Avoidance of Insulin-induced Lipohypertophy in People With Diabetes Using Ultrasound Scanning Within Diabetes Clinics

Launched by IMPERIAL COLLEGE LONDON · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a common issue faced by people with diabetes who use insulin: the development of fatty lumps at injection sites, known as lipohypertrophy or "Lipos." These Lipos can make it harder for insulin to work properly, leading to swings in blood sugar levels. The trial aims to see if using ultrasound scanning can help identify these areas and ultimately improve blood sugar control for those who experience significant fluctuations in their glucose levels.

To participate, you must be at least 18 years old, have been diagnosed with any type of diabetes for at least a year, and currently use insulin with a continuous glucose monitor that has been used over 70% of the time in the last month. If you take part, you will have an exam and an ultrasound scan to check for Lipos. If any are found, you’ll receive guidance on how to avoid those spots for future injections and learn better injection techniques. Throughout the 24-week study, your blood sugar data will be monitored, and you'll have a follow-up scan at the end. This study also aims to train healthcare providers to perform these scans and may lead to advanced technology in the future for detecting Lipos more easily.

Gender

ALL

Eligibility 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