Clinical trial NCT05377268: The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control
Official title: The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Lipohypertrophy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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)

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

Primary outcomes:
measure: Assessment of lipohypertrophy by US machine
timeFrame: First 12 months of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital Diabetes Centre
state: British Columbia
Study officials:
References: