Avoidance of Insulin-induced Lipohypertophy in People With Diabetes: A Feasibility Study of Implementation of Ultrasound Scanning Within Diabetes Clinics
Trial ID: NCT06782568
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-01-01
Completion date: 2027-05-31
Sponsor: Imperial College London
Collaborators: Imperial College Healthcare NHS Trust
Conditions: Type 1 Diabetes (T1D); Type 2 Diabetes, Insulin Requiring
Interventions: Ultrasound Scan
Locations: Imperial College Healthcare NHS Trust
Countries: United Kingdom
Enrollment: 50
Age range: 18 Years - None
Sex: ALL

Summary:
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.

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

Outcomes:
Time in Range (3.9 to 10.0 mmol/l)