Glycemic Control and Variability for Congestive Heart Failure Exacerbation
2 other identifiers
interventional
75
1 country
1
Brief Summary
High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2009
Longer than P75 for phase_1
1 active site
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
First Submitted
Initial submission to the registry
December 19, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
December 31, 2013
CompletedDecember 31, 2013
November 1, 2013
3.6 years
December 19, 2008
September 6, 2013
November 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hospital Length of Stay
Duration of hospitalization
participants were followed for the duration of hospital stay, median hospital stay 8 day
Hospital Readmission
All-cause hospital readmission within 30 days
30 days
Secondary Outcomes (8)
High Frequency Heart Rate Variability
24 hours
Pre-ejection Period (PEP)
24 hours
High Sensitivity C-reactive Protein (Hs-CRP)
72 hours
Brain Natriuretic Peptide (BNP)
72 hours
Quality of Life
30 days
- +3 more secondary outcomes
Study Arms (2)
Intravenous insulin
EXPERIMENTALSubcutaneous Insulin
ACTIVE COMPARATOR4 injections of insulin/day
Interventions
Patients will receive continuous insulin infusion through the vein.
Eligibility Criteria
You may qualify if:
- Age 18 and above
- Admitted (less than 48 hours) to the with worsening heart failure
- Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c \>6.5%.
You may not qualify if:
- Type 1 diabetes
- Receiving comfort care measures only
- Hospital stay expected to be less than 2 days
- Pregnancy
- Prisoners
- Participation in the study on prior hospitalizations
- Acute myocardial infarction within 3 months
- End stage renal or liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was limited by study drop-out. Sensor glucose values were reduced due to sensor failures, and cardiac assessments were limited due to a high number of patients with ectopy, arrhythmia or paced rhythms at baseline precluding analysis.
Results Point of Contact
- Title
- Kathleen Dungan, MD, MPH
- Organization
- Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen M Dungan, MD
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 19, 2008
First Posted
December 22, 2008
Study Start
January 1, 2009
Primary Completion
August 1, 2012
Study Completion
September 1, 2013
Last Updated
December 31, 2013
Results First Posted
December 31, 2013
Record last verified: 2013-11