A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens
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
- Rochester, Minnesota: 21-004938
NCT ID: NCT05036343
About this study
The objectives of this study are to determine whether the InPen® alters the glycemic control and variability in adolescents and emerging adults with type 1 diabetes, and to determine if InPen® use alters the perceived burden of diabetes cares, diabetes distress scores, transition readiness scores, and parental experience of child illness scale (11-13).
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:
- Individuals between the ages of 13 and 21 years.
- Patients with Type 1 diabetes for at least 6 months.
- Defined as either a c peptide <1 , one or more positive diabetes autoantibodies, or a clinical diagnosis with age of onset prior to puberty.
- Patients who currently receive insulin injections with a CGM.
- English speaking.
- Have access to a smart phone.
- on an insulin to carbohydrate ratio.
Exclusion Criteria:
- Individuals less than 13 years of age.
- Non-English speaking.
- No access to a smart phone.
- Intellectual disability that would impact their ability to utilize the technology.
- Known pregnant women.
- Taking chronic steroids (equivalent equal to or greater then 5mg of prednisone daily).
Inclusion Criteria - For parents filling out the survey:
- Child with type 1 diabetes who is eligeable for the study.
- Ability to read and comprehend English.
Exclusion Criteria - For parents filling out the survey:
- Do not have a child with type 1 diabetes.
Eligibility last updated 9/13/21. Questions regarding updates should be directed to the study team contact.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Ana Creo, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available