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: Active, not recruiting
• Conditions: Diabetes Mellitus; Lipohypertrophy
• Intervention / Treatment: Procedure: LH Protocol

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: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital Diabetes Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Number of Arms

2

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.	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; 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; 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; 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: 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?

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

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H22-01168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No