The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

NCT ID: NCT05377268

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-12-31

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.

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)

Conditions

Diabetes Mellitus; Lipohypertrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

LH Protocol

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

LH Protocol

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Madden

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vancouver General Hospital Diabetes Centre

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H22-01168

Identifier Type: -

Identifier Source: org_study_id