Ultrasound Technology for Detecting Lipohypertrophy in Diabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must be taking: Insulin

Must not be taking: GLP-1 agonists, Glucocorticoids

Disqualifiers: Non-lipohypertrophic dermatological condition

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ultrasound technology can detect lipohypertrophy, a condition where fatty tissue swells near insulin injection sites in people with diabetes. The study aims to determine if ultrasound can identify tissue changes not easily detected by touch and how these changes affect insulin absorption. Participants with diabetes who use insulin injections or pumps and have no history of certain skin conditions may be suitable candidates. The trial will compare two groups: one injecting insulin into areas identified by ultrasound and the other into normal tissue. The goal is to understand how these different sites affect blood sugar control. This process is part of the LH Protocol, the primary focus of the study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve diabetes management.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking a glucagon-like peptide-1 agonist or a systemic glucocorticoid.

What prior data suggests that this ultrasound technology is safe for detecting lipohypertrophy in diabetes?

Research has shown that many people with diabetes develop a condition called lipohypertrophy, where the fatty tissue under the skin swells at insulin injection sites. This common issue affects up to 64.4% of insulin users. Studies indicate that failing to rotate injection sites properly can increase the risk of developing this condition.

The trial studies an ultrasound technique designed to detect these hidden tissue changes. While specific data on the safety of this exact ultrasound method is unavailable, ultrasound technology is generally safe and non-invasive. It is widely used in medical settings for various conditions without causing harm.

In this trial, the LH Protocol guides patients to inject insulin into areas identified by ultrasound. Although this method is experimental, using ultrasound carries minimal risk. Participants will have their blood sugar levels closely monitored to ensure safety throughout the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to detect and manage lipohypertrophy in people with diabetes using ultrasound technology. Unlike current practices that rely on physical examination to identify these problematic areas for insulin injection, this protocol aims to pinpoint lipohypertrophy more accurately and non-invasively. By improving detection, the trial could lead to better insulin absorption and glucose control, potentially enhancing overall diabetes management.

What evidence suggests that this ultrasound technology is effective for detecting lipohypertrophy in diabetes?

Research shows that injecting insulin into areas with lipohypertrophy (LH)—lumps or bumps under the skin from repeated injections—affects insulin absorption. Studies have found that this can cause blood sugar levels to fluctuate and may require more insulin. One study using a euglycemic clamp discovered that insulin absorbs much slower when injected into these areas, meaning the body doesn't efficiently receive the insulin it needs. This can lead to problems like a higher risk of low or high blood sugar and more emergency room visits. In this trial, participants will be randomized into two groups: one following the LH Protocol, where they will inject insulin in sites of subclinical lipohypertrophy, and the other following the Normal Protocol, where they will inject insulin in sites of normal subcutaneous tissue. Teaching patients proper injection techniques can help reduce the total amount of insulin needed. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with Type 1 or Type 2 diabetes who have been treating it with at least one daily insulin injection or an insulin pump for over two years. It's not open to those who've had skin conditions other than lipohypertrophy near their insulin injection sites, or are on certain diabetes medications like GLP-1 agonists.

Inclusion Criteria

Current treatment with a minimum of one insulin injection daily or insulin pump for at least 2 years

You have a diagnosis of Type 1 or Type 2 diabetes mellitus.

Exclusion Criteria

You have had a skin condition in areas where insulin is usually injected.

You are currently taking medication called glucagon-like peptide-1 agonist or systemic glucocorticoid.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Detection

Use of computer-based technology to detect lipohypertrophy on portable ultrasound images

12 months

Phase 2: Randomized Crossover Study

Participants with subclinical lipohypertrophy are randomized to inject insulin in different tissue sites to compare glucose control

28 days

Multiple visits for protocol adherence and glucose monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LH Protocol

Trial Overview The study tests if using ultrasound to detect 'subclinical lipohypertrophy'—unseen changes in the fatty tissue where insulin is injected—affects how well the body uses insulin. In Phase 2, patients with these ultrasound-detected changes will monitor their glucose levels to see if avoiding these areas improves glycemic control.

How Is the Trial Designed?

Group I: LH Protocol Experimental Treatment 1 Intervention

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 II: Normal Protocol Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5750448/

An Effective Intervention for Diabetic Lipohypertrophy A recent PK study using a euglycemic clamp with deliberate injections into LH showed significant blunting of insulin absorption profiles and markedly increased ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10658672/

Lipohypertrophy and Insulin: An Update From the Diabetes ... Lipohypertrophy is associated with a higher risk of hypoglycemia, hyperglycemia, and glucose fluctuations, which can lead to more emergency room visits, ...

3. liebertpub.com liebertpub.com/doi/full/10.1089/dia.2023.0491

Relationship Between Lipohypertrophy, Glycemic Control ... Our study aimed to assess the potential correlation between lipohypertrophy and glycemic control, as well as insulin dosing in patients with diabetes.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0040595721000986

A meta-analysis and meta-regression on the prevalence of ... The pooled prevalence of LH in studies only on type 1 and type 2 DM patients was 39.9% (95% CI: 28.3% to 51.6%) and 45.9% (95% CI: 29.5% to 62.4%) respectively.

5. bmjopen.bmj.com bmjopen.bmj.com/content/12/3/e055529

Efficacy of education on injection technique for patients ... The present meta-analysis suggests that providing education on IT to patients with diabetes with LH may slightly reduce the TDD of insulin.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11924065/

Risk factors for Lipohypertrophy in People With Insulin ... This systematic review with meta-analysis revealed that incorrect injection site rotation and needle reuse are the most substantial factors in developing ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1262363613001213

Prevalence and risk factors of lipohypertrophy in insulin- ... Nearly two-thirds (64.4%) of patients had LH. There was a strong relationship between the presence of LH and non-rotation of sites, with correct rotation ...

8. liebertpub.com liebertpub.com/doi/10.1089/dia.2017.0165

An Effective Intervention for Diabetic Lipohypertrophy Abstract Background: Lipohypertrophy (LH) is highly prevalent and is potentially harmful to insulin-injecting patients.

9. mdpi.com mdpi.com/2673-4540/5/7/53

Insulin-Related Skin Lipohypertrophy in Type Two Diabetes Results: Data observed confirm a strong relationship between LH and diabetes chronic complications other than poor glycemic control. Histology of biopsies ...