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A Prospective Pilot Study on the Clinical Utility of Using the Diabetes Management App 'DT.E66' for the Treatment and Management of Type 2 Diabetes

A Prospective Pilot Study on the Clinical Utility of Using the Diabetes Management App 'DT.E66' for the Treatment and Management of Type 2 Diabetes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010650
Enrollment
30
Registered
2025-06-19
Start date
2025-02-27
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

None listed

Interventions

Behavioral : This study is a prospective, single-arm, interventional pilot study designed to evaluate the clinical effectiveness and utility of the diabetes management program ‘DT.E66’ over a 12-week

Sponsors

Kyung Hee University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 65 2) Individuals who were diagnosed with type 2 diabetes mellitus 3) Individuals who voluntarily agreed to participate in the study and signed the informed consent form for the study

Exclusion criteria

Exclusion criteria: 1) Individuals currently undergoing insulin therapy 2) Individuals with a BMI below 18.5 kg/m² or above 30.0 kg/m² 3) Individuals who have undergone treatment with anti-obesity medications, weight-loss drugs, or other weight-reduction therapies (e.g., surgery) within 3 months prior to enrollment 4) Individuals with systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg (for those diagnosed with hypertension, blood pressure measured while on medication) 5) Individuals with AST, ALT, or creatinine levels more than twice the normal range 6) Individuals diagnosed with or currently receiving treatment for dementia, anxiety disorders, alcoholism, substance abuse, psychiatric disorders, autoimmune diseases, thyroid disorders, severe cerebrovascular diseases (e.g., stroke, cerebral hemorrhage), renal diseases (e.g., end-stage renal disease, dialysis), or cardiovascular diseases (e.g., angina, myocardial infarction, heart failure, arrhythmia) 7) Individuals who have been diagnosed with or treated for cancer within the past 5 years 8) Individuals with a history of major surgery within the past 6 months 9) Individuals currently undergoing hormone replacement therapy 10) Pregnant or lactating women, or women planning to become pregnant within the next 6 months 11) Individuals who participated in another clinical trial or human study within 1 month prior to this study 12) Individuals unable to read or with limited reading abilities. 13) Individuals unable to use mobile devices 14) Individuals deemed unsuitable for participation by the principal investigator.

Design outcomes

Primary

MeasureTime frame
HbA1c

Secondary

MeasureTime frame
Blood profiles (FBG, Insulin, HOMA-IR, Total cholesterol, LDL-C, HDL-C, Triglyceride, CGM);SDSCA, Summary of Diabetes Self-Care Activities;EQ-5D-5L, The EuroQol-5 Dimensions-5 Levels

Countries

Korea, Republic of

Contacts

Public ContactMinkyung Bok

Research Institute of Medical Nutrition

yoccobbong03@naver.com+82-2-969-7715

Outcome results

None listed

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