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 个研究点目标入组 71 人开始时间: 2021年7月9日最近更新: 2024年8月19日

适应症

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•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
•- Able and willing to follow all study procedures and attend follow-up visits. This includes sharing de-identified glucose data from their fGM with the Sponsor.
•- Smart phone with an operating system able to run the DiGA application

•- 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.

发起方

Becton Dickinson - Diabetes Care