Assessment of glycemic responses and patient reported outcomes (PROs) in people with diabetes using insulin following 4 weeks use of BD’s Digital Application (DiGA): A Feasibility study - DBC-21DIGADE001

Becton Dickinson - Diabetes Care0 sites71 target enrollmentJuly 9, 2021

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2021

End Date

July 4, 2022

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

Becton Dickinson - Diabetes Care

•Adult patients (\= 18 years old) with T1DM or T2DM
•\- HbA1c \= 7\.0%, at time of screening.
•\- Must be taking at least one basal and one bolus injection per day.
•\- Must be using the Abbot Freestyle Libre for at least 3 months prior to study start and be willing to share this data with the Sponsor.
•\- Must not have a change in class or addition of a new diabetes drugs within the last 2 months.
•\- Meet one of the following criteria:
•\- Currently have lipohypertrophy
•\- Need additional training on injection technique (score in yellow or red on the ITQ)
•\- Self\-report being occasionally non\-adherent to insulin therapy (accidentally or purposely miss at least 3 doses per month)
•\- Provision of signed and dated informed consent form

•\- Patients who are not comfortable with technology or using digital apps
•\- Patients currently using the BD DC app
•\- Patient is currently pregnant or breast feeding (self\-attested)
•\- Any condition which, in the opinion of the investigator, precludes the patient from participation in the study.