The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes

Not Applicable

Completed

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

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.

Arm && Interventions

Group	Intervention	Description
Intervention	Diabetes medication management	Diabetes survival skills self-management education; plus diabetes medication management using medication algorithm by diabetes educator supervised by endocrinologist, plus health system naviagation. Metformin, sulfonylureas and basal insulin were included in the algorithm. Survival skills DSME included: BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.

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.