An interventional study of Accu-Chek 360° View Blood Glucose Analysis Tool and Accu-Chek Aviva Glucose Meter in Diabetes Mellitus, Type 2, sponsored by Hoffmann-La Roche. Completed at 29 sites in United States. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2013-10-21.
Sponsored by Hoffmann-La Roche · Not applicable, Interventional, and Diagnostic
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.
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This study's enrollment of 522 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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.
Device: Accu-Chek Aviva Glucose Meter
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.
Device: Accu-Chek 360° View Blood Glucose Analysis Tool · Device: Accu-Chek Aviva Glucose Meter
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
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
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
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
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
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
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
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
| Milestone | Active Control Group (ACG) | Structured Testing Group (STG) |
|---|---|---|
| Started | 230 | 269 |
| Intent to treat population | 227 | 256 |
| Completed | 187 | 188 |
| Not completed | 43 | 81 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Subject withdrew consent | 12 | 19 |
| Withdrew: Lost to follow-up | 25 | 53 |
| Withdrew: Other reasons | 4 | 8 |
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.
| Percent | Active Control Group (ACG) | Structured Testing Group (STG) |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 | -0.88 ± 0.10 | -1.16 ± 0.09 |
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.)
| Visits | Active Control Group (ACG) | Structured Testing Group (STG) |
|---|---|---|
| Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations | 1.1 ± 1.0 | 2.7 ± 1.5 |
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.
| Score on a scale | Active Control Group (ACG) | Structured Testing Group (STG) |
|---|---|---|
| Change From Baseline in Depression Severity (PHQ-8) | -1.1 ± 0.3 | -1.7 ± 0.3 |
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.
| Score on a scale | Active Control Group (ACG) | Structured Testing Group (STG) |
|---|---|---|
| Change From Baseline in the Diabetes Distress Scale (DDS) | -0.40 ± 0.07 | -0.55 ± 0.06 |
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.
| Score on a scale | Active Control Group (ACG) | Structured Testing Group (STG) |
|---|---|---|
| Change From Baseline in the World Health Organization (WHO-5) Well-being Index | 4.1 ± 1.5 | 7.4 ± 1.5 |
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.
| Score on a scale | Active Control Group (ACG) | Structured Testing Group (STG) |
|---|---|---|
| Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2) | 2.7 ± 1.1 | 5.8 ± 1.1 |
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.
| Tests/day | Active Control Group (ACG) | Structured Testing Group (STG) |
|---|---|---|
| Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day | 1.15 ± 0.80 | 0.89 ± 0.70 |
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.
| mg/dL | Structured Testing Group (STG) |
|---|---|
| Post-Prandial Glucose Excursion Breakfast Month 1 | 44.0 ± 2.3 |
| Post-Prandial Glucose ExcursionBreakfast Month 12 | 34.7 ± 2.7 |
| Post-Prandial Glucose Excursion Lunch Month 1 | 25.0 ± 2.4 |
| Post- Prandial Glucose Excursion Lunch Month 12 | 17.3 ± 2.8 |
| Post-Prandial Glucose Excursion Supper Month 1 | 33.6 ± 2.8 |
| Post-Prandial Glucose Excursion Supper: Month 12 | 25.8 ± 3.3 |
| Mean Amplitude of Glucose Excursions: Month 1 | 38.5 ± 0.9 |
| Mean Amplitude of Glucose Excursions: Month 12 | 34.3 ± 1.0 |
| Maximum Glucose Rise: Breakfast Month 1 | 80.2 ± 2.9 |
| Maximum Glucose Rise: Breakfast Month 12 | 64.0 ± 3.5 |
| Maximum Glucose Rise: Lunch Month 1 | 65.6 ± 3.2 |
| Maximum Glucose Rise: Lunch Month 12 | 53.3 ± 3.8 |
| Maximum Glucose Rise: Supper Month 1 | 72.3 ± 3.5 |
| Maximum Glucose Rise: Supper Month 12 | 60.8 ± 4.1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Structured Testing Group (STG) | — | 14/256 (5.5%) | 33/256 (12.9%) |
| Active Control Group (ACG) | — | 21/227 (9.3%) | 35/227 (15.4%) |
| Event | Structured Testing Group (STG) | Active Control Group (ACG) |
|---|---|---|
| Atrial fibrillationCardiac disorders | 0/256 | 2/227 |
| Shortness of breathRespiratory, thoracic and mediastinal disorders | 1/256 | 2/227 |
| SVT (Supraventricular tachycardia)Cardiac disorders | 0/256 | 1/227 |
| Atrial fibrillation/bradycardiaCardiac disorders | 0/256 | 1/227 |
| Exacerbation of coronary artery diseaseCardiac disorders | 0/256 | 1/227 |
| Emergency CABG x 5 (Coronary artery bypass graft)Cardiac disorders | 0/256 | 1/227 |
| ColitisGastrointestinal disorders | 0/256 | 1/227 |
| Chest painGeneral disorders | 1/256 | 1/227 |
| Abdominal painGeneral disorders | 0/256 | 1/227 |
| Anterior and epigastric chest painGeneral disorders | 0/256 | 1/227 |
| Event | Structured Testing Group (STG) | Active Control Group (ACG) |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 18/256 | 20/227 |
| SinusitisInfections and infestations | 15/256 | 15/227 |
Intent to treat population included all enrolled participants who completed the baseline training visit.
| Age Continuous(years) | Active Control Group (ACG) | Structured Testing Group (STG) | Total |
|---|---|---|---|
| Mean | 57.0 ± 11.2 | 54.8 ± 10.1 | 55.8 ± 10.7 |
| Sex: Female, Male(Participants) | Active Control Group (ACG) | Structured Testing Group (STG) | Total |
|---|---|---|---|
| Female | 105 | 121 | 226 |
| Male | 122 | 135 | 257 |
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