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Completed

NCT Number: NCT02269098

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Disease Attributes Emergencies Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Hyperglycemia Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes medication management

Other

As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care appointment no later than 4 weeks after study completion. Final contact was via telephone at 90 days. The MMS© (Morisky Medication Adherence Survey) was taken at 2 and 4 weeks and during the final telephone visit. Interim return visits to the ED or admissions to the hospital were queried at each visit. A follow up HbA1C was obtained at week 4 using the POC A1CNow+ ®, and a venous HbA1C was drawn if the POC result was above 13% .

Other names: Survival skills self-management education

Primary outcomes

  1. Hemoglobin A1C at 4 Weeks

    Time frame: 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.

  2. Medication Adherence

    Time frame: 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 outcomes

  1. Blood Glucose < 180mg/dL

    Time frame: 4 weeks

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

  2. Hypoglycemia

    Time frame: 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.

Other outcomes

  1. ED Visits and Hospitalizations

    Time frame: 12 weeks

    number ED visits and hospitalizations pre and post intervention as self-reported by participants

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • American Diabetes Association
  • Bayer
  • Sanofi

Registry information

Official study title

The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes: STEP-Diabetes.

Acronym: STEP-DM

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 20, 2014
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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