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

Not Applicable
Completed
Conditions
Diabetes Mellitus, Type 2
HYPERGLYCEMIA
Medication 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Hemoglobin A1C at 4 Weeks4 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 Adherence4 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
NameTimeMethod
Blood Glucose < 180mg/dL4 weeks

Number of patients in each group with BG \< 180 mg/dl at 4 weeks from baseline

Hypoglycemia4 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

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