Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06782568

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

Led by Imperial College London · Updated on 2026-02-13

50

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

I

Imperial College Healthcare NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years and above
  • Diagnosis of any type of diabetes for at least 1 year managed with multiple daily insulin injections or insulin pump therapy
  • Currently using continuous glucose monitoring (CGM) with more than 70% use in the last 4 weeks
  • No expected changes to diabetes treatment in the next 6 months
  • Coefficient of variation of CGM glucose above 36% and time in range between 3.9 to 10.0 mmol/l below 70%
  • Willing and able to undergo two ultrasound scans of insulin injection sites
  • Able to understand English sufficiently for safe participation
Not Eligible

You will not qualify if you...

  • Any other physical disease or severe mental illness that could interfere with study conduct or results as judged by the investigator
  • Known lipodystrophy disorders, primary or secondary
  • Dercum's disease
  • Women who are pregnant or planning pregnancy
  • Active life-threatening illness limiting life expectancy to less than 6 months
  • Estimated Glomerular Filtration Rate (e-GFR) less than 25

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Imperial College Healthcare NHS Trust

London, United Kingdom, M13 9WL

Actively Recruiting

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Research Team

L

Lalantha Leelarathna, PhD FRCP (UK)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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