Status:
COMPLETED
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)?
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
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 dai...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01460446
Start Date
October 1 2011
End Date
September 1 2012
Last Update
February 6 2014
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
Aschaffenburg, Germany, 63739
2
Augsburg, Germany, 86150
3
Berlin, Germany, 01627
4
Berlin, Germany, 12351