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

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00898534
First received: May 8, 2009
Last updated: May 11, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Glycemic Control
Device: Bayer DCA2000+ Hemoglobin A1c analyzer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 1 year after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 3, 6, and 9 months after enrollment ] [ Designated as safety issue: No ]
  • Pain rating of hemoglobin A1c test [ Time Frame: 3, 6, 9, and 12 months after enrollment ] [ Designated as safety issue: No ]
  • Change in diabetes management (insulin, diet, exercise, glucose self-monitoring) [ Time Frame: 3, 6, 9, and 12 months after enrollment ] [ Designated as safety issue: No ]
  • Episodes of severe hypoglycemia [ Time Frame: 3, 6, 9, and 12 months after enrollment ] [ Designated as safety issue: Yes ]
  • Hospital admissions for diabetes related event [ Time Frame: 3, 6, 9, and 12 months after enrollment ] [ Designated as safety issue: Yes ]
  • Number of phone and/or email contacts between practitioner and patient [ Time Frame: 3, 6, 9, and 12 months after enrollment ] [ Designated as safety issue: No ]

Enrollment: 234
Study Start Date: November 2003
Study Completion Date: January 2006
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Feedback
Subjects receive point-of-care hemoglobin A1c testing prior to their diabetes clinic visit, with results made available to the provider during the visit.
Device: Bayer DCA2000+ Hemoglobin A1c analyzer
Point-of-care hemoglobin A1c measurement of blood obtained by fingerstick
No Intervention: Conventional Feedback
Subjects receive laboratory hemoglobin A1c testing at the clinic visit, with results made available to the provider several days later.

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

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898534

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Michael SD Agus, MD Children's Hospital Boston
  More Information

No publications provided by Children's Hospital Boston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Agus, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00898534     History of Changes
Other Study ID Numbers: 03-07-121
Study First Received: May 8, 2009
Last Updated: May 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Pediatrics
Hemoglobin A1c
Point of Care testing

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014