DRKS00022923
Completed
未知
Randomized controlled trial to evaluate the digital health application mySugr PRO
Roche Diabetes Care GmbH - DCSDB0 sites424 target enrollmentOctober 22, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- E10
- Sponsor
- Roche Diabetes Care GmbH - DCSDB
- Enrollment
- 424
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? Diagnosed type 1 diabetes (E10\) or type 2 diabetes (E11\) or gestational diabetes (O24\.4\)
- •? Carrying out regular, daily blood sugar measurements and using the blod glucose values to carry out or adjust diabetes therapy
- •? Age \= 16 years
- •? Last measured HbA1c value \<12% or 107\.6 mmol / mol
- •? Use of a smartphone compatible with the mySugr PRO (Android 5\.0 or higher; iOS 11\.4 or higher)
- •? Willingness to consent to the terms and conditions of the mySugr PRO
- •? Knowledge of spoken and written German
- •? Given written declaration of consent to participate in the study.
- •For adolescents: a written declaration of consent for participation in the study must be available both from the adolescent himself and from a legal guardian
Exclusion Criteria
- •? Use of continuous glucose measurement systems (rtCGM, isCGM)
- •? Use of a digital diabetes diary or a (diabetes) app for digital therapy documentation in the last 3 months
- •? Existence of an acute psychiatric illness which, in the opinion of the investigator, impairs the patient's ability to properly carry out the diabetes therapy or the study
- •? In adults (\= 18 years): Lack of consent due to restricted legal capacity or legal support
- •? Dependency on the sponsor or the clinical investigator (e.g. employees of the sponsor or a test center and their family members)
- •? Simultaneous participation in another clinical study
Outcomes
Primary Outcomes
Not specified
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