Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
1 other identifier
interventional
234
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2003
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 8, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedMay 12, 2009
May 1, 2009
1.8 years
May 8, 2009
May 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
1 year after enrollment
Secondary Outcomes (6)
Hemoglobin A1c
3, 6, and 9 months after enrollment
Pain rating of hemoglobin A1c test
3, 6, 9, and 12 months after enrollment
Change in diabetes management (insulin, diet, exercise, glucose self-monitoring)
3, 6, 9, and 12 months after enrollment
Episodes of severe hypoglycemia
3, 6, 9, and 12 months after enrollment
Hospital admissions for diabetes related event
3, 6, 9, and 12 months after enrollment
- +1 more secondary outcomes
Study Arms (2)
Immediate Feedback
EXPERIMENTALSubjects receive point-of-care hemoglobin A1c testing prior to their diabetes clinic visit, with results made available to the provider during the visit.
Conventional Feedback
NO INTERVENTIONSubjects receive laboratory hemoglobin A1c testing at the clinic visit, with results made available to the provider several days later.
Interventions
Point-of-care hemoglobin A1c measurement of blood obtained by fingerstick
Eligibility Criteria
You may qualify if:
- Type 1 diabetes mellitus diagnosed at least 2 years prior to enrollment in study
- Less than 18 years of age
You may not qualify if:
- Cystic fibrosis related diabetes
- Type 2 diabetes
- Any other suspected non-type 1 diabetes (e.g., maturity onset diabetes of the young)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 20070556DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael SD Agus, MD
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 8, 2009
First Posted
May 12, 2009
Study Start
November 1, 2003
Primary Completion
September 1, 2005
Study Completion
January 1, 2006
Last Updated
May 12, 2009
Record last verified: 2009-05