Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
NCT ID: NCT00898534
Last Updated: 2009-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
234 participants
INTERVENTIONAL
2003-11-30
2006-01-31
Brief Summary
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Detailed Description
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In many clinical settings, A1c is determined in a central laboratory on a blood sample obtained by venipuncture and results usually are available one to two business days after the sample is obtained. If the A1c value is different than predicted from a review of available SMBG data at the visit, the practitioner must contact the family to review the results and, revise any care decisions made during the visit. This system is inefficient and fraught with the potential for less than optimal care relating to delays in the practitioner seeing the result, delays in reaching the subject or parents, and absence of the subject's participation in the phone call updating the care plan. Furthermore, many children dread venipuncture, which is often poorly tolerated and makes clinic visits painful, emotionally traumatic and unpleasant experiences.
Because there are no published data on the utility of point-of-care A1c testing in children and adolescents with diabetes, we designed a prospective randomized controlled trial to determine if subjects who received immediate feedback of A1c results at their clinic visits would have a lower A1c as compared to those who received A1c results after the clinic visit. We intend to determine whether immediate feedback of A1c results will enable the clinicians providing diabetes care to make more adjustments to the subject's management plan at the time of the clinic visit, and whether this will lead to fewer communications with the subject/family between visits. Finally we will assess the relative pain caused by fingerstick blood sampling as compared to venipuncture.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate Feedback
Subjects receive point-of-care hemoglobin A1c testing prior to their diabetes clinic visit, with results made available to the provider during the visit.
Bayer DCA2000+ Hemoglobin A1c analyzer
Point-of-care hemoglobin A1c measurement of blood obtained by fingerstick
Conventional Feedback
Subjects receive laboratory hemoglobin A1c testing at the clinic visit, with results made available to the provider several days later.
No interventions assigned to this group
Interventions
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Bayer DCA2000+ Hemoglobin A1c analyzer
Point-of-care hemoglobin A1c measurement of blood obtained by fingerstick
Eligibility Criteria
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Inclusion Criteria
* Less than 18 years of age
Exclusion Criteria
* Type 2 diabetes
* Any other suspected non-type 1 diabetes (e.g., maturity onset diabetes of the young)
2 Years
18 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Children's Hospital Boston
Principal Investigators
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Michael SD Agus, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Children's Hospital Boston
Boston, Massachusetts, United States
Countries
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References
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Agus MS, Alexander JL, Wolfsdorf JI. Utility of immediate hemoglobin A1c in children with type I diabetes mellitus. Pediatr Diabetes. 2010 Nov;11(7):450-4. doi: 10.1111/j.1399-5448.2009.00635.x.
Other Identifiers
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03-07-121
Identifier Type: -
Identifier Source: org_study_id
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