Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-02 @ 4:17 AM
Study NCT ID:
NCT05377268
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: