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

This study has been completed.
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00207207
First received: September 13, 2005
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Diabetes Mellitus
Procedure: Alternate site blood glucose testing
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

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

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

Estimated Enrollment: 174
Study Start Date: July 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207207

Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Food and Drug Administration (FDA)
Investigators
Principal Investigator: Caroline Apovian, MD Boston University
  More Information

Publications:

Responsible Party: Caroline Apovian, MD, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00207207     History of Changes
Other Study ID Numbers: Protocol # 03-004C, Contract #: 233-02-0077
Study First Received: September 13, 2005
Last Updated: February 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Alternate Site
Blood Glucose Testing
Blood Sugar Testing
Hemoglobin A1C

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014