Patient-Centered Smartphone-Based Diabetes Care

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02313363

Enrollment

Registered

2014-12-10

Start date

2013-12-31

Completion date

2014-03-31

Last updated

2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Health care systems, Mobile applications, Self-care, Diabetes mellitus, Smartphone

Brief summary

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

Interventions

DEVICEpatient-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
change of HbA1c	baseline and the end of 12 week

Secondary

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

Other

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026