NCT02769377

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4 diabetes

Timeline
Completed

Started Sep 2014

Typical duration for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

May 9, 2016

Last Update Submit

May 12, 2016

Conditions

Diabetes

Keywords

diabetes, glucometer, mobile-phone

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    HbA1c change from baseline at month 3 and 6

Secondary Outcomes (1)

  • Hypoglycemia

    event of hypoglycemia at month 3 and 6

Study Arms (3)

Control

NO INTERVENTION

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

Breeze2 glucometer

ACTIVE COMPARATOR

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

Device: Breeze2 glucometer

Breeze2 glucometer and H2

EXPERIMENTAL

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

Device: Breeze2 glucometerDevice: Breeze2 glucometer and H2

Interventions

Breeze2 glucometerDEVICE

Breeze2 glucometer for self-monitoring of blood glucose

Breeze2 glucometerBreeze2 glucometer and H2
Breeze2 glucometer and H2DEVICE

Breeze2 glucometer and Health2Sync Mobile App for data transfer

Breeze2 glucometer and H2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with diabetes
  • Patients' providers advised self-monitor of blood glucose
  • Provided written informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Wayne Sheu, MD. Ph.D.

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wayne Sheu, MD. Ph.D.

CONTACT

+886-4-23592525whhsheu@vghtc.gov.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 11, 2016

Study Start

September 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 16, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)