NCT06782568Recruiting
Avoidance of Insulin-induced Lipohypertophy in People With Diabetes Using Ultrasound Scanning Within Diabetes Clinics
Avoidance of Insulin-induced Lipohypertophy in People With Diabetes: A Feasibility Study of Implementation of Ultrasound Scanning Within Diabetes Clinics
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
Diabetes is a common long-term health condition globally. Type 1 diabetes requires insulin treatment right from diagnosis. Similarly, many living with type 2 diabetes eventually require insulin injections as the condition progresses. A common but often underappreciated complication associated with insulin use is the formation of fatty tissue at injection sites, known as "Lipos," a shorthand for "Lipohypertrophy." These Lipos can interfere with insulin absorption, leading to an altered insulin action profile. This results in glucose fluctuations increasing the risk of both high and low glucose levels. In current medical practice, Lipos are assessed through clinical examination, specifically by physically palpating the injection sites. Research indicates that approximately 40% of insulin-treated individuals may have Lipos. However, manual palpation can often overlook these fatty deposits. Ultrasound scanning (USS) presents a more effective method for detecting Lipos. Studies that have employed ultrasound scanning have reported a much higher prevalence, reaching up to 86%. The primary goal of this study is to ascertain whether the avoidance of ultrasound-identified Lipos can improve glucose regulation. The focus will be on individuals using continuous glucose monitoring who exhibit high glucose fluctuations and less time within their target range. By focusing on this population, the chances of identifying those with Lipos will increase. Participants will undergo a clinical examination followed by an ultrasound scan. Those found to have Lipos will receive guidance on avoiding those sites and education on insulin injection techniques. Glucose data will be collected periodically over the next 24 weeks. After this period, participants will return for a follow-up ultrasound scan. Additionally, members of the diabetes care team will be trained to conduct the ultrasound scans. Data from this study may also be utilized to develop artificial intelligence algorithms aimed at identifying Lipos in future ultrasound scans.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Imperial College London
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06782568
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Jan 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- The participant has an active major life-threatening illness limiting the participants life-expectancy to \<6 months
Lab values
- Estimated Glomerular Filtration Rate (e-GFR) \< 25
Other
- Women who are pregnant or planning pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.