Insulin Injection Sites for Diabetes
Trial Summary
Will I have to stop taking my current medications?
You may need to stop taking certain medications. The trial excludes people taking insulin secretagogues (like gliclazide or glyburide), other injectable diabetes medications (like liraglutide), and systemic steroids (like prednisone).
What data supports the effectiveness of the treatment for lipohypertrophy in diabetes?
Is it safe to use insulin injections for diabetes?
How does the treatment for lipohypertrophy differ from other treatments?
What is the purpose of this trial?
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.
Research Team
Jordanna Kapeluto, MD
Principal Investigator
University of British Columbia
Graydon Meneilly, MD
Principal Investigator
University of British Columbia
Breay Paty, MD
Principal Investigator
University of British Columbia
Eligibility Criteria
This trial is for people over 19 who have had Type 1 or Type 2 diabetes for at least two years and are using insulin. They must have been part of phase 1 of the study and identified with subclinical lipohypertrophy. Those on certain diabetes medications, steroids, or unable to communicate in English without a translator cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to inject insulin into areas of subclinical lipohypertrophy or normal subcutaneous tissue, monitored with continuous glucose sensors
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lipohypertrophy
- Normal Subcutaneous Tissue
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc