NCT02068989

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

February 19, 2014

Last Update Submit

September 2, 2016

Conditions

Stress HyperglycemiaDiabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects with an HbA1c greater than or equal to 6.5%

    1 year

Study Arms (2)

Stress Hyperglycemic Group

Repeat HbA1C in 1 year

Euglycemic Group

Repeat HbA1C in 1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive Care Unit admissions who are not known to be diabetic

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale New Haven Hospital St. Raphael Campus

New Haven, Connecticut, 06511, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06850, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Stephen Atlas, MD

    Yale New Haven Hospital

    PRINCIPAL INVESTIGATOR

  • Jonathon Fine, MD

    Norwalk Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

February 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 5, 2016

Record last verified: 2016-09

Locations

US(2)