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Clinical Trials/DRKS00022923
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.

Registry
who.int
Start Date
October 22, 2020
End Date
October 4, 2022
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Roche Diabetes Care GmbH - DCSDB

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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