Patient-Centered Smartphone-Based Diabetes Care

December 9, 2014 updated by: Seoul National University Hospital

Feasibility of a Patient-Centered Smartphone-Based Diabetes Care System: a Pilot Study

The investigators developed a patient-centered smartphone-based diabetes care system (PSDCS). This study was aimed to test the feasibility of the PSDCS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2 diabetes
  • HbA1c levels ≥ 6.5%

Exclusion Criteria:

  • severe diabetic complication including severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy, chronic kidney disease stage 4-5, severe diabetic neuropathy, history of diabetic foot, history of angina pectoris, myocardial infarction, and cerebrovascular disease, and peripheral arterial disease
  • type 1 diabetes
  • insulin therapy other than insulin glargine
  • subjects with insulin pump
  • history of drug addiction
  • history of psychotic disorder
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSDCS
using the patient-centered smartphone-based diabetes care system (PSDCS) for 12 weeks
Device: patient-centered smartphone-based diabetes care system
patient-centered smartphone-based diabetes care system (PSDCS) is composed of 4 modules such as glucose module, diet module, physical activity module, and SNS module. Participants were instructed to use the PSDCS and to measure blood glucose levels with a Bluetooth glucometer, input daily food intake, and wear an activity tracker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of HbA1c
Time Frame: baseline and the end of 12 week
baseline and the end of 12 week

Secondary Outcome Measures

Outcome Measure
Time Frame
change of fasting plasma glucose
Time Frame: baseline and after 12 weeks (within 3 days)
baseline and after 12 weeks (within 3 days)
change of lipid profile
Time Frame: baseline and after 12 weeks (within 3 days)
baseline and after 12 weeks (within 3 days)
change of body weight
Time Frame: baseline and after 12 weeks (within 3 days)
baseline and after 12 weeks (within 3 days)
change of the scores of Summary of Diabetes Self-Care Activities (SDSCA)
Time Frame: baseline and after 12 weeks (within 3 days)
baseline and after 12 weeks (within 3 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of events of serious hyperglycemia
Time Frame: 12 weeks
320 mg/dL or higher by the glucometer readouts
12 weeks
number of events of hypoglycemia
Time Frame: 12 weeks
less than 70 mg/dL by the glucometer readouts
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1301-075-459

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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