Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus, Glycemic Control
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bayer DCA2000+ Hemoglobin A1c analyzer
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Pediatrics, Hemoglobin A1c, Point of Care testing
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes mellitus diagnosed at least 2 years prior to enrollment in study
- Less than 18 years of age
Exclusion Criteria:
- Cystic fibrosis related diabetes
- Type 2 diabetes
- Any other suspected non-type 1 diabetes (e.g., maturity onset diabetes of the young)
Sites / Locations
- Children's Hospital Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Immediate Feedback
Conventional Feedback
Arm Description
Subjects receive point-of-care hemoglobin A1c testing prior to their diabetes clinic visit, with results made available to the provider during the visit.
Subjects receive laboratory hemoglobin A1c testing at the clinic visit, with results made available to the provider several days later.
Outcomes
Primary Outcome Measures
Hemoglobin A1c
Secondary Outcome Measures
Hemoglobin A1c
Pain rating of hemoglobin A1c test
Change in diabetes management (insulin, diet, exercise, glucose self-monitoring)
Episodes of severe hypoglycemia
Hospital admissions for diabetes related event
Number of phone and/or email contacts between practitioner and patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00898534
Brief Title
Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
Official Title
Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Glycemic Control
Keywords
Pediatrics, Hemoglobin A1c, Point of Care testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Feedback
Arm Type
Experimental
Arm Description
Subjects receive point-of-care hemoglobin A1c testing prior to their diabetes clinic visit, with results made available to the provider during the visit.
Arm Title
Conventional Feedback
Arm Type
No Intervention
Arm Description
Subjects receive laboratory hemoglobin A1c testing at the clinic visit, with results made available to the provider several days later.
Intervention Type
Device
Intervention Name(s)
Bayer DCA2000+ Hemoglobin A1c analyzer
Intervention Description
Point-of-care hemoglobin A1c measurement of blood obtained by fingerstick
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Time Frame
1 year after enrollment
Secondary Outcome Measure Information:
Title
Hemoglobin A1c
Time Frame
3, 6, and 9 months after enrollment
Title
Pain rating of hemoglobin A1c test
Time Frame
3, 6, 9, and 12 months after enrollment
Title
Change in diabetes management (insulin, diet, exercise, glucose self-monitoring)
Time Frame
3, 6, 9, and 12 months after enrollment
Title
Episodes of severe hypoglycemia
Time Frame
3, 6, 9, and 12 months after enrollment
Title
Hospital admissions for diabetes related event
Time Frame
3, 6, 9, and 12 months after enrollment
Title
Number of phone and/or email contacts between practitioner and patient
Time Frame
3, 6, 9, and 12 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes mellitus diagnosed at least 2 years prior to enrollment in study
Less than 18 years of age
Exclusion Criteria:
Cystic fibrosis related diabetes
Type 2 diabetes
Any other suspected non-type 1 diabetes (e.g., maturity onset diabetes of the young)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael SD Agus, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20070556
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
We'll reach out to this number within 24 hrs