Using ultrasound to find hidden insulin injection lumps (lipohypertrophy)
Official title: The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability
Run by University of British Columbia · NCT05377268 · Data updated 2026-11-12
This project will test whether using portable ultrasound to find hidden lipohypertrophy and avoiding injections in those spots improves blood sugar control in adults with type 1 or type 2 diabetes who use insulin.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of British Columbia Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Vancouver, British Columbia) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT05377268 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19 or older with type 1 or type 2 diabetes who have been using insulin injections or an insulin pump for at least two years, with phase 2 enrollment limited to those found to have subclinical lipohypertrophy on ultrasound.
✕Probably not a fit
People who do not use insulin, those taking GLP-1 agonists or systemic glucocorticoids, those with non-lipohypertrophic skin disease at injection sites, or those unable to participate in English (without a translator) are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study first uses portable ultrasound plus computer-based image detection to identify both obvious and subclinical lipohypertrophy in adults with diabetes who use insulin. In phase 1, up to 100 participants will undergo ultrasound imaging to train and test the detection technology. In phase 2, about 40 participants who are found to have subclinical lipohypertrophy will take part in a randomized crossover comparison where they will alternate injecting into lipohypertrophy-free areas versus areas with lipohypertrophy while monitoring glucose. Researchers will compare glucose control and insulin requirements between the two injection strategies.
Why it matters
Potential benefit: If successful, this approach could help people lower insulin doses and improve blood glucose control by identifying and avoiding lipohypertrophy when injecting.
How similar studies have gone: Previous studies have shown that injecting into palpable lipohypertrophy impairs insulin absorption and raises insulin needs, but using ultrasound to detect subclinical lipohypertrophy and testing its direct effect on glucose control is a relatively new approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with a diagnosis of Type 1 or Type 2 diabetes mellitus * Current treatment with a minimum of one insulin injection daily or insulin pump for at least 2 years Exclusion Criteria: * Subjects taking a glucagon-like peptide-1 agonist or a systemic glucocorticoid * Past history of a non-lipohypertrophic dermatological condition in the insulin injection site area
Where it's running
-
Vancouver General Hospital Diabetes Centre
Vancouver, British Columbia, Canada Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.