Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00898534|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 12, 2009
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Glycemic Control||Device: Bayer DCA2000+ Hemoglobin A1c analyzer||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||January 2006|
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.
- Hemoglobin A1c [ Time Frame: 1 year after enrollment ]
- Hemoglobin A1c [ Time Frame: 3, 6, and 9 months after enrollment ]
- Pain rating of hemoglobin A1c test [ Time Frame: 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 ]
- Episodes of severe hypoglycemia [ Time Frame: 3, 6, 9, and 12 months after enrollment ]
- Hospital admissions for diabetes related event [ Time Frame: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898534
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Michael SD Agus, MD||Boston Children’s Hospital|