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

May 11, 2009 updated by: Boston Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c
Time Frame: 1 year after enrollment
1 year after enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c
Time Frame: 3, 6, and 9 months after enrollment
3, 6, and 9 months after enrollment
Pain rating of hemoglobin A1c test
Time Frame: 3, 6, 9, and 12 months after enrollment
3, 6, 9, and 12 months after enrollment
Change in diabetes management (insulin, diet, exercise, glucose self-monitoring)
Time Frame: 3, 6, 9, and 12 months after enrollment
3, 6, 9, and 12 months after enrollment
Episodes of severe hypoglycemia
Time Frame: 3, 6, 9, and 12 months after enrollment
3, 6, 9, and 12 months after enrollment
Hospital admissions for diabetes related event
Time Frame: 3, 6, 9, and 12 months after enrollment
3, 6, 9, and 12 months after enrollment
Number of phone and/or email contacts between practitioner and patient
Time Frame: 3, 6, 9, and 12 months after enrollment
3, 6, 9, and 12 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Michael SD Agus, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

May 12, 2009

Last Update Submitted That Met QC Criteria

May 11, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-07-121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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