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

NCT ID: NCT02269098

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-12-31

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.

Conditions

Diabetes Mellitus, Type 2; Medication Adherence; HYPERGLYCEMIA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diabetes medication management

Intervention Type: 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% .

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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% .

Intervention Type: OTHER

Other Intervention Names

Survival skills self-management education

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle F Magee, MD, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

MedStar Washington Hospital Center

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22226261 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23610182 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25804628 (View on PubMed)

Other Identifiers

2011-010

Identifier Type: -

Identifier Source: org_study_id