Trial Outcomes & Findings for Stop Emergency Room Visits for Hyperglycemia Project - District of Columbia (DC) (NCT NCT01033773)

Last Updated: 2020-10-05

Results Overview

Total Number of hypoglycemic events defined as Blood Glucose \< 60 within 24 hours of index emergency room visit (baseline)

Recruitment status

COMPLETED

Study phase

Target enrollment

86 participants

Primary outcome timeframe

24 hours

Results posted on

2020-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Diabetes Education and Medication Management All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters.
Overall Study STARTED	86
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stop Emergency Room Visits for Hyperglycemia Project - District of Columbia (DC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=86 Participants All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters.
Age, Customized Age 18-44	28 Participants n=99 Participants
Age, Customized Age 45-64	51 Participants n=99 Participants
Age, Customized Age 65 and older	7 Participants n=99 Participants
Sex: Female, Male Female	42 Participants n=99 Participants
Sex: Female, Male Male	44 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	76 Participants n=99 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=99 Participants

PRIMARY outcome

Timeframe: 24 hours

Total Number of hypoglycemic events defined as Blood Glucose \< 60 within 24 hours of index emergency room visit (baseline)

Outcome measures

Outcome measures
Measure	Intervention n=86 Participants All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters.
Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit	0 events

SECONDARY outcome

Timeframe: 30 days

Population: This data was only available for 51 patients therefore only 51 patients' results were analyzed.

Mean difference in of blood glucose in mg/dl between baseline mean BG and end of intervention mean BG 30 days from baseline

Outcome measures

Outcome measures
Measure	Intervention n=51 Participants All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters.
Change in Mean Blood Glucose From Time of Presentation to Emergency Room to End of Intervention 30 Days From Baseline Mean BG at baseline	356 mg/dl Standard Deviation 110
Change in Mean Blood Glucose From Time of Presentation to Emergency Room to End of Intervention 30 Days From Baseline Mean BG at end of intervention	183 mg/dl Standard Deviation 103

SECONDARY outcome

Timeframe: 30 days

Population: Only 46 patients had a baseline and end of intervention A1C available therefore only 46 participants are included in the data

difference between mean hemoglobin A1C at baseline and mean Hemoglobin A1C to end of intervention

Outcome measures

Outcome measures
Measure	Intervention n=46 Participants All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters.
Change in Hemoglobin A1C From Baseline to End of Intervention at 30 Days Mean baseline A1C	12.0 percentage of hemoglobin A1C Standard Deviation 1.5
Change in Hemoglobin A1C From Baseline to End of Intervention at 30 Days Mean end of intervention A1C	11.6 percentage of hemoglobin A1C Standard Deviation 1.6

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=86 participants at risk All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters.
Endocrine disorders Hypoglycemia	16.3% 14/86 • Number of events 26

Additional Information

Dr Michelle Magee

MedStar Health Research Institute

Phone: 2028772383

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place