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 ID: NCT01460446

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-09-30

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Aviva Expert blood glucose meter

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Aviva Nano blood glucose meter

Intervention Type: DEVICE

Interventions

Aviva Expert blood glucose meter

Intervention Type: DEVICE

Aviva Nano blood glucose meter

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iris Vesper

Role: STUDY_DIRECTOR

Roche Diagnostics GmbH

Locations

Aschaffenburg, , Germany

Augsburg, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Duisburg, , Germany

Essen, , Germany

Furth im Wald, , Germany

Köln-Weiden, , Germany

Leipzig, , Germany

München, , Germany

Münster, , Germany

Rostock, , Germany

Simmern, , Germany

Unterhaching, , Germany

Wurzen, , Germany

Blackburn, , United Kingdom

Bournemouth, , United Kingdom

Bradford, , United Kingdom

Chester, , United Kingdom

Cosham, , United Kingdom

Coventry, , United Kingdom

Derby, , United Kingdom

Exeter, , United Kingdom

Leicester, , United Kingdom

Lindley, Huddersfield, , United Kingdom

Middlesbrough, , United Kingdom

Northampton, , United Kingdom

Nottingham, , United Kingdom

Rotherham, , United Kingdom

Scunthorpe, , United Kingdom

Sheffield, , United Kingdom

Countries

Germany; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 23062116 (View on PubMed)

Other Identifiers

RD001333

Identifier Type: -

Identifier Source: org_study_id