HyperglycemiaNCT00813280
Barriers to the Implementation of Complete Insulin Order Sets
An observational study of Hyperglycemia, run by HealthPartners Institute at 1 site in United States.
Trial summary
The major purpose of this Quality Improvement project is to begin to address the issues surrounding glycemic control in the hospital setting by collecting accurate, reliable and verifiable data on the occurrence of hyperglycemia (BG >300 mg/dL), and whether or not CIO is used (immediately before and 72 hours after the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 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: hospitalized patients with blood glucose >300 mg/dL
Who may be able to join
- Park Nicollet Methodist Hospital patient
- recorded BG > 300 mg/dL during the study data collection period
- admitted to general floor hospital units
Who cannot join
- birth center
- intensive care units
- eating disorder unit
- pediatric patients < 18 years of age
- patients receiving insulin infusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Methodist Hospital
Minneapolis, Minnesota, 55416
About this study
Official title: Barriers to the Implementation of Complete Insulin Order Sets in the Management of Individuals With Hyperglycemia or Diabetes at Park Nicollet Methodist Hospital
The major purpose of this Quality Improvement project is to begin to address the issues surrounding glycemic control in the hospital setting by collecting accurate, reliable and verifiable data on the occurrence of hyperglycemia (BG >300 mg/dL), and whether or not CIO is used (immediately before and 72 hours after the BG >300 mg/dl).
- Conditions
- Hyperglycemia
- Medical subject headings
- Hyperglycemia
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 |
|---|---|---|
| hyperglycemia | hospitalized patients with BG >300 ml/dL |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose levels
Measured: 72 hours
Secondary outcomes (1)
type of insulin treatment
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Park Nicollet Foundation
- Investigators
- Lisa Fish, MD, Principal investigator, Park Nicollet Health Services EndocrinologyRobert M Cuddihy, MD, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813280
- Sponsor's protocol ID
- 03735-08-A
- Status last verified
- Dec 2008
- First submitted
- 19 Dec 2008
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
PubMed 11794168Malmberg K, Ryden L, Efendic S, Herlitz J, Nicol P, Waldenstrom A, Wedel H, Welin L. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol. 1995 Jul;26(1):57-65. doi: 10.1016/0735-1097(95)00126-k.
PubMed 7797776
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to the Implementation of Complete Insulin Order Sets in the Management of Individuals With Hyperglycemia or Diabetes at Park Nicollet Methodist Hospital
- ClinicalTrials.gov ID
- NCT00813280
- Acronym / sponsor ID
- 03735-08-A
- Conditions
- Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Park Nicollet Foundation
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Dec 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.
The major purpose of this Quality Improvement project is to begin to address the issues surrounding glycemic control in the hospital setting by collecting accurate, reliable and verifiable data on the occurrence of hyperglycemia (BG >300 mg/dL), and whether or not CIO is used (immediately before and 72 hours after the BG >300 mg/dl).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyperglycemia | – | –hospitalized patients with BG >300 ml/dL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized patients with blood glucose >300 mg/dL
Key inclusion criteria (3 listed)
- Park Nicollet Methodist Hospital patient
- recorded BG > 300 mg/dL during the study data collection period
- admitted to general floor hospital units
Key exclusion criteria (5 listed)
- birth center
- intensive care units
- eating disorder unit
- pediatric patients < 18 years of age
- patients receiving insulin infusions
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
glucose levels
Time frame: 72 hours
1 secondary outcome
type of insulin treatment
Time frame: 72 hours
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 26 Nov 2015.
- Background: PubMed 11794168van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
- Background: PubMed 7797776Malmberg K, Ryden L, Efendic S, Herlitz J, Nicol P, Waldenstrom A, Wedel H, Welin L. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol. 1995 Jul;26(1):57-65. doi: 10.1016/0735-1097(95)00126-k.
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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.
Lisa Fish, MD principal investigator
Park Nicollet Health Services Endocrinology
Robert M Cuddihy, MD principal investigator
International Diabetes Center at Park Nicollet
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 Hyperglycemia, run by HealthPartners 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 3 inclusion and 5 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 26 Nov 2015. 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?
glucose levels (time frame: 72 hours). 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 NCT00813280, 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 26 Nov 2015.