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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment LH Protocol for detecting lipohypertrophy in diabetes?

The research suggests that using ultrasound technology can effectively detect lipohypertrophy (a thickening of the skin due to repeated insulin injections) in people with diabetes, which might not be visible or felt by touch. This implies that the LH Protocol, which likely involves ultrasound, could be effective in identifying these skin changes. ^{1 2 3 4 5}

How does the LH Protocol treatment for lipohypertrophy in diabetes differ from other treatments?

The LH Protocol uses ultrasound technology to detect lipohypertrophy (a thickening of the skin due to repeated insulin injections) more accurately than traditional methods like palpation (feeling with hands) or visual examination. This approach allows for better identification and management of the condition, potentially improving insulin absorption and blood sugar control. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Clinical significance of lipohypertrophy without visual and palpable changes detected by ultrasonography of subcutaneous fat. [2022]

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

A Systematic Review of Ultrasound-Detected Lipohypertrophy in Insulin-Exposed People with Diabetes. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Ultrasound detection of insulin-induced lipohypertrophy in Type 1 and Type 2 diabetes. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Hypothesis on the Progression of Insulin-Induced Lipohypertrophy: An Integrated Result of High-Frequency Ultrasound Imaging and Blood Glucose Control of Patients. [2023]

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

Insulin-Induced Skin Lipohypertrophy in Type 2 Diabetes: a Multicenter Regional Survey in Southern Italy. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Characteristics and morphology of lipohypertrophic lesions in adults with type 1 diabetes with ultrasound screening: an exploratory observational study. [2021]