An observational study in Diabetes and Lipohypertrophy, sponsored by University of British Columbia. Terminated at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by University of British Columbia · Observational
This is a pilot study to enroll 100 people to assess the incidence of lipohypertrophy as detected with ultrasound and its impact on glycemic variability.
Lipohypertrophy is a well documented phenomenon in patients with diabetes in which hypertrophy and differentiation of adipocytes occurs in the dermal reticular layer at the sites of subcutaneous insulin injection. Currently, lipohypertrophy is assessed by palpating insulin injection sites. The detection on early, non palpable (subclinical) lipohypertrophy remains difficult in the clinical setting. Recent studies have identified distinct ultrasonographic features of hyperechogenicity in areas of adipose tissue consistent with clinical evidence of lipohypertrophy at insulin injection sites, and have detected changes int he thickness of subcutaneous tissue where not clinically evident in population of patients with type 1 diabetes. Lipohypertrophy can adversely affect glycemic control. Injecting into lipohypertrophic areas leads to poor absorption and the need for increasing doses of insulin.
In this study study participants will undergo an assessment for lipohypertrophy during a scheduled visit at the VGH Diabetes Centre. A Diabetes Nurse will assess lipohypertrophy by palpation according to the FIT Protocol. A second diabetes nurse who was not present at the palpation will assess insulin injection sites for lipohypertrophy by ultrasound using a linear probe.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 100 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
People age 19 and over with type 1 or type 2 diabetes who take insulin to manage their diabetes.
Exclusion Criteria:
Abdomen scanned with portable ultrasound to determine presence of subclinical lipohypertrophy.
Number of Participants With Presence of Subclinical Lipohypertrophy
Lipohypertrophy seen on ultrasound but not felt by palpation
Time frame: Assessed one time only at the time of clinic visit
| Milestone | Diabetes Patients Treated With Insulin |
|---|---|
| Started | 100 |
| Completed | 100 |
| Not completed | 0 |
Lipohypertrophy seen on ultrasound but not felt by palpation
| Participants | Diabetes Patients Treated With Insulin |
|---|---|
| Number of Participants With Presence of Subclinical Lipohypertrophy | 20 |
Collected over During study procedure within study visit up to 1 hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diabetes Patients Treated With Insulin | 0/100 (0%) | 0/100 (0%) | 1/100 (1%) |
| Event | Diabetes Patients Treated With Insulin |
|---|---|
| Skin infectionSkin and subcutaneous tissue disorders | 1/100 |
This is a pilot study in a minimum of 100 patients with diabetes who have been using insulin therapy for at least two years and being treated with insulin at the time of the study.
| Age, Categorical(Participants) | Diabetes Patients Treated With Insulin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 80 |
| >=65 years | 20 |
| Age, Continuous(years) | Diabetes Patients Treated With Insulin |
|---|---|
| Mean | 50 (19 to 77) |
| Sex: Female, Male(Participants) | Diabetes Patients Treated With Insulin |
|---|---|
| Female | 50 |
| Male | 50 |
| Race (NIH/OMB)(Participants) | Diabetes Patients Treated With Insulin |
|---|---|
| American Indian or Alaska Native | 5 |
| Asian | 25 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 30 |
| More than one race | 15 |
| Unknown or Not Reported | 15 |
| Region of Enrollment(Participants) | Diabetes Patients Treated With Insulin |
|---|---|
| Canada | 100 |
| Presence of Lipohypertrophy(participants) | Diabetes Patients Treated With Insulin |
|---|---|
| Number | 100 |
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Plan to share: No
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of British Columbia