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A comparative clinical trial to evaluate the effectiveness and safety of a digital intervention used to improve glycemic control of patients with type 2 diabetes

A comparative clinical trial to evaluate the effectiveness and safety of a digital intervention used to improve glycemic control of patients with type 2 diabetes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007462
Enrollment
320
Registered
2022-06-29
Start date
2022-04-27
Completion date
Unknown
Last updated
2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The intervention group uses digital intervention for clinical trials based on cognitive behavioral treatment in the form of an app for 12 weeks, and periodically measures and records

Sponsors

Soon Chun Hyang University Hospital Seoul
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A person who satisfies all of the selection criteria presented by the target group - Those who are 19 years of age or older and meet the criteria for diagnosing type 2 diabetes - Patients with HbA1c 6.5-9.0% in the last 3 months - A person who has no difficulty in reading and writing Korean - A person who has no difficulty using a mobile application using a smartphone - A person who upon receiving and understanding sufficient explanation of this clinical trial, the written consent to voluntarily decide to participate and comply with the precautions - A person who voluntarily agrees and visits for observation after explaining the clinical trial

Exclusion criteria

Exclusion criteria: A person who has any of the exclusion criteria - A person who has difficulty using surveys and applications without the help of his/her own doctor or guardian - Patients with type 1 diabetes, gestational diabetes, insulin therapy - A person who has diabetes medication changes in 3 months prior to the clinical study period or those with plans to change during the study period - A person against one's will - A person who are in critical or vulnerable mental conditions - A person who has difficulty in listening, writing, and speaking Korean - A person who has difficulty in using general-purpose equipment

Design outcomes

Primary

MeasureTime frame
Safety;Primary efficacy endpoint: HbA1c

Secondary

MeasureTime frame
No Secondary Outcome

Countries

Korea, Republic of

Contacts

Public ContactJung Yeon Sim

Yonsei University

shimppi@naver.com+82-2-2228-2881

Outcome results

None listed

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