Trial Outcomes & Findings for ACCU-CHEK® Aviva Expert Study: Does Use of a Bolus Advisor Improve Glycemic Control in Patients Not Achieving Optimal Control Using Multiple Daily Injections (MDI)? (NCT NCT01460446)
NCT ID: NCT01460446
Last Updated: 2014-02-06
Results Overview
HbA1C was measured in blood samples at a central laboratory.
COMPLETED
NA
218 participants
Baseline to Week 24
2014-02-06
Participant Flow
Participant milestones
| Measure |
Aviva Expert Blood Glucose Meter
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
113
|
|
Overall Study
COMPLETED
|
100
|
93
|
|
Overall Study
NOT COMPLETED
|
5
|
20
|
Reasons for withdrawal
| Measure |
Aviva Expert Blood Glucose Meter
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Overall Study
Non-compliance
|
2
|
9
|
|
Overall Study
Consent Withdrawn
|
0
|
4
|
|
Overall Study
Non-compliance & Consent Withdrawn
|
1
|
3
|
|
Overall Study
Surgery/Illness
|
1
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Other Reasons Incl. Lost for Follow-Up
|
0
|
3
|
Baseline Characteristics
ACCU-CHEK® Aviva Expert Study: Does Use of a Bolus Advisor Improve Glycemic Control in Patients Not Achieving Optimal Control Using Multiple Daily Injections (MDI)?
Baseline characteristics by cohort
| Measure |
Aviva Expert Blood Glucose Meter
n=105 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=113 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
42.4 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat population: All randomized participants who completed the study.
HbA1C was measured in blood samples at a central laboratory.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=100 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=93 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24
|
-0.66 Percentage
Standard Deviation 0.72
|
-0.47 Percentage
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Screening to Week 24Population: Intent-to-treat population: All randomized participants who completed the study.
Participants measured their blood glucose at least 3-4 times daily throughout the study. The mean blood glucose level was calculated for each 3-day period from Baseline to Week 24 and the percentage of 3-day blood glucose levels with the target range of 70-180 mg/dL (3.9-10 mmol/L) was calculated for the 2 reporting periods of Screening to Baseline and Week 23 to Week 24.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=100 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=93 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24
Screening to Baseline (n=92, 86)
|
50.6 Percentage of measurements
Standard Deviation 14.3
|
50.7 Percentage of measurements
Standard Deviation 15.1
|
|
Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24
Week 23 to Week 24 (n=92, 86)
|
49.3 Percentage of measurements
Standard Deviation 17.2
|
52.2 Percentage of measurements
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: Screening to Week 24Population: Intent-to-treat population: All randomized participants who completed the study.
A symptomatic hypoglycemic episode was defined as an event with symptoms consistent with hypoglycemia which was confirmed by a blood glucose reading \< 70 mg/dL (3.9 mmol/L). Symptoms might include but were not limited to sweating, dizziness, lightheadedness, tremors, nervousness, hunger, headaches, and weakness or tiredness.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=100 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=93 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24
Screening to Baseline (n=100, 93)
|
18.9 Episodes per year
Standard Deviation 50.8
|
23.2 Episodes per year
Standard Deviation 73.8
|
|
Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24
Week 23 to Week 24 (n=93, 91)
|
17.0 Episodes per year
Standard Deviation 43.6
|
15.8 Episodes per year
Standard Deviation 56.7
|
SECONDARY outcome
Timeframe: 3 days prior to Baseline to Week 24Population: Intent-to-treat population: All randomized participants with continuous glucose monitoring data at Baseline and at Week 24 who completed the study.
Approximately half of the investigational sites monitored glucose levels in participants enrolled in this study using the DexCom Seven® Plus Continuous Glucose Monitoring device. The device provides glucose measurements every 5 minutes for up to 7 days. The system contains a sensor, transmitter, and receiver. The sensor is a flexible round wire that goes under the skin to read glucose levels. The transmitter snaps into the sensor and wirelessly sends glucose readings to the receiver. Data was obtained from approximately one-third of participants and was used to calculate MAGE. Data were collected in the 3 days prior to Baseline and the Week 24 visit. The standard deviation of the blood glucose measurements in each 3-day period was calculated. For each glucose measurement, the difference from the previous reading was calculated. Absolute differences smaller than the standard deviation were discarded. MAGE is the mean of the remaining difference scores.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=34 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=35 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24
|
-20.2 mg/dL
Standard Deviation 41.1
|
-2.9 mg/dL
Standard Deviation 32.1
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat population: All randomized participants.
Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=105 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study
|
73.5 Percentage of opportunities
Standard Deviation 21.9
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat population: All randomized participants.
Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=105 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study
|
0.3 Number of advices modified per day
Standard Deviation 0.5
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat population: All randomized participants who completed the study. Results are only reported for participants using the Aviva Nano blood glucose meter who had data available for analysis.
Participants using the Aviva Nano blood glucose meter received individualized advice in how to use their insulin:carbohydrate ratio (I:CHO) and insulin sensitivity factor (ISF) values to determine their insulin dose. The I:CHO ratio advice was considered to have been used correctly if the meal bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant's total carbohydrate intake and the I:CHO ratio. The ISF advice was considered to have been correctly used if the correction bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant's blood glucose target, current blood glucose value, and the ISF.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=88 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Correct and Incorrect Use of Insulin:Carbohydrate Ratio (I:CHO) and Insulin Sensitivity Factor (ISF) Advice by Participants Using the Aviva Nano Blood Glucose Meter During the Study
I:CHO - correct (n=88)
|
1.55 Number of advices per day
Standard Deviation 1.1
|
—
|
|
Correct and Incorrect Use of Insulin:Carbohydrate Ratio (I:CHO) and Insulin Sensitivity Factor (ISF) Advice by Participants Using the Aviva Nano Blood Glucose Meter During the Study
I:CHO - incorrect (n=88)
|
1.77 Number of advices per day
Standard Deviation 0.9
|
—
|
|
Correct and Incorrect Use of Insulin:Carbohydrate Ratio (I:CHO) and Insulin Sensitivity Factor (ISF) Advice by Participants Using the Aviva Nano Blood Glucose Meter During the Study
ISF - correct (n=78)
|
0.81 Number of advices per day
Standard Deviation 0.7
|
—
|
|
Correct and Incorrect Use of Insulin:Carbohydrate Ratio (I:CHO) and Insulin Sensitivity Factor (ISF) Advice by Participants Using the Aviva Nano Blood Glucose Meter During the Study
ISF - incorrect (n=78)
|
2.14 Number of advices per day
Standard Deviation 0.9
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.
Participants were asked to assess the carbohydrate content (grams) of 10 standardized meals by using a set of Dose Adjustment for Normal Eating (DAFNE) plates, which provide standardized photographs of meals with known carbohydrate values. The mean meal error (MME), an indicator of accuracy, and mean meal absolute error (MMAE), an indicator of variability were calculated from their responses. The MME is defined as the mean of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. A negative MME indicates an underestimation and a positive MME indicates an overestimation of the actual carbohydrate content. The MMAE is defined as the mean of the absolute value of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. The MMAE is ≥ 0 with a lower value indicating a better ability to estimate the actual carbohydrate content.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=99 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=92 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Change in Carbohydrate Counting Accuracy From Baseline to Week 24
Mean Meal Error
|
-0.90 Grams
Standard Deviation 10.0
|
0.07 Grams
Standard Deviation 11.2
|
|
Change in Carbohydrate Counting Accuracy From Baseline to Week 24
Mean Meal Absolute Error
|
-2.9 Grams
Standard Deviation 8.2
|
0.9 Grams
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat population: All randomized participants who had data available for analysis.
The Patient Health Questionnaire depression scale (PHQ-8) contains 8 items which can be rated from 0='not at all' to 3='nearly every day'. The total PHQ-8 score is the sum of the responses to the 8 items and ranges from 0 to 24. A lower score indicates less depression. A negative change score indicates improvement.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=95 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=89 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24
|
-0.36 Units on a scale
Standard Deviation 3.21
|
-0.08 Units on a scale
Standard Deviation 3.87
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat population: All randomized participants who completed the study.
The Major Depression Disorder (MDD) scale is derived from the Patient Health Questionnaire depression scale (PHQ-8) and was used to categorize participants in regard to the severity of their depression. There are 5 categories on the MDD scale: None, mild, moderate, moderately severe, and severe. The category for each participant is determined from their PHQ-8 score. A total PHQ-8 score of 0 to 4 represents no significant depressive symptoms. A total PHQ-8 score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. A higher score indicates more depression.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=100 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=93 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Baseline - None (n=100, 93)
|
66 Participants
|
55 Participants
|
|
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Baseline - Mild (n=100, 93)
|
22 Participants
|
26 Participants
|
|
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Baseline - Moderate (n=100, 93)
|
11 Participants
|
9 Participants
|
|
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Baseline - Moderately Severe (n=100, 93)
|
1 Participants
|
2 Participants
|
|
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Baseline - Severe (n=100, 93)
|
0 Participants
|
1 Participants
|
|
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Week 24 - None (n=95, 89)
|
67 Participants
|
54 Participants
|
|
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Week 24 - Mild (n=95, 89)
|
21 Participants
|
23 Participants
|
|
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Week 24 - Moderate (n=95, 89)
|
7 Participants
|
10 Participants
|
|
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Week 24 - Moderately Severe (n=95, 89)
|
0 Participants
|
2 Participants
|
|
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Week 24 - Severe (n=95, 89)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.
The Problem Area in Diabetes (PAID) scale contains 20 items which can be rated from 0='not a problem' to 4='serious problem'. The total PAID scale score ranges from 0 to 80 with a higher score indicating more diabetes-related problems. A negative change score indicates improvement.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=97 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=91 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24
|
-4.4 Units on a scale
Standard Deviation 11.2
|
-4.4 Units on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.
The Hypoglycemia Fear Survey-II (HFS-II) contains 33 items (15 items regarding behavior and 18 items regarding worry) which can be rated from 0='never' to 4='always'). The total HFS-II score ranges from 0 to 132 with a higher score indicating more fear. A negative change score indicates improvement.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=97 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=91 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24
|
-3.7 Units on a scale
Standard Deviation 13.3
|
-5.9 Units on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat population: All randomized participants who completed the study.
The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) contains 6 items which can be scored from 0='very bad' to 6='very good'. The total score is the sum of the scores of the 6 items and ranges from 0 to 36. A higher score indicates more satisfaction. This questionnaire was administered at Baseline only. The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3='much worse now' to 3='much better now'). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only.
Outcome measures
| Measure |
Aviva Expert Blood Glucose Meter
n=100 Participants
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=93 Participants
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score
Baseline (n=99, 93)
|
27.9 Units on a scale
Standard Deviation 6.2
|
28.1 Units on a scale
Standard Deviation 5.7
|
|
The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score
Week 24 (n=98, 92)
|
11.4 Units on a scale
Standard Deviation 6.0
|
8.9 Units on a scale
Standard Deviation 6.3
|
Adverse Events
Aviva Expert Blood Glucose Meter
Aviva Nano Blood Glucose Meter
Serious adverse events
| Measure |
Aviva Expert Blood Glucose Meter
n=105 participants at risk
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=113 participants at risk
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
2.7%
3/113
Intent-to-treat population: All randomized participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/105
Intent-to-treat population: All randomized participants.
|
0.88%
1/113
Intent-to-treat population: All randomized participants.
|
|
Cardiac disorders
Angina pectoris
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
0.00%
0/113
Intent-to-treat population: All randomized participants.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/105
Intent-to-treat population: All randomized participants.
|
0.88%
1/113
Intent-to-treat population: All randomized participants.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
0.00%
0/113
Intent-to-treat population: All randomized participants.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
0.00%
0/113
Intent-to-treat population: All randomized participants.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/105
Intent-to-treat population: All randomized participants.
|
0.88%
1/113
Intent-to-treat population: All randomized participants.
|
|
Infections and infestations
Urinary tract infection viral
|
0.00%
0/105
Intent-to-treat population: All randomized participants.
|
0.88%
1/113
Intent-to-treat population: All randomized participants.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
0.00%
0/113
Intent-to-treat population: All randomized participants.
|
|
Injury, poisoning and procedural complications
Tracheal injury
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
0.00%
0/113
Intent-to-treat population: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/105
Intent-to-treat population: All randomized participants.
|
0.88%
1/113
Intent-to-treat population: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
0.00%
0/113
Intent-to-treat population: All randomized participants.
|
|
Eye disorders
Retinal haemorrhage
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
0.00%
0/113
Intent-to-treat population: All randomized participants.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
0.00%
0/113
Intent-to-treat population: All randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
0/105
Intent-to-treat population: All randomized participants.
|
0.88%
1/113
Intent-to-treat population: All randomized participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/105
Intent-to-treat population: All randomized participants.
|
0.88%
1/113
Intent-to-treat population: All randomized participants.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/105
Intent-to-treat population: All randomized participants.
|
0.88%
1/113
Intent-to-treat population: All randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
0.00%
0/113
Intent-to-treat population: All randomized participants.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.95%
1/105
Intent-to-treat population: All randomized participants.
|
0.00%
0/113
Intent-to-treat population: All randomized participants.
|
Other adverse events
| Measure |
Aviva Expert Blood Glucose Meter
n=105 participants at risk
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
Aviva Nano Blood Glucose Meter
n=113 participants at risk
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
41.9%
44/105
Intent-to-treat population: All randomized participants.
|
30.1%
34/113
Intent-to-treat population: All randomized participants.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
15/105
Intent-to-treat population: All randomized participants.
|
26.5%
30/113
Intent-to-treat population: All randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/105
Intent-to-treat population: All randomized participants.
|
5.3%
6/113
Intent-to-treat population: All randomized participants.
|
Additional Information
Medical Communications
Hoffmann-La Roche
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