Trial Outcomes & Findings for Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol. (NCT NCT00591227)

Results Overview

hospital length of stay in days

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

176 participants

Primary outcome timeframe

from hospital admission to hospital discharge

Results posted on

2022-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	Aspart Detemir these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER (emergency room) evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.	Usual Care these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
Overall Study STARTED	89	87
Overall Study COMPLETED	89	87
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspart Detemir n=89 Participants these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.	Usual Care n=87 Participants these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.	Total n=176 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=39 Participants	68 Participants n=41 Participants	136 Participants n=35 Participants
Age, Categorical >=65 years	21 Participants n=39 Participants	19 Participants n=41 Participants	40 Participants n=35 Participants
Age, Continuous	55 years STANDARD_DEVIATION 15 • n=39 Participants	55 years STANDARD_DEVIATION 15 • n=41 Participants	55 years STANDARD_DEVIATION 15 • n=35 Participants
Sex: Female, Male Female	46 Participants n=39 Participants	53 Participants n=41 Participants	99 Participants n=35 Participants
Sex: Female, Male Male	43 Participants n=39 Participants	34 Participants n=41 Participants	77 Participants n=35 Participants
Region of Enrollment United States	89 participants n=39 Participants	87 participants n=41 Participants	176 participants n=35 Participants

PRIMARY outcome

Timeframe: from hospital admission to hospital discharge

hospital length of stay in days

Outcome measures

Outcome measures
Measure	Aspart Detemir n=89 Participants these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.	Usual Care n=87 Participants these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
Hospital Length of Stay	2.7 days Interval 0.7 to 4.7	3.1 days Interval 1.2 to 5.0

SECONDARY outcome

Timeframe: from admission to discharge

Population: PI no longer at institution, study is over 10 years old, data unavailable.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from hospital admission to discharge

Population: PI no longer at institution, study is over 10 years old, data unavailable.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from emergency room admission to discharge

Population: PI no longer at institution, study is over 10 years old, data unavailable.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from emergency room admission to discharge

Population: PI no longer at institution, study is over 10 years old, data unavailable.

Outcome measures

Outcome data not reported

Adverse Events

Aspart Detemir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

David Baldwin MD

Rush University Medical Center

Phone: 312-942-6163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place