Diabetes MellitusNCT00718198
Effects of a Computerized Physician Order Entry (CPOE)-Based Inpatient Insulin Protocol on Glycemic Outcomes
An observational study of Diabetes Mellitus, run by Cook County Health at 1 site in United States.
Trial summary
Retrospective cross-sectional study measuring the impact of a computer=based insulin correction protocol and nursing inservicing on diabetes outcomes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 413 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2008
- Phase
- Observational
- 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
Study population: Diabetic patients admitted to Medicine Services
Who may be able to join
- Clinical diagnosis of Diabetes Mellitus
Who cannot join
- Admitted to Non-Medicine Hospital Services
Trial locations and contacts
1 site in 1 country.
United States1 site
John H. Stroger Jr. Hospital
Chicago, Illinois, 60612
About this study
Retrospective cross-sectional study measuring the impact of a computer=based insulin correction protocol and nursing inservicing on diabetes outcomes
Read the detailed description
This study is a retrospective cross-sectional study at one institution, where the investigators compared diabetic patients admitted to Medicine Services from March-April 2006 (before CPOE was implemented) to patients admitted from October-November 2007 (one year after CPOE implementation). Capillary blood glucose values, Hemoglobin AIC, diabetes medication profile and demographic data were obtained to compare between groups. The investigators hypothesized that a computer-based protocol that emphasizes basal-bolus and correctional insulin orders and excludes sliding scale, in conjunction with nursing personnel inservicing, improves outcomes.
- Conditions
- Diabetes Mellitus
- Keywords
- Inpatient, Computer Physician Order Entry, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-protocol group | Group admitted 1 (one) month before CPOE protocol changes were made | |
| Post-protocol group | Group admitted 1 (one) year after CPOE protocol changes were made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Inpatient Glucose
Baseline glucose
Measured: From day of admission to hospital until day of discharge from hospital
Secondary outcomes (8)
Percentage of normoglycemic (70 to 150 mg/dl) patient-days
Percentage of inpatient days at glucose target
Measured: From day of admission to hospital until day of discharge from hospital
Percentage of hyperglycemic patient-days
Percentage of inpatient days above glucose target
Measured: From day of admission to hospital until day of discharge from hospital
Percentage of Patient-days with glucose less than 70 mg/dl
Percentage of inpatient days below glucose target
Measured: From day of admission to hospital until day of discharge from hospital
Percentage of Patients with inpatient or recent (less than 6 months) hemoglobin AIC
Percentage of patients with recent A1c
Measured: From day of admission to hospital until day of discharge from hospital
Length of stay
Number of days inpatient
Measured: From day of admission to hospital until day of discharge from hospital
Distribution of oral hypoglycemic use
Rate of oral diabetes medication use
Measured: From day of admission to hospital until day of discharge from hospital
Distribution of type of insulin therapy used
Rate of insulin use
Measured: From day of admission to hospital until day of discharge from hospital
Percent of patient-days with severe hypoglycemia
Percentage of patient days with glucose below 55 mg/dL
Measured: From day of admission to hospital until day of discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionJun 2008
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yannis Guerra, Cook County Health
- Investigators
- Yannis S Guerra, MD, Principal investigator, Rush University Hospital/John H Stroger Jr. HospitalKrishna Das, MD, Study chair, John H. Stroger Jr. HospitalPete Antonopoulos, MD, Study chair, John H. Stroger Jr. HospitalIrene Benson, RN, Study chair, John H. Stroger Jr. HospitalShane Borkowski, MD, Study chair, John H. Stroger Jr. HospitalLeon Fogelfeld, MD, Study chair, John H. Stroger Jr. HospitalMelanie Gordon, MD, Study chair, John H. Stroger Jr. HospitalBetsy Palal, MD, Study chair, John H. Stroger Jr. Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718198
- Sponsor's protocol ID
- 06-063 JHSEndo01
- Status last verified
- Nov 2023
- First submitted
- 16 Jul 2008
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Computerized Physician Order Entry (CPOE)-Based Inpatient Insulin Protocol on Glycemic Outcomes
- ClinicalTrials.gov ID
- NCT00718198
- Acronym / sponsor ID
- 06-063 JHSEndo01
- Conditions
- Diabetes Mellitus
- Keywords
- Inpatient, Computer Physician Order Entry, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Jul 2008 (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.
Retrospective cross-sectional study measuring the impact of a computer=based insulin correction protocol and nursing inservicing on diabetes outcomes
Detailed description
This study is a retrospective cross-sectional study at one institution, where the investigators compared diabetic patients admitted to Medicine Services from March-April 2006 (before CPOE was implemented) to patients admitted from October-November 2007 (one year after CPOE implementation). Capillary blood glucose values, Hemoglobin AIC, diabetes medication profile and demographic data were obtained to compare between groups. The investigators hypothesized that a computer-based protocol that emphasizes basal-bolus and correctional insulin orders and excludes sliding scale, in conjunction with nursing personnel inservicing, improves outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-protocol group | – | –Group admitted 1 (one) month before CPOE protocol changes were made |
| Post-protocol group | – | –Group admitted 1 (one) year after CPOE protocol changes were made |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients admitted to Medicine Services
Key inclusion criteria (1 listed)
- Clinical diagnosis of Diabetes Mellitus
Key exclusion criteria (1 listed)
- Admitted to Non-Medicine Hospital Services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Inpatient Glucose
Time frame: From day of admission to hospital until day of discharge from hospital
Baseline glucose
8 secondary outcomes
Percentage of normoglycemic (70 to 150 mg/dl) patient-days
Time frame: From day of admission to hospital until day of discharge from hospital
Percentage of hyperglycemic patient-days
Time frame: From day of admission to hospital until day of discharge from hospital
Percentage of Patient-days with glucose less than 70 mg/dl
Time frame: From day of admission to hospital until day of discharge from hospital
Percentage of Patients with inpatient or recent (less than 6 months) hemoglobin AIC
Time frame: From day of admission to hospital until day of discharge from hospital
Length of stay
Time frame: From day of admission to hospital until day of discharge from hospital
Distribution of oral hypoglycemic use
Time frame: From day of admission to hospital until day of discharge from hospital
Distribution of type of insulin therapy used
Time frame: From day of admission to hospital until day of discharge from hospital
Percent of patient-days with severe hypoglycemia
Time frame: From day of admission to hospital until day of discharge from hospital
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 28 Nov 2023.
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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.
Yannis S Guerra, MD principal investigator
Rush University Hospital/John H Stroger Jr. Hospital
Krishna Das, MD study chair
John H. Stroger Jr. Hospital
Pete Antonopoulos, MD study chair
John H. Stroger Jr. Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Cook County Health 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 28 Nov 2023. 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?
Mean Inpatient Glucose (time frame: From day of admission to hospital until day of discharge from hospital). 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 28 Nov 2023.