The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Assessment of lipohypertrophy by US machine — 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.

Trial sites (1)

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