Self Monitoring of Blood Glucose With Finger Tip vs. Alternate Site Sampling: Effect on Long Term Glycemic Control
Randomized Trial to Assess the Effect of Using Alternate Site Blood Glucose Testing Versus Finger-Tip Testing on Long-Term Glycemic Control.
2 other identifiers
interventional
174
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus
Started Jul 2003
Typical duration for phase_1 diabetes-mellitus
1 active site
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
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFebruary 11, 2009
February 1, 2009
2.3 years
September 13, 2005
February 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of diabetic control as measured by 7-month HbA1c.
Secondary Outcomes (2)
Compliance with testing.
Number of hypoglycemic episodes.
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Medical Centerlead
- Department of Health and Human Servicescollaborator
- Food and Drug Administration (FDA)collaborator
Study Sites (1)
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Related Publications (8)
Ellison JM, Stegmann JM, Colner SL, Michael RH, Sharma MK, Ervin KR, Horwitz DL. Rapid changes in postprandial blood glucose produce concentration differences at finger, forearm, and thigh sampling sites. Diabetes Care. 2002 Jun;25(6):961-4. doi: 10.2337/diacare.25.6.961.
PMID: 12032099BACKGROUNDSaaddine JB, Engelgau MM, Beckles GL, Gregg EW, Thompson TJ, Narayan KM. A diabetes report card for the United States: quality of care in the 1990s. Ann Intern Med. 2002 Apr 16;136(8):565-74. doi: 10.7326/0003-4819-136-8-200204160-00005.
PMID: 11955024BACKGROUNDIntensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
PMID: 9742976BACKGROUNDDiabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PMID: 8366922BACKGROUNDFineberg SE, Bergenstal RM, Bernstein RM, Laffel LM, Schwartz SL. Use of an automated device for alternative site blood glucose monitoring. Diabetes Care. 2001 Jul;24(7):1217-20. doi: 10.2337/diacare.24.7.1217.
PMID: 11423505BACKGROUNDKuwa K, Nakayama T, Hoshino T, Tominaga M. Relationships of glucose concentrations in capillary whole blood, venous whole blood and venous plasma. Clin Chim Acta. 2001 May;307(1-2):187-92. doi: 10.1016/s0009-8981(01)00426-0.
PMID: 11369356BACKGROUNDJungheim K, Koschinsky T. Glucose monitoring at the arm: risky delays of hypoglycemia and hyperglycemia detection. Diabetes Care. 2002 Jun;25(6):956-60. doi: 10.2337/diacare.25.6.956.
PMID: 12032098BACKGROUNDde Veciana M, Major CA, Morgan MA, Asrat T, Toohey JS, Lien JM, Evans AT. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. N Engl J Med. 1995 Nov 9;333(19):1237-41. doi: 10.1056/NEJM199511093331901.
PMID: 7565999BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline Apovian, MD
Boston University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
July 1, 2003
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
February 11, 2009
Record last verified: 2009-02