Trial Outcomes & Findings for Glucose Control Using 1,5-AG Testing (NCT NCT03765164)
NCT ID: NCT03765164
Last Updated: 2020-10-28
Results Overview
Difference-in-differences regression analysis between the control and the intervention group's identification and treatment of hyperglycemia, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each domain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
156 participants
Primary outcome timeframe
3 months
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
Control
Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
Intervention
Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
|---|---|---|
|
Pre-intervention
STARTED
|
78
|
78
|
|
Pre-intervention
COMPLETED
|
73
|
72
|
|
Pre-intervention
NOT COMPLETED
|
5
|
6
|
|
Post-intervention
STARTED
|
73
|
72
|
|
Post-intervention
COMPLETED
|
0
|
0
|
|
Post-intervention
NOT COMPLETED
|
73
|
72
|
Reasons for withdrawal
| Measure |
Control
Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
Intervention
Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
|---|---|---|
|
Pre-intervention
Withdrawal by Subject
|
5
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=73 Participants
Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
Intervention
n=72 Participants
Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<40
|
5 Participants
n=73 Participants
|
3 Participants
n=72 Participants
|
8 Participants
n=145 Participants
|
|
Age, Customized
40-55
|
45 Participants
n=73 Participants
|
42 Participants
n=72 Participants
|
87 Participants
n=145 Participants
|
|
Age, Customized
>55
|
23 Participants
n=73 Participants
|
27 Participants
n=72 Participants
|
50 Participants
n=145 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=73 Participants
|
18 Participants
n=72 Participants
|
29 Participants
n=145 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=73 Participants
|
54 Participants
n=72 Participants
|
116 Participants
n=145 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Practice locale (urban, suburban, or rural)
Urban
|
14 Participants
n=73 Participants
|
24 Participants
n=72 Participants
|
38 Participants
n=145 Participants
|
|
Practice locale (urban, suburban, or rural)
Suburban
|
45 Participants
n=73 Participants
|
33 Participants
n=72 Participants
|
78 Participants
n=145 Participants
|
|
Practice locale (urban, suburban, or rural)
Rural
|
14 Participants
n=73 Participants
|
15 Participants
n=72 Participants
|
29 Participants
n=145 Participants
|
|
U.S. Region Location of Practice
Midwest
|
20 Participants
n=73 Participants
|
13 Participants
n=72 Participants
|
33 Participants
n=145 Participants
|
|
U.S. Region Location of Practice
Northeast
|
17 Participants
n=73 Participants
|
13 Participants
n=72 Participants
|
30 Participants
n=145 Participants
|
|
U.S. Region Location of Practice
South
|
22 Participants
n=73 Participants
|
30 Participants
n=72 Participants
|
52 Participants
n=145 Participants
|
|
U.S. Region Location of Practice
West
|
14 Participants
n=73 Participants
|
16 Participants
n=72 Participants
|
30 Participants
n=145 Participants
|
PRIMARY outcome
Timeframe: 3 monthsDifference-in-differences regression analysis between the control and the intervention group's identification and treatment of hyperglycemia, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each domain.
Outcome measures
| Measure |
Control
n=73 Participants
Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
Intervention
n=72 Participants
Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
|---|---|---|
|
Diagnosis-Treatment
Round 2
|
31.7 CPV diagnosis-treatment percentage score
Standard Deviation 13.4
|
35.0 CPV diagnosis-treatment percentage score
Standard Deviation 15.0
|
|
Diagnosis-Treatment
Round 1
|
29.1 CPV diagnosis-treatment percentage score
Standard Deviation 12.3
|
31.9 CPV diagnosis-treatment percentage score
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 3 monthsDifference-in-differences regression analysis between the control and the intervention group's overall quality of care scores. In each CPV case, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each case.
Outcome measures
| Measure |
Control
n=73 Participants
Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
Intervention
n=72 Participants
Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
|---|---|---|
|
Quality of Care
Round 2
|
51.4 CPV overall percentage score
Standard Deviation 11.1
|
52.1 CPV overall percentage score
Standard Deviation 12.3
|
|
Quality of Care
Round 1
|
50.9 CPV overall percentage score
Standard Deviation 10.0
|
48.9 CPV overall percentage score
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 3 monthsDifference-in-differences regression analysis between between the control and the intervention group in the average cost of diagnostic tests ordered.
Outcome measures
| Measure |
Control
n=73 Participants
Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
Intervention
n=72 Participants
Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
|
|---|---|---|
|
Workup Costs
Round 2
|
78 US$
Standard Deviation 156
|
37 US$
Standard Deviation 87
|
|
Workup Costs
Round 1
|
54 US$
Standard Deviation 100
|
60 US$
Standard Deviation 116
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place