The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes (STEP-DM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02269098|
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Medication Adherence HYPERGLYCEMIA||Other: Diabetes medication management||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes: STEP-Diabetes.|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||December 2013|
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.
- 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.
- 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.
- ED Visits and Hospitalizations [ Time Frame: 12 weeks ]number ED visits and hospitalizations pre and post intervention as self-reported by participants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269098
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Michelle F Magee, MD, MBBCh||Medstar Health Research Institute|