Glycemic Control and Variability for Congestive Heart Failure Exacerbation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00812487
First received: December 19, 2008
Last updated: November 9, 2013
Last verified: November 2013
Results First Received: September 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Congestive Heart Failure
Diabetes Mellitus
Interventions: Drug: Intravenous insulin
Drug: Subcutaneous insulin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Hospitalized patients with type 2 diabetes and heart failure exacerbation were recruited between 2008-2013 from an academic medical center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized to intravenous or subcutaneous insulin. There were no pre-assignment changes in therapy before randomization. One patient was excluded after consent but prior to randomization due to receipt of corticosteroids which is an exclusion criterion.

Reporting Groups
  Description
Intravenous Insulin Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
Subcutaneous Insulin Patients received basal and bolus insulin, approximately 5 injections of insulin/day

Participant Flow:   Overall Study
    Intravenous Insulin     Subcutaneous Insulin  
STARTED     32     42  
COMPLETED     26     39  
NOT COMPLETED     6     3  
Lost to Follow-up                 2                 0  
Withdrawal by Subject                 3                 2  
Transfer to ICU prior to intervention                 1                 0  
Protocol Violation                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients were excluded from the analyses as described in "Participant Flow"

Reporting Groups
  Description
Intravenous Insulin Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
Subcutaneous Insulin Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Total Total of all reporting groups

Baseline Measures
    Intravenous Insulin     Subcutaneous Insulin     Total  
Number of Participants  
[units: participants]
  26     39     65  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     23     41  
>=65 years     8     16     24  
Age  
[units: years]
Mean ± Standard Deviation
  61  ± 9.6     61.3  ± 12.4     61  ± 9.6  
Gender  
[units: participants]
     
Female     8     13     21  
Male     18     26     44  
Region of Enrollment  
[units: participants]
     
United States     26     39     65  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hospital Length of Stay   [ Time Frame: participants were followed for the duration of hospital stay, median hospital stay 8 day ]

2.  Primary:   Hospital Readmission   [ Time Frame: 30 days ]

3.  Secondary:   High Frequency Heart Rate Variability   [ Time Frame: 24 hours ]

4.  Secondary:   Pre-ejection Period (PEP)   [ Time Frame: 24 hours ]

5.  Secondary:   High Sensitivity C-reactive Protein (Hs-CRP)   [ Time Frame: 72 hours ]

6.  Secondary:   Brain Natriuretic Peptide (BNP)   [ Time Frame: 72 hours ]

7.  Secondary:   Quality of Life   [ Time Frame: 30 days ]

8.  Secondary:   Glycemic Lability Index (GLI)   [ Time Frame: 24 hours ]

9.  Secondary:   Coefficient of Variation (CV)   [ Time Frame: 24 hours ]

10.  Secondary:   Mean Glucose   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Kathleen Dungan, MD, MPH
Organization: Ohio State University
phone: 614-685-3333
e-mail: kathleen.dungan@osumc.edu


No publications provided


Responsible Party: Kathleen Dungan, The Ohio State University
ClinicalTrials.gov Identifier: NCT00812487     History of Changes
Other Study ID Numbers: 2008H0087, 1R21DK081877-01
Study First Received: December 19, 2008
Results First Received: September 6, 2013
Last Updated: November 9, 2013
Health Authority: United States: Food and Drug Administration