Study of Stress Hyperglycemia as an Indicator of Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2014 by Yale University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Yale University Identifier:
First received: February 19, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2 diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood glucose readings reviewed during their intensive care unit stay. All subjects are consented and have a HbA1C level drawn to determine if they have diabetes mellitus or not. They are then followed up in 1 year and the HbA1C repeated to determine if they have developed diabetes mellitus over the course.

Stress Hyperglycemia
Diabetes Mellitus Type 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress Hyperglycemia as an Indicator for Future Diabetes Mellitus: A Prospective Cohort Study

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Percentage of Subjects with an HbA1c greater than or equal to 6.5% [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Whole Blood

Estimated Enrollment: 400
Study Start Date: February 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Stress Hyperglycemic Group
Repeat HbA1C in 1 year
Euglycemic Group
Repeat HbA1C in 1 year


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intensive Care Unit admissions who are not known to be diabetic

Inclusion Criteria:

  • All patients admitted to the intensive care unit at the Yale New Haven Hospital St. Raphael Campus and Norwalk Hospital

Exclusion Criteria:

  • Patients with prior history of diabetes mellitus
  • Elevated admission HbA1c (≥6.5%)
  • Age >80 years
  • Metastatic disease with expected life expectancy of less than 12 months
  • Pregnancy or a woman who plans to become pregnant
  Contacts and Locations
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Please refer to this study by its identifier: NCT02068989

Contact: Anu Sharma, MBBS 2036801560
Contact: Stephen Atlas, MD 2037893103

United States, Connecticut
Yale New Haven Hospital St. Raphael Campus Recruiting
New Haven, Connecticut, United States, 06511
Contact: Anu Sharma, MBBS    203-680-1560   
Sub-Investigator: Anu Sharma, MBBS         
Norwalk Hospital Recruiting
Norwalk, Connecticut, United States, 06850
Contact: Jonathon Fine, MD   
Principal Investigator: Jonathon Fine, MD         
Sponsors and Collaborators
Yale University
Principal Investigator: Stephen Atlas, MD Yale New Haven Hospital
Principal Investigator: Jonathon Fine, MD Norwalk Hospital
  More Information

Responsible Party: Yale University Identifier: NCT02068989     History of Changes
Other Study ID Numbers: 1301011408 
Study First Received: February 19, 2014
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on August 29, 2016