N/A
N=101
The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes
Diabetes Mellitus, Type 2 · Medication Adherence · HYPERGLYCEMIA
Bottom Line
View on ClinicalTrials.gov: NCT02269098 ↗Enrolled (actual)
101
Serious AEs
1.0%
Results posted
Jan 2017
Primary outcome: Primary: Hemoglobin A1C at 4 Weeks — 10.5; 11.1 percentage of glycosylated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diabetes medication management (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medstar Health Research Institute
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1C at 4 Weeks |
10.5; 11.1 | — |
| PRIMARY Medication Adherence |
1.6; 2.5 | — |
| SECONDARY Blood Glucose < 180mg/dL |
24; 11 | — |
| SECONDARY Hypoglycemia |
2; 1 | — |
Summary
A 4 week prospective, randomized controlled study was carried out to assess the impact of a care delivery intervention which focused on blood glucose (BG) management among adults with type 2 diabetes presenting to the Emergency Department (ED) with BG > 200mg/dL (11.1 mmol/L). The intervention was designed by a multi-disciplinary team of ED physicians and nurses, endocrinologists and diabetes educators. The intervention incorporated three components: a guideline-based algorithm for diabetes medication management; survival skills diabetes self-management education (DSME); and support for health system navigation. The control group received usual care per the ED's policies and procedures for management of high blood glucose.
Eligibility Criteria
Inclusion Criteria
- A new or existing diagnosis of type 2 diabetes;
- BG > 200 mg/dl in the ED;
- age >/= 18 years;
- willing and able to check BG and self-inject insulin, if required and otherwise stable for discharge to the outpatient setting.
Exclusion Criteria
- type 1 diabetes and other specific types of diabetes per the American Diabetes Association Position Statement on the Classification of Diabetes Mellitus,
- pregnancy or anticipated conception in the next 3 months;
- treatment with a glucocorticoid, unless at a stable physiologic replacement dose; or
- a history of diabetic ketoacidosis.
Data sourced from ClinicalTrials.gov (NCT02269098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.