NCT01820871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

8 months

First QC Date

March 26, 2013

Last Update Submit

November 26, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

T2DMsmartphone applicationserum fasting glucoseHbA1c

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • body weight and BMI

    3months after enrollemnt (day 0-day 90)

  • Lipid profile

    3months after enrollment (day 0-90)

Study Arms (2)

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.

Other: Self-Management Using Smartphone Application for Type2 DM

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.

Other: self-management using booklet for management type 2 DM

Interventions

Self-Management Using Smartphone Application for Type2 DMOTHER
application arm
self-management using booklet for management type 2 DMOTHER
conventional arm

Eligibility Criteria

Age21 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haeundae Paik Hospital

Busan, 612-030, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jongha Park, MD

    Inje University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study principal investigator

Study Record Dates

First Submitted

March 26, 2013

First Posted

March 29, 2013

Study Start

November 1, 2012

Primary Completion

July 1, 2013

Study Completion

October 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

KR(1)