Type 1 Diabetes MellitusPhase 4NCT00898534
Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
A Phase 4 study testing Bayer DCA2000+ Hemoglobin A1c analyzer in people with Type 1 Diabetes Mellitus and Glycemic Control, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Glycemic Control
- What is being tested?
- Bayer DCA2000+ Hemoglobin A1c analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Jan 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes mellitus diagnosed at least 2 years prior to enrollment in study
- Less than 18 years of age
Who cannot join
- Cystic fibrosis related diabetes
- Type 2 diabetes
- Any other suspected non-type 1 diabetes (e.g., maturity onset diabetes of the young)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus, Glycemic Control
- Being tested
- Bayer DCA2000+ Hemoglobin A1c analyzer
- Keywords
- Pediatrics, Hemoglobin A1c, Point of Care testing
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bayer DCA2000+ Hemoglobin A1c analyzerDevice
Point-of-care hemoglobin A1c measurement of blood obtained by fingerstick
| Study group | Role | What they receive |
|---|---|---|
| Immediate Feedback | Experimental | Subjects receive point-of-care hemoglobin A1c testing prior to their diabetes clinic visit, with results made available to the provider during the visit. Receives: Device: Bayer DCA2000+ Hemoglobin A1c analyzer |
| Conventional Feedback | No intervention | Subjects receive laboratory hemoglobin A1c testing at the clinic visit, with results made available to the provider several days later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Measured: 1 year after enrollment
Secondary outcomes (6)
Hemoglobin A1c
Measured: 3, 6, and 9 months after enrollment
Pain rating of hemoglobin A1c test
Measured: 3, 6, 9, and 12 months after enrollment
Change in diabetes management (insulin, diet, exercise, glucose self-monitoring)
Measured: 3, 6, 9, and 12 months after enrollment
Episodes of severe hypoglycemia
Measured: 3, 6, 9, and 12 months after enrollment
Hospital admissions for diabetes related event
Measured: 3, 6, 9, and 12 months after enrollment
Number of phone and/or email contacts between practitioner and patient
Measured: 3, 6, 9, and 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startNov 2003
- Primary completionSep 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Michael SD Agus, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898534
- Sponsor's protocol ID
- 03-07-121
- Status last verified
- May 2009
- First submitted
- 8 May 2009
- Last updated
- 12 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20070556
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immediate Hemoglobin A1c on Glycemic Control in Children With Type I Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00898534
- Acronym / sponsor ID
- 03-07-121
- Conditions
- Type 1 Diabetes Mellitus, Glycemic Control
- Keywords
- Pediatrics, Hemoglobin A1c, Point of Care testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Feedback | Experimental | Device: Bayer DCA2000+ Hemoglobin A1c analyzerSubjects receive point-of-care hemoglobin A1c testing prior to their diabetes clinic visit, with results made available to the provider during the visit. |
| Conventional Feedback | No intervention | –Subjects receive laboratory hemoglobin A1c testing at the clinic visit, with results made available to the provider several days later. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Type 1 diabetes mellitus diagnosed at least 2 years prior to enrollment in study
- Less than 18 years of age
Key exclusion criteria (3 listed)
- Cystic fibrosis related diabetes
- Type 2 diabetes
- Any other suspected non-type 1 diabetes (e.g., maturity onset diabetes of the young)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bayer DCA2000+ Hemoglobin A1c analyzerPoint-of-care hemoglobin A1c measurement of blood obtained by fingerstick | Device | Immediate Feedback |
Primary outcome
Hemoglobin A1c
Time frame: 1 year after enrollment
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
- Derived from this study: PubMed 20070556Agus 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.
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael SD Agus, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bayer DCA2000+ Hemoglobin A1c analyzer in people with Type 1 Diabetes Mellitus and Glycemic Control, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 1 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00898534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2009.