Trial information
A Study of Accu-Chek Advisor Insulin Guidance Software for Maintaining Glycemic Control and Preventing Hypoglycemia in Intensively Treated Patients with Type 1 Diabetes
Status: Completed
Protocol number: 2004-08
Sponsor: Roche Diagnostics
Company division: Diagnostic
Brief summary: This study will evaluate the effect of the Accu-Chek Advisor Insulin Guidance Software program for personal data assistants (PDAs), compared with the standard of care, in patients diagnosed with Type 1 diabetes on multiple daily insulin injections.
Study type: Interventional study
Condition: Diabetes Mellitus, Type 1
Intervention type: Diagnostic Test
Intervention name: Accu-Chek Advisor Insulin Guidance Software
Inclusion criteria: • adult patients 18–60 years of age;
• diagnosis of Type 1 diabetes mellitus for >=6 months;
• insulin dose 0.5–2.0 U/kg;
• weight 100–300 pounds;
• dual insulin therapy supported by Accu-Chek Insulin Advisor software
• willing to perform >=3 blood glucose tests/day
• HbA1c > 7.5% and < 11.0%
Exclusion criteria: • insulin pump therapy;
• oral, inhaled, or pre-mixed insulin;
• 30 minutes of cardiovascular (aerobic) exercise 5 days of a 7-day week.
• renal insufficiency
• on a day shift schedule (this is a limitation of the Accu-Chek Advisor software)
• renal insufficiency
• diagnosis of liver disease, hepatitis, hemoglobinopathy
• pregnant or intends to become pregnant
• severe hypoglycemia requiring Emergency Department admission
Gender: Males or Females
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
