Diabetes
Conditions
Keywords
Lucica, glycated albumin, GA, fructosamine
Brief summary
To confirm that Lucica ® Glycated Albumin-L is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes.
Detailed description
In order to confirm that Lucica ® Glycated Albumin-L is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes, subjects with Type 1 or Type 2 diabetes will be enrolled whose HbA1c values range from 7.5% to 12% (or higher) in Group 1 and \<7.5% in Group 2 at Visit 1, and the comparison of glycated albumin (GA) and other glycemic control indices will be performed during 6 months in 8 clinical sites in US. Group 1 will consist of 90 evaluable subjects who have a change in diabetes management to improve glycemic control; this therapy can include oral agents, insulin, or noninsulin injectable anti-diabetic medications. Group 2 will consist of 40 evaluable subjects already on a stable diabetic management program, who have had no change in treatment in the last 3 months and for whom there is no plan to make a change during the study period.
Interventions
None listed
Sponsors
Asahi Kasei Pharma Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects may be included in the study if they meet all the following criteria: 1. Male and female subjects 18 years of age and older 2. Subjects with Type 1 or Type 2 diabetes (enrolled in an approximate ratio of 1:1, respectively) 3. Subjects with an HbA1c value within the range of 7.5% to 12% (or higher) for Group 1 and \<7.5% for Group 2 Note: The study investigator or primary physician must be planning to institute, or must be in the process of instituting, therapy to improve glycemic control for subjects in Group 1; this therapy can include oral agents, insulin, or non-insulin injectable anti-diabetic medications. 4. Willingness to complete the protocol requirements, including the use of self-monitoring of blood glucose (SMBG) and attendance at all scheduled study visits; if selected for continious glucose monitoring (CGM) , a willingness to follow the additional requirements and to use only the CGM device model provided for the study 5. Satisfactory completion of home SMBG measurements during the screening period of the study prior to enrollment at Visit 2
Exclusion criteria
Subjects will be excluded from the study if they meet any of the following criteria: 1. Any clinically significant disease, as determined by the investigator, that would interfere with study evaluations including but not limited to the following current or historical conditions/procedures (self-reported by the subject): 1. End-stage renal disease 2. Chronic kidney disease of Stage 3 or greater 3. Liver cirrhosis 4. Uncontrolled or untreated thyroid disease 5. Any other acute or chronic conditions that, in the opinion of the investigator, may significantly influence albumin or glucose metabolism (Note: routine iron deficiencies and abnormal hemoglobin variants are not exclusions) 2. History within the last 6 months of a blood transfusion 3. Any other condition or factor that, in the opinion of the investigator, would complicate or compromise the study or the well-being of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8 | From baseline to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1 | From baseline to the first 3 months after enrollment in Group 1 | Comparing the Spearman correlation of changes in GA and MBG to the Spearman correlation of changes in HbA1c and MBG, from baseline to any matching post-baseline visit in the first 3 months in Group 1. |
| Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1 | From baseline to the first 3 months after enrollment in Group 1 | Comparing the Kendall correlation of changes in GA and MBG to the Kendall correlation of changes in HbA1c and MBG, from baseline to any matching post-baseline visit in the first 3 months in Group 1. |
Countries
United States
Participant flow
Recruitment details
This was a prospective, multicenter, comparative, pivotal study of assay performance in the clinical setting. The target population for this study included up to 150 patients placed into 2 groups, each containing approximately equal numbers of patients with Type 1 or Type 2 diabetes.
Pre-assignment details
A total of 165 patients were screened for the study, 150 patients were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications). | 98 |
| Group 2 Group 2 consisted of at least 40 patients with HbA1c values \<7.5% at Visit 1 who were already on a stable diabetic management program, had no change in treatment in the 3 months prior to screening, and for whom no change was planned during the study period. | 52 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Leave the country or the state | 1 | 1 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1 | Total | Group 2 |
|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 15.61 | 50.5 years STANDARD_DEVIATION 15.63 | 50.3 years STANDARD_DEVIATION 15.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 29 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 121 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 17 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 80 Participants | 126 Participants | 46 Participants |
| Region of Enrollment United States | 98 participants | 150 participants | 52 participants |
| Sex: Female, Male Female | 53 Participants | 80 Participants | 27 Participants |
| Sex: Female, Male Male | 45 Participants | 70 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 52 |
| other Total, other adverse events | 53 / 98 | 28 / 52 |
| serious Total, serious adverse events | 5 / 98 | 3 / 52 |
Outcome results
Primary
Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8
Time frame: From baseline to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HbA1c Values Ranged From ≥7.5% to 12% (or Higher) | Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8 | 0.7056 Pearson correlation coefficient |
| HbA1c Values <7.5% | Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8 | 0.5271 Pearson correlation coefficient |
p-value: >0.999995% CI: [-0.2204, -0.1113]t-test, 2 sided
Secondary
Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1
Comparing the Kendall correlation of changes in GA and MBG to the Kendall correlation of changes in HbA1c and MBG, from baseline to any matching post-baseline visit in the first 3 months in Group 1.
Time frame: From baseline to the first 3 months after enrollment in Group 1
Population: It is pre-specified to collect and report data for only participants who had a change in treatment (Group 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HbA1c Values Ranged From ≥7.5% to 12% (or Higher) | Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1 | Correlation coefficient betwenn GA and MBG | 0.341 kendall correaltion coefficient |
| HbA1c Values Ranged From ≥7.5% to 12% (or Higher) | Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1 | Correlation coefficient betwenn HbA1c and MBG | 0.160 kendall correaltion coefficient |
p-value: <0.000195% CI: [0.096, 0.265]t-test, 2 sided
Secondary
Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1
Comparing the Spearman correlation of changes in GA and MBG to the Spearman correlation of changes in HbA1c and MBG, from baseline to any matching post-baseline visit in the first 3 months in Group 1.
Time frame: From baseline to the first 3 months after enrollment in Group 1
Population: It is pre-specified to collect and report data for only participants who had a change in treatment (Group 1).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HbA1c Values Ranged From ≥7.5% to 12% (or Higher) | Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1 | Correlation coefficent between GA and MBG | 0.481 spearman correlation coefficient |
| HbA1c Values Ranged From ≥7.5% to 12% (or Higher) | Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1 | Correlation coefficent between HbA1c and MBG | 0.233 spearman correlation coefficient |
p-value: <0.000195% CI: [0.13, 0.364]t-test, 2 sided