Clinical trial NCT02269098: The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes
Official title: The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes: STEP-Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Medication Adherence
HYPERGLYCEMIA
Keywords: type 2 diabetes
hyperglycemia
Emergency Department
Patient Education as Topic
Drug Therapy
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
name: Sanofi
name: Bayer
First posted: 2014-10-20
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: We evaluated a concise diabetes care delivery intervention designed to advance glycemic medications and deliver diabetes self-management education (DSME) among adults with type 2 diabetes presenting to the emergency department (ED) with uncontrolled hyperglycemia. The primary hypothesis was that there would be improvement in HbA1c.

A 4 week, randomized controlled trial provided algorithm-based antihyperglycemic medications management, survival skills DSME and navigation to primary care for ED patients with BG \> 200mg/dL. Medications were titrated and DSME delivered by endocrinologist-supervised certified diabetes educators. Controls received usual care.

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.

Primary outcomes:
measure: Hemoglobin A1C at 4 Weeks
timeFrame: 4 weeks
measure: Medication Adherence
timeFrame: 4 weeks
Secondary outcomes:
measure: Blood Glucose < 180mg/dL
timeFrame: 4 weeks
measure: Hypoglycemia
timeFrame: 4 weeks
Other outcomes:
measure: ED Visits and Hospitalizations
timeFrame: 12 weeks
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Michelle F Magee, MD, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magee MF, Nassar C. Hemoglobin A1c testing in an emergency department. J Diabetes Sci Technol. 2011 Nov 1;5(6):1437-43. doi: 10.1177/193229681100500615.
citation: Magee MF, Nassar CM, Copeland J, Fokar A, Sharretts JM, Dubin JS, Smith MS. Synergy to reduce emergency department visits for uncontrolled hyperglycemia. Diabetes Educ. 2013 May-Jun;39(3):354-64. doi: 10.1177/0145721713484593. Epub 2013 Apr 22.
citation: Lewis VR, Benda N, Nassar C, Magee M. Successful patient diabetes education in the emergency department. Diabetes Educ. 2015 Jun;41(3):343-50. doi: 10.1177/0145721715577484. Epub 2015 Mar 24.