NCT02362607

Brief Summary

The investigators aim to assess whether using integrated diabetes management protocol using smartphone would increase glucose control among diabetes patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

8 months

First QC Date

February 2, 2015

Last Update Submit

February 3, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose Control Status Measured by HbA1c

    Blood test results for HbA1c after three months.

    After three months

Secondary Outcomes (1)

  • Patient Satisfaction Measured by Questionnaire

    After three months

Study Arms (2)

Integrated Diabetes Management Protocol

EXPERIMENTAL

Smartphone apps for food diary, activity monitor, blood glucose will be used for three months.

Behavioral: Integrated Diabetes Management Protocol

Standard Diabetes Management Protocol

ACTIVE COMPARATOR

Subjects will receive standard diabetes management protocol with standard education and standard blood glucose measurement devices.

Behavioral: Standard Diabetes Management Protocol

Interventions

Integrated Diabetes Management ProtocolBEHAVIORAL
Integrated Diabetes Management Protocol
Standard Diabetes Management ProtocolBEHAVIORAL
Standard Diabetes Management Protocol

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes, type 1 diabetes, gestational diabetes

You may not qualify if:

  • Medications which interfere glucose control
  • Cancer
  • Chronic kidney injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University

Cheongju-si, North Chungcheong, 361-711, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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
Clinical Assistant Professor

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 13, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

KR(1)