to examine impact of LH lumps on glucose variability and the behaviours involved in injecting insulin.
Participants volunteering, from clinics at Guys and St Thomas’ Hospitals, will be asked to answer a series of questions about their injecting practices and be fitted with a glucose monitor, for a week. This will be followed by both a manual and ultrasound examination, to establish if lumps are present. They will then be asked to inject that into lump free areas. We will reduce insulin doses in this period to avoid low glucose levels and when their insulin has been adjusted they will be refitted with a second glucose monitor, for a week to assess the impact on glucose variability. They will also re-answer the questions asked of them at the start of the study.
At the end of the study we will conduct a short exit interview with participants, to gather information on their experience of injecting into a lump free site. Finally, the participants will have a session with a diabetes specialist nurse, who will advise them on maintaining a stable glucose level and refer on as appropriate to their diabetes team.
REC name
London - Bromley Research Ethics Committee
REC reference
17/LO/1242
Date of REC Opinion
2 Aug 2017
REC opinion
Favourable Opinion