Trial Outcomes & Findings for Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation (NCT NCT00779701)

NCT ID: NCT00779701

Last Updated: 2017-03-16

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.

Results posted on

2017-03-16

Participant Flow

Participant milestones

Participant milestones
Measure
Insulin Infusion
All subjects placed on insulin infusion. Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL
Overall Study
STARTED
27
Overall Study
COMPLETED
27
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Insulin Infusion
n=27 Participants
All subjects placed on insulin infusion. Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=99 Participants
Age, Categorical
>=65 years
15 Participants
n=99 Participants
Sex: Female, Male
Female
11 Participants
n=99 Participants
Sex: Female, Male
Male
16 Participants
n=99 Participants
Region of Enrollment
United States
27 participants
n=99 Participants

PRIMARY outcome

Timeframe: Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.

Outcome measures

Outcome measures
Measure
Insulin Infusion
n=27 Participants
All subjects placed on insulin infusion. Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL
Time to Achieve Glycemic Control
225 Minutes
Standard Deviation 48.8

Adverse Events

Insulin Infusion

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nina Gentile

Temple University Hospital

Phone: 215-707-2000

Results disclosure agreements

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