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

• Conditions: E10; E11; Type 1 diabetes mellitus; Type 2 diabetes mellitus

• Registration Number: DRKS00025823
• Lead Sponsor: Becton Dickinson - Diabetes Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-09
• Study Completion: 2022-07-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 71

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

- 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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Mean Amplitude of the Glycemia Excursion (MAGE), Standard Deviation (SD), and Coefficient of Variation (CV)<br>- Mean of daily differences (MODD)<br>- Time in range <br>- 24-hour Mean Glucose<br>

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are evaluations of the patient reported outcomes