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Ultrasound Technology for Detecting Lipohypertrophy in Diabetes

N/A

Waitlist Available

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 12 months of the study

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a new ultrasound technology can detect early signs of lipohypertrophy, and if injecting insulin into these areas affects how insulin is absorbed.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves monitoring and changing injection sites based on ultrasound findings rather than a new medication, typical drug side effects aren't expected. However, there may be some discomfort associated with additional ultrasounds and potential changes in blood sugar levels as injection practices change.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 12 months of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first 12 months of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 12 months of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of lipohypertrophy by US machine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LH ProtocolExperimental Treatment1 Intervention

Group II: Normal ProtocolActive Control1 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.

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