Back to resultsACCU-CHEK® Aviva Expert Study: Does Use of a Bolus Advisor Improve Glycemic Control in Patients Not Achieving Optimal Control Using Multiple Daily Injections (MDI)? (ABACUS)
Primary Purpose
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Aviva Expert blood glucose meter
Aviva Nano blood glucose meter
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus, Type 1
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aviva Expert blood glucose meter
Aviva Nano blood glucose meter
Arm 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.
Outcomes
Primary Outcome Measures
Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24
HbA1C was measured in blood samples at a central laboratory.
Secondary Outcome Measures
Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 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.
Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 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.
Change in the Mean Amplitude of Glucose Excursion (MAGE) From 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.
Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study
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.
Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study
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.
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
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.
Change in Carbohydrate Counting Accuracy From 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.
Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From 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.
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and 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.
Change in the Problem Area in Diabetes (PAID) Scale Score From 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.
Change in the Hypoglycemia Fear Survey (HFS-II) Score From 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.
The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01460446
Brief Title
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)?
Acronym
ABACUS
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aviva Expert blood glucose meter
Arm Type
Experimental
Arm 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.
Arm Title
Aviva Nano blood glucose meter
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Aviva Expert blood glucose meter
Intervention Type
Device
Intervention Name(s)
Aviva Nano blood glucose meter
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Vesper
Organizational Affiliation
Roche Diagnostics
Official's Role
Study Director
Facility Information:
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
City
Berlin
ZIP/Postal Code
01627
Country
Germany
City
Berlin
ZIP/Postal Code
12351
Country
Germany
City
Berlin
ZIP/Postal Code
13088
Country
Germany
City
Berlin
ZIP/Postal Code
13597
Country
Germany
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
City
Essen
ZIP/Postal Code
45335
Country
Germany
City
Furth im Wald
ZIP/Postal Code
93437
Country
Germany
City
Köln-Weiden
ZIP/Postal Code
50858
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
München
ZIP/Postal Code
81479
Country
Germany
City
Münster
ZIP/Postal Code
48155
Country
Germany
City
Rostock
ZIP/Postal Code
18057
Country
Germany
City
Simmern
ZIP/Postal Code
55469
Country
Germany
City
Unterhaching
ZIP/Postal Code
82008
Country
Germany
City
Wurzen
ZIP/Postal Code
04808
Country
Germany
City
Blackburn
ZIP/Postal Code
BB23HH
Country
United Kingdom
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
City
Bradford
ZIP/Postal Code
BD96RJ
Country
United Kingdom
City
Chester
ZIP/Postal Code
CH21UL
Country
United Kingdom
City
Cosham
ZIP/Postal Code
PO63LY
Country
United Kingdom
City
Coventry
ZIP/Postal Code
CV22DX
Country
United Kingdom
City
Derby
ZIP/Postal Code
DE223NE
Country
United Kingdom
City
Exeter
ZIP/Postal Code
EX25DW
Country
United Kingdom
City
Leicester
ZIP/Postal Code
LE15WW
Country
United Kingdom
City
Lindley, Huddersfield
ZIP/Postal Code
HD33EA
Country
United Kingdom
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Northampton
ZIP/Postal Code
NN15BD
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG72UH
Country
United Kingdom
City
Rotherham
ZIP/Postal Code
S602UD
Country
United Kingdom
City
Scunthorpe
ZIP/Postal Code
DN157BH
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S57AU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23062116
Citation
Cavan DA, Ziegler R, Cranston I, Barnard K, Ryder J, Vogel C, Parkin CG, Koehler W, Vesper I, Petersen B, Wagner RS. Automated bolus advisor control and usability study (ABACUS): does use of an insulin bolus advisor improve glycaemic control in patients failing multiple daily insulin injection (MDI) therapy? [NCT01460446]. BMC Fam Pract. 2012 Oct 13;13:102. doi: 10.1186/1471-2296-13-102.
Results Reference
derived
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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)?
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