The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2HYPERGLYCEMIAMedication Adherence
- Registration Number
- NCT02269098
- Lead Sponsor
- Medstar Health Research Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hemoglobin A1C at 4 Weeks 4 weeks Hemoglobin A1C at index/baseline visit in the ED and at 4 weeks. A1C was measured using the Bayer A1C-Now+ point of care test system device. If the reading was over 13%, the upper limit of the assay, a venous sample A1C was sent to the hospital lab for analysis.
Medication Adherence 4 weeks Score on 8 item Modified Morisky Medication Scale used to assess medication adherence. This scale is a structured and widely used self reported questionnaire used to assess medication taking behaviors.The total score ranges from 0 to 8. A score of 0 is considered "high"adherence, 1 to 2 is considered "medium" adherence, and \>2 is considered "low" adherence.
- Secondary Outcome Measures
Name Time Method Blood Glucose < 180mg/dL 4 weeks Number of patients in each group with BG \< 180 mg/dl at 4 weeks from baseline
Hypoglycemia 4 weeks Hypoglycemia was defined as BG \< 70mg/dL. Severe hypoglycemia was defined as BG \<40mg/dL and/or requiring assistance to treat. We tracked the total number of hypoglycemia episodes in each group.
Trial Locations
- Locations (1)
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
MedStar Washington Hospital Center🇺🇸Washington, District of Columbia, United States