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

RecruitingNAAges 18 Years - anyAllImperial College London
NCT06782568 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Ultrasound Scan
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Where

1 site
Imperial College Healthcare NHS Trust
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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