No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
19 – 80
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
100 (estimated)
Sponsor
University of British Columbia · Other
Who this trial is looking for
This trial is looking for people with diabetes who use insulin. Participants will undergo ultrasound testing to check for a condition called lipohypertrophy, which may affect insulin absorption.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Type 1 or Type 2 diabetes.
I use insulin injections or an insulin pump at least once a day.
I have been using insulin for at least 2 years.
You may not be able to join if
I take a glucagon-like peptide-1 agonist.
I take a systemic glucocorticoid.
I have a history of a skin condition in the area where I inject insulin.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
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 …
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
Contacts
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