Insulin Injection Sites for Diabetes

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

9 Participants Needed

Trial Summary

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).

What data supports the effectiveness of the treatment for lipohypertrophy in diabetes?

Avoiding injection in areas with lipohypertrophy (swelling under the skin) can lead to partial or full reduction of these swellings, as seen in 6 out of 11 cases over a year. Additionally, changing the insulin type and injection sites has shown to prevent further worsening of skin issues. ^{1 2 3 4 5}

Is it safe to use insulin injections for diabetes?

Insulin injections are generally safe, but they can cause a common side effect called lipohypertrophy, which is a lump or swelling under the skin at the injection site. This can be minimized by rotating injection sites and using proper techniques. ^{1 2 6 7 8}

How does the treatment for lipohypertrophy differ from other treatments?

This treatment for lipohypertrophy involves avoiding repeated insulin injections in the same area, which can help reduce tissue swelling. Unlike other treatments, it emphasizes the importance of rotating injection sites to prevent and manage the condition. ^{1 3 6 9 10}

What is the purpose of this trial?

Evaluation of insulin absorption at sites affected by clinically apparent lipohypertrophy through short-term continuous glucose monitoring has shown inconsistent results and it is yet unknown how or if subclinical lipohypertrophy affects absorption. In this study investigators propose to enroll at least 20 people who participated in phase 1 and who were determined to have subclinical lipohypertrophy to examine the correlation between glycemic control and amount of insulin injected in subclinical hypertrophic areas using capillary blood glucose and continuous glucose monitoring.

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

Eligibility Criteria

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

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

I am currently taking injectable diabetes medications.

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

Timeline

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

Treatment Details

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.

Participant Groups

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

References

1. Germany pubmed.ncbi.nlm.nih.gov

Prevalence of lipohypertrophy in insulin-treated diabetic patients and predisposing factors. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Insulin-induced lipohypertrophy treated by liposuction. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Successful treatment of insulin lipoatrophy. A case report. [2011]

4. Poland pubmed.ncbi.nlm.nih.gov

[Lipoatrophy associated with rapid-acting insulin analogues in young patients with type 1 diabetes mellitus]. [2014]

5. Italy pubmed.ncbi.nlm.nih.gov

Insulin-induced lipodystrophy and predisposing factors in children and adolescents with type 1 diabetes mellitus (T1DM) in a tertiary care Egyptian center. [2023]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

[Insulin application techniques in adult patients with diabetes]. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Worldwide Injection Technique Questionnaire Study: Injecting Complications and the Role of the Professional. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Insulin-Related Lipohypertrophy: Lipogenic Action or Tissue Trauma? [2019]

9. England pubmed.ncbi.nlm.nih.gov

Insulin injection site tissue depths and localization of a simulated insulin bolus using a novel air contrast ultrasonographic technique in insulin treated diabetic subjects. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[The treatment of type-1 diabetics with insulin-induced lipohypertrophy by liposuction]. [2011]