Patient-Centered Smartphone-Based Diabetes Care

NCT02313363 | Completed Early Phase 1 DMC

• 1 other identifier: H-1301-075-459
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• change of HbA1c

  baseline and the end of 12 week

Secondary Outcomes (4)

• change of fasting plasma glucose

  baseline and after 12 weeks (within 3 days)

• change of lipid profile

  baseline and after 12 weeks (within 3 days)

• change of body weight

  baseline and after 12 weeks (within 3 days)

• change of the scores of Summary of Diabetes Self-Care Activities (SDSCA)

  baseline and after 12 weeks (within 3 days)

Other Outcomes (2)

• number of events of serious hyperglycemia

  12 weeks

• number of events of hypoglycemia

  12 weeks

Study Arms (1)

PSDCS

EXPERIMENTAL

using the patient-centered smartphone-based diabetes care system (PSDCS) for 12 weeks

Device: patient-centered smartphone-based diabetes care system

Interventions

patient-centered smartphone-based diabetes care system DEVICE

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.

PSDCS

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes
• HbA1c levels ≥ 6.5%

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Young Min Cho, MD, PHD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-12