Back to resultsThe Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes (STEP-DM)
Primary Purpose
Diabetes Mellitus, Type 2, Medication Adherence, HYPERGLYCEMIA
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes medication management
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring type 2 diabetes, hyperglycemia, Emergency Department, Patient Education as Topic, Drug Therapy
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.
Sites / Locations
- MedStar Washington Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Blood Glucose < 180mg/dL
Number of patients in each group with BG < 180 mg/dl at 4 weeks from baseline
Hypoglycemia
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.
Full Information
NCT ID
NCT02269098
First Posted
October 15, 2014
Last Updated
November 10, 2016
Sponsor
Medstar Health Research Institute
Collaborators
American Diabetes Association, Sanofi, Bayer
1. Study Identification
Unique Protocol Identification Number
NCT02269098
Brief Title
The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes
Acronym
STEP-DM
Official Title
The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes: STEP-Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
American Diabetes Association, Sanofi, Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Medication Adherence, HYPERGLYCEMIA
Keywords
type 2 diabetes, hyperglycemia, Emergency Department, Patient Education as Topic, Drug Therapy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diabetes medication management
Other Intervention Name(s)
Survival skills self-management education
Intervention Description
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% .
Primary Outcome Measure Information:
Title
Hemoglobin A1C at 4 Weeks
Description
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.
Time Frame
4 weeks
Title
Medication Adherence
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Blood Glucose < 180mg/dL
Description
Number of patients in each group with BG < 180 mg/dl at 4 weeks from baseline
Time Frame
4 weeks
Title
Hypoglycemia
Description
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.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
ED Visits and Hospitalizations
Description
number ED visits and hospitalizations pre and post intervention as self-reported by participants
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle F Magee, MD, MBBCh
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
22226261
Citation
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.
Results Reference
background
PubMed Identifier
23610182
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.
Results Reference
result
PubMed Identifier
25804628
Citation
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.
Results Reference
result
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The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes
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