Diabetes MellitusNCT00258674
Improving Diabetes Care:Effectiveness of Physician Profiling and Care Coordination by a Diabetes Resource Nurse
A study testing Medicare Claims Feedback, Medical Record Review and Diabetes Resource Nurse in people with Diabetes Mellitus, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of physician profiling and care coordination by a diabetes resource nurse in improving the quality of diabetes care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Medicare Claims Feedback, Medical Record Review and Diabetes Resource Nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,891 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Dec 2001
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age ≥ 65 years on January 1, 2000
- diagnosis of diabetes mellitus
- diabetes related visit to HTPN physician within the past year
- Resident of Texas
- Medicare insurance coverage
Who cannot join
- Patient chart not available for abstraction
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Health Care System Institute for Health Care Research and Improvement
Dallas, Texas, 75206
About this study
Official title: A Randomized Trial of Strategies to Improve Diabetes Care: Effectiveness and Costs of Physician Profiling and Care Coordination by a Diabetes Resource Nurse
The purpose of this study is to test the effectiveness of physician profiling and care coordination by a diabetes resource nurse in improving the quality of diabetes care.
Read the detailed description
HealthTexas Provider Network primary care practices with at least 10 Medicare diabetes patients over the age of 65 were randomized to one of 3 intervention arms: physician feedback of process measures using Medicare claims data ("Claims"); feedback of Medicare claims data plus clinical measures from medical record abstraction ("Claims+MR"); or both types of feedback plus a practice-based DRN ("DRN"). For the 12 months prior to the intervention and 12 months post-intervention, performance data on diabetes related processes of care (annual HbA1c testing, annual LDL cholesterol screening, annual hypertension screening, annual eye, foot, and renal assessment) and patient outcomes (HbA1c level, LDL cholesterol level, blood pressure) were collected from medical record abstraction and Medicare claims data. Pre-post change scores will be compared between intervention arms to examine effectiveness of physician profiling and care coordination by a diabetes resource nurse.
- Conditions
- Diabetes Mellitus
- Being tested
- Medicare Claims Feedback, Medical Record Review, Diabetes Resource Nurse
- Keywords
- Diabetes, Care coordination, Case management, Physician profiling
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicare Claims FeedbackOther
Physician practices received periodic feedback on their performance on selected diabetes quality of care measures as reflected by the Medicare claims data for their patients.
Medical Record ReviewOther
Physician practices received period feedback on their performance on selected diabetes quality of care measures, as reflected by data collected from their patients' medical records. These data were compiled by trained nurse abstractors using a standardized data collection tool developed for this study.
Diabetes Resource NurseOther
Diabetes Resource Nurses (DRNs) were registered nurses with 3-5 years of experience as certified diabetes educations who performed initial patient assessments, developed plans of care, administered screening tools, and monitored clinical outcomes. Physicians at the practices randomised to this intervention had could access the DRN's services for their diabetes patients, but neither physicians nor patients had to take advantage of this resource.
| Study group | Role | What they receive |
|---|---|---|
| Medicare Claims Feedback | Active comparator | Practices randomised to the Medicare Claims Feedback arm received period feedback on their performance on selected diabetes quality of care measures as reflected in the claims data for their diabetes patients. Receives: Other: Medicare Claims Feedback |
| Medicare Claims+Medical Record Feedback | Experimental | Practices randomised to the Medicare Claims + Medical Record Review Feedback arm received periodic feedback on their performance on selected diabetes quality of care measures as reflected in both the Medicare claims for the diabetes patients AND review/audit of their diabetes patients' medical records. Receives: Other: Medicare Claims Feedback; Other: Medical Record Review |
| Medicare Claims+Medical Chart Review+DRN | Experimental | In addition to the performance data from both Medicare Claims data and from review of patients' medical records, practices randomised to the Medicare Claims + Medical Record review + Diabetes Resource Nurse (DRN) had a diabetes resource nurse assigned to them, who was available to provide diabetes education and care-coordination type services for their diabetes patients. Receives: Other: Medicare Claims Feedback; Other: Medical Record Review; Other: Diabetes Resource Nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Score for "HbA1c <9 Percent"
Each patient was assigned a "change score" of -1, 0, or 1. A positive value indicated a patient non-adherent to the guideline recommendation for HbA1c <9 percent at baseline had achieved such a level at follow up. Patient-level change scores were then summed and averaged over each study arm.
Measured: This measure compared baseline values (01/01/2000-12/31/2000) to follow-up values (01/01/2001-12/31/2001)
Change Score for "LDL <100 mg/dL"
Each patient was assigned a "change score" of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of LDL <100 mg/dL at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/2001-12/31/2001)
Change Score for "Blood Pressure (b.p.) <130/80 mmHg"
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of blood pressure <130/80 mmHg at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/200112/31/2001)
Secondary outcomes (14)
Change Score for "HbA1c Level"
Change score was calculated by subtracting the follow-up HbA1c value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Diastolic Blood Pressure"
Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "LDL Level"
Change score was calculated by subtracting the follow-up LDL value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Systolic Blood Pressure"
Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual HbA1c Assessment" (as Determined From Medical Record Review)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Lipid Assessment" (as Determined From Medical Record Review)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Blood Pressure Assessment" (as Determined From Medical Record Review)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual blood pressure assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Foot Exam" (as Determined by Medical Record Review)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual foot exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Eye Exam" (as Determined From Medical Record Review)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Renal Function Assessment" (as Determined From Medical Record Review)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual renal function assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual HbA1c Assessment" (as Determined From Medicare Claims Data)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Eye Exam" (as Determined From Medicare Claims Data)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Lipid Assessment" (as Determined From Medicare Claims Data)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Semiannual HbA1c Assessment" (as Determined From Medicare Claims Data)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for a semi-annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.
Measured: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startJan 2000
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,891 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- David J Ballard, MD,MSPH,PhD, Principal investigator, Baylor Health Care System Institute for Health Care Research and Improvement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258674
- Sponsor's protocol ID
- 000-113
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2005
- Last updated
- 3 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hollander P, Nicewander D, Couch C, Winter D, Herrin J, Haydar Z, Ballard DJ. Quality of care of Medicare patients with diabetes in a metropolitan fee-for-service primary care integrated delivery system. Am J Med Qual. 2005 Nov-Dec;20(6):344-52. doi: 10.1177/1062860605280205.
PubMed 16280398Herrin J, Nicewander DA, Hollander PA, Couch CE, Winter FD, Haydar ZR, Warren SS, Ballard DJ. Effectiveness of diabetes resource nurse case management and physician profiling in a fee-for-service setting: a cluster randomized trial. Proc (Bayl Univ Med Cent). 2006 Apr;19(2):95-102. doi: 10.1080/08998280.2006.11928137.
PubMed 16609732
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Strategies to Improve Diabetes Care: Effectiveness and Costs of Physician Profiling and Care Coordination by a Diabetes Resource Nurse
- ClinicalTrials.gov ID
- NCT00258674
- Acronym / sponsor ID
- 000-113
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Care coordination, Case management, Physician profiling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,891 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jan 2000
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 28 Nov 2005 (estimated)
- Results
- Posted 23 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effectiveness of physician profiling and care coordination by a diabetes resource nurse in improving the quality of diabetes care.
Detailed description
HealthTexas Provider Network primary care practices with at least 10 Medicare diabetes patients over the age of 65 were randomized to one of 3 intervention arms: physician feedback of process measures using Medicare claims data ("Claims"); feedback of Medicare claims data plus clinical measures from medical record abstraction ("Claims+MR"); or both types of feedback plus a practice-based DRN ("DRN"). For the 12 months prior to the intervention and 12 months post-intervention, performance data on diabetes related processes of care (annual HbA1c testing, annual LDL cholesterol screening, annual hypertension screening, annual eye, foot, and renal assessment) and patient outcomes (HbA1c level, LDL cholesterol level, blood pressure) were collected from medical record abstraction and Medicare claims data. Pre-post change scores will be compared between intervention arms to examine effectiveness of physician profiling and care coordination by a diabetes resource nurse.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medicare Claims Feedback | Active comparator | Other: Medicare Claims FeedbackPractices randomised to the Medicare Claims Feedback arm received period feedback on their performance on selected diabetes quality of care measures as reflected in the claims data for their diabetes patients. |
| Medicare Claims+Medical Record Feedback | Experimental | Other: Medicare Claims Feedback, Other: Medical Record ReviewPractices randomised to the Medicare Claims + Medical Record Review Feedback arm received periodic feedback on their performance on selected diabetes quality of care measures as reflected in both the Medicare claims for the diabetes patients AND review/audit of their diabetes patients' medical records. |
| Medicare Claims+Medical Chart Review+DRN | Experimental | Other: Medicare Claims Feedback, Other: Medical Record Review, Other: Diabetes Resource NurseIn addition to the performance data from both Medicare Claims data and from review of patients' medical records, practices randomised to the Medicare Claims + Medical Record review + Diabetes Resource Nurse (DRN) had a diabetes resource nurse assigned to them, who was available to provide diabetes education and care-coordination type services for their diabetes patients. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- age ≥ 65 years on January 1, 2000
- diagnosis of diabetes mellitus
- diabetes related visit to HTPN physician within the past year
- Resident of Texas
- Medicare insurance coverage
Key exclusion criteria (1 listed)
- Patient chart not available for abstraction
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 |
|---|---|---|
| Medicare Claims FeedbackPhysician practices received periodic feedback on their performance on selected diabetes quality of care measures as reflected by the Medicare claims data for their patients. | Other | Medicare Claims Feedback, Medicare Claims+Medical Chart Review+DRN, Medicare Claims+Medical Record Feedback |
| Medical Record ReviewPhysician practices received period feedback on their performance on selected diabetes quality of care measures, as reflected by data collected from their patients' medical records. These data were compiled by trained nurse abstractors using a standardized data collection tool developed for this study. | Other | Medicare Claims+Medical Chart Review+DRN, Medicare Claims+Medical Record Feedback |
| Diabetes Resource NurseDiabetes Resource Nurses (DRNs) were registered nurses with 3-5 years of experience as certified diabetes educations who performed initial patient assessments, developed plans of care, administered screening tools, and monitored clinical outcomes. Physicians at the practices randomised to this intervention had could access the DRN's services for their diabetes patients, but neither physicians nor patients had to take advantage of this resource. | Other | Medicare Claims+Medical Chart Review+DRN |
Primary outcome
Change Score for "HbA1c <9 Percent"
Time frame: This measure compared baseline values (01/01/2000-12/31/2000) to follow-up values (01/01/2001-12/31/2001)
Each patient was assigned a "change score" of -1, 0, or 1. A positive value indicated a patient non-adherent to the guideline recommendation for HbA1c <9 percent at baseline had achieved such a level at follow up. Patient-level change scores were then summed and averaged over each study arm.
Change Score for "LDL <100 mg/dL"
Time frame: change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/2001-12/31/2001)
Each patient was assigned a "change score" of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of LDL <100 mg/dL at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm.
Change Score for "Blood Pressure (b.p.) <130/80 mmHg"
Time frame: change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/200112/31/2001)
Each patient was assigned a change score of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of blood pressure <130/80 mmHg at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm.
14 secondary outcomes
Change Score for "HbA1c Level"
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Diastolic Blood Pressure"
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "LDL Level"
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Systolic Blood Pressure"
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual HbA1c Assessment" (as Determined From Medical Record Review)
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Lipid Assessment" (as Determined From Medical Record Review)
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Blood Pressure Assessment" (as Determined From Medical Record Review)
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Foot Exam" (as Determined by Medical Record Review)
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Eye Exam" (as Determined From Medical Record Review)
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Renal Function Assessment" (as Determined From Medical Record Review)
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual HbA1c Assessment" (as Determined From Medicare Claims Data)
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Eye Exam" (as Determined From Medicare Claims Data)
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Annual Lipid Assessment" (as Determined From Medicare Claims Data)
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Change Score for "Semiannual HbA1c Assessment" (as Determined From Medicare Claims Data)
Time frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16280398Hollander P, Nicewander D, Couch C, Winter D, Herrin J, Haydar Z, Ballard DJ. Quality of care of Medicare patients with diabetes in a metropolitan fee-for-service primary care integrated delivery system. Am J Med Qual. 2005 Nov-Dec;20(6):344-52. doi: 10.1177/1062860605280205.
- Results publication: PubMed 16609732Herrin J, Nicewander DA, Hollander PA, Couch CE, Winter FD, Haydar ZR, Warren SS, Ballard DJ. Effectiveness of diabetes resource nurse case management and physician profiling in a fee-for-service setting: a cluster randomized trial. Proc (Bayl Univ Med Cent). 2006 Apr;19(2):95-102. doi: 10.1080/08998280.2006.11928137.
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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.
David J Ballard, MD,MSPH,PhD principal investigator
Baylor Health Care System Institute for Health Care Research and Improvement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicare Claims Feedback, Medical Record Review and Diabetes Resource Nurse in people with Diabetes Mellitus, run by Baylor Research Institute 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 5 inclusion and 1 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 3 Mar 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change Score for "HbA1c <9 Percent" (time frame: This measure compared baseline values (01/01/2000-12/31/2000) to follow-up values (01/01/2001-12/31/2001)). The study lists 3 primary outcomes in all. 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 NCT00258674, which also lists 2 linked publications.
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 3 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.