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)

Hoffmann-La Roche0 sites218 target enrollmentOctober 2011

ConditionsDiabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 1
Sponsor: Hoffmann-La Roche
Enrollment: 218
Primary Endpoint: Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

September 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24

Time Frame: Baseline to Week 24

HbA1C was measured in blood samples at a central laboratory.

Secondary Outcomes

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)
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(Baseline to Week 24)
Change in Carbohydrate Counting Accuracy From Baseline to Week 24(Baseline to Week 24)
Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24(Baseline to Week 24)
Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24(Baseline to Week 24)
Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24(Baseline to Week 24)
Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24(Baseline to Week 24)
The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score(Baseline to Week 24)