Glucometer and Mobile-phone Based Data Transfer System in Diabetes

Phase 4

• Conditions: Diabetes
• Interventions: Device: Breeze2 glucometer; Device: Breeze2 glucometer and H2

• Registration Number: NCT02769377
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-16
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breeze2 glucometer	Breeze2 glucometer	patients who do self-monitoring of blood glucose, but do not transfer data via mobile-phone
Breeze2 glucometer and H2	Breeze2 glucometer	patients who do self-monitoring of blood glucose and transfer data via mobile-phone
Breeze2 glucometer and H2	Breeze2 glucometer and H2	patients who do self-monitoring of blood glucose and transfer data via mobile-phone

Primary Outcome Measures

Name	Time	Method
HbA1c	HbA1c change from baseline at month 3 and 6

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia	event of hypoglycemia at month 3 and 6	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).

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan