Diabetes Mellitus, Type 2STEP-DMNCT02269098
The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes
A study testing Diabetes medication management in people with Diabetes Mellitus, Type 2 and Medication Adherence, run by Medstar Health Research Institute at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Medication Adherence, HYPERGLYCEMIA
- What is being tested?
- Diabetes medication management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes: STEP-Diabetes.
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.
Read the 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.
- Being tested
- Diabetes medication management
- Keywords
- type 2 diabetes, hyperglycemia, Emergency Department, Patient Education as Topic, Drug Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence, Hyperglycemia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes medication managementOther
Also called Survival skills self-management education
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% .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (2)
Blood Glucose < 180mg/dL
Number of patients in each group with BG < 180 mg/dl at 4 weeks from baseline
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle F Magee, MD, MBBCh, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269098
- Sponsor's protocol ID
- 2011-010
- Acronym
- STEP-DM
- Status last verified
- Nov 2016
- First submitted
- 15 Oct 2014
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 22226261Magee 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.
PubMed 23610182Lewis 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.
PubMed 25804628
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes: STEP-Diabetes.
- ClinicalTrials.gov ID
- NCT02269098
- Acronym / sponsor ID
- STEP-DM / 2011-010
- Keywords
- type 2 diabetes, hyperglycemia, Emergency Department, Patient Education as Topic, Drug Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- American Diabetes Association, Sanofi, Bayer
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Posted 9 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Diabetes medication managementDiabetes 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes medication managementAlso: Survival skills self-management educationAs 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 | Intervention |
Primary outcome
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.
2 secondary outcomes
Blood Glucose < 180mg/dL
Time frame: 4 weeks
Hypoglycemia
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22226261Magee 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 publication: PubMed 23610182Magee 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 publication: PubMed 25804628Lewis 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle F Magee, MD, MBBCh principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes medication management in people with Diabetes Mellitus, Type 2 and Medication Adherence, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C at 4 Weeks (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02269098, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.