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The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes (STEP-DM)

This study has been completed.
Sponsor:
Collaborators:
American Diabetes Association
Sanofi
Bayer
Washington Hospital Center
Information provided by (Responsible Party):
Medstar Health Research Institute
ClinicalTrials.gov Identifier:
NCT02269098
First received: October 15, 2014
Last updated: November 10, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 2
Medication Adherence
HYPERGLYCEMIA
Other: Diabetes medication management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes: STEP-Diabetes.

Resource links provided by NLM:


Further study details as provided by Medstar Health Research Institute:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • Blood Glucose < 180mg/dL [ Time Frame: 4 weeks ]
    Number of patients in each group with BG < 180 mg/dl at 4 weeks from baseline

  • 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 Outcome Measures:
  • ED Visits and Hospitalizations [ Time Frame: 12 weeks ]
    number ED visits and hospitalizations pre and post intervention as self-reported by participants


Enrollment: 101
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention

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.

Other: Diabetes medication management
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 Name: Survival skills self-management education
No Intervention: Control
Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02269098

Locations
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
American Diabetes Association
Sanofi
Bayer
Washington Hospital Center
Investigators
Principal Investigator: Michelle F Magee, MD, MBBCh Medstar Health Research Institute
  More Information

Publications:
Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT02269098     History of Changes
Other Study ID Numbers: 2011-010
Study First Received: October 15, 2014
Results First Received: January 15, 2016
Last Updated: November 10, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is currently no plan to share IPD. Study results data have been published and shared at national meetings. The PI is open to discussions about the data as requested.

Keywords provided by Medstar Health Research Institute:
type 2 diabetes
hyperglycemia
Emergency Department
Patient Education as Topic
Drug Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Emergencies
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2017