DiabetesNCT02228642
Hypoglycemia in Hospitalized Patients
An observational study of Diabetes and Hypoglycemia, run by University of Pittsburgh at 1 site in United States.
Trial summary
Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at risk for losing the ability to develop symptoms that warn them that they are having a low blood sugar. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes, Hypoglycemia
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Mar 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-critically ill hospitalized patients with a diagnosis of diabetes at time of admission using established ADA criteria or prior physician diagnosis who experience a documented episode of hypoglycemia, defined as a blood glucose < 70 mg/dl. .
Who may be able to join
- Diagnosis of diabetes
- Non-critically ill hospitalized surgical and medical patients
- Anticipated length of stay (LOS) >3 days
- Anticipated life expectancy > 1 year
- Mentally competent individuals
Who cannot join
- Patients who are admitted for hypoglycemia or Diabetic Ketoacidosis
- Anticipated LOS <3 days
- Mentally incompetent individuals defined as any patient with evidence of dementia or delirium recorded in their medical history or progress note
- Patients receiving Total Parenteral Nutrition
- Treatment with high dose narcotic medications
- Patients who would not be able to follow up at 3 to 6 and 9-12 months by telephone call
- Patients with expected life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center PUH SSY
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Prospective Investigation Into the Causes, Symptoms, and Outcomes in Patients With Diabetes Who Experience Hypoglycemia During Their Hospitalization
Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at risk for losing the ability to develop symptoms that warn them that they are having a low blood sugar. There is almost no available information investigating how the inability to feel symptoms of a low blood sugar contributes to the risk of this happening when people with diabetes are hospitalized. The purpose of this study is to develop a symptom score model that will help to identify patients at risk for low blood sugars in the hospital and to examine what happens to patients who do experience a low blood sugar in the hospital.
Read the detailed description
Patients who develop recurrent hypoglycemia are predisposed to developing hypoglycemia-associated autonomic failure (HAAF, impaired awareness). There is almost no information investigating the contribution of HAAF as a risk factor for hypoglycemia in hospitalized patients. Our central aim is to develop a validated inpatient hypoglycemic symptom score model to examine HAAF and its correlation with cognitive dysfunction, re-hospitalization rates, inpatient morbidity and mortality.
This will be a prospective non-blinded study performed in a tertiary care center that will include non-critically insulin treated patients with Type 1 and 2 Diabetes. We will identify patients who have experienced moderate hypoglycemia (40-70 mg/dl) or severe hypoglycemia (< 40 mg/dl) within the prior 24 hours by daily generated computerized reports. Participants will be asked to complete a Hypoglycemia Symptom Scores Questionnaire and cognitive testing within 24-36 hours post event. Participants will be contacted at 6 and 12 months following the index hospitalization to obtain information regarding recurrent episodes of hypoglycemia, need for re-hospitalization, and occurrence of any new diabetes related complications.
- Conditions
- Diabetes, Hypoglycemia
- Keywords
- Type 1 diabetes, Type 2 diabetes, Hypoglycemia, Cognition disorders, Inpatient
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Cognition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Hypoglycemia Associated Autonomic Failure in the inpatient setting as assessed by hypoglycemia symptom scores
Hypoglycemia Symptom Score Questionnaires will be administered to participants in time frame described. These questionnaires include a list of potential autonomic and neuroglycopenic symptoms that can occur in response to hypoglycemia.
Measured: Within 24-36 hours following a hypoglycemia event.
Secondary outcomes (1)
Measures of cognitive function following a hypoglycemic event
Cognitive function testing will be performed using the St Louis University Mental Status Exam Survey (SLUMS)
Measured: Within 24 to 36 hours of a hypoglycemia event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Korytkowski, University of Pittsburgh
- Investigators
- Mary T Korytkowski, MD, Principal investigator, University of Pittsburgh School of Medicine, Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228642
- Sponsor's protocol ID
- PRO14030372
- Other IDs
- PRO14030372
- Status last verified
- Sep 2018
- First submitted
- 27 Aug 2014
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Investigation Into the Causes, Symptoms, and Outcomes in Patients With Diabetes Who Experience Hypoglycemia During Their Hospitalization
- ClinicalTrials.gov ID
- NCT02228642
- Acronym / sponsor ID
- PRO14030372
- Conditions
- Diabetes, Hypoglycemia
- Keywords
- Type 1 diabetes, Type 2 diabetes, Hypoglycemia, Cognition disorders, Inpatient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Aug 2014 (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.
Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at risk for losing the ability to develop symptoms that warn them that they are having a low blood sugar. There is almost no available information investigating how the inability to feel symptoms of a low blood sugar contributes to the risk of this happening when people with diabetes are hospitalized. The purpose of this study is to develop a symptom score model that will help to identify patients at risk for low blood sugars in the hospital and to examine what happens to patients who do experience a low blood sugar in the hospital.
Detailed description
Patients who develop recurrent hypoglycemia are predisposed to developing hypoglycemia-associated autonomic failure (HAAF, impaired awareness). There is almost no information investigating the contribution of HAAF as a risk factor for hypoglycemia in hospitalized patients. Our central aim is to develop a validated inpatient hypoglycemic symptom score model to examine HAAF and its correlation with cognitive dysfunction, re-hospitalization rates, inpatient morbidity and mortality.
This will be a prospective non-blinded study performed in a tertiary care center that will include non-critically insulin treated patients with Type 1 and 2 Diabetes. We will identify patients who have experienced moderate hypoglycemia (40-70 mg/dl) or severe hypoglycemia (< 40 mg/dl) within the prior 24 hours by daily generated computerized reports. Participants will be asked to complete a Hypoglycemia Symptom Scores Questionnaire and cognitive testing within 24-36 hours post event. Participants will be contacted at 6 and 12 months following the index hospitalization to obtain information regarding recurrent episodes of hypoglycemia, need for re-hospitalization, and occurrence of any new diabetes related complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-critically ill hospitalized patients with a diagnosis of diabetes at time of admission using established ADA criteria or prior physician diagnosis who experience a documented episode of hypoglycemia, defined as a blood glucose < 70 mg/dl. .
Key inclusion criteria (5 listed)
- Diagnosis of diabetes
- Non-critically ill hospitalized surgical and medical patients
- Anticipated length of stay (LOS) >3 days
- Anticipated life expectancy > 1 year
- Mentally competent individuals
Key exclusion criteria (7 listed)
- Patients who are admitted for hypoglycemia or Diabetic Ketoacidosis
- Anticipated LOS <3 days
- Mentally incompetent individuals defined as any patient with evidence of dementia or delirium recorded in their medical history or progress note
- Patients receiving Total Parenteral Nutrition
- Treatment with high dose narcotic medications
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
Prevalence of Hypoglycemia Associated Autonomic Failure in the inpatient setting as assessed by hypoglycemia symptom scores
Time frame: Within 24-36 hours following a hypoglycemia event.
Hypoglycemia Symptom Score Questionnaires will be administered to participants in time frame described. These questionnaires include a list of potential autonomic and neuroglycopenic symptoms that can occur in response to hypoglycemia.
1 secondary outcome
Measures of cognitive function following a hypoglycemic event
Time frame: Within 24 to 36 hours of a hypoglycemia event.
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 7 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mary T Korytkowski, MD principal investigator
University of Pittsburgh School of Medicine, Department of Medicine
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 University of Pittsburgh 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 7 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 7 Sep 2018. 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?
Prevalence of Hypoglycemia Associated Autonomic Failure in the inpatient setting as assessed by hypoglycemia symptom scores (time frame: Within 24-36 hours following a hypoglycemia event.). 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 7 Sep 2018.