Recruiting

Lipohypertrophy Detection

Sponsor:

University of British Columbia

Code:

NCT05377268

Conditions

Diabetes Mellitus

Lipohypertrophy

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

LH Protocol

Study Details

Brief summary:

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

Diabetes Mellitus

Lipohypertrophy

Study ID

NCT05377268

Start date

Mar 1, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: LH Protocol

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 and by written instruction to inject insulin in sites of subclinical lipohypertrophy.

active comparator: Normal Protocol

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 and by written instruction to inject insulin in sites of normal subcutaneous tissue.

Outcomes measured will consist of mean glucose, glucose standard deviation around the mean value, percentage of time with glucose below 3 mmol/liter, and percentage of time spent with glicose above 10 mmol/liter. The device will be calibrated and placed by a trained research nurse. There will be a member of the rsearch team available 24 hours per day to answer subject questions.

Interventions

LH Protocol

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

Primary outcome measure

  • Assessment of lipohypertrophy by US machine [ Time Frame: First 12 months of the study ]

Central Contacts and Locations

Locations

Vancouver General Hospital Diabetes Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Boris Feldman

604-875-5115boris.feldman@vch.ca

Principal Investigator:

Kenneth Madden, MD

More Information

Sponsor

University of British Columbia

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-01.