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OpenTrials
Completed

NCT Number: NCT02228642

Hypoglycemia in Hospitalized Patients

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh Medical Center PUH SSY

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Measures of cognitive function following a hypoglycemic event

    Time frame: Within 24 to 36 hours of a hypoglycemia event.

    Cognitive function testing will be performed using the St Louis University Mental Status Exam Survey (SLUMS)

Other outcomes

  1. Adverse events following a hypoglycemic event.

    Time frame: Up to one year following the hypoglycemia event

    Information regarding falls, myocardial infarction, arrhythmia, seizures or other adverse events that occur following the hypoglycemia event will be collected.

  2. Measure of cognitive function

    Time frame: Within 24 to 36 hours of the index hypoglycemic event

    STROOP color word interference test

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

A Prospective Investigation Into the Causes, Symptoms, and Outcomes in Patients With Diabetes Who Experience Hypoglycemia During Their Hospitalization

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 29, 2014
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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