The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LH Protocol.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Lipohypertrophy. Basic parameters: 19 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability
Overview
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.
Detailed description
Purpose:
In Phase 1: to use computer based technology to detect lipohypertrophy on portable ultrasound images.
In Phase 2: to demonstrate that injecting insulin into areas to be free of lipohypertrophy will have better glucose control as compared to injecting into areas demonstrated to have lipohypertrophy.
Eligibility:
You can participate in this study if:
* You have been diagnosed with Type 1 or Type 2 diabetes * You are currently using injection of insulin daily or insulin pump for at least 2 years * You are 19 years of age or older
You should not participate in this study if:
* You are taking a glucagon-like peptide medication * You are currently using a systemic steroid agent (e.g. prednisone) * You have history of a non-lipohypertrophic skin disease in the insulin injection area * You are not fluent in English (unless accompanied by a translator)
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
Primary outcome measures
- Assessment of lipohypertrophy by US machine [Time frame: First 12 months of the study]
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 history of a non-lipohypertrophic dermatological condition in the insulin injection site area
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- Vancouver General Hospital Diabetes Centre — Vancouver
Identifiers
NCT: NCT05377268 · H22-01168