Insulin Injection Sites for Diabetes

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must be taking: Insulin

Must not be taking: Insulin secretagogues, Injectable diabetes, Steroids

Disqualifiers: Not fluent in English

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

Compensation: Varies

Number of Visits: 2

Duration: 12 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores insulin absorption in people with diabetes who have subclinical lipohypertrophy (small, hidden areas of fatty tissue growth). The study compares insulin absorption when injected into these areas versus normal subcutaneous tissue. Participants will be divided into two groups: one injecting into lipohypertrophy and the other into normal tissue. It suits those with Type 1 or Type 2 diabetes for at least two years who are already using insulin, especially if they participated in phase 1 of this study. As an unphased trial, this study offers a unique opportunity to enhance understanding of insulin absorption in different tissues, potentially improving diabetes management.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. The trial excludes people taking insulin secretagogues (like gliclazide or glyburide), other injectable diabetes medications (like liraglutide), and systemic steroids (like prednisone).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that injecting insulin into areas with lumpy skin from repeated injections (known as lipohypertrophy) can cause insulin to be absorbed more slowly or unpredictably, potentially complicating blood sugar control. A small number of people, about 3%, reported infections at their injection sites, while most people, around 73%, sometimes experienced pain when injecting insulin.

In normal fatty tissue under the skin, insulin absorption tends to be more predictable. However, the same rates of infections and occasional pain during injections have been reported. These issues are common whether injecting into lumpy skin or normal tissue.

Overall, the treatment is generally well-tolerated, with minor side effects like pain or infection at injection sites. There is no significant difference in safety between injecting into lumpy skin or normal tissue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of insulin injection sites on diabetes management. Unlike traditional methods that don't differentiate where insulin is injected, this trial examines the effects of injecting insulin into areas of lipohypertrophy versus normal subcutaneous tissue. Lipohypertrophy, a common issue in people with diabetes who inject insulin, can affect how insulin is absorbed. By understanding the differences in absorption and effectiveness between these sites, researchers hope to optimize insulin therapy and improve blood sugar control for patients.

What evidence suggests that this trial's treatments could be effective for diabetes?

This trial will compare insulin injection sites in people with diabetes. Participants in one arm will inject insulin into areas of lipohypertrophy. Research has shown that thickened skin from repeated injections can slow insulin absorption, potentially reducing insulin effectiveness and complicating blood sugar control. Studies have found that up to 95.3% of insulin users inject into these thickened areas. Participants in the other arm will inject insulin into normal subcutaneous tissue, which is associated with better insulin absorption. This can improve blood sugar control and may reduce the insulin dose needed by more than 20%. ^{2 4 6 7 8}

Who Is on the Research Team?

Jordanna Kapeluto, MD

Principal Investigator

University of British Columbia

Graydon Meneilly, MD

Principal Investigator

University of British Columbia

Breay Paty, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for people over 19 who have had Type 1 or Type 2 diabetes for at least two years and are using insulin. They must have been part of phase 1 of the study and identified with subclinical lipohypertrophy. Those on certain diabetes medications, steroids, or unable to communicate in English without a translator cannot join.

Inclusion Criteria

I am 19 years old or older.

I have been diagnosed with diabetes for at least 2 years.

Participation in phase 1

Exclusion Criteria

I am currently taking injectable diabetes medications.

Not fluent in speaking and writing English (unless accompanied by a translator)

I am taking medication to increase my body's insulin production.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to inject insulin into areas of subclinical lipohypertrophy or normal subcutaneous tissue, monitored with continuous glucose sensors

12 days

2 visits (in-person) for sensor placement and removal

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lipohypertrophy
• Normal Subcutaneous Tissue

Trial Overview The study is looking into how well insulin is absorbed in areas affected by subclinical lipohypertrophy—a kind of localized swelling due to repeated injections. At least 20 participants will use continuous glucose monitoring to see if there's a link between their blood sugar control and the amount of insulin injected into these swollen spots.

How Is the Trial Designed?

Group I: Normal Subcutaneous Tissue Experimental Treatment 1 Intervention

Participants inject their insulin into the abdomen into areas with normal subcutaneous tissue.

Group II: Lipohypertrophy Experimental Treatment 1 Intervention

Participants inject their insulin into the abdomen into areas of lipohypertrophy that were identified by ultrasound in Phase 1 of the study.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1530891X22008680

Evaluation of Lipohypertrophy in Patients With Type 1 ... Insulin is a life-saving treatment for patients with T1DM that can be preferred as multiple daily injections or a continuous subcutaneous infusion.

2. diabetesjournals.org diabetesjournals.org/spectrum/article/34/3/308/137711/Leveraging-Mechanical-Forces-to-Target-Insulin

Leveraging Mechanical Forces to Target Insulin Injection ... Insulin therapy is less effective. Fibrosis and lipohypertrophy cause significantly reduced insulin absorption and effect (23,24). This ...

3. 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 ...

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

Lipohypertrophy and Insulin: An Update From the Diabetes ... Lipohypertrophy is a common skin complication associated with insulin-treated diabetes. The impact of lipohypertrophy as a contributing factor to suboptimal ...

5. liebertpub.com liebertpub.com/doi/10.1089/dia.2023.0491

Relationship Between Lipohypertrophy, Glycemic Control ... Available data indicate that insulin injections into lipohypertrophic areas may occur in up to 95.3% of patients with diabetes receiving insulin therapy.

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

Prevalence and risk factors of lipohypertrophy in insulin- ... Most studies suggest that insulin absorption from sites with LH may be delayed or erratic, thereby potentially worsening diabetes management [15], [16], [17], [ ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jep.14226

Insulin Injection Technique and Related Complications in ... About 2.99% of patients reported having infection at the injection sites. Most patients (72.55%) occasionally felt pain at the injection site ...

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

Risk factors for Lipohypertrophy in People With Insulin ... Performed meta-analyses indicate that the strongest contributor to lipohypertrophy was incorrect injection site rotation (pOR = 8.85 [95% CI: ...