Trial · NCT00812253

Intensive Glycemic Control for Congestive Heart Failure Exacerbation

NCT00812253, Phase 2, Completed, Kathleen Dungan; results first posted 2014-08-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Intensive Glycemic Control for Congestive Heart Failure Exacerbation. Trials, record NCT00812253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00812253

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Intensive Glycemic Control for Congestive Heart Failure Exacerbation
NCT number: NCT00812253
Status: Completed
Phases: Phase 2
Enrollment: 74 participants, actual
Lead sponsor: Kathleen Dungan
Conditions: Congestive Heart Failure, Diabetes Mellitus
Interventions: Intravenous insulin, Subcutaneous insulin
First posted: 2008-12-22
Last updated: 2018-01-02
Results first posted: 2014-08-07
Limitations and caveats: HRV and impedance data were limited due to medical devices, conditions that preclude measurement of HRV such as arrhythmias, or technical problems (N=2). The remainder of missing data were due to early hospital discharge.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hospital Length of Stay	Days	Duration of hospitalization in days
Secondary	Hospital Readmission	30 days	All-cause hospital readmission at 30 days after discharge
Secondary	Heart Rate Variability	72 hours	High frequency (HF) Heart rate variability (HRV). HRV was assessed with a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration and impedance cardiography was performed using a standard tetrapolar arrangement. Measures were performed at baseline and each morning (0800-1000 hour) during and following the intervention for 7 minutes each. Software (Mindware, Gahanna, OH) was used to derive HF HRV. The middle five minutes of the recordings were scored minute by minute and the first suitable1 minute period was used for calculation. Five minute epochs were not feasible due to an unexpectedly high frequency of ectopy. One minute intervals allow calculation of HF (parasympathetic tone) but not low frequency (combination of sympathetic and parasympathetic tone).
Secondary	Change in Quality of Life	30 day	Change in Quality of Life questionnaire measured from baseline (enrollment) to 30 days following discharge. The questionnaire is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on health related quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL),
Secondary	Brain Natriuretic Peptide (BNP)	72 hours	Brain natriuretic peptide (BNP) was measured at day 3
Secondary	Cardiac Output	72 hours	Cardiac output measured using impedance cardiography at 72 hours.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Hospital Length of Stay	Days		days	MEDIAN
SECONDARY	Hospital Readmission	30 days		participants	NUMBER
SECONDARY	Heart Rate Variability	72 hours	Subjects with medical devices, conditions that preclude measurement of HRV such as arrhythmias, or technical problems could not be analyzed.	ms^2	MEDIAN
SECONDARY	Change in Quality of Life	30 day		units on a scale	MEAN
SECONDARY	Brain Natriuretic Peptide (BNP)	72 hours		pg/ml	MEDIAN
SECONDARY	Cardiac Output	72 hours	Patients without data due to medical devices, conditions that preclude measurement of PEP such as arrhythmias, or technical problems.	liter/min	MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Hospital Length of Stay	Intravenous (IV) Insulin		7	Inter-Quartile Range 5 to 11	days
Hospital Length of Stay	Subcutaneous (SQ) Insulin		8	Inter-Quartile Range 5 to 12	days
Hospital Readmission	Intravenous (IV) Insulin	Readmitted	7		participants
Hospital Readmission	Subcutaneous (SQ) Insulin	Readmitted	15		participants
Hospital Readmission	Intravenous (IV) Insulin	Not readmitted	19		participants
Hospital Readmission	Subcutaneous (SQ) Insulin	Not readmitted	24		participants
Heart Rate Variability	Intravenous (IV) Insulin		5.1	Inter-Quartile Range 2.26 to 14.8	ms^2
Heart Rate Variability	Subcutaneous (SQ) Insulin		20.7	Inter-Quartile Range 4.92 to 312.9	ms^2
Change in Quality of Life	Intravenous (IV) Insulin		-22.4	Standard Deviation 22.0	units on a scale
Change in Quality of Life	Subcutaneous (SQ) Insulin		-22.6	Standard Deviation 26.3	units on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Intravenous Insulin (IV)	32
Overall Study	STARTED	Subcutaneous Insulin	42
Overall Study	COMPLETED	Intravenous Insulin (IV)	26
Overall Study	COMPLETED	Subcutaneous Insulin	39
Overall Study	NOT COMPLETED	Intravenous Insulin (IV)	6
Overall Study	NOT COMPLETED	Subcutaneous Insulin	3

Source ClinicalTrials.gov

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypoglycemia	Endocrine disorders	Intravenous (IV) Insulin	9	26
other	Hypoglycemia	Endocrine disorders	Subcutaneous (SQ) Insulin	3	39

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intravenous (IV) Insulin
Total, all-cause mortality	Subcutaneous (SQ) Insulin
Total, other adverse events	Intravenous (IV) Insulin	9	26
Total, other adverse events	Subcutaneous (SQ) Insulin	3	39
Total, serious adverse events	Intravenous (IV) Insulin	0	26
Total, serious adverse events	Subcutaneous (SQ) Insulin	0	39

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
K23DK080891	Intensive glycemic control for congestive heart failure exacerbation	DUNGAN, KATHLEEN MARIE	OHIO STATE UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2008 to 2012

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Intravenous (IV) Insulin vs Subcutaneous (SQ) Insulin: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00812253

GET https://conductscience.org/api/trials/v1/NCT00812253/registered

API reference For AI assistants