Trial Outcomes & Findings for Effect of Glycemic Variability on Autonomic Tone in Hospitalized Patients With Type 2 Diabetes (NCT NCT01409239)

Last Updated: 2013-12-04

Results Overview

difference in mean low frequency/high frequency heart rate variability (LF/HF HRV)at 6 hour. 2 patients were excluded who did not have usable LF/HF HRV data at 6 hours. These patients remained in the study as they did have other measures.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

6 hour

Results posted on

2013-12-04

Participant Flow

Patients were recruited from medical wards of the Ohio State University Wexner Medical Center from 9/1/11 to 5/31/12

Basal insulin was held prior to initiation of IV insulin and all non-insulin diabetes medications were held for the study. 42 patients signed consent. However, 9 subjects were removed due to protocol violation (new arrhythmia 2\], new altered mental status \[1\], initiation of IV insulin \[2\], early hospital discharge \[2\], or sensor failure \[2\].

Participant milestones

Participant milestones
Measure	Subcutaneous Insulin Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.	Intravenous Insulin IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
Overall Study STARTED	16	17
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Glycemic Variability on Autonomic Tone in Hospitalized Patients With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subcutaneous Insulin n=16 Participants Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.	Intravenous Insulin n=17 Participants IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.	Total n=33 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	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age Continuous	55 years STANDARD_DEVIATION 11 • n=5 Participants	54 years STANDARD_DEVIATION 11 • n=7 Participants	54 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	17 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hour

Outcome measures

Outcome measures
Measure	Subcutaneous Insulin n=15 Participants Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.	Intravenous Insulin n=16 Participants IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
Difference Between Heart Rate Variability Between Intravenous and Subcutaneous Group	1.0 none (ratio) Interval 0.55 to 2.2	2.6 none (ratio) Interval 0.94 to 5.3

Adverse Events

Subcutaneous Insulin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Intravenous Insulin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Subcutaneous Insulin n=16 participants at risk Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.	Intravenous Insulin n=17 participants at risk IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
Endocrine disorders Hypoglycemia	18.8% 3/16 • Number of events 3	5.9% 1/17 • Number of events 1

Additional Information

Kathleen Dungan

The Ohio State University

Phone: 614-685-3333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place