The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control
- Conditions
- Diabetes MellitusLipohypertrophy
- Interventions
- Procedure: LH Protocol
- Registration Number
- NCT05377268
- Lead Sponsor
- University of British Columbia
- Brief 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.
- 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)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Normal Protocol 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 and by written instruction to inject insulin in sites of normal subcutaneous tissue. Outcomes measured will consist of mean glucose, glucose standard deviation around the mean value, percentage of time with glucose below 3 mmol/liter, and percentage of time spent with glicose above 10 mmol/liter. The device will be calibrated and placed by a trained research nurse. There will be a member of the rsearch team available 24 hours per day to answer subject questions. LH Protocol 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 and by written instruction to inject insulin in sites of subclinical lipohypertrophy.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vancouver General Hospital Diabetes Centre
🇨🇦Vancouver, British Columbia, Canada