Diabetes Mellitus, Type 2
Conditions
Brief summary
This randomized, parallel group study will determine whether the use of episodic, intensive glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive effect on overall glycemic control. Patients will be randomized into either the 'usual care' group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose analysis system. The effect of each treatment regimen on glycemic control will be assessed by measurement of change in baseline HbA1c values at 12 months. The anticipated time on study treatment is 1 year, and the target sample size is 504 individuals.
Interventions
DEVICEAccu-Chek 360° View Blood Glucose Analysis Tool
DEVICEAccu-Chek Aviva Glucose Meter
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients \>= 25 years of age * Type 2 diabetes for \>= 1 year * Hemoglobin A1c \>= 7.5% and \<=11% * Diabetes managed by exercise and diet, prescription oral medication or an injectable incretin mimetic
Exclusion criteria
* Type 1 diabetes * On any type of insulin therapy at start of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 | Baseline, Month 12 | Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Depression Severity (PHQ-8) | Baseline, Month 12 | The Patient Health Questionnaire-8 (PHQ-8) is an eight-item patient questionnaire to measure the severity of depression disorders over the previous 2 weeks. Each item is rated on a 4-point scale of: 0=not at all to 3=nearly every day. The total score for all items range from 0 (best) to 24 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline PHQ-8, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement. |
| Change From Baseline in the Diabetes Distress Scale (DDS) | Baseline, Month 12 | Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement. |
| Change From Baseline in the World Health Organization (WHO-5) Well-being Index | Baseline, Month 12 | Participants used the WHO-5 to rate their well-being (feeling good and cheerful) for the past 2 weeks using a 6-point scale: 0=At no time to 5=All of the time for a total possible score of 0 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline WHO-5, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement. |
| Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations | 12 Months | Treatment intensification was assessed at each clinic visit. The physician evaluated the patient and made recommendations of a change in two areas: changes in diabetic medication and/or changes in lifestyle (such as diet, exercise and education.) |
| Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day | 12 Months | SMBG data for all participants was collected by the glucose meter and were uploaded directly to a web server. The mean number of SMBG tests/day was calculated for the entire study period. |
| Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Month 1, Month 12 | Glycemic Variability was evaluated in the STG group for each 3-day set that corresponded to the days the subjects completed the tool before each post-baseline clinic visit. Some parameters used to estimate glycemic variability over the 3-day profile included mean and maximum post-prandial glucose excursions (differences between pre- and post-meal blood glucose levels), mean blood glucose and mean amplitude of glycemic excursion. The calculation used a Linear mixed model with visit, Month 1 value, gender, age and race (White and Non-White) as fixed effects; and site and subject as random effects. |
| Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2) | Baseline, Month 12 | Participants rated how confident they felt about managing each of 20 diabetes self-care tasks using the CIDS-2 questionnaire. Responses were given on a 5-point scale ranging from 1=not at all confident to 5=completely confident for a total possible score of 20 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline CIDS-2, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement. |
Countries
United States
Participant flow
Pre-assignment details
770 patients were screened. 522 patients were enrolled in the study. 23 patients at 1 site used the incorrect self monitored blood glucose device and were excluded. 499 patients met inclusion/exclusion criteria and were included in the analyses.
Participants by arm
| Arm | Count |
|---|---|
| Active Control Group (ACG) Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes. | 227 |
| Structured Testing Group (STG) Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly. | 256 |
| Total | 483 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 25 | 53 |
| Overall Study | Other reasons | 4 | 8 |
| Overall Study | Subject withdrew consent | 12 | 19 |
Baseline characteristics
| Characteristic | Active Control Group (ACG) | Structured Testing Group (STG) | Total |
|---|---|---|---|
| Age Continuous | 57.0 years STANDARD_DEVIATION 11.2 | 54.8 years STANDARD_DEVIATION 10.1 | 55.8 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 105 Participants | 121 Participants | 226 Participants |
| Sex: Female, Male Male | 122 Participants | 135 Participants | 257 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 256 | 35 / 227 |
| serious Total, serious adverse events | 14 / 256 | 21 / 227 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12
Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.
Time frame: Baseline, Month 12
Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Control Group (ACG) | Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 | -0.88 Percent | Standard Error 0.1 |
| Structured Testing Group (STG) | Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 | -1.16 Percent | Standard Error 0.09 |
p-value: 0.041695% CI: [0.01, 0.54]Fisher Exact
Secondary
Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2)
Participants rated how confident they felt about managing each of 20 diabetes self-care tasks using the CIDS-2 questionnaire. Responses were given on a 5-point scale ranging from 1=not at all confident to 5=completely confident for a total possible score of 20 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline CIDS-2, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.
Time frame: Baseline, Month 12
Population: Per protocol population included all enrolled participants who completed the baseline training visit, completed at least 4 of 5 clinical visits, and had evaluable HbA1c data at Month 12. The Structured Testing Group also had to have at least 80% of the blood glucose values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Control Group (ACG) | Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2) | 2.7 Score on a scale | Standard Error 1.1 |
| Structured Testing Group (STG) | Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2) | 5.8 Score on a scale | Standard Error 1.1 |
p-value: 0.047t-test, 2 sided
Secondary
Change From Baseline in Depression Severity (PHQ-8)
The Patient Health Questionnaire-8 (PHQ-8) is an eight-item patient questionnaire to measure the severity of depression disorders over the previous 2 weeks. Each item is rated on a 4-point scale of: 0=not at all to 3=nearly every day. The total score for all items range from 0 (best) to 24 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline PHQ-8, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.
Time frame: Baseline, Month 12
Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Control Group (ACG) | Change From Baseline in Depression Severity (PHQ-8) | -1.1 Score on a scale | Standard Error 0.3 |
| Structured Testing Group (STG) | Change From Baseline in Depression Severity (PHQ-8) | -1.7 Score on a scale | Standard Error 0.3 |
p-value: 0.2777t-test, 2 sided
Secondary
Change From Baseline in the Diabetes Distress Scale (DDS)
Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.
Time frame: Baseline, Month 12
Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Control Group (ACG) | Change From Baseline in the Diabetes Distress Scale (DDS) | -0.40 Score on a scale | Standard Error 0.07 |
| Structured Testing Group (STG) | Change From Baseline in the Diabetes Distress Scale (DDS) | -0.55 Score on a scale | Standard Error 0.06 |
p-value: 0.116t-test, 2 sided
Secondary
Change From Baseline in the World Health Organization (WHO-5) Well-being Index
Participants used the WHO-5 to rate their well-being (feeling good and cheerful) for the past 2 weeks using a 6-point scale: 0=At no time to 5=All of the time for a total possible score of 0 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline WHO-5, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.
Time frame: Baseline, Month 12
Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Control Group (ACG) | Change From Baseline in the World Health Organization (WHO-5) Well-being Index | 4.1 Score on a scale | Standard Error 1.5 |
| Structured Testing Group (STG) | Change From Baseline in the World Health Organization (WHO-5) Well-being Index | 7.4 Score on a scale | Standard Error 1.5 |
p-value: 0.1146t-test, 2 sided
Secondary
Glycemic Variability Pre and Post-Prandial Excursions at Each Meal
Glycemic Variability was evaluated in the STG group for each 3-day set that corresponded to the days the subjects completed the tool before each post-baseline clinic visit. Some parameters used to estimate glycemic variability over the 3-day profile included mean and maximum post-prandial glucose excursions (differences between pre- and post-meal blood glucose levels), mean blood glucose and mean amplitude of glycemic excursion. The calculation used a Linear mixed model with visit, Month 1 value, gender, age and race (White and Non-White) as fixed effects; and site and subject as random effects.
Time frame: Month 1, Month 12
Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Post-Prandial Glucose Excursion Breakfast Month 1 | 44.0 mg/dL | Standard Error 2.3 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Post-Prandial Glucose ExcursionBreakfast Month 12 | 34.7 mg/dL | Standard Error 2.7 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Post-Prandial Glucose Excursion Lunch Month 1 | 25.0 mg/dL | Standard Error 2.4 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Post- Prandial Glucose Excursion Lunch Month 12 | 17.3 mg/dL | Standard Error 2.8 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Post-Prandial Glucose Excursion Supper Month 1 | 33.6 mg/dL | Standard Error 2.8 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Post-Prandial Glucose Excursion Supper: Month 12 | 25.8 mg/dL | Standard Error 3.3 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Mean Amplitude of Glucose Excursions: Month 1 | 38.5 mg/dL | Standard Error 0.9 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Mean Amplitude of Glucose Excursions: Month 12 | 34.3 mg/dL | Standard Error 1 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Maximum Glucose Rise: Breakfast Month 1 | 80.2 mg/dL | Standard Error 2.9 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Maximum Glucose Rise: Breakfast Month 12 | 64.0 mg/dL | Standard Error 3.5 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Maximum Glucose Rise: Lunch Month 1 | 65.6 mg/dL | Standard Error 3.2 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Maximum Glucose Rise: Lunch Month 12 | 53.3 mg/dL | Standard Error 3.8 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Maximum Glucose Rise: Supper Month 1 | 72.3 mg/dL | Standard Error 3.5 |
| Active Control Group (ACG) | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Maximum Glucose Rise: Supper Month 12 | 60.8 mg/dL | Standard Error 4.1 |
Secondary
Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day
SMBG data for all participants was collected by the glucose meter and were uploaded directly to a web server. The mean number of SMBG tests/day was calculated for the entire study period.
Time frame: 12 Months
Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Control Group (ACG) | Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day | 1.15 Tests/day | Standard Error 0.8 |
| Structured Testing Group (STG) | Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day | 0.89 Tests/day | Standard Error 0.7 |
p-value: 0.0003t-test, 2 sided
Secondary
Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations
Treatment intensification was assessed at each clinic visit. The physician evaluated the patient and made recommendations of a change in two areas: changes in diabetic medication and/or changes in lifestyle (such as diet, exercise and education.)
Time frame: 12 Months
Population: Intent to treat population included all enrolled participants who completed the Baseline training visit. Participants who dropped out before Month 1 visit were not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Control Group (ACG) | Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations | 1.1 Visits | Standard Deviation 1 |
| Structured Testing Group (STG) | Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations | 2.7 Visits | Standard Deviation 1.5 |
p-value: <0.0001Fisher Exact