Trial Outcomes & Findings for A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes (NCT NCT00674986)
NCT ID: NCT00674986
Last Updated: 2013-10-21
Results Overview
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.
COMPLETED
NA
522 participants
Baseline, Month 12
2013-10-21
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
269
|
|
Overall Study
Intent to Treat Population
|
227
|
256
|
|
Overall Study
COMPLETED
|
187
|
188
|
|
Overall Study
NOT COMPLETED
|
43
|
81
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Subject withdrew consent
|
12
|
19
|
|
Overall Study
Lost to Follow-up
|
25
|
53
|
|
Overall Study
Other reasons
|
4
|
8
|
Baseline Characteristics
A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Active Control Group (ACG)
n=227 Participants
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.
|
Structured Testing Group (STG)
n=256 Participants
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.
|
Total
n=483 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.0 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
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.
Outcome measures
| Measure |
Active Control Group (ACG)
n=227 Participants
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.
|
Structured Testing Group (STG)
n=256 Participants
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.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12
|
-0.88 Percent
Standard Error 0.10
|
-1.16 Percent
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 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.
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.)
Outcome measures
| Measure |
Active Control Group (ACG)
n=218 Participants
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.
|
Structured Testing Group (STG)
n=237 Participants
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.
|
|---|---|---|
|
Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations
|
1.1 Visits
Standard Deviation 1.0
|
2.7 Visits
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
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.
Outcome measures
| Measure |
Active Control Group (ACG)
n=227 Participants
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.
|
Structured Testing Group (STG)
n=256 Participants
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.
|
|---|---|---|
|
Change From Baseline in Depression Severity (PHQ-8)
|
-1.1 Score on a scale
Standard Error 0.3
|
-1.7 Score on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
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.
Outcome measures
| Measure |
Active Control Group (ACG)
n=227 Participants
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.
|
Structured Testing Group (STG)
n=256 Participants
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.
|
|---|---|---|
|
Change From Baseline in the Diabetes Distress Scale (DDS)
|
-0.40 Score on a scale
Standard Error 0.07
|
-0.55 Score on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
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.
Outcome measures
| Measure |
Active Control Group (ACG)
n=227 Participants
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.
|
Structured Testing Group (STG)
n=256 Participants
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.
|
|---|---|---|
|
Change From Baseline in the World Health Organization (WHO-5) Well-being Index
|
4.1 Score on a scale
Standard Error 1.5
|
7.4 Score on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: 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.
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.
Outcome measures
| Measure |
Active Control Group (ACG)
n=161 Participants
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.
|
Structured Testing Group (STG)
n=130 Participants
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.
|
|---|---|---|
|
Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2)
|
2.7 Score on a scale
Standard Error 1.1
|
5.8 Score on a scale
Standard Error 1.1
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intent to treat population included all enrolled participants who completed the baseline training visit.
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.
Outcome measures
| Measure |
Active Control Group (ACG)
n=227 Participants
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.
|
Structured Testing Group (STG)
n=256 Participants
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.
|
|---|---|---|
|
Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day
|
1.15 Tests/day
Standard Error 0.80
|
0.89 Tests/day
Standard Error 0.70
|
SECONDARY outcome
Timeframe: Month 1, Month 12Population: Intent to treat population included all enrolled participants who completed the baseline training visit.
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.
Outcome measures
| Measure |
Active Control Group (ACG)
n=256 Participants
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.
|
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.
|
|---|---|---|
|
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
|
—
|
|
Glycemic Variability Pre and Post-Prandial Excursions at Each Meal
Post-Prandial Glucose ExcursionBreakfast Month 12
|
34.7 mg/dL
Standard Error 2.7
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
Glycemic Variability Pre and Post-Prandial Excursions at Each Meal
Mean Amplitude of Glucose Excursions: Month 12
|
34.3 mg/dL
Standard Error 1.0
|
—
|
|
Glycemic Variability Pre and Post-Prandial Excursions at Each Meal
Maximum Glucose Rise: Breakfast Month 1
|
80.2 mg/dL
Standard Error 2.9
|
—
|
|
Glycemic Variability Pre and Post-Prandial Excursions at Each Meal
Maximum Glucose Rise: Breakfast Month 12
|
64.0 mg/dL
Standard Error 3.5
|
—
|
|
Glycemic Variability Pre and Post-Prandial Excursions at Each Meal
Maximum Glucose Rise: Lunch Month 1
|
65.6 mg/dL
Standard Error 3.2
|
—
|
|
Glycemic Variability Pre and Post-Prandial Excursions at Each Meal
Maximum Glucose Rise: Lunch Month 12
|
53.3 mg/dL
Standard Error 3.8
|
—
|
|
Glycemic Variability Pre and Post-Prandial Excursions at Each Meal
Maximum Glucose Rise: Supper Month 1
|
72.3 mg/dL
Standard Error 3.5
|
—
|
|
Glycemic Variability Pre and Post-Prandial Excursions at Each Meal
Maximum Glucose Rise: Supper Month 12
|
60.8 mg/dL
Standard Error 4.1
|
—
|
Adverse Events
Structured Testing Group (STG)
Active Control Group (ACG)
Serious adverse events
| Measure |
Structured Testing Group (STG)
n=256 participants at risk
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.
|
Active Control Group (ACG)
n=227 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/256
|
0.88%
2/227
|
|
Cardiac disorders
SVT (Supraventricular tachycardia)
|
0.00%
0/256
|
0.44%
1/227
|
|
Cardiac disorders
Atrial fibrillation/bradycardia
|
0.00%
0/256
|
0.44%
1/227
|
|
Cardiac disorders
Exacerbation of coronary artery disease
|
0.00%
0/256
|
0.44%
1/227
|
|
Cardiac disorders
Emergency CABG x 5 (Coronary artery bypass graft)
|
0.00%
0/256
|
0.44%
1/227
|
|
Cardiac disorders
Artherosclerotic coronary disease
|
0.39%
1/256
|
0.00%
0/227
|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
1/256
|
0.00%
0/227
|
|
Cardiac disorders
Blockage in left descending coronary artery
|
0.39%
1/256
|
0.00%
0/227
|
|
Injury, poisoning and procedural complications
MVA - high speed (Motor vehicle accident)
|
0.39%
1/256
|
0.00%
0/227
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/256
|
0.44%
1/227
|
|
General disorders
Chest pain
|
0.39%
1/256
|
0.44%
1/227
|
|
General disorders
Abdominal pain
|
0.00%
0/256
|
0.44%
1/227
|
|
General disorders
Mid sternal chest pain, acute onset
|
0.39%
1/256
|
0.00%
0/227
|
|
General disorders
Chest pain associated with pulled muscle
|
0.39%
1/256
|
0.00%
0/227
|
|
General disorders
Non-cardiac chest pain
|
0.39%
1/256
|
0.00%
0/227
|
|
General disorders
Anterior and epigastric chest pain
|
0.00%
0/256
|
0.44%
1/227
|
|
Hepatobiliary disorders
Acute cholecystitus
|
0.00%
0/256
|
0.44%
1/227
|
|
Hepatobiliary disorders
Biliary pancreatitis
|
0.00%
0/256
|
0.44%
1/227
|
|
Infections and infestations
Acute bronchitis
|
0.00%
0/256
|
0.44%
1/227
|
|
Infections and infestations
Pneumonia/bronchitis
|
0.00%
0/256
|
0.44%
1/227
|
|
Infections and infestations
Influenza a
|
0.00%
0/256
|
0.44%
1/227
|
|
Metabolism and nutrition disorders
Arm and leg swelling
|
0.39%
1/256
|
0.00%
0/227
|
|
Metabolism and nutrition disorders
Dehydration
|
0.39%
1/256
|
0.00%
0/227
|
|
Musculoskeletal and connective tissue disorders
Intractable pain status post lumbar fusion
|
0.00%
0/256
|
0.44%
1/227
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent colon cancer
|
0.00%
0/256
|
0.44%
1/227
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left breast mastectomy
|
0.00%
0/256
|
0.44%
1/227
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/256
|
0.44%
1/227
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign tumor on thyroid gland
|
0.00%
0/256
|
0.44%
1/227
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.00%
0/256
|
0.44%
1/227
|
|
Nervous system disorders
Vertigo/labyrinthitis/ataxia
|
0.00%
0/256
|
0.44%
1/227
|
|
Nervous system disorders
Brain stem CVA (Cerebrovascular accident)
|
0.00%
0/256
|
0.44%
1/227
|
|
Psychiatric disorders
Major depressive symptoms - emptiness, nervousness
|
0.39%
1/256
|
0.00%
0/227
|
|
Psychiatric disorders
Major depressive disorder, recurrent, severe and adjustment disorder
|
0.39%
1/256
|
0.00%
0/227
|
|
Injury, poisoning and procedural complications
Complex fluid collection posterior to the operative site
|
0.00%
0/256
|
0.44%
1/227
|
|
Renal and urinary disorders
Renal failure
|
0.39%
1/256
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.39%
1/256
|
0.88%
2/227
|
|
Respiratory, thoracic and mediastinal disorders
Congestive heart failure
|
0.00%
0/256
|
0.44%
1/227
|
|
Respiratory, thoracic and mediastinal disorders
Worsening chronic obstructive pulmonary disease
|
0.00%
0/256
|
0.44%
1/227
|
|
Skin and subcutaneous tissue disorders
Cellulitis of leg, left lower extremity
|
0.39%
1/256
|
0.00%
0/227
|
|
Skin and subcutaneous tissue disorders
Blister on right foot big toe
|
0.39%
1/256
|
0.00%
0/227
|
|
Surgical and medical procedures
Feeding tube placed problems eating
|
0.00%
0/256
|
0.44%
1/227
|
|
Surgical and medical procedures
Lower lumbar surgery
|
0.00%
0/256
|
0.44%
1/227
|
|
Surgical and medical procedures
Lower lumber decompression & laminectomy at L3-4, lumbar decompression, laminectomy, fusion at L4-5
|
0.00%
0/256
|
0.44%
1/227
|
|
Nervous system disorders
Possible RIND (Reversible ischemic neurologic deficit)
|
0.39%
1/256
|
0.00%
0/227
|
Other adverse events
| Measure |
Structured Testing Group (STG)
n=256 participants at risk
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.
|
Active Control Group (ACG)
n=227 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
18/256
|
8.8%
20/227
|
|
Infections and infestations
Sinusitis
|
5.9%
15/256
|
6.6%
15/227
|
Additional Information
Medical Communications
Hoffman-LaRoche
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER