Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus; Glycemic Control
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Bayer DCA2000+ Hemoglobin A1c analyzer
Intervention type(s): Device
Intervention description(s): Point-of-care hemoglobin A1c measurement of blood obtained by fingerstick
Intervention MeSH terms: Chrysarobin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatrics; Hemoglobin A1c; Point of Care testing