Clinical trial NCT01460446: 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)?
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24
timeFrame: Screening to Week 24
measure: Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24
timeFrame: Screening to Week 24
measure: Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24
timeFrame: 3 days prior to Baseline to Week 24
measure: Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study
timeFrame: Baseline to Week 24
measure: Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study
timeFrame: Baseline to Week 24
measure: 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
timeFrame: Baseline to Week 24
measure: Change in Carbohydrate Counting Accuracy From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
timeFrame: Baseline to Week 24
measure: Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
city: Augsburg
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Duisburg
country: Germany
city: Essen
country: Germany
city: Furth im Wald
country: Germany
city: Köln-Weiden
country: Germany
city: Leipzig
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Rostock
country: Germany
city: Simmern
country: Germany
city: Unterhaching
country: Germany
city: Wurzen
country: Germany
city: Blackburn
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: Bradford
country: United Kingdom
city: Chester
country: United Kingdom
city: Cosham
country: United Kingdom
city: Coventry
country: United Kingdom
city: Derby
country: United Kingdom
city: Exeter
country: United Kingdom
city: Leicester
country: United Kingdom
city: Lindley, Huddersfield
country: United Kingdom
city: Middlesborough
country: United Kingdom
city: Northampton
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Rotherham
country: United Kingdom
city: Scunthorpe
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Roche Diagnostics GmbH
name: Iris Vesper
role: STUDY_DIRECTOR
References:
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.