Clinical trial NCT02228642: Hypoglycemia in Hospitalized Patients
Official title: A Prospective Investigation Into the Causes, Symptoms, and Outcomes in Patients With Diabetes Who Experience Hypoglycemia During Their Hospitalization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Hypoglycemia
Keywords: Type 1 diabetes
Type 2 diabetes
Hypoglycemia
Cognition disorders
Inpatient
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of Hypoglycemia Associated Autonomic Failure in the inpatient setting as assessed by hypoglycemia symptom scores
timeFrame: Within 24-36 hours following a hypoglycemia event.
Secondary outcomes:
measure: Measures of cognitive function following a hypoglycemic event
timeFrame: Within 24 to 36 hours of a hypoglycemia event.
Other outcomes:
measure: Adverse events following a hypoglycemic event.
timeFrame: Up to one year following the hypoglycemia event
measure: Measure of cognitive function
timeFrame: Within 24 to 36 hours of the index hypoglycemic event
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center PUH SSY
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh School of Medicine, Department of Medicine
name: Mary T Korytkowski, MD
role: PRINCIPAL_INVESTIGATOR
References: