ABACUS: 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)?

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01460446
• Collaborator: (none)
• Enrollment: 218
• Locations: 33
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This clinical, prospective, randomized, multi-center study determined if the use of an insulin bolus advisor improves glycemic control as measured by a change in HbA1c in patients failing multiple daily injection/intensified conventional therapy (MDI/ICT).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2	Device: Aviva Expert blood glucose meter; Device: Aviva Nano blood glucose meter	N/A

Detailed Description

Eligible participants were randomized to 24 weeks multiple daily injection therapy using either the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor or the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 218 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Prospective, Multi-centre Study With Diabetic Patients Randomized to 24 Weeks Treatment Supported by Either Accu-Chek® Aviva Expert Blood Glucose Meter With an Integrated Bolus Advisor or MDI Standard Therapy With Accu-Chek® Aviva Nano Meter (Without Bolus Advisor)
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Aviva Expert blood glucose meter
Active Comparator: 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.	Device: Aviva Nano blood glucose meter

Outcome Measures

Primary Outcome Measures

1. Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24 [Baseline to Week 24]

   HbA1C was measured in blood samples at a central laboratory.

Secondary Outcome Measures

1. Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24 [Screening to Week 24]

   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.

2. Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24 [Screening to Week 24]

   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.

3. Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24 [3 days prior to Baseline to Week 24]

   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.

4. Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study [Baseline to Week 24]

   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.

5. Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study [Baseline to Week 24]

   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.

6. 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 [Baseline to Week 24]

   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.

7. Change in Carbohydrate Counting Accuracy From Baseline to Week 24 [Baseline to Week 24]

   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.

8. Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24 [Baseline to Week 24]

   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.

9. Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24 [Baseline to Week 24]

   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.

10. Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24 [Baseline to Week 24]

    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.

11. Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24 [Baseline to Week 24]

    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.

12. The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score [Baseline to Week 24]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must be 18 years of age or older.

• Diagnosed with Type 1 or Type 2 diabetes.

• Recent HbA1c > 7.5% (measured within the last 6 weeks at local laboratory).

• On multiple daily injection (MDI) therapy for at least 6 months consisting of 1-2 injections per day of long-acting basal insulin (Lantus® or Detemir®) and at least 2 injections per day of regular or rapid-acting analog insulin for meal coverage.

• Subject adjusts meal insulin doses based on carbohydrate content of meals.

• Subject with Type 2 diabetes may be on stable metformin therapy (therapy unchanged during 3 months prior to study).

• Subject has been in Investigator's practice for at least 3 months but may have been seen by another physician in the practice.

• Subject has completed carbohydrate (CHO) training within the last 2 years.

Exclusion Criteria:

• Subject is on a therapy regimen that conflicts with the study:

• Neutral protamine Hagedorn (NPH) or pre-mixed insulin;

• oral anti-diabetic agents, with the exception of metformin;

• injectable anti-diabetic agents other than long-acting insulin and rapid-acting insulin analogs or regular insulin (eg, fixed dose therapy);

• use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose (bG) results.

• Subject has participated in another interventional trial within 6 weeks prior to study.

• Subject has been diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at Investigator's discretion).

• Subject has used systemic oral or inhaled steroids for more than 7 days within the last 3 months.

• Subject is on chemotherapy or radiation therapy (self-reported).

• Subject is pregnant or lactating or is currently planning a pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Aschaffenburg		Germany	63739
2		Augsburg		Germany	86150
3		Berlin		Germany	01627
4		Berlin		Germany	12351
5		Berlin		Germany	13088
6		Berlin		Germany	13597
7		Duisburg		Germany	47179
8		Essen		Germany	45335
9		Furth im Wald		Germany	93437
10		Köln-Weiden		Germany	50858
11		Leipzig		Germany	04103
12		München		Germany	81479
13		Münster		Germany	48155
14		Rostock		Germany	18057
15		Simmern		Germany	55469
16		Unterhaching		Germany	82008
17		Wurzen		Germany	04808
18		Blackburn		United Kingdom	BB23HH
19		Bournemouth		United Kingdom	BH7 7DW
20		Bradford		United Kingdom	BD96RJ
21		Chester		United Kingdom	CH21UL
22		Cosham		United Kingdom	PO63LY
23		Coventry		United Kingdom	CV22DX
24		Derby		United Kingdom	DE223NE
25		Exeter		United Kingdom	EX25DW
26		Leicester		United Kingdom	LE15WW
27		Lindley, Huddersfield		United Kingdom	HD33EA
28		Middlesborough		United Kingdom	TS4 3BW
29		Northampton		United Kingdom	NN15BD
30		Nottingham		United Kingdom	NG72UH
31		Rotherham		United Kingdom	S602UD
32		Scunthorpe		United Kingdom	DN157BH
33		Sheffield		United Kingdom	S57AU

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Iris Vesper, Roche Diagnostics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01460446
• Other Study ID Numbers: RD001333
• First Posted: Oct 26, 2011
• Last Update Posted: Feb 6, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Study Results

Participant Flow

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	105	113
COMPLETED	100	93
NOT COMPLETED	5	20

Baseline Characteristics

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	105	113	218
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.7 (13.5)	42.0 (14.5)	42.4 (14.0)
Sex: Female, Male (Count of Participants)
Female	44 41.9%	53 46.9%	97 44.5%
Male	61 58.1%	60 53.1%	121 55.5%

Outcome Measures

1. Primary Outcome

Title	Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24
Description	HbA1C was measured in blood samples at a central laboratory.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who completed the study.

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Measure Participants	100	93
Mean (Standard Deviation) [Percentage]	-0.66 (0.72)	-0.47 (0.70)

2. Secondary Outcome

Title	Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24
Description	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.
Time Frame	Screening to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who completed the study.

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Measure Participants	100	93
Screening to Baseline (n=92, 86)	50.6 (14.3)	50.7 (15.1)
Week 23 to Week 24 (n=92, 86)	49.3 (17.2)	52.2 (15.5)

3. Secondary Outcome

Title	Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24
Description	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.
Time Frame	Screening to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who completed the study.

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Measure Participants	100	93
Screening to Baseline (n=100, 93)	18.9 (50.8)	23.2 (73.8)
Week 23 to Week 24 (n=93, 91)	17.0 (43.6)	15.8 (56.7)

4. Secondary Outcome

Title	Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24
Description	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.
Time Frame	3 days prior to Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants with continuous glucose monitoring data at Baseline and at Week 24 who completed the study.

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Measure Participants	34	35
Mean (Standard Deviation) [mg/dL]	-20.2 (41.1)	-2.9 (32.1)

5. Secondary Outcome

Title	Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants.

Arm/Group Title	Aviva Expert Blood Glucose Meter
Arm/Group Description	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.
Measure Participants	105
Mean (Standard Deviation) [Percentage of opportunities]	73.5 (21.9)

6. Secondary Outcome

Title	Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants.

Arm/Group Title	Aviva Expert Blood Glucose Meter
Arm/Group Description	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.
Measure Participants	105
Mean (Standard Deviation) [Number of advices modified per day]	0.3 (0.5)

7. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.
Measure Participants	88
I:CHO - correct (n=88)	1.55 (1.1)
I:CHO - incorrect (n=88)	1.77 (0.9)
ISF - correct (n=78)	0.81 (0.7)
ISF - incorrect (n=78)	2.14 (0.9)

8. Secondary Outcome

Title	Change in Carbohydrate Counting Accuracy From Baseline to Week 24
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Measure Participants	99	92
Mean Meal Error	-0.90 (10.0)	0.07 (11.2)
Mean Meal Absolute Error	-2.9 (8.2)	0.9 (9.4)

9. Secondary Outcome

Title	Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who had data available for analysis.

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Measure Participants	95	89
Mean (Standard Deviation) [Units on a scale]	-0.36 (3.21)	-0.08 (3.87)

10. Secondary Outcome

Title	Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who completed the study.

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Measure Participants	100	93
Baseline - None (n=100, 93)	66 62.9%	55 48.7%
Baseline - Mild (n=100, 93)	22 21%	26 23%
Baseline - Moderate (n=100, 93)	11 10.5%	9 8%
Baseline - Moderately Severe (n=100, 93)	1 1%	2 1.8%
Baseline - Severe (n=100, 93)	0 0%	1 0.9%
Week 24 - None (n=95, 89)	67 63.8%	54 47.8%
Week 24 - Mild (n=95, 89)	21 20%	23 20.4%
Week 24 - Moderate (n=95, 89)	7 6.7%	10 8.8%
Week 24 - Moderately Severe (n=95, 89)	0 0%	2 1.8%
Week 24 - Severe (n=95, 89)	0 0%	0 0%

11. Secondary Outcome

Title	Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Measure Participants	97	91
Mean (Standard Deviation) [Units on a scale]	-4.4 (11.2)	-4.4 (8.6)

12. Secondary Outcome

Title	Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Measure Participants	97	91
Mean (Standard Deviation) [Units on a scale]	-3.7 (13.3)	-5.9 (11.9)

13. Secondary Outcome

Title	The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who completed the study.

Arm/Group Title	Aviva Expert Blood Glucose Meter	Aviva Nano Blood Glucose Meter
Arm/Group Description	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.	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.
Measure Participants	100	93
Baseline (n=99, 93)	27.9 (6.2)	28.1 (5.7)
Week 24 (n=98, 92)	11.4 (6.0)	8.9 (6.3)

Adverse Events

Adverse Event Reporting Description	Intent-to-treat population: All randomized participants.
Arm/Group Title	Aviva Expert Blood Glucose Meter		Aviva Nano Blood Glucose Meter
Arm/Group Description	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.		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.
All Cause Mortality
	Aviva Expert Blood Glucose Meter		Aviva Nano Blood Glucose Meter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Aviva Expert Blood Glucose Meter		Aviva Nano Blood Glucose Meter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/105 (7.6%)		10/113 (8.8%)
Cardiac disorders
Angina pectoris	1/105 (1%)		0/113 (0%)
Coronary artery disease	0/105 (0%)		1/113 (0.9%)
Left ventricular dysfunction	1/105 (1%)		0/113 (0%)
Eye disorders
Retinal haemorrhage	1/105 (1%)		0/113 (0%)
Gastrointestinal disorders
Change of bowel habit	1/105 (1%)		0/113 (0%)
Infections and infestations
Lower respiratory tract infection	1/105 (1%)		0/113 (0%)
Pyelonephritis	0/105 (0%)		1/113 (0.9%)
Urinary tract infection viral	0/105 (0%)		1/113 (0.9%)
Injury, poisoning and procedural complications
Ankle fracture	1/105 (1%)		0/113 (0%)
Tracheal injury	1/105 (1%)		0/113 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	1/105 (1%)		3/113 (2.7%)
Hyperglycaemia	0/105 (0%)		1/113 (0.9%)
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	0/105 (0%)		1/113 (0.9%)
Pain in extremity	1/105 (1%)		0/113 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer	0/105 (0%)		1/113 (0.9%)
Nervous system disorders
Dizziness	0/105 (0%)		1/113 (0.9%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/105 (0%)		1/113 (0.9%)
Skin and subcutaneous tissue disorders
Skin ulcer	1/105 (1%)		0/113 (0%)
Vascular disorders
Peripheral vascular disorder	1/105 (1%)		0/113 (0%)
Other (Not Including Serious) Adverse Events
	Aviva Expert Blood Glucose Meter		Aviva Nano Blood Glucose Meter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	49/105 (46.7%)		56/113 (49.6%)
Gastrointestinal disorders
Diarrhoea	2/105 (1.9%)		6/113 (5.3%)
Infections and infestations
Nasopharyngitis	15/105 (14.3%)		30/113 (26.5%)
Metabolism and nutrition disorders
Hypoglycaemia	44/105 (41.9%)		34/113 (30.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.