Evaluation of the Impact of DiGAs in Patients with Type 2 Diabetes mellitus in daily practice
- Conditions
- E11Type 2 diabetes mellitus
- Registration Number
- DRKS00031271
- Lead Sponsor
- niversitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, Medizinische Klinik III, Abteilung Prävention und Versorgung des Diabetes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 82
?Patients = 18 years old
?Type 2 diabetes patients benefiting from improved self-management
?Enrolled in the Disease Management Program (DMP) for type 2 diabetes diabetes in Germany for at least the last 6 months
?Patients using/willing to use a Diabetes DiGA as part of their diabetes management
?HbA1c at baseline = 6.5 % and = 11.0 %
?Patients with internet access and a computer and/or smartphone compatible with the Diabetes DiGA
?Digital literacy to use a smartphone adequately and willing to use it for their diabetes self-management
?Sufficient understanding of user interface (UI) of the Diabetes DiGA
?Participants willing and able to comply with all scheduled visits, laboratory tests, lifestyle considerations and other study procedures
?Participants capable of giving personal informed consent
• Patients using other Apps for their diabetes management
• Patients who have been using a Diabetes DiGA in the past twelve months
•Patients with impairments – including mental or psychic impairments – or conditions which, in the opinion of the investigator, would seriously compromise the integrity of the study
• Patients under 18 years of age
• Patients participating in a weight loss program in the last 6 months
• Patients who are pregnant or breastfeeding
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method