Glucometer and Mobile-phone Based Data Transfer System in Diabetes

NCT ID: NCT02769377

Last Updated: 2016-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

patients who decline or unable to do self-monitoring of blood glucose

Group Type NO_INTERVENTION

No interventions assigned to this group

Breeze2 glucometer

patients who do self-monitoring of blood glucose, but do not transfer data via mobile-phone

Group Type ACTIVE_COMPARATOR

Breeze2 glucometer

Intervention Type DEVICE

Breeze2 glucometer for self-monitoring of blood glucose

Breeze2 glucometer and H2

patients who do self-monitoring of blood glucose and transfer data via mobile-phone

Group Type EXPERIMENTAL

Breeze2 glucometer

Intervention Type DEVICE

Breeze2 glucometer for self-monitoring of blood glucose

Breeze2 glucometer and H2

Intervention Type DEVICE

Breeze2 glucometer and Health2Sync Mobile App for data transfer

Interventions

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Breeze2 glucometer

Breeze2 glucometer for self-monitoring of blood glucose

Intervention Type DEVICE

Breeze2 glucometer and H2

Breeze2 glucometer and Health2Sync Mobile App for data transfer

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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TCVGH

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wayne Sheu, MD. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wayne Sheu, MD. Ph.D.

Role: CONTACT

+886-4-23592525 ext. 2002

Facility Contacts

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Wayne H Sheu, MD, PhD

Role: primary

886-4-23592525 ext. 3068

Other Identifiers

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CE15126B

Identifier Type: -

Identifier Source: org_study_id

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