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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820871
• Other study ID #: SMART-DM
• Status: Completed
• Phase: N/A
• First received: March 26, 2013
• Last updated: November 26, 2013
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Self-Management Using Smartphone Application for Type2 DM

• self-management using booklet for management type 2 DM

Locations

Country	Name	City	State
Korea, Republic of	Haeundae Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting serum glucose and HbA1c	we will check the fasting serum glucose and HbA1C at the day of enrollment (day0)and those at 3months after enrollment (day 90)	3months after enrollemnt (day 0-day 90)	No
Secondary	body weight and BMI	we will check body weight and BMI at the day of enrollment (day0)and those at 3months after enrollment (day 90)	3months after enrollemnt (day 0-day 90)	No
Secondary	Lipid profile	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)	3months after enrollment (day 0-90)	No