Using ultrasound to prevent insulin-related fatty lumps in people with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-centre, prospective, open-label feasibility study at Imperial College Healthcare NHS Trust that uses ultrasound scanning of insulin injection sites to detect lipohypertrophy. Participants are adults with any type of diabetes treated with multiple daily injections or an insulin pump who use continuous glucose monitoring at least 70% of the time and show high glucose variability. Each participant will undergo clinical examination and ultrasound scans of injection sites (two scans specified) to compare detection and document injection-site findings alongside CGM metrics. The study will test the practicality of adding ultrasound to routine clinic care and collect data on detection rates and feasibility of implementing this approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years and above
* Any type of diabetes of at least 1-year duration managed with multiple daily injections (MDI \[ie separate rapid-acting and basal insulin injections\]) or insulin pump therapy (CSII)
* Currently using any form of continuous glucose monitoring (CGM) with use \>70% in the last 4 weeks
* No anticipated changes to diabetes treatment in the next 6 months such as introduction of novel agents like GLP-1, SGLT2 or introduction (Tupe 2 diabetes) or AID (Type 1 diabetes)
* Coefficient of variation (CV) of CGM glucose \>36% and Time in the range between 3.9 to 10.0 mmol/l is \<70%
* The participant is willing and able to implement the study requirements and undergo two ultrasound scans of the insulin injection sites
* Participants is able understand English sufficiently for safe study conduct

Exclusion Criteria:

* Any other physical disease or people with known severe mental illness that are likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
* Known to have any form of lipodystrophy disorder either primary or secondary to other medical conditions
* Dercum's disease
* Women who are pregnant or planning pregnancy
* The participant has an active major life-threatening illness limiting the participants life-expectancy to \<6 months
* Estimated Glomerular Filtration Rate (e-GFR) \< 25

Where it's running

• Imperial College Healthcare NHS Trust
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Lalantha Leelarathna, PhD FRCP — Imperial College London
• Study coordinator: Lalantha Leelarathna, PhD FRCP (UK)
• Email: e.leelarathna@imperial.ac.uk
• Phone: +447984477771

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.