A Study to Evaluate Innovative Application for Personalized Diabetes Care
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-012737
Sponsor Protocol Number: 19-012737
About this study
The multi-purpose of this study is to examine the effectiveness of “InsulisiteGuider” in patients with type 1 diabetes (T1D) through a two-group randomized controlled trial, to characterize the RNA biomarkers in skin epithelial cells isolated from the continuous subcutaneous insulin infusion (CSII) cannulas from T1D patients, and to characterize RNA biomarkers in the blood and saliva of TID patients.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Arizona Mayo Clinic Type 1 diabetes outpatients.
- Subjects older than 18 years old and younger than 70 years old.
- Non-pregnant.
- English speaking.
- Subjects who have been using a CSII and CGM for at least one year.
- Subjects who have been in contact with the Mayo Clinic Division of Endocrinology during the last year.
Exclusion Criteria:
- Subjects younger than 18 and older than 70.
- Subjects with fragile health.
- Subjects with limited life expectancy.
- Subjects with history of mental health problems.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Bithika Thompson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available