Diabetes MellitusNCT00271700
Improving Glycemic Control on GMS: A Quality Improvement Study
A study testing Order Set, Education, Feedback in people with Diabetes Mellitus, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study will examine whether new processes and technologies for monitoring diabetic patients' insulin levels improves patient care at Brigham and Women's Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Order Set, Education, Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Mar 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will include all type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women's Hospital (BWH) who do not have an indication for IV insulin.
Who cannot join
- Type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women's Hospital (BWH) who have an indication for IV insulin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
This study will examine whether new processes and technologies for monitoring diabetic patients' insulin levels improves patient care at Brigham and Women's Hospital.
Read the detailed description
This study will examine whether new processed and technologies for monitoring diabetic patients' insulin levels improves patient care. Patients at Brigham and Women's Hospital (BWH), staying on the General Medicine Service, who have Type 2 diabetes and who are not on IV insulin can participate in this study. Physicians and nurses will be taught new rules to care for diabetic patients, while in the hospital. Also, the BWH computer system will be updated to include these new rules for administering insulin. Patients who participate in the study will be randomly placed into one of two groups: one group that will be cared for by physicians and nurses who have learned these new rules for administering insulin; or the second group, who will receive diabetes care at BWH before the new rules were adopted. The study will last approximately 1 year.
- Conditions
- Diabetes Mellitus
- Being tested
- Order Set, Education, Feedback
- Keywords
- Diabetes Mellitus, Outcome Assessment (Healthcare), Inpatients, Hospital Information Systems, Education
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Order Set, Education, FeedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | admission to medical team floor to usual care |
| Intervention | Experimental | consists of usual care as well as an admission order set built into BWH's proprietary computer provider order entry (CPOE) system Receives: Behavioral: Order Set, Education, Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Point-of-care testing glucose values (percent of routine glucose readings between 60 and 180 mg/dL)
- Lab glucose values (percent of routine glucose readings between 60 and 180 mg/dL)
Secondary outcomes (1)
- Quality of insulin orders using explicit criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startMay 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Brigham and Women'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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
- Investigators
- Jeffrey L Schnipper, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271700
- Sponsor's protocol ID
- 2005-P-001880/1
- Other IDs
- 2005-P-001880/1
- Status last verified
- Aug 2019
- First submitted
- 30 Dec 2005
- Last updated
- 13 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Glycemic Control on GMS: A Quality Improvement Study
- ClinicalTrials.gov ID
- NCT00271700
- Acronym / sponsor ID
- 2005-P-001880/1
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Outcome Assessment (Healthcare), Inpatients, Hospital Information Systems, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- May 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Jan 2006 (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.
This study will examine whether new processes and technologies for monitoring diabetic patients' insulin levels improves patient care at Brigham and Women's Hospital.
Detailed description
This study will examine whether new processed and technologies for monitoring diabetic patients' insulin levels improves patient care. Patients at Brigham and Women's Hospital (BWH), staying on the General Medicine Service, who have Type 2 diabetes and who are not on IV insulin can participate in this study. Physicians and nurses will be taught new rules to care for diabetic patients, while in the hospital. Also, the BWH computer system will be updated to include these new rules for administering insulin. Patients who participate in the study will be randomly placed into one of two groups: one group that will be cared for by physicians and nurses who have learned these new rules for administering insulin; or the second group, who will receive diabetes care at BWH before the new rules were adopted. The study will last approximately 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –admission to medical team floor to usual care |
| Intervention | Experimental | Behavioral: Order Set, Education, Feedbackconsists of usual care as well as an admission order set built into BWH's proprietary computer provider order entry (CPOE) system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects will include all type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women's Hospital (BWH) who do not have an indication for IV insulin.
Key exclusion criteria (1 listed)
- Type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women's Hospital (BWH) who have an indication for IV insulin.
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 |
|---|---|---|
| Order Set, Education, Feedback | Behavioural | Intervention |
Primary outcome
- Point-of-care testing glucose values (percent of routine glucose readings between 60 and 180 mg/dL)
- Lab glucose values (percent of routine glucose readings between 60 and 180 mg/dL)
1 secondary outcome
- Quality of insulin orders using explicit criteria
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 13 Aug 2019.
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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.
Jeffrey L Schnipper, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Order Set, Education, Feedback in people with Diabetes Mellitus, run by Brigham and Women'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 1 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 13 Aug 2019. 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?
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?
- Point-of-care testing glucose values (percent of routine glucose readings between 60 and 180 mg/dL). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2019.