The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

Study Overview
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Brief Summary
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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
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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)

Official Title
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The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability

Conditions
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Diabetes Mellitus, Lipohypertrophy

Intervention / Treatment
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* Procedure: LH Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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 (recorded on a standardized grid as in our lab's previous work, see Appendix)11 to inject insulin in sites of subclinical lipohypertrophy (LH protocol) or normal subcutaneous tissue (Normal protocol). During each protocol, each subject will have glycemic variability measured.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LH Protocol<br>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. | Procedure: LH Protocol<br>* 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<br>* Other names: 40 patients identified with subclinical lipohypertrophy in Phase 1 will be recruited to a randomized crossover design examining glycemic variability by glucose monitor.;|
| Active Comparator: Normal Protocol<br>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. | Procedure: LH Protocol<br>* 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<br>* Other names: 40 patients identified with subclinical lipohypertrophy in Phase 1 will be recruited to a randomized crossover design examining glycemic variability by glucose monitor.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of lipohypertrophy by US machine | 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 |