Actively Recruiting

Phase Not Applicable
Age: 19Years - 80Years
All Genders
NCT05377268

The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

Led by University of British Columbia · Updated on 2026-05-01

100

Participants Needed

1

Research Sites

200 weeks

Total Duration

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AI-Summary

What this Trial Is About

Lipohypertrophy is swelling of the fatty tissue located below the skin ("subcutaneous tissue") where many patients with diabetes inject their insulin. Lipohypertrophy can sometimes be felt as firm swelling, lumps or small bumps near insulin injection sites. Previous studies have shown that injecting insulin into areas of lipohypertrophy can affect how insulin is absorbed, and can increase insulin requirements in patients. New data suggest that lipohypertrophy can be detected using ultrasound technology. The ultrasonographic presence of changes to the subcutaneous tissue without swelling that can be felt ("subclinical lipohypertrophy") and the effect of injecting insulin into these sites is unknown. 100 people will participate in the Phase 1 of this study. In the second phase of the study, 40 patients identified with subclinical lipohypertrophy in Phase 1 will be asked to participate in the randomized study using crossover design by checking your glucose levels.

CONDITIONS

Official Title

The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

Who Can Participate

Age: 19Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Type 1 or Type 2 diabetes mellitus
  • Using at least one insulin injection daily or insulin pump treatment for at least 2 years
  • Aged between 19 and 80 years
Not Eligible

You will not qualify if you...

  • Taking glucagon-like peptide-1 agonist or systemic glucocorticoid medications
  • History of non-lipohypertrophic skin disease in the insulin injection area
  • Not fluent in English without a translator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vancouver General Hospital Diabetes Centre

Vancouver, British Columbia, Canada, V5Z 1M9

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control | DecenTrialz