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

Diabetes Mellitus, Type 2 Clinical Trial

— STEP-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269098
• Other study ID #: 2011-010
• Status: Completed
• Phase: N/A
• First received: October 15, 2014
• Last updated: May 4, 2015
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Emergencies
• Hyperglycemia
• Medication Adherence

Intervention

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% .

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Medstar Research Institute	American Diabetes Association, Bayer, Sanofi, Washington Hospital Center

References & Publications (3)

Lewis VR, Benda N, Nassar C, Magee M. Successful patient diabetes education in the emergency department. Diabetes Educ. 2015 Jun;41(3):343-50. doi: 10.1177/0145721715577484. Epub 2015 Mar 24. — View Citation

Magee MF, Nassar C. Hemoglobin A1c testing in an emergency department. J Diabetes Sci Technol. 2011 Nov 1;5(6):1437-43. — View Citation

Magee MF, Nassar CM, Copeland J, Fokar A, Sharretts JM, Dubin JS, Smith MS. Synergy to reduce emergency department visits for uncontrolled hyperglycemia. Diabetes Educ. 2013 May-Jun;39(3):354-64. doi: 10.1177/0145721713484593. Epub 2013 Apr 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ED visits and hospitalizations	Self-reported by participants	12 weeks	No
Primary	Hemoglobin A1C		4 weeks	No
Secondary	Blood glucose < 180mg/dL		4 weeks	No
Secondary	Hypoglycemia		4 weeks	Yes
Secondary	Medication Adherence	8 item Modified Morisky Medication Scale used to assess medication adherence	4 weeks and 12 weeks	No