Glucometer and Mobile-phone Based Data Transfer System in Diabetes

Diabetes Clinical Trial

Official title:

Efficacy of Combination of Glucometer and Mobile-phone Based Data Transfer System on Glycemic Control in Patients With Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02769377
• Other study ID #: CE15126B
• Status: Recruiting
• Phase: Phase 4
• First received: May 9, 2016
• Last updated: May 12, 2016
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Taichung Veterans General Hospital
• Contact: Wayne Sheu, MD. Ph.D.
• Phone: +886-4-23592525
• Email: whhsheu[@]vghtc.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

To determine if glucometer combined with mobile-phone based data transfer system would be useful for patient diabetes to manage their glycemic control.

Description:

Patients with diabetes who are advised by their providers to self-monitoring of blood glucose are eligible. Patients who decline or are not able to do self-monitoring of blood glucose will serve as controls.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patient with diabetes

2. Patients' providers advised self-monitor of blood glucose

3. Provided written informed consent.

Exclusion Criteria:

1. Patients had other medical condition that were considered not eligible by the medical team members

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Breeze2 glucometer
Breeze2 glucometer for self-monitoring of blood glucose
• Breeze2 glucometer and H2
Breeze2 glucometer and Health2Sync Mobile App for data transfer

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		HbA1c change from baseline at month 3 and 6	No
Secondary	Hypoglycemia	Hypoglycemia was defined as a glucose value less than 70 mg/dl, or with typical symptoms of hypoglycemia. The information of hypoglycemia will be collected at each site visit (every 1-2 month).	event of hypoglycemia at month 3 and 6	Yes