Type 2 Diabetes (T2D) Clinical Trials

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The Use of Machine Learning Detection of Lipohypertrophy to Improve Glycemic Variability

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Vancouver General Hospital Diabetes Centre
RECRUITING
Vancouver
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: LH Protocol
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.
Active_comparator: Normal Protocol
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.
Related Therapeutic Areas
Sponsors
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov