Diabetes Mellitus, Type 2, HYPERGLYCEMIA, Medication Adherence
Conditions
Keywords
type 2 diabetes, hyperglycemia, Emergency Department, Patient Education as Topic, Drug Therapy
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.
Interventions
OTHERDiabetes 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% .
Sponsors
American Diabetes Association
Sanofi
Bayer
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C at 4 Weeks | 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 | 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 highadherence, 1 to 2 is considered medium adherence, and \>2 is considered low adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose < 180mg/dL | 4 weeks | Number of patients in each group with BG \< 180 mg/dl at 4 weeks from baseline |
| Hypoglycemia | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| ED Visits and Hospitalizations | 12 weeks | number ED visits and hospitalizations pre and post intervention as self-reported by participants |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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 | 51 |
| 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. | 50 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 9 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 48 Participants | 95 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 12 | 50 years STANDARD_DEVIATION 14 | 50 years STANDARD_DEVIATION 13 |
| Gender Female | 24 Participants | 31 Participants | 55 Participants |
| Gender Male | 26 Participants | 20 Participants | 46 Participants |
| Region of Enrollment United States | 50 participants | 51 participants | 101 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 51 | 3 / 50 |
| serious Total, serious adverse events | 0 / 51 | 1 / 50 |
Outcome results
Primary
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.
Time frame: 4 weeks
Population: Participants who completed the full 4 week study period were included in the primary outcomes analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Hemoglobin A1C at 4 Weeks | 10.5 percentage of glycosylated hemoglobin | Standard Deviation 1.9 |
| Control | Hemoglobin A1C at 4 Weeks | 11.1 percentage of glycosylated hemoglobin | Standard Deviation 2.1 |
Primary
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 highadherence, 1 to 2 is considered medium adherence, and \>2 is considered low adherence.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Medication Adherence | 1.6 units on a scale | Standard Deviation 1.4 |
| Control | Medication Adherence | 2.5 units on a scale | Standard Deviation 2.2 |
Secondary
Blood Glucose < 180mg/dL
Number of patients in each group with BG \< 180 mg/dl at 4 weeks from baseline
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Blood Glucose < 180mg/dL | 24 participants |
| Control | Blood Glucose < 180mg/dL | 11 participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Hypoglycemia | 2 total incidents of hypoglycemia |
| Control | Hypoglycemia | 1 total incidents of hypoglycemia |
Other Pre-specified
ED Visits and Hospitalizations
number ED visits and hospitalizations pre and post intervention as self-reported by participants
Time frame: 12 weeks
Population: Self reported Number of ED visits and hospitalizations 3 months prior to and 3 months after the intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | ED Visits and Hospitalizations | 7 number of ED visits and hospitlizations |
| Control | ED Visits and Hospitalizations | 10 number of ED visits and hospitlizations |