The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control
The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability
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.
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Recruiting
- Vancouver General Hospital Diabetes Centre
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Contact:
- Boris Feldman
- Phone Number: 604-875-5115
- Email: boris.feldman@vch.ca
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Principal Investigator:
- Kenneth Madden, MD
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Sub-Investigator:
- Graydon Meneilly, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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
Other Names:
|
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Active Comparator: Normal 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. |
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of lipohypertrophy by US machine
Time Frame: 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. |
First 12 months of the study
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H22-01168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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