Trial Summary
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.
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
I am 19 years old or older.
I have been diagnosed with diabetes for at least 2 years.
Participation in phase 1
+1 more
Exclusion Criteria
Not fluent in speaking and writing English (unless accompanied by a translator)
I am currently taking injectable diabetes medications.
I am taking medication to increase my body's insulin production.
+1 more
Participant Groups
The study is looking into how well insulin is absorbed in areas affected by subclinical lipohypertrophy—a kind of localized swelling due to repeated injections. At least 20 participants will use continuous glucose monitoring to see if there's a link between their blood sugar control and the amount of insulin injected into these swollen spots.
2Treatment groups
Experimental Treatment
Group I: Normal Subcutaneous TissueExperimental Treatment1 Intervention
Participants inject their insulin into the abdomen into areas with normal subcutaneous tissue.
Group II: LipohypertrophyExperimental Treatment1 Intervention
Participants inject their insulin into the abdomen into areas of lipohypertrophy that were identified by ultrasound in Phase 1 of the study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Gerontology Research LabVancouver, Canada
Vancouver General Hospital Diabetes CentreVancouver, Canada
Loading ...
Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
MedtronicIndustry Sponsor