Diabetes MellitusNCT05377268
The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control
A study testing LH Protocol in people with Diabetes Mellitus and Lipohypertrophy, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Lipohypertrophy
- What is being tested?
- LH Protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a diagnosis of Type 1 or Type 2 diabetes mellitus
- Current treatment with a minimum of one insulin injection daily or insulin pump for at least 2 years
Who cannot join
- Subjects taking a glucagon-like peptide-1 agonist or a systemic glucocorticoid
- Past history of a non-lipohypertrophic dermatological condition in the insulin injection site area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital Diabetes Centre
Vancouver, British Columbia, V5Z 1M9
Boris Feldman, 604-875-5115, boris.feldman@vch.ca
Kenneth Madden, MD
About this study
Official title: The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability
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.
Read the detailed description
Purpose:
In Phase 1: to use computer based technology to detect lipohypertrophy on portable ultrasound images.
In Phase 2: to demonstrate that injecting insulin into areas to be free of lipohypertrophy will have better glucose control as compared to injecting into areas demonstrated to have lipohypertrophy.
Eligibility:
You can participate in this study if:
- You have been diagnosed with Type 1 or Type 2 diabetes
- You are currently using injection of insulin daily or insulin pump for at least 2 years
- You are 19 years of age or older
You should not participate in this study if:
- You are taking a glucagon-like peptide medication
- You are currently using a systemic steroid agent (e.g. prednisone)
- You have history of a non-lipohypertrophic skin disease in the insulin injection area
- You are not fluent in English (unless accompanied by a translator)
- Conditions
- Diabetes Mellitus, Lipohypertrophy
- Being tested
- LH Protocol
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LH ProtocolProcedure or surgery
Also called 40 patients identified with subclinical lipohypertrophy in Phase 1 will be recruited to a randomized crossover design examining glycemic variability by glucose monitor.
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 to inject insulin in sites of subclinical lipohypertrophy
| Study group | Role | What they receive |
|---|---|---|
| LH Protocol | Experimental | 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. Receives: Procedure: LH Protocol |
| Normal Protocol | Active comparator | 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. Receives: Procedure: LH Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of lipohypertrophy by US machine
Validation of machine algorithm, such as a web-based convolutional network to detect lipohypertrophy on portable ultrasound images.
Each image will be evaluated by an experience ultrasonographer (Dr.Areshnikoff0 and labelled as either having the presence or absence of lipohypertrophy.
Measured: First 12 months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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 (recorded on a standardized grid as in our lab's previous work, see Appendix)11 to inject insulin in sites of subclinical lipohypertrophy (LH protocol) or normal subcutaneous tissue (Normal protocol). During each protocol, each subject will have glycemic variability measured.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Madden, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377268
- Sponsor's protocol ID
- H22-01168
- Status last verified
- Apr 2026
- First submitted
- 5 May 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability
- ClinicalTrials.gov ID
- NCT05377268
- Acronym / sponsor ID
- H22-01168
- Conditions
- Diabetes Mellitus, Lipohypertrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose:
In Phase 1: to use computer based technology to detect lipohypertrophy on portable ultrasound images.
In Phase 2: to demonstrate that injecting insulin into areas to be free of lipohypertrophy will have better glucose control as compared to injecting into areas demonstrated to have lipohypertrophy.
Eligibility:
You can participate in this study if:
- You have been diagnosed with Type 1 or Type 2 diabetes
- You are currently using injection of insulin daily or insulin pump for at least 2 years
- You are 19 years of age or older
You should not participate in this study if:
- You are taking a glucagon-like peptide medication
- You are currently using a systemic steroid agent (e.g. prednisone)
- You have history of a non-lipohypertrophic skin disease in the insulin injection area
- You are not fluent in English (unless accompanied by a translator)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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 (recorded on a standardized grid as in our lab's previous work, see Appendix)11 to inject insulin in sites of subclinical lipohypertrophy (LH protocol) or normal subcutaneous tissue (Normal protocol). During each protocol, each subject will have glycemic variability measured.
| Arm | Type | Receives |
|---|---|---|
| LH Protocol | Experimental | Procedure: LH ProtocolPatients 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. |
| Normal Protocol | Active comparator | Procedure: LH ProtocolPatients 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 may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with a diagnosis of Type 1 or Type 2 diabetes mellitus
- Current treatment with a minimum of one insulin injection daily or insulin pump for at least 2 years
Key exclusion criteria (2 listed)
- Subjects taking a glucagon-like peptide-1 agonist or a systemic glucocorticoid
- Past history of a non-lipohypertrophic dermatological condition in the insulin injection site area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LH ProtocolAlso: 40 patients identified with subclinical lipohypertrophy in Phase 1 will be recruited to a randomized crossover design examining glycemic variability by glucose monitor.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 to inject insulin in sites of subclinical lipohypertrophy | Procedure or surgery | LH Protocol, Normal Protocol |
Primary outcome
Assessment of lipohypertrophy by US machine
Time frame: First 12 months of the study
Validation of machine algorithm, such as a web-based convolutional network to detect lipohypertrophy on portable ultrasound images. Each image will be evaluated by an experience ultrasonographer (Dr.Areshnikoff0 and labelled as either having the presence or absence of lipohypertrophy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LH Protocol in people with Diabetes Mellitus and Lipohypertrophy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of lipohypertrophy by US machine (time frame: First 12 months of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.