Glucometer and Mobile-phone Based Data Transfer System in Diabetes

May 12, 2016 updated by: TCVGH, Taichung Veterans General Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Sub-Investigator:
          • Jun-Sing Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
patients who decline or unable to do self-monitoring of blood glucose
ACTIVE_COMPARATOR: Breeze2 glucometer
patients who do self-monitoring of blood glucose, but do not transfer data via mobile-phone
Device: Breeze2 glucometer
Breeze2 glucometer for self-monitoring of blood glucose
EXPERIMENTAL: Breeze2 glucometer and H2
patients who do self-monitoring of blood glucose and transfer data via mobile-phone
Device: Breeze2 glucometer
Breeze2 glucometer for self-monitoring of blood glucose
Device: Breeze2 glucometer and H2
Breeze2 glucometer and Health2Sync Mobile App for data transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: HbA1c change from baseline at month 3 and 6
HbA1c change from baseline at month 3 and 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemia
Time Frame: 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).
event of hypoglycemia at month 3 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: Wayne Sheu, MD. Ph.D., Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (ESTIMATE)

May 11, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE15126B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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