Using ultrasound to prevent insulin-related fatty lumps in people with diabetes
Avoidance of Insulin-induced Lipohypertophy in People With Diabetes: A Feasibility Study of Implementation of Ultrasound Scanning Within Diabetes Clinics
This project will try using ultrasound scans in diabetes clinics to find hidden insulin-related fatty lumps (lipohypertrophy) in adults on insulin who use CGM and have variable glucose levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06782568 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18 years and above) with at least one year of diabetes managed by multiple daily injections or an insulin pump who use CGM ≥70% of the time and have high glucose variability (CV >36% and TIR <70%), with no planned diabetes treatment changes and who are willing to undergo clinic exams and ultrasound scans.
Not a fit: People unlikely to benefit include those not using CGM, those with stable glucose control (low variability), pregnant people, those with known lipodystrophy or Dercum's disease, significant comorbidity (eGFR <25), or those unable to attend clinic appointments.
Why it matters
Potential benefit: If successful, routine ultrasound could identify lipohypertrophy missed by touch, enabling changes in injection technique or site that may reduce unpredictable highs and lows in glucose.
How similar studies have performed: Previous research indicates ultrasound detects lipohypertrophy more often than manual palpation and that about 40% of insulin-treated people have lipohypertrophy, but routine clinic use of ultrasound remains relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.