The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05377268
• Other study ID #: H22-01168
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Lipohypertrophy

Intervention

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

Locations

Country	Name	City	State
Canada	Vancouver General Hospital Diabetes Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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