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NCT Number: NCT05377268

The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Lipohypertrophy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver General Hospital Diabetes Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location status: Recruiting

Location contact

Boris Feldman

CONTACT

[email protected]

604-875-5115

Graydon Meneilly, MD

SUB_INVESTIGATOR

Kenneth Madden, MD

PRINCIPAL_INVESTIGATOR

About this study

Purpose:

In Phase 1: to use computer based technology to detect lipohypertrophy on portable ultrasound images.

In Phase 2: to demonstrate that injecting insulin into areas to be free of lipohypertrophy will have better glucose control as compared to injecting into areas demonstrated to have lipohypertrophy.

Eligibility:

You can participate in this study if:

  • You have been diagnosed with Type 1 or Type 2 diabetes
  • You are currently using injection of insulin daily or insulin pump for at least 2 years
  • You are 19 years of age or older

You should not participate in this study if:

  • You are taking a glucagon-like peptide medication
  • You are currently using a systemic steroid agent (e.g. prednisone)
  • You have history of a non-lipohypertrophic skin disease in the insulin injection area
  • You are not fluent in English (unless accompanied by a translator)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with a diagnosis of Type 1 or Type 2 diabetes mellitus
  • Current treatment with a minimum of one insulin injection daily or insulin pump for at least 2 years

Exclusion criteria

  • Subjects taking a glucagon-like peptide-1 agonist or a systemic glucocorticoid
  • Past history of a non-lipohypertrophic dermatological condition in the insulin injection site area

Treatment and study plan

LH Protocol

Procedure

Patients will be randomized and data interpreters will be blinded to two, randomized, alternating 14-day protocols where the patients will be advised by the nurse educator verbally to inject insulin in sites of subclinical lipohypertrophy

Other names: 40 patients identified with subclinical lipohypertrophy in Phase 1 will be recruited to a randomized crossover design examining glycemic variability by glucose monitor.

Primary outcomes

  1. Assessment of lipohypertrophy by US machine

    Time frame: First 12 months of the study

    Validation of machine algorithm, such as a web-based convolutional network to detect lipohypertrophy on portable ultrasound images.

    Each image will be evaluated by an experience ultrasonographer (Dr.Areshnikoff0 and labelled as either having the presence or absence of lipohypertrophy.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 17, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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