Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-29 @ 12:59 PM
Study NCT ID:
NCT00898534
Status:
COMPLETED
Last Update Posted:
2009-05-12
First Post:
2009-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: