Patient-Centered Smartphone-Based Diabetes Care

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313363
• Other study ID #: H-1301-075-459
• Status: Completed
• Phase: Phase 0
• First received: December 8, 2014
• Last updated: December 9, 2014
• Start date: December 2013
• Est. completion date: March 2014

Study information

• Verified date: December 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of events of serious hyperglycemia	320 mg/dL or higher by the glucometer readouts	12 weeks	Yes
Other	number of events of hypoglycemia	less than 70 mg/dL by the glucometer readouts	12 weeks	Yes
Primary	change of HbA1c		baseline and the end of 12 week	No
Secondary	change of fasting plasma glucose		baseline and after 12 weeks (within 3 days)	No
Secondary	change of lipid profile		baseline and after 12 weeks (within 3 days)	No
Secondary	change of body weight		baseline and after 12 weeks (within 3 days)	No
Secondary	change of the scores of Summary of Diabetes Self-Care Activities (SDSCA)		baseline and after 12 weeks (within 3 days)	No