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

NCT02269098 | Completed Results

• 1 other identifier: 2011-010
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Medication Adherence; HYPERGLYCEMIA

Keywords

type 2 diabetes; hyperglycemia; Emergency Department; Patient Education as Topic; Drug Therapy

Outcome Measures

Primary Outcomes (2)

• Hemoglobin A1C at 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.

  4 weeks

• Medication Adherence

  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.

  4 weeks

Secondary Outcomes (2)

• Blood Glucose < 180mg/dL

  4 weeks

• Hypoglycemia

  4 weeks

Other Outcomes (1)

• ED Visits and Hospitalizations

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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% .

Also known as: Survival skills self-management education

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• American Diabetes Association: collaborator
• Sanofi: collaborator
• Bayer: collaborator

Study Sites (1)

MedStar Washington Hospital Center

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

Location

Related Publications (3)

• Magee MF, Nassar C. Hemoglobin A1c testing in an emergency department. J Diabetes Sci Technol. 2011 Nov 1;5(6):1437-43. doi: 10.1177/193229681100500615.

  PMID: 22226261 BACKGROUND

• 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.

  PMID: 23610182 RESULT

• 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.

  PMID: 25804628 RESULT

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Not all subjects completed the study, yet dropout rates by arm were similar. Medication adherence was self-reported - concurrent improvement in glycemic control was concordant with its improvement. Impact on ED return visits could not be determined.

Results Point of Contact

• Title: Michelle F Magee, MD
• Organization: Medstar Health Research Institute

michelle.f.magee@medstar.net

202-877-0351

Study Officials

• Michelle F Magee, MD, MBBCh

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: February 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 9, 2017
• Results First Posted: January 9, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)