NCT00205335

Brief Summary

This study is designed to determine if there is an impact on blood glucose control in patients who receive free test strips. Patients in the study have no insurance or insurance that does not cover the purchase of test strips. A comparison of weight, blood pressure, and Hemoglobin A1C from entry to the final visit will be used to compare patients' management of their diabetes. Recommended values for these parameters will be used as the standard for comparisons. The investigators anticipate that patients receiving free test strips will show an improvement in the listed parameters as well as in satisfaction with their care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

3.8 years

First QC Date

September 13, 2005

Last Update Submit

September 29, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (3)

  • Weight

    one year

  • Blood pressure

    one year

  • Hemoglobin A1C

    one year

Secondary Outcomes (1)

  • Satisfaction with care

    one year

Study Arms (1)

glucose monitoring

OTHER

Each participant received a Bayer Breeze Monitor and glucose test strips for monitoring blood sugar.

Device: Ascencia Breeze Glucose meterDevice: Breeze Glucose Monitor (Bayer)

Interventions

Ascencia Breeze Glucose meterDEVICE

All study participants received glucose meter and test strips.

Also known as: Ascencia Breeze glucose meters made by Bayer and test strips
glucose monitoring
Breeze Glucose Monitor (Bayer)DEVICE

Each participant received a Breeze monitor and glucose test strips.

Also known as: Ascencia Breeze Glucose Meter, Bayer
glucose monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of diabetes who have no health insurance or insurance that does not pay for purchase of blood test strips

You may not qualify if:

  • Patients with a diagnosis of diabetes who have health insurance that pays for purchase of blood test strips

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sherree Drezner, ACSW, LCSW

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

US(1)