RecruitingNot ApplicableNCT06782568

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


Sponsor

Imperial College London

Enrollment

50 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ultrasound guidance when injecting insulin can help people with diabetes avoid developing hard lumps (lipohypertrophy) under the skin from repeated injections in the same spot. These lumps can affect how well insulin is absorbed and lead to unpredictable blood sugar levels. **You may be eligible if...** - You are 18 or older - You have any type of diabetes managed with multiple daily insulin injections or an insulin pump - You have been using continuous glucose monitoring (CGM) for at least 70% of the past 4 weeks - Your blood sugar control is not ideal (high variability or low time in range) **You may NOT be eligible if...** - You have a known lipodystrophy (abnormal fat distribution) condition - You have serious physical or severe mental health conditions that may interfere with the study - You are unable to read and understand English sufficiently for safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTUltrasound Scan

Participants will undergo an ultrasound scan of insulin injection sites at baseline and after 6 months.


Locations(1)

Imperial College Healthcare NHS Trust

London, United Kingdom

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NCT06782568


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