Self-Management Using Smartphone Application for Type2 DM in Real siTuation (SMART-DM)

A Pilot Study of Self Management Using Application for Chronic Disease Care in Real siTuation (SMART) - DM

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01820871

Enrollment

Registered

2013-03-29

Start date

2012-11-30

Completion date

2013-10-31

Last updated

2013-11-27

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

Conditions

Type 2 Diabetes Mellitus

Keywords

T2DM, smartphone application, serum fasting glucose, HbA1c

Brief summary

The purpose of this study is to evaluate the effectiveness of smartphone application for management of type 2 diabetes mellitus (DM). Type 2 DM is an almost incurable chronic disease and continuous management is important for long-term prognosis. However, patient's compliance to conventional medical intervention is generally unsatisfactory and many patients feel difficult to access to the detail medical advice for type 2 DM. Thus, the investigators developed a smartphone application for giving programed medical intervention to patients according to patients data; blood pressure, fasting blood sugar, body weight, calorie intake,exercise amount, etc.

Interventions

OTHERSelf-Management Using Smartphone Application for Type2 DM

OTHERself-management using booklet for management type 2 DM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 69 Years

Healthy volunteers

Inclusion criteria

* Type 2 DM using oral hypoglycemic agent * 6.5% \< HbA1c \< 10% * systolic blood pressure \> 130 mmHg or diastolic blood pressure \> 80 mmHg * BMI over 23.0 * 20 \< age \< 70 * smartphone user (android OS based)

Exclusion criteria

* Serum fasting glucose \> 250 mg/L or post prandial 2 hour serum glucose \> 350 mg/L * systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg * Diabetes mellitus patient using insulin * severe chronic diabetic complications (diabetic foot ulcer, severe diabetic retinopathy, diabetic nephropathy with severe proteinuria) * congestive heart failure (NYHA III-IV or left ventricular ejection fraction \< 30%) * Aspartate aminotransferase (AST) or alanine transaminase (ALT) over 3 times of upper normal limit * Serum creatinine \> 1.5 mg/dL * refusal to participate in the study * drug addiction or alcohol addiction * major psychiatric illness * steroid treatment or hormonal treatment with changing the drug or drug dosage in 1 month * changing dosage of antihypertensive agent, oral hypoglycemic agent or lipid lowering agent in 1 month * malignant cancer * pregnancy

Design outcomes

Primary

Measure	Time frame	Description
fasting serum glucose and HbA1c	3months after enrollemnt (day 0-day 90)	we will check the fasting serum glucose and HbA1C at the day of enrollment (day0)and those at 3months after enrollment (day 90)

Secondary

Measure	Time frame	Description
body weight and BMI	3months after enrollemnt (day 0-day 90)	we will check body weight and BMI at the day of enrollment (day0)and those at 3months after enrollment (day 90)
Lipid profile	3months after enrollment (day 0-90)	we will check the lipid profile (total cholesterol, Triglyceride, LDL/HDL cholesterol)at the day of enrollment (day0)and those at 3months after enrollment (day 90)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026