DiabetesNCT00826007
Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes
An observational study of Diabetes and Hypoglycemia, run by Corewell Health East at 1 site in United States.
Trial summary
The purpose of the study is to review incidences of mild, moderate, and severe hypoglycemia in preoperative care units, operating rooms, and postanesthesia care units and analyze associated conditions and treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Hypoglycemia
- How many people
- 587 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgical patients
Who may be able to join
- Patients who underwent surgery at William Beaumont Hospital in Royal Oak, Michigan between January 1, 2003, and January 1, 2009.
- Point of care testing identified a blood sugar value less than 69 mg/dl at any time in the perioperative area; or a value between 70-89 mg/dl in the preoperative area; or a glucose value greater than 250 mg/dl in the preoperative area.
Who cannot join
- Obstetric patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
The purpose of the study is to review incidences of mild, moderate, and severe hypoglycemia in preoperative care units, operating rooms, and postanesthesia care units and analyze associated conditions and treatment.
Read the detailed description
With evidence linking surgical morbidity to hyperglycemia (high blood sugar), attention to glucose control is warranted during surgery as well as in the postoperative period. Consequently, measures to prevent and treat hyperglycemia - coupled with fasting status - places patients at considerable risk for perioperative hypoglycemia (low blood sugar). Outpatient patient studies support that profound hypoglycemia can be deleterious and even fatal to patients.
This descriptive study will utilize retrospective chart review to examine factors associated with hypoglycemia. Charts from 700 subjects who experienced blood glucose values less than 70 mg/dl primarily in the preoperative and postanesthesia care units at William Beaumont Hospital-Royal Oak will be reviewed. Another 1600 charts will be screened for subsequent intraoperative hypoglycemia: 800 that had low normal preoperative glucose values and 800 that had high preoperative values (with likelihood of insulin therapy).
Numerous factors believed to be associated with perioperative hypoglycemia will be analyzed including type and duration of diabetes, usual diabetes treatment regimen and alterations on day of surgery, self-reported usual fasting blood sugar range, duration of fasting, type of surgery and anesthesia, co-morbidities, and medications associated with hypoglycemia.
Determining factors associated with perioperative hypoglycemia will improve prediction of which patients are at highest risk for hypoglycemia, enabling healthcare providers to institute more conservative insulin therapy when indicated, initiate early maintenance intravenous dextrose, and/ or perform more frequent glucose testing. Identifying associated factors will improve hypoglycemic predictions and interventions which should lead to safer, more effective care for patients with diabetes.
- Conditions
- Diabetes, Hypoglycemia
- Keywords
- perioperative hypoglycemia diabetes surgery, surgery
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia Incidence
Blood glucose values <70 mg/dl
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionJul 2011
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.
- Other trials for DiabetesStudies 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
- Time perspective
- Retrospective
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Oakland University
- Responsible party
- Principal investigator, Tamra Dukatz, Corewell Health East
- Investigators
- Solomon I Rosenblatt, MD, Principal investigator, Michigan Endocrine ConsultantsTamra Dukatz, CRNA, Principal investigator, Beaumont Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826007
- Sponsor's protocol ID
- 2008-281
- Status last verified
- Mar 2013
- First submitted
- 19 Jan 2009
- Last updated
- 27 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT00826007
- Acronym / sponsor ID
- 2008-281
- Conditions
- Diabetes, Hypoglycemia
- Keywords
- perioperative hypoglycemia diabetes surgery, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Oakland University
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Posted 27 May 2013
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 the study is to review incidences of mild, moderate, and severe hypoglycemia in preoperative care units, operating rooms, and postanesthesia care units and analyze associated conditions and treatment.
Detailed description
With evidence linking surgical morbidity to hyperglycemia (high blood sugar), attention to glucose control is warranted during surgery as well as in the postoperative period. Consequently, measures to prevent and treat hyperglycemia - coupled with fasting status - places patients at considerable risk for perioperative hypoglycemia (low blood sugar). Outpatient patient studies support that profound hypoglycemia can be deleterious and even fatal to patients.
This descriptive study will utilize retrospective chart review to examine factors associated with hypoglycemia. Charts from 700 subjects who experienced blood glucose values less than 70 mg/dl primarily in the preoperative and postanesthesia care units at William Beaumont Hospital-Royal Oak will be reviewed. Another 1600 charts will be screened for subsequent intraoperative hypoglycemia: 800 that had low normal preoperative glucose values and 800 that had high preoperative values (with likelihood of insulin therapy).
Numerous factors believed to be associated with perioperative hypoglycemia will be analyzed including type and duration of diabetes, usual diabetes treatment regimen and alterations on day of surgery, self-reported usual fasting blood sugar range, duration of fasting, type of surgery and anesthesia, co-morbidities, and medications associated with hypoglycemia.
Determining factors associated with perioperative hypoglycemia will improve prediction of which patients are at highest risk for hypoglycemia, enabling healthcare providers to institute more conservative insulin therapy when indicated, initiate early maintenance intravenous dextrose, and/ or perform more frequent glucose testing. Identifying associated factors will improve hypoglycemic predictions and interventions which should lead to safer, more effective care for patients with diabetes.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgical patients
Key inclusion criteria (2 listed)
- Patients who underwent surgery at William Beaumont Hospital in Royal Oak, Michigan between January 1, 2003, and January 1, 2009.
- Point of care testing identified a blood sugar value less than 69 mg/dl at any time in the perioperative area; or a value between 70-89 mg/dl in the preoperative area; or a glucose value greater than 250 mg/dl in the preoperative area.
Key exclusion criteria (1 listed)
- Obstetric patients.
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
Hypoglycemia Incidence
Time frame: perioperative period
Blood glucose values <70 mg/dl
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Solomon I Rosenblatt, MD principal investigator
Michigan Endocrine Consultants
Tamra Dukatz, CRNA principal investigator
Beaumont Health
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 and Hypoglycemia, run by Corewell Health East 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 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 27 May 2013. 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 27 May 2013). 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?
Hypoglycemia Incidence (time frame: perioperative period). 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 27 May 2013.