Relationship Between Lipohypertrophy, Glycemic Control, and Insulin Dosing: A Systematic Meta-Analysis.
Julia K Mader, Ricardo Fornengo, Ahmed Hassoun...
https://pubmed.ncbi.nlm.nih.gov/38215209Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06782568
Avoidance of Insulin-induced Lipohypertophy in People With Diabetes: A Feasibility Study of Implementation of Ultrasound Scanning Within Diabetes Clinics
Led by Imperial College London · Updated on 2026-02-13
50
Participants Needed
1
Research Sites
21 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 affecting many people worldwide. Both type 1 diabetes, which requires insulin from diagnosis, and type 2 diabetes, which often requires insulin as it progresses, can lead to a complication called lipohypertrophy (Lipos). Lipos are fatty lumps that form at insulin injection sites and can disrupt insulin absorption, causing fluctuations in blood glucose levels. This study aims to find out if avoiding Lipos detected by ultrasound scanning can improve glucose control in people with diabetes who use continuous glucose monitoring and experience significant glucose variability. Participants will receive a clinical examination and an ultrasound scan of their insulin injection sites. If Lipos are found, participants will be given a personalized map of these sites and advised to avoid injecting insulin there for 24 weeks. They will also receive education on proper insulin injection techniques, including needle length and injection methods. Follow-up visits will occur remotely or in person at 4 and 12 weeks, with a final visit at 24 weeks including repeat clinical examination and ultrasound scanning to assess changes. Throughout the study, continuous glucose monitoring data will be collected to evaluate time spent in the target glucose range and other glucose measures. Blood samples for HbA1c and kidney function will be taken at the beginning and end of the study. The study will also train diabetes care teams to perform ultrasound scans to detect Lipos. Overall participation lasts about 24 weeks, with data collected on glucose control, insulin doses, and lipohypertrophy resolution.
CONDITIONS
Brief 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
You may qualify if you...
- Age 18 years and above
- Any type of diabetes of at least 1-year duration managed with multiple daily injections or insulin pump therapy
- Currently using continuous glucose monitoring with use over 70% in the last 4 weeks
- No planned changes to diabetes treatment in the next 6 months
- Coefficient of variation of glucose over 36% and time in range between 3.9 to 10.0 mmol/l less than 70%
- Willing and able to undergo two ultrasound scans of insulin injection sites
- Able to understand English sufficiently for safe study participation
You will not qualify if you...
- Any physical disease or severe mental illness likely to interfere with the study
- Known primary or secondary lipodystrophy disorders
- Dercum's disease
- Women who are pregnant or planning pregnancy
- Active major life-threatening illness limiting life expectancy to less than 6 months
- Estimated glomerular filtration rate less than 25
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Run-in Period
Duration - 2 weeks
Participants undergo baseline clinical examination and ultrasound scanning (USS) of insulin injection sites. If lipohypertrophy (LH) is detected, an individual map of LH sites is created and participants are advised to avoid these sites for 24 weeks.
1 visit (in-person) for baseline clinical examination and USS
Monitoring
Duration - 24 weeks
Participants provide continuous glucose monitoring (CGM) data remotely or in-person to track glucose levels and variability during the study. Follow-up assessments are conducted to monitor changes in glucose control and insulin dosing.
Remote or in-person visits at 4 weeks and 12 weeks for CGM data collection
Diagnostic Evaluation
Duration - 1 day at 24 weeks
At the end of the study, participants undergo repeat clinical examination and ultrasound scanning of insulin injection sites to assess resolution of lipohypertrophy.
1 visit (in-person) including clinical examination, USS, blood sample for HbA1c, and insulin dose information collection
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)
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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