EVALUATION OF THE IMPACT OF ESYSTA® ON HBA1C - the AOK START II Project

EVALUATION OF THE IMPACT OF ESYSTA® ON HBA1C - the AOK START II Project - START (II) Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035153

Enrollment

255

Registered

2024-09-27

Start date

2012-09-01

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: The intervention group uses the ESYSTA® digital health application (consisting of app, portal and compatible connected devices for blood glucose measurement and insulin injections) as part of

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diabetes mellitus type 1 or type 2 Treated with insulin HbA1c at baseline = 7.5% - <= 11 % insured at the AOK Nordost participation in the Disease Management Program (DMP) for T1DM / T2DM

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
Change in HbA1c value during the use of ESYSTA® (data collection by measuring the HbA1c value) after 12 months	—

Secondary

Measure	Time frame
Change in HbA1c value during the use of ESYSTA® (data collection by measuring the HbA1c value) after 6 months	—

Countries

Germany

Contacts

Public ContactPeter Schwarz

Universitätsklinikum Carl Gustav Carus

peter.schwarz@ukdd.de+493514582715

Outcome results

None listed

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