---
title: Self-Management Using Smartphone Application for Type2 DM in Real siTuation (SMART-DM)
nct_id: NCT01820871
overall_status: COMPLETED
phase: NA
sponsor: Inje University
study_type: INTERVENTIONAL
primary_condition: Type 2 Diabetes Mellitus
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01820871.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01820871"
ct_last_update_post_date: 2013-11-27
last_seen_at: "2026-05-12T06:34:55.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Self-Management Using Smartphone Application for Type2 DM in Real siTuation (SMART-DM)

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

**NCT ID:** [NCT01820871](https://clinicaltrials.gov/study/NCT01820871)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Inje University
- **Conditions:** Type 2 Diabetes Mellitus
- **Start Date:** 2012-11
- **Completion Date:** 2013-10
- **CT.gov Last Update:** 2013-11-27

## 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.

## Eligibility

- **Minimum age:** 21 Years
- **Maximum age:** 69 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **application arm** (EXPERIMENTAL) — The patients of application arm have the smartphone application (android) for management of type 2 DM.

The application contains action plans and alarm system for each situation of serum fasting glucose, blood pressure, body weight, exercise amount, calori intake, medication, etc.
- **conventional arm** (ACTIVE_COMPARATOR) — The patients of conventional arm have the booklet for management of type 2 DM. The application contains general medical guideline and knowledge for management of type 2 DM such as,exercise amount, calori intake, medication, etc.

## Interventions

- **Self-Management Using Smartphone Application for Type2 DM** (OTHER)
- **self-management using booklet for management type 2 DM** (OTHER)

## Primary Outcomes

- **fasting serum glucose and HbA1c** _(time frame: 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 Outcomes

- **body weight and BMI** _(time frame: 3months after enrollemnt (day 0-day 90))_
- **Lipid profile** _(time frame: 3months after enrollment (day 0-90))_

## Locations (1)

- Haeundae Paik Hospital, Busan, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.haeundae paik hospital|busan||south korea` — added _(2026-05-12)_

---

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