Phase 2
N=74
Glycemic Control and Variability for Congestive Heart Failure Exacerbation
Congestive Heart Failure · Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00812487 ↗Enrolled (actual)
74
Serious AEs
56.9%
Results posted
Dec 2013
Primary outcome: Primary: Hospital Length of Stay — 7; 8 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intravenous insulin (Drug); Subcutaneous insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kathleen Dungan
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Length of Stay |
7; 8 | — |
| PRIMARY Hospital Readmission |
7; 15 | — |
| SECONDARY High Frequency Heart Rate Variability |
15.5; 13.9 | — |
| SECONDARY Pre-ejection Period (PEP) |
120; 117 | — |
| SECONDARY High Sensitivity C-reactive Protein (Hs-CRP) |
10.5; 15.9 | — |
| SECONDARY Brain Natriuretic Peptide (BNP) |
360; 299 | — |
| SECONDARY Quality of Life |
50.5; 45 | — |
| SECONDARY Glycemic Lability Index (GLI) |
0.83; 0.66 | — |
| SECONDARY Coefficient of Variation (CV) |
24.5; 18.6 | — |
| SECONDARY Mean Glucose |
139; 169 | — |
Summary
High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.
Eligibility Criteria
Inclusion Criteria
- 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%.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00812487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.