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

NCT06782568 | Recruiting

• 2 other identifiers: Edge 175976WREE_PA7435
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes, Insulin Requiring; Type 1 Diabetes (T1D)

Keywords

Lipohypertophy; Diabetes

Outcome Measures

Primary Outcomes (1)

• Time in Range (3.9 to 10.0 mmol/l)

  Time spent in the target glucose range between 3.9 to 10.0 mmol/l (70 to 180 mg/dl) based on sensor glucose levels for the last 4 weeks of the 24 week study period

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (12)

• HbA1c

  From enrollment to the end of treatment at 24 weeks

• Mean glucose

  From enrollment to the end of treatment at 24 weeks

• Time above range (Level 1)

  From enrollment to the end of treatment at 24 weeks

• Time above range (Level 2)

  From enrollment to the end of treatment at 24 weeks

• Time below range (Level 1)

  From enrollment to the end of treatment at 24 weeks

Other Outcomes (1)

• Adverse Events

  From enrollment to the end of treatment at 24 weeks

Study Arms (1)

Ultrasound scanning of insulin injection sites

EXPERIMENTAL

Participants will undergo clinical examination followed by ultrasound scanning (USS) of the injection sites at baseline. If there is no significant lipohypertophy (LH) detected by USS, participants will take no further part in the study. If there is LH detected on USS, an individualised map of LH sites and clear sites will be drawn, and the participant will be asked to avoid LH sites for the next 6 months. Follow up remote/virtual/F2F visits will be conducted at 1 and 3 months. The final visit at 6 months will consist of a repeat clinical examination followed by a repeat USS.

Diagnostic Test: Ultrasound Scan

Interventions

Ultrasound Scan DIAGNOSTIC_TEST

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

Ultrasound scanning of insulin injection sites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, M13 9WL, United Kingdom

RECRUITING

Related Publications (1)

• Mader JK, Fornengo R, Hassoun A, Heinemann L, Kulzer B, Monica M, Nguyen T, Sieber J, Renard E, Reznik Y, Rys P, Stozek-Tutro A, Wilmot EG. Relationship Between Lipohypertrophy, Glycemic Control, and Insulin Dosing: A Systematic Meta-Analysis. Diabetes Technol Ther. 2024 May;26(5):351-362. doi: 10.1089/dia.2023.0491. Epub 2024 Feb 12.

  PMID: 38215209 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Lalantha Leelarathna, PhD FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lalantha Leelarathna, PhD FRCP (UK)

CONTACT

+447984477771; e.leelarathna@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm non-randomised feasibility study

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)