Glucose Variability in Subclinical Hypertrophy
1 other identifier
interventional
9
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Oct 2016
Longer than P75 for not_applicable diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedMay 1, 2026
April 1, 2026
8.7 years
April 20, 2016
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood glucose levels
iPro2 Continuous Blood Glucose Monitor
Continuously for 12 days
Study Arms (2)
Lipohypertrophy
OTHERParticipants inject their insulin into the abdomen into areas of lipohypertrophy that were identified by ultrasound in Phase 1 of the study.
Normal Subcutaneous Tissue
OTHERParticipants inject their insulin into the abdomen into areas with normal subcutaneous tissue.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Medtroniccollaborator
Study Sites (2)
Gerontology Research Lab
Vancouver, British Columbia, V5Z 1M9, Canada
Vancouver General Hospital Diabetes Centre
Vancouver, British Columbia, V5Z 1M9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Graydon Meneilly, MD
University of British Columbia
- PRINCIPAL INVESTIGATOR
Jordanna Kapeluto, MD
University of British Columbia
- PRINCIPAL INVESTIGATOR
Breay Paty, MD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, UBC Department of Medicine
Study Record Dates
First Submitted
April 20, 2016
First Posted
April 22, 2016
Study Start
October 1, 2016
Primary Completion
June 1, 2025
Study Completion
September 1, 2025
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share