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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00207207
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 11, 2009
Department of Health and Human Services
Food and Drug Administration (FDA)
Information provided by:
Boston Medical Center

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 appear to lag behind FSBG measurements at times of changing glucose concentration, it is possible that ASBG measurements will yield lower postprandial readings than FTBG, potentially causing a negative impact on long-term control. It is also possible that since ASBG is reportedly more comfortable than FTBG testing, it's use might improve adherence to testing and improve long term control.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Procedure: Alternate site blood glucose testing Phase 1

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 include history of severe hypoglycemic episodes, current use of ASBG measurements, serious co-morbid illness or pregnancy. For eligible subjects baseline data including HbA1C is obtained. The goal for enrollment is 176 subjects. Subjects are randomized into either a fingertip or an arm-testing group within strata of baseline HbA1C. Each subject who does not already have one receives a One Touch Ultra® SMBG device. All subjects receive training in the use of this device, but for those in the arm-testing group this includes training on obtaining samples from the forearm. Arm- testing subjects are encouraged to use arm testing as much as possible but to use finger testing if they are not able to obtain a sample from the arm. All subjects are asked to perform SMBG testing before breakfast, before dinner and 2 hours after dinner and to complete diaries of all SMBG readings. At 1, 3 and 5 months after the training visit subjects see a diabetes provider who makes adjustments in the therapeutic regimen based on the SMBG measurements, as they would during routine diabetes management. Diary sheets are then collected and the data they contain is entered into a database. At months 2, 4 and 7 subjects present for a visit to drop off their diary sheets. At months 4 and 7 they have blood drawn for HbA1C measurement. The principal outcome variable is level of diabetic control as measured by 7-month HbA1c. The means for each group will be compared, and we will test the hypothesis that glycemic control as represented by 7-month HbA1C is not worse for the ASBG group than the FTBG group. Secondary outcome variables are compliance with testing and number of hypoglycemic episodes.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial to Assess the Effect of Using Alternate Site Blood Glucose Testing Versus Finger-Tip Testing on Long-Term Glycemic Control.
Study Start Date : July 2003
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Primary Outcome Measures :
  1. Level of diabetic control as measured by 7-month HbA1c.

Secondary Outcome Measures :
  1. Compliance with testing.
  2. Number of hypoglycemic episodes.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00207207

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United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Department of Health and Human Services
Food and Drug Administration (FDA)
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Principal Investigator: Caroline Apovian, MD Boston University


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Responsible Party: Caroline Apovian, MD, Boston Medical Center Identifier: NCT00207207     History of Changes
Other Study ID Numbers: Protocol # 03-004C
Contract #: 233-02-0077
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009
Keywords provided by Boston Medical Center:
Alternate Site
Blood Glucose Testing
Blood Sugar Testing
Hemoglobin A1C