A Phase 4 interventional study of Bayer DCA2000+ Hemoglobin A1c analyzer in Type 1 Diabetes Mellitus and Glycemic Control, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2009-05-12.
Sponsored by Boston Children's Hospital · Phase 4, Interventional, and Treatment
Immediate feedback of hemoglobin A1c (A1c) results to adults with type 1 and 2 diabetes allows more appropriate care decisions at the clinic visit and may improve glycemic control. The investigators' objective is to determine whether immediate feedback of A1c results to children with type 1 diabetes will improve patient care and glycemic control.
Because glycosylated hemoglobin (A1c) has been shown to reflect average glycemia over several months and has a strong predictive value for diabetes complications, routine quarterly measurements is a standard of care in children and adolescents with Type 1 diabetes mellitus. The A1c value determines whether the patient's glycemic targets have been reached or maintained. The availability of the A1c result at the time the patient is seen (point-of-care testing) has been reported in adults with diabetes to result in increased intensification of therapy and improvement in glycemic control in type 1 and insulin-treated type 2 diabetes and in type 2 diabetes. The A1c may also serve as a check on the accuracy of the patient's glucose meter and the validity of the patient's reported self monitored blood glucose (SMBG) results.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 234 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects receive point-of-care hemoglobin A1c testing prior to their diabetes clinic visit, with results made available to the provider during the visit.
Device: Bayer DCA2000+ Hemoglobin A1c analyzer
Subjects receive laboratory hemoglobin A1c testing at the clinic visit, with results made available to the provider several days later.
Point-of-care hemoglobin A1c measurement of blood obtained by fingerstick
Hemoglobin A1c
Time frame: 1 year after enrollment
Hemoglobin A1c
Time frame: 3, 6, and 9 months after enrollment
Pain rating of hemoglobin A1c test
Time frame: 3, 6, 9, and 12 months after enrollment
Change in diabetes management (insulin, diet, exercise, glucose self-monitoring)
Time frame: 3, 6, 9, and 12 months after enrollment
Episodes of severe hypoglycemia
Time frame: 3, 6, 9, and 12 months after enrollment
Hospital admissions for diabetes related event
Time frame: 3, 6, 9, and 12 months after enrollment
Number of phone and/or email contacts between practitioner and patient
Time frame: 3, 6, 9, and 12 months after enrollment
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
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Boston Children's Hospital