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)

Roche

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Device: Aviva Nano blood glucose meter; Device: Aviva Expert blood glucose meter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01460446

RD001333

Details and patient eligibility

About

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).

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Aviva Expert blood glucose meter

Experimental 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.

Treatment:

Device: Aviva Expert blood glucose meter

Aviva Nano blood glucose meter

Active Comparator 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.

Treatment:

Device: Aviva Nano blood glucose meter