Trial Outcomes & Findings for Glycemic Control and Variability for Congestive Heart Failure Exacerbation (NCT NCT00812487)

NCT ID: NCT00812487

Last Updated: 2013-12-31

Results Overview

Duration of hospitalization

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 75 participants
• Primary outcome timeframe: participants were followed for the duration of hospital stay, median hospital stay 8 day
• Results posted on: 2013-12-31

Participant Flow

Hospitalized patients with type 2 diabetes and heart failure exacerbation were recruited between 2008-2013 from an academic medical center.

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.

Participant milestones

Measure	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
Overall Study STARTED	32	42
Overall Study COMPLETED	26	39
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Measure	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
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	3	2
Overall Study Transfer to ICU prior to intervention	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Glycemic Control and Variability for Congestive Heart Failure Exacerbation

Baseline characteristics by cohort

Measure	Intravenous Insulin n=26 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=39 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants
Age Continuous	61 years STANDARD_DEVIATION 9.6 • n=5 Participants	61.3 years STANDARD_DEVIATION 12.4 • n=7 Participants	61 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	26 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	39 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: participants were followed for the duration of hospital stay, median hospital stay 8 day

Duration of hospitalization

Outcome measures

Measure	Intravenous Insulin n=26 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=39 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Hospital Length of Stay	7 days Interval 5.0 to 10.5	8 days Interval 5.0 to 12.0

PRIMARY outcome

Timeframe: 30 days

All-cause hospital readmission within 30 days

Outcome measures

Measure	Intravenous Insulin n=26 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=39 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Hospital Readmission	7 participants	15 participants

SECONDARY outcome

Timeframe: 24 hours

High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis.

Outcome measures

Measure	Intravenous Insulin n=15 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=12 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day
High Frequency Heart Rate Variability	15.5 ms^2 Interval 1.4 to 58.0	13.9 ms^2 Interval 2.7 to 207.0

SECONDARY outcome

Timeframe: 24 hours

Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone.

Outcome measures

Measure	Intravenous Insulin n=14 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=14 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Pre-ejection Period (PEP)	120 ms Standard Deviation 24	117 ms Standard Deviation 20

SECONDARY outcome

Timeframe: 72 hours

High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany).

Outcome measures

Measure	Intravenous Insulin n=26 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=34 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day
High Sensitivity C-reactive Protein (Hs-CRP)	10.5 mg/dl Interval 5.2 to 26.0	15.9 mg/dl Interval 8.3 to 32.0

SECONDARY outcome

Timeframe: 72 hours

Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits

Outcome measures

Measure	Intravenous Insulin n=22 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=38 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Brain Natriuretic Peptide (BNP)	360 pg/ml Interval 167.0 to 878.0	299 pg/ml Interval 135.0 to 713.0

SECONDARY outcome

Timeframe: 30 days

Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105).

Outcome measures

Measure	Intravenous Insulin n=20 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=34 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Quality of Life	50.5 units on a scale Interval 25.0 to 74.5	45 units on a scale Interval 22.5 to 71.5

SECONDARY outcome

Timeframe: 24 hours

GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements

Outcome measures

Measure	Intravenous Insulin n=24 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=34 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Glycemic Lability Index (GLI)	0.83 (mg/dl)^2/hr*day-1 Interval 0.31 to 1.44	0.66 (mg/dl)^2/hr*day-1 Interval 0.29 to 2.01

SECONDARY outcome

Timeframe: 24 hours

CV is a measure of glycemic variability

Outcome measures

Measure	Intravenous Insulin n=24 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=33 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Coefficient of Variation (CV)	24.5 percentage (mean glucose/SD) Standard Deviation 10.2	18.6 percentage (mean glucose/SD) Standard Deviation 8.5

SECONDARY outcome

Timeframe: 24 hours

mean sensor glucose

Outcome measures

Measure	Intravenous Insulin n=24 Participants Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=33 Participants Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Mean Glucose	139 mg/dl Standard Deviation 23	169 mg/dl Standard Deviation 49

Adverse Events

Intravenous Insulin

Serious events: 16 serious events

Other events: 8 other events

Deaths: 0 deaths

Subcutaneous Insulin

Serious events: 21 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intravenous Insulin n=26 participants at risk Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=39 participants at risk Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Cardiac disorders Death	7.7% 2/26 • Number of events 2	5.1% 2/39 • Number of events 2
Respiratory, thoracic and mediastinal disorders Mechanical ventilation	7.7% 2/26 • Number of events 2	2.6% 1/39 • Number of events 1
Infections and infestations Infection	15.4% 4/26 • Number of events 4	15.4% 6/39 • Number of events 6
Cardiac disorders Arrhythmia	7.7% 2/26 • Number of events 2	10.3% 4/39 • Number of events 4
Renal and urinary disorders Acute Renal Failure	23.1% 6/26 • Number of events 6	20.5% 8/39 • Number of events 8

Other adverse events

Measure	Intravenous Insulin n=26 participants at risk Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.	Subcutaneous Insulin n=39 participants at risk Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Metabolism and nutrition disorders Hypoglycemia	30.8% 8/26 • Number of events 25	10.3% 4/39 • Number of events 11

Additional Information

Kathleen Dungan, MD, MPH

Ohio State University

Phone: 614-685-3333

Email: kathleen.dungan@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place