Trial Outcomes & Findings for The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes (NCT NCT02269098)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Diabetes survival skills self-management education (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.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation. .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	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.
Overall Study STARTED	51	50
Overall Study COMPLETED	37	41
Overall Study NOT COMPLETED	14	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Diabetes survival skills self-management education (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.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation. .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	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.
Overall Study Lost to Follow-up	14	9

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=51 Participants Diabetes survival skills self-management education (G 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. ; plus diabetes medication management using medication algorithm ( Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation. 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	Control n=50 Participants 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.	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=99 Participants	47 Participants n=107 Participants	95 Participants n=206 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Age, Continuous	50 years STANDARD_DEVIATION 14 • n=99 Participants	50 years STANDARD_DEVIATION 12 • n=107 Participants	50 years STANDARD_DEVIATION 13 • n=206 Participants
Gender Female	31 Participants n=99 Participants	24 Participants n=107 Participants	55 Participants n=206 Participants
Gender Male	20 Participants n=99 Participants	26 Participants n=107 Participants	46 Participants n=206 Participants
Region of Enrollment United States	51 participants n=99 Participants	50 participants n=107 Participants	101 participants n=206 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Participants who completed the full 4 week study period were included in the primary outcomes analysis.

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.

Outcome measures

Outcome measures
Measure	Intervention n=37 Participants Diabetes survival skills self-management education (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.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation. .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	Control n=41 Participants 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	10.5 percentage of glycosylated hemoglobin Standard Deviation 1.9	11.1 percentage of glycosylated hemoglobin Standard Deviation 2.1

PRIMARY outcome

Timeframe: 4 weeks

Population: 33 patients in the intervention group and 30 in the control group completed the scale at baseline and at 4 weeks and their data was analyzed for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Intervention n=33 Participants Diabetes survival skills self-management education (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.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation. .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	Control n=30 Participants 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.
Medication Adherence	1.6 units on a scale Standard Deviation 1.4	2.5 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 4 weeks

Number of patients in each group with BG \< 180 mg/dl at 4 weeks from baseline

Outcome measures

Outcome measures
Measure	Intervention n=37 Participants Diabetes survival skills self-management education (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.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation. .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	Control n=41 Participants 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.
Blood Glucose < 180mg/dL	24 participants	11 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: we collected data on the total number of hypoglycemia episodes in each group, not the number or participants with hypoglycemia as some participants had more than 1 episode and we wanted to capture those as separate incidents.

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.

Outcome measures

Outcome measures
Measure	Intervention n=37 Participants Diabetes survival skills self-management education (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.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation. .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	Control n=41 Participants 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.
Hypoglycemia	2 total incidents of hypoglycemia	1 total incidents of hypoglycemia

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Self reported Number of ED visits and hospitalizations 3 months prior to and 3 months after the intervention

number ED visits and hospitalizations pre and post intervention as self-reported by participants

Outcome measures

Outcome measures
Measure	Intervention n=37 Participants Diabetes survival skills self-management education (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.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation. .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	Control n=41 Participants 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.
ED Visits and Hospitalizations	7 number of ED visits and hospitlizations	10 number of ED visits and hospitlizations

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=51 participants at risk Diabetes survival skills self-management education (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.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation. .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	Control n=50 participants at risk 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.
Gastrointestinal disorders hospitalization due to exacerbation of gastroperisis	0.00% 0/51	2.0% 1/50 • Number of events 1

Other adverse events

Other adverse events
Measure	Intervention n=51 participants at risk Diabetes survival skills self-management education (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.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation. .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	Control n=50 participants at risk 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.
Endocrine disorders hyperglycemia requiring return to Emergency room	0.00% 0/51	2.0% 1/50 • Number of events 1
Renal and urinary disorders Urinary tract infection	2.0% 1/51 • Number of events 1	2.0% 1/50 • Number of events 1
Musculoskeletal and connective tissue disorders arthritis pain exacerbation	2.0% 1/51 • Number of events 1	2.0% 1/50 • Number of events 1

Additional Information

Michelle F Magee, MD

Medstar Health Research Institute

Phone: 202-877-0351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place