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ACTIVE NOT RECRUITING
NCT05377268
NA

The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

Sponsor: University of British Columbia

View on ClinicalTrials.gov

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.

Official title: The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-03-01

Completion Date

2025-12-31

Last Updated

2024-05-09

Healthy Volunteers

No

Interventions

PROCEDURE

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

Locations (1)

Vancouver General Hospital Diabetes Centre

Vancouver, British Columbia, Canada