N/A
Completed N=218
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)?
Diabetes Mellitus, Type 1 · Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01460446 ↗
Enrolled (actual)
218
Serious AEs
8.3%
Results posted
Feb 2014
Primary outcomePrimary: Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24 — -0.66; -0.47 Percentage
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24 |
-0.66; -0.47 | — |
| SECONDARY Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24 |
50.6; 50.7; 49.3; 52.2 | — |
| SECONDARY Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24 |
18.9; 23.2; 17.0; 15.8 | — |
| SECONDARY Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24 |
-20.2; -2.9 | — |
| SECONDARY Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study |
73.5 | — |
| SECONDARY Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study |
0.3 | — |
| SECONDARY 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 |
1.55; 1.77; 0.81; 2.14 | — |
| SECONDARY Change in Carbohydrate Counting Accuracy From Baseline to Week 24 |
-0.90; 0.07; -2.9; 0.9 | — |
| SECONDARY Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24 |
-0.36; -0.08 | — |
| SECONDARY Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24 |
66; 55; 22; 26; 11; 9 | — |
| SECONDARY Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24 |
-4.4; -4.4 | — |
| SECONDARY Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24 |
-3.7; -5.9 | — |
| SECONDARY The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score |
27.9; 28.1; 11.4; 8.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01460446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.