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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of lipohypertrophy by US machine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LH ProtocolExperimental Treatment1 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 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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Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,422 Previous Clinical Trials
2,468,160 Total Patients Enrolled
10 Trials studying Diabetes
363 Patients Enrolled for Diabetes

Media Library

LH Protocol Clinical Trial Eligibility Overview. Trial Name: NCT05377268 — N/A
Diabetes Research Study Groups: LH Protocol, Normal Protocol
Diabetes Clinical Trial 2023: LH Protocol Highlights & Side Effects. Trial Name: NCT05377268 — N/A
LH Protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377268 — N/A
~55 spots leftby Dec 2025
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