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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025823

Enrollment

Registered

2021-07-09

Start date

2021-09-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10 E11

Interventions

Group 1: prospective, single group, open-label, 2-period study, period 1: no use of the digital application, period 2: use of the digital application

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
- Mean Amplitude of the Glycemia Excursion (MAGE), Standard Deviation (SD), and Coefficient of Variation (CV) - Mean of daily differences (MODD) - Time in range - 24-hour Mean Glucose	—

Secondary

Measure	Time frame
The secondary endpoints are evaluations of the patient reported outcomes	—

Countries

Germany

Contacts

Public ContactWinfried Huesmann

Becton Dickinson - Diabetes Care

winfried.huesmann@bd.com004915154403197

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026