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The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control
Sponsor: University of British Columbia
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
Conditions
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
Locations (1)
Vancouver General Hospital Diabetes Centre
Vancouver, British Columbia, Canada