Clinical trial NCT00898534: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Glycemic Control
Keywords: Pediatrics
Hemoglobin A1c
Point of Care testing
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 234
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 1 year after enrollment
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 3, 6, and 9 months after enrollment
measure: Pain rating of hemoglobin A1c test
timeFrame: 3, 6, 9, and 12 months after enrollment
measure: Change in diabetes management (insulin, diet, exercise, glucose self-monitoring)
timeFrame: 3, 6, 9, and 12 months after enrollment
measure: Episodes of severe hypoglycemia
timeFrame: 3, 6, 9, and 12 months after enrollment
measure: Hospital admissions for diabetes related event
timeFrame: 3, 6, 9, and 12 months after enrollment
measure: Number of phone and/or email contacts between practitioner and patient
timeFrame: 3, 6, 9, and 12 months after enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Michael SD Agus, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.