The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

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

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

Conditions3

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