The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

NCT05377268 | Recruiting

• 1 other identifier: H22-01168
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Lipohypertrophy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

LH Protocol

EXPERIMENTAL

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

Normal Protocol

ACTIVE COMPARATOR

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

Interventions

LH Protocol PROCEDURE

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

Also known as: 40 patients identified with subclinical lipohypertrophy in Phase 1 will be recruited to a randomized crossover design examining glycemic variability by glucose monitor.

LH Protocol; Normal Protocol

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital Diabetes Centre

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The subject and the investigators will be blinded to the order of the two crossover protocols
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 17, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)