Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, Uncontrolled hyperglycemia, Emergency Department
Brief summary
To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled hyperglycemia enables safe and effective glycemic management and reduces emergency room re-visits. We assessed hypoglycemia BG \< 60mg/dL; change in mean blood glucose and A1C, and ED revisits for hyperglycemia.
Detailed description
Patients with BG \> 200mg/dL presenting to an urban tertiary care hospital ED were enrolled in a 4 week prospective intervention with historic self-controls. Subjects returned at 12-72 hours, 2 and 4 weeks. 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. Survival skills self-management education and navigation to outpatient services were provided.
Interventions
DRUGAntihyperglycemic 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.
BEHAVIORALDiabetes 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.
Sponsors
Medstar Health Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Type 2 Diabetes Mellitus, * random BG \> 200 mg/dL, * willing and able to provide informed consent and to participate in diabetes self-management education (DSME) * stable for discharge from the ED once hyperglycemia treatment initiated.
Exclusion criteria
* type 1 Diabetes Mellitus, * diabetic ketoacidosis or hyperosmolar non-ketotic state, * concomitant treatment with glucocorticoids (other than stable maintenance dose therapy), * cognitive or physical impairment preventing participation in DSME * unwillingness or inability to provide consent and/or attend follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit | 24 hours | Total Number of hypoglycemic events defined as Blood Glucose \< 60 within 24 hours of index emergency room visit (baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Blood Glucose From Time of Presentation to Emergency Room to End of Intervention 30 Days From Baseline | 30 days | Mean difference in of blood glucose in mg/dl between baseline mean BG and end of intervention mean BG 30 days from baseline |
| Change in Hemoglobin A1C From Baseline to End of Intervention at 30 Days | 30 days | difference between mean hemoglobin A1C at baseline and mean Hemoglobin A1C to end of intervention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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. | 86 |
| Total | 86 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Customized Age 18-44 | 28 Participants |
| Age, Customized Age 45-64 | 51 Participants |
| Age, Customized Age 65 and older | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 86 |
| other Total, other adverse events | 14 / 86 |
| serious Total, serious adverse events | 0 / 86 |
Outcome results
Primary
Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit
Total Number of hypoglycemic events defined as Blood Glucose \< 60 within 24 hours of index emergency room visit (baseline)
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit | 0 events |
Secondary
Change in Hemoglobin A1C From Baseline to End of Intervention at 30 Days
difference between mean hemoglobin A1C at baseline and mean Hemoglobin A1C to end of intervention
Time frame: 30 days
Population: Only 46 patients had a baseline and end of intervention A1C available therefore only 46 participants are included in the data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | 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 |
| Intervention | 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 |
Secondary
Change in Mean Blood Glucose From Time of Presentation to Emergency Room to End of Intervention 30 Days From Baseline
Mean difference in of blood glucose in mg/dl between baseline mean BG and end of intervention mean BG 30 days from baseline
Time frame: 30 days
Population: This data was only available for 51 patients therefore only 51 patients' results were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | 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 |
| Intervention | 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 |