Status:

COMPLETED

Self Monitoring of Blood Glucose With Finger Tip vs. Alternate Site Sampling: Effect on Long Term Glycemic Control

Lead Sponsor:

Boston Medical Center

Collaborating Sponsors:

Department of Health and Human Services

Food and Drug Administration (FDA)

Conditions:

Diabetes Mellitus

Eligibility:

All Genders

18-70 years

Phase:

PHASE1

Brief Summary

The objective is to assess the effect of using ASBG (alternate site blood glucose) versus FTBG (finger tip blood glucose) testing on long-term glycemic control in diabetics. Since ASBG measurements ap...

Detailed Description

Patients undergo an initial screening visit. Inclusion criteria include adults 18 -70 years of age with type II diabetes currently using insulin and recording SMBG measurements. Exclusion criteria inc...

Eligibility Criteria

Inclusion

  • Inclusion criteria will include adults 18 -70 years of age with type II diabetes currently using insulin and recording SMBG measurements.

Exclusion

  • Patients will be excluded who have a history of hypoglycemic episodes, within the last two years, requiring urgent medical attention, hypoglycemia resulting in cognitive impairment, a lack of symptoms during hypoglycemic episodes. Subjects will also be excluded who have type I DM as determined by the investigators on a case-by-case basis, subjects who already utilize ASBG measurements or who have serious co-morbid illness (unstable cardiovascular disease, metastatic CA). Pregnant patients will also be excluded because of the more intense diabetic control they require.

Key Trial Info

Start Date :

July 1 2003

Trial Type :

INTERVENTIONAL

End Date :

October 1 2005

Estimated Enrollment :

174 Patients enrolled

Trial Details

Trial ID

NCT00207207

Start Date

July 1 2003

End Date

October 1 2005

Last Update

February 11 2009

Active Locations (1)

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1

Boston University Medical Center

Boston, Massachusetts, United States, 02118