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)?
ABACUS
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)
1 other identifier
interventional
218
2 countries
33
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2011
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
February 6, 2014
CompletedFebruary 6, 2014
January 1, 2014
11 months
September 22, 2011
November 14, 2013
January 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24
HbA1C was measured in blood samples at a central laboratory.
Baseline to Week 24
Secondary Outcomes (12)
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
Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24
Screening to Week 24
Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24
3 days prior to Baseline to Week 24
Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study
Baseline to Week 24
Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study
Baseline to Week 24
- +7 more secondary outcomes
Study Arms (2)
Aviva Expert blood glucose meter
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Aschaffenburg, 63739, Germany
Unknown Facility
Augsburg, 86150, Germany
Unknown Facility
Berlin, 01627, Germany
Unknown Facility
Berlin, 12351, Germany
Unknown Facility
Berlin, 13088, Germany
Unknown Facility
Berlin, 13597, Germany
Unknown Facility
Duisburg, 47179, Germany
Unknown Facility
Essen, 45335, Germany
Unknown Facility
Furth im Wald, 93437, Germany
Unknown Facility
Köln-Weiden, 50858, Germany
Unknown Facility
Leipzig, 04103, Germany
Unknown Facility
München, 81479, Germany
Unknown Facility
Münster, 48155, Germany
Unknown Facility
Rostock, 18057, Germany
Unknown Facility
Simmern, 55469, Germany
Unknown Facility
Unterhaching, 82008, Germany
Unknown Facility
Wurzen, 04808, Germany
Unknown Facility
Blackburn, BB23HH, United Kingdom
Unknown Facility
Bournemouth, BH7 7DW, United Kingdom
Unknown Facility
Bradford, BD96RJ, United Kingdom
Unknown Facility
Chester, CH21UL, United Kingdom
Unknown Facility
Cosham, PO63LY, United Kingdom
Unknown Facility
Coventry, CV22DX, United Kingdom
Unknown Facility
Derby, DE223NE, United Kingdom
Unknown Facility
Exeter, EX25DW, United Kingdom
Unknown Facility
Leicester, LE15WW, United Kingdom
Unknown Facility
Lindley, Huddersfield, HD33EA, United Kingdom
Unknown Facility
Middlesbrough, TS4 3BW, United Kingdom
Unknown Facility
Northampton, NN15BD, United Kingdom
Unknown Facility
Nottingham, NG72UH, United Kingdom
Unknown Facility
Rotherham, S602UD, United Kingdom
Unknown Facility
Scunthorpe, DN157BH, United Kingdom
Unknown Facility
Sheffield, S57AU, United Kingdom
Related Publications (1)
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.
PMID: 23062116DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Iris Vesper
Roche Diagnostics GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2011
First Posted
October 26, 2011
Study Start
October 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
February 6, 2014
Results First Posted
February 6, 2014
Record last verified: 2014-01