Diabetes MellitusNCT02748434
Glucose Variability in Subclinical Hypertrophy
A study testing Lipohypertrophy and Normal Subcutaneous Tissue in people with Diabetes Mellitus and Lipohypertrophy, run by University of British Columbia at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Lipohypertrophy
- What is being tested?
- Lipohypertrophy and Normal Subcutaneous Tissue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2016to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in phase 1
- Type 1 or Type 2 diabetes for at least 2 years
- Using insulin to manage diabetes
- At least 19 years of age
Who cannot join
- Taking insulin secretagogues (gliclazide, glyburide, glipizide
- Taking other injectable diabetes medications (i.e. liraglutide, Victoza)
- Taking systemic steroids (e.g. prednisone)
- Not fluent in speaking and writing English (unless accompanied by a translator)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Gerontology Research Lab
Vancouver, British Columbia, V5Z 1M9
Vancouver General Hospital Diabetes Centre
Vancouver, British Columbia, V5Z 1M9
About this study
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.
Read the detailed description
Patients will be randomized and data interpreters will be blinded to two alternating six-day protocols where the patients will be advised verbally and by written instruction to inject insulin in sites of subclinical lipohypertrophy or normal subcutaneous tissue. Patients will be asked to monitor and record their capillary blood glucose with meals and prior to bedtime using their own capillary blood glucose monitor. A trained research nurse at the Diabetes Centre will instrument each patient with an iPro 2 glucose sensor (Medtronic Canada). These sensors continuously measure blood glucose for periods of up to 7 days. A trained nurse will clean the skin with a superficial disinfectant and a small catheter will be inserted in the subcutaneous tissue at a non-lipohypertrophic site. The catheter will then be attached to a glucose sensor. Patients will wear this sensor for two periods of 6 days each at different sites. At the end of each of the two six day periods, the sensor will be removed.
- Conditions
- Diabetes Mellitus, Lipohypertrophy
- Being tested
- Lipohypertrophy, Normal Subcutaneous Tissue
- Keywords
- iPro2 Continuous Blood Glucose Recorder, Subclinical
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipohypertrophyOther
Normal Subcutaneous TissueOther
| Study group | Role | What they receive |
|---|---|---|
| Lipohypertrophy | Other | Participants inject their insulin into the abdomen into areas of lipohypertrophy that were identified by ultrasound in Phase 1 of the study. Receives: Other: Lipohypertrophy |
| Normal Subcutaneous Tissue | Other | Participants inject their insulin into the abdomen into areas with normal subcutaneous tissue. Receives: Other: Normal Subcutaneous Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose levels
iPro2 Continuous Blood Glucose Monitor
Measured: Continuously for 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2025
- Study completion1 Sep 2025
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Graydon Meneilly, University of British Columbia
- Investigators
- Graydon Meneilly, MD, Principal investigator, University of British ColumbiaJordanna Kapeluto, MD, Principal investigator, University of British ColumbiaBreay Paty, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748434
- Sponsor's protocol ID
- H16-01025
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2016
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Glucose Variability in Subclinical Hypertrophy
- ClinicalTrials.gov ID
- NCT02748434
- Acronym / sponsor ID
- H16-01025
- Conditions
- Diabetes Mellitus, Lipohypertrophy
- Keywords
- iPro2 Continuous Blood Glucose Recorder, Subclinical
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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.
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.
Detailed description
Patients will be randomized and data interpreters will be blinded to two alternating six-day protocols where the patients will be advised verbally and by written instruction to inject insulin in sites of subclinical lipohypertrophy or normal subcutaneous tissue. Patients will be asked to monitor and record their capillary blood glucose with meals and prior to bedtime using their own capillary blood glucose monitor. A trained research nurse at the Diabetes Centre will instrument each patient with an iPro 2 glucose sensor (Medtronic Canada). These sensors continuously measure blood glucose for periods of up to 7 days. A trained nurse will clean the skin with a superficial disinfectant and a small catheter will be inserted in the subcutaneous tissue at a non-lipohypertrophic site. The catheter will then be attached to a glucose sensor. Patients will wear this sensor for two periods of 6 days each at different sites. At the end of each of the two six day periods, the sensor will be removed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipohypertrophy | Other | Other: LipohypertrophyParticipants inject their insulin into the abdomen into areas of lipohypertrophy that were identified by ultrasound in Phase 1 of the study. |
| Normal Subcutaneous Tissue | Other | Other: Normal Subcutaneous TissueParticipants inject their insulin into the abdomen into areas with normal subcutaneous tissue. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participation in phase 1
- Type 1 or Type 2 diabetes for at least 2 years
- Using insulin to manage diabetes
- At least 19 years of age
Key exclusion criteria (4 listed)
- Taking insulin secretagogues (gliclazide, glyburide, glipizide
- Taking other injectable diabetes medications (i.e. liraglutide, Victoza)
- Taking systemic steroids (e.g. prednisone)
- Not fluent in speaking and writing English (unless accompanied by a translator)
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 |
|---|---|---|
| Lipohypertrophy | Other | Lipohypertrophy |
| Normal Subcutaneous Tissue | Other | Normal Subcutaneous Tissue |
Primary outcome
Blood glucose levels
Time frame: Continuously for 12 days
iPro2 Continuous Blood Glucose Monitor
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Graydon Meneilly, MD principal investigator
University of British Columbia
Jordanna Kapeluto, MD principal investigator
University of British Columbia
Breay Paty, MD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipohypertrophy and Normal Subcutaneous Tissue in people with Diabetes Mellitus and Lipohypertrophy, run by University of British Columbia at 2 sites 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 4 inclusion and 4 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: stopped early, 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 2 sites 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose levels (time frame: Continuously for 12 days). 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.