Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898534
• Other study ID #: 03-07-121
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2009
• Last updated: May 11, 2009
• Start date: November 2003
• Est. completion date: January 2006

Study information

• Verified date: May 2009
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: January 2006
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Glycemic Control
• Type 1 Diabetes Mellitus

Intervention

Device:
• Bayer DCA2000+ Hemoglobin A1c analyzer
Point-of-care hemoglobin A1c measurement of blood obtained by fingerstick

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c		1 year after enrollment	No
Secondary	Hemoglobin A1c		3, 6, and 9 months after enrollment	No
Secondary	Pain rating of hemoglobin A1c test		3, 6, 9, and 12 months after enrollment	No
Secondary	Change in diabetes management (insulin, diet, exercise, glucose self-monitoring)		3, 6, 9, and 12 months after enrollment	No
Secondary	Episodes of severe hypoglycemia		3, 6, 9, and 12 months after enrollment	Yes
Secondary	Hospital admissions for diabetes related event		3, 6, 9, and 12 months after enrollment	Yes
Secondary	Number of phone and/or email contacts between practitioner and patient		3, 6, 9, and 12 months after enrollment	No